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VAERS ID: 1000272

AGE: UNK| SEX: F|State: FR

Description

This is a spontaneous report from a contactable pharmacist and other healthcare professional received through a Regional Market Access Manager Pfizer Colleague. A 34-year-old female patient received first dose of BNT162B2 (COMIRNATY, Batch # PAA 156571, LOT # EJ6796, Exp: 30Apr2021) intramuscular 0.3ml at single dose at deltoid on 30Dec2020 13:15 for COVID-19 vaccination. The patient's medical history included tonsillitis from 18Dec2020 to 22Dec2020 treated with ibuprofen and azithromycin. Patient weight: 90kg in 2015 during pregnancy. History of any previous allergies to specific products or any conditions indicative of an allergy: the patient have a history of urticaria, pruritus as conditions indicative of an allergy. In Oct2015, there was a record of urticaria on the trunk and foot. On 09Aug2019 (during pregnancy of 38 + 2 weeks), erythematous maculopapular rash on abdomen and legs lasting 7 days and that disappeared under illegible. On 16Aug2019, continued with itching in abdomen and rash, stopped in Aug2019. Both episodes not related to medications, foods or allergens described in the medical history. No allergies identified in family medical history. Last emergency visit was on 22Aug2019: preterm premature rupture of membranes, initiation of labor in the first 24 hours after rupture, third trimester. Last hospitalization on 25Aug2019: delivery with premature rupture of membranes. The concomitant medications included: ibuprofen at 600mg/8h for 5days from 18Dec2020 to 22Dec2020 for tonsillitis and azithromycin at 500mg/24h for 3 days; start 18Dec2020 stop: 20Dec2020 for tonsillitis. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient experienced anaphylactic adverse reaction 30 minutes after vaccination on 30Dec2020 13:45. The signs and symptoms of the anaphylactic reaction were dizziness, hypotension, tingling in limbs. Later, she began to feel dyspneic, with uvular edema, and facial flushing. Ebastel vo + Urbason 80 mg IM + Diazepan 10 mg IM have been administered. After swelling/edema of the tongue, facial blush a few minutes later, adrenaline 0.4 mg IM + Actocortin 200 mg ev was administered during transfer to hospital. The patient seen in the Emergency Department: new episode of dyspnea at 14:28 and adrenaline 0.5 mg sc was administered. After a new episode of dyspnea at 14:51, a new dose of Adrenaline 0.5 mg sc. Upon arrival at the emergency room, she was clinically and hemodynamically stable. Slight tongue edema and mild increasing dyspnea, for which medication (polaramine, actcortin, ranitidine) was administered. She reported slight paresthesias in lower limbs. She has been hospitalized on 30Dc2020 at 14:54 for 1 day. The patient required hospital admission. She was not admitted to lntensive Care Unit. Laboratory tests or diagnostic studies performed: Physical exploration: vital signs:, Saturation: O2 = 98%, Sat Type. O2 = No Oxygen, Total Glasgow = 13, Verbal Glasgow = 4, Engine Glasgow = 5, Glasgow eyes = 4. BP 149/104. Good general condition, No skin lesions. No facial blush. Conscious and oriented. ENT: mild uvular edema (less than at the beginning), no tongue edema. Heart action: rhythmic, no murmurs. AP: Vesicular murmur preserved without added noise. Not wheezing. Abdomen: soft and depressible, not tender to palpation, no signs of peritoneal irritation; no masses or visceromegaly; lower Limbs: No edema. Hemogram: Leukocytes 25.0 x10 "3/uL* (4.0-13.5). Neutrophils (%) 82.4%, Lymphocytes (%) 15.4%, Monocytes (%) 1.6%, Eosinophils (%) 0.2%, Basophils (%) 0.4%, Neutrophils (Abs) 20.6 x10 "3/ul * (1.5-7.0), Lymphocytes (Abs) 3.9 x10 "3/ul * (1.2-3.5), Monocytes (Abs) 0.4 x10 "3/ul (0.0-0.8), Eosinophils (Abs) 0, 1 x10 "3/ul (or-0.5), Basophils (Abs) 0,1 x10 "3/ul (or-0.3), Red blood cells 5.0 x10 "6 / ul (3.7-5.2), Hemoglobin 13.2 g/dl (12.0-16.0), Hematocrit 40.8% (36.0-46.0), Mean corpuscular volume (MCV) 81.3 fl (79.0-99.0), Mean corpuscular hemoglobin (HCM) 26.4 pg (26.0-34.0) , Mean corpuscular hemoglobin concentration (MCHC) 32.4 g/dl (31.0-37.0), Red blood cell width distribution 13.6% (11, 5-14.5), Platelets 355.0 x10 "3/ul (150.0-450.0), Mean platelet volume (MPV) 8.9 fl (7.4-11.0), Plaquetocrit 0.32, Platelet distribution width 16.5, Coagulation Prothrombin Time (PT) 13 seconds Quick 100% index (70-100), Partial Thromboplastin Time (APTT) 26.3 seconds * (28, 0 -40, 0), Thromboplastin Time Ratio 0.94 (0.80-1.22), Fibrinogen 347 mg/dl (200-400), INR 1.0, Biochemistry Glucose (serum, plasma) 245 mg / dL * (75-110) (Fasting only), Urea (serum, plasma) 39 mg/dL (20-50), Creatinine (serum, plasma) 1.00 mg/dL * (0.5-0.9), Sodium (serum, plasma) 139 mmol/L (135-145). Potassium (serum, plasma) 2.9 mmol/L* (3.6-5.2), ECG: sinus rhythm at 90x, no conduction disturbances or signs of acute ischemia, good evolution persists. Craft tension: 149/109 at 15:14; 129/63 at 16:00; 128/89 at 19:00. Axillary temperature 37.4 at 15:14. Heart rate: 100x at 15:14; 96x at 16:00; 88x at 19:00. The patient remained asymptomatic without dyspnea or odynophagia. She tolerates liquids well. BP: 115/70 mm Hg, heart rate: 90x', SpO2: 98%. Faced with a good clinical situation, discharge at home is decided. Clinical evolution: At 15:22: Administration of ACTOCORTINA 500 mg vial (200), RANITIDINE 50mg/10ml prediluted (2 amp), POLARAMINE 2 mg tab. At 16:29: Stable situation, no dyspnea or dysphagia, no discomfort at the uvula level. BP: 125/75 mm Hg, Sat O2: 99%, good general condition, NH, NC. No skin lesions. ENT: mild uvular erythema without edema. PA: vesicular murmur without added noise, not wheezing. At 18:31: Stable situation, asymptomatic, she only refers to a slight headache. BP: 125/80 mm Hg, SatO2: 98%, Heart rate: 75x'. She was perfused with PERFALGAN 1 g (10 mg / ml) vial (ev). At 19: 18: Administration of URBASON 40 mg vial (ev), pantoprazole (ANAGASTRA) IV 40mg vial (ev). At 20:45: Good evolution persists. The patient remains asymptomatic without dyspnea or odynophagia. She tolerated liquids well. BP: 115/70 mm Hg, Heart: 90x', SatO2: 98%. Faced with a good clinical situation, she decides to discharge at home. Treatments and Recommendations to follow: home observation 24-48 hours. Prednisone 30 mg 1 tablet a day for 2 days. Polaramine 1 tablet every 12 hours for 2 days. Omeprazole 20 mg per day. If symptoms reappear, go again for evaluation. Hospitalization lasted 1 day and the patient was discharged. As of 21Jan2021, it was reported that the patient had an event of churning of stomach, vomited, diarrhea, muscular weakness and anxiety on 30Dec2020, and experienced fatigue on 31Dec2020. The outcome of the event anaphylactic adverse reaction was recovered on 30Dec2020, while the events fatigue, nausea, vomiting, diarrhea, anxiety and muscular weakness recovered on 08Jan2021. The reporter considered there was a reasonable possibility that the event was related to the suspected vaccine. Information on the batch number has been requested. Follow-up (31Dec2020): New information reported from the same contactable pharmacist included: Patient demographic details (Race, Ethnic Group); medical, past drug/vaccine history; suspect information (vaccination time, route of administration, Batch and Lot number, Exp. Date); concomitant drugs; event details; treatment; lab data; course of events. Follow-up (19Jan2021): Follow-up attempts are completed. No further information is expected. Follow-up (21Jan2021): New information received from the contactable other healthcare professional downloaded from the European Medicines Agency (EMA) EudraVigilance ES-AEMPS-710995 includes: reporter details (other HCP was added), suspect drug details (complete expiration date 30Apr2021), new events (churning of stomach, vomited, diarrhea, muscular weakness and anxiety added). No follow-up attempts possible. No further information expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic adverse reaction and other reported adverse events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

Symptoms

Activated partial thromboplastin time, Blood creatinine, Blood thromboplastin, Ear, nose and throat examination, Haemoglobin, Mean cell haemoglobin, Muscular weakness, Platelet count, Vomiting, Anaphylactic reaction, Blood fibrinogen, Blood urea, Electrocardiogram, Heart rate, Mean cell haemoglobin concentration, Nausea, Platelet distribution width, White blood cell count, Anxiety, Blood glucose, Body temperature increased, Eosinophil count, International normalised ratio, Mean cell volume, Neutrophil count, Prothrombin time, Auscultation, Blood pressure measurement, Coma scale, Fatigue, Investigation, Mean platelet volume, Oxygen saturation, Red blood cell analysis, Basophil count, Blood sodium, Diarrhoea, Haematocrit, Lymphocyte count, Monocyte count, Physical examination, Red blood cell count

Vaccines

VAX DATE: 29 December 2020 | ONSET DATE: 29 December 2020 | DAYS TO ONSET: 0
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 1
  • OT
  • EJ6796

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
Y
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
Y
LAB_DATA:
Test Date: 20201230; Test Name: Partial Thromboplastin Time; Test Result: 26.3 s; Comments: APTT; Test Date: 20201230; Test Name: Heart action; Result Unstructured Data: Test Result:rhythmic, no murmurs; Comments: Heart action. AP: Vesicular murmur preserved without added noise. Not wheezing.; Test Date: 20201230; Test Name: Basophils; Result Unstructured Data: Test Result:0, 1 x10 "3 / ul; Comments: (Abs) (or - 0.3); Test Date: 20201230; Test Name: Basophils; Test Result: 0.4 %; Test Date: 20201230; Test Name: Creatinine; Test Result: 1.00 mg/dl; Comments: (serum, plasma); Test Date: 20201230; Test Name: Fibrinogen; Test Result: 347 mg/dl; Test Date: 20201230; Test Name: Biochemistry Glucose; Test Result: 245 mg/dl; Comments: Biochemistry Glucose (serum, plasma) (Fasting only); Test Date: 20201230; Test Name: BP; Result Unstructured Data: Test Result:149/104; Test Date: 20201230; Test Name: BP; Result Unstructured Data: Test Result:115/70 mm Hg; Test Date: 20201230; Test Name: BP; Result Unstructured Data: Test Result:125/75 mm Hg; Comments: At 16:29; Test Date: 20201230; Test Name: BP; Result Unstructured Data: Test Result:125/80 mm Hg; Comments: At 18:31; Test Date: 20201230; Test Name: BP; Result Unstructured Data: Test Result:115/70 mm Hg; Comments: At 20:45; Test Date: 20201230; Test Name: Sodium; Result Unstructured Data: Test Result:139 mmol/L; Comments: (serum, plasma); Test Date: 20201230; Test Name: Thromboplastin Time Ratio; Result Unstructured Data: Test Result:0.94; Comments: Thromboplastin Time Ratio; Test Date: 20201230; Test Name: Urea; Test Result: 39 mg/dl; Comments: Urea (serum, plasma; Test Date: 20201230; Test Name: Axillary temperature; Result Unstructured Data: Test Result:37.4; Comments: Axillary temperature at 15:14; Test Date: 20201230; Test Name: Glasgow; Result Unstructured Data: Test Result:13; Comments: Total Glasgow; Test Date: 20201230; Test Name: Glasgow; Result Unstructured Data: Test Result:4; Comments: Verbal Glasgow; Test Date: 20201230; Test Name: Glasgow; Result Unstructured Data: Test Result:5; Comments: Engine Glasgow; Test Date: 20201230; Test Name: ENT; Result Unstructured Data: Test Result:mild uvular edema (less than at the beginning), no; Comments: mild uvular edema (less than at the beginning), no tongue edema; Test Date: 20201230; Test Name: ENT; Result Unstructured Data: Test Result:mild uvular erythema without edema; Comments: At 16:29; Test Date: 20201230; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm at 90 x; Comments: sinus rhythm at 90 x. No conduction disturbances or signs of acute ischemia, good evolution persists.; Test Date: 20201230; Test Name: Eosinophils; Result Unstructured Data: Test Result:0, 1 x10 "3 / ul; Comments: (Abs)(or - 0.5); Test Date: 20201230; Test Name: Eosinophils; Test Result: 0.2 %; Test Date: 20201230; Test Name: Hematocrit; Test Result: 40.8 %; Test Date: 20201230; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.2 g/dl; Test Date: 20201230; Test Name: Heart rate; Result Unstructured Data: Test Result:90x'; Test Date: 20201230; Test Name: Heart rate; Result Unstructured Data: Test Result:75x'; Test Date: 20201230; Test Name: Heart rate; Result Unstructured Data: Test Result:90x'; Test Date: 20201230; Test Name: Heart rate; Result Unstructured Data: Test Result:100x; Comments: at 15:14; Test Date: 20201230; Test Name: Heart rate; Result Unstructured Data: Test Result:96x; Comments: at 16:00; Test Date: 20201230; Test Name: Heart rate; Result Unstructured Data: Test Result:88x; Comments: at 19:00; Test Date: 20201230; Test Name: INR; Result Unstructured Data: Test Result:1; Test Date: 20201230; Test Name: Craft tension; Result Unstructured Data: Test Result:149/109; Comments: Craft tension at 15:14; Test Date: 20201230; Test Name: Craft tension; Result Unstructured Data: Test Result:129/63; Comments: Craft tension at 16:00; Test Date: 20201230; Test Name: Craft tension; Result Unstructured Data: Test Result:128/89; Comments: Craft tension at 19:00; Test Date: 20201230; Test Name: Plaquetocrit; Result Unstructured Data: Test Result:0.32; Comments: Plaquetocrit; Test Date: 20201230; Test Name: Lymphocytes; Test Result: 15.4 %; Test Date: 20201230; Test Name: Mean corpuscular hemoglobin; Result Unstructured Data: Test Result:26.4 pg; Comments: HCM; Test Date: 20201230; Test Name: Mean corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:32.4 g/dl; Comments: MCHC; Test Date: 20201230; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:81.3 fl; Test Date: 20201230; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:8.9 fl; Comments: MPV 8.9 fl; Test Date: 20201230; Test Name: Monocytes; Result Unstructured Data: Test Result:0.4 x10 "3 / ul; Comments: (Abs) (0.0 - 0.8); Test Date: 20201230; Test Name: Monocytes; Test Result: 1.6 %; Test Date: 20201230; Test Name: Neutrophils; Result Unstructured Data: Test Result:20.6 x10 "3 / ul; Comments: Abs; Test Date: 20201230; Test Name: Neutrophils; Test Result: 82.4 %; Test Date: 20201230; Test Name: oxygen saturation; Test Result: 98 %; Comments: No Oxygen; Test Date: 20201230; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20201230; Test Name: oxygen saturation; Test Result: 99 %; Comments: At 16:29; Test Date: 20201230; Test Name: oxygen saturation; Test Result: 98 %; Comments: At 18:31; Test Date: 20201230; Test Name: oxygen saturation; Test Result: 98 %; Comments: At 20:45; Test Date: 20201230; Test Name: Abdomen; Result Unstructured Data: Test Result:Abdomen: soft and depressible, not tender to palpa; Comments: Abdomen: soft and depressible, not tender to palpation, no signs of peritoneal irritation; No masses or visceromegaly; lower Limbs: No edema.; Test Date: 20201230; Test Name: Platelets; Result Unstructured Data: Test Result:355.0 x10 "3 / ul; Comments: 355.0 x10 "3 / ul; Test Date: 20201230; Test Name: Platelet distribution width; Result Unstructured Data: Test Result:16.5; Test Date: 20201230; Test Name: Coagulation Prothrombin Time; Result Unstructured Data: Test Result:13 seconds Quick 100% index; Comments: Coagulation Prothrombin Time (PT) 13 seconds Quick 100% index; Test Date: 20201230; Test Name: Red blood cell width distribution; Test Result: 13.6 %; Comments: Red blood cell width distribution; Test Date: 20201230; Test Name: Red blood cells; Result Unstructured Data: Test Result:5.0 x10 "6 / ul; Comments: (3.7 - 5.2); Test Date: 20201230; Test Name: Leukocytes; Result Unstructured Data: Test Result:25.0 x10 "3 / uL; Comments: (4.0 - 13.5); Test Date: 20201230; Test Name: Leukocytes; Result Unstructured Data: Test Result:(Abs) 3.9 x10 "3 / ul (1.2 - 3.5); Comments: (Abs) (1.2 - 3.5)
V_ADMINBY:
OTH
OTHER_MEDS:
IBUPROFEN; AZITHROMYCIN
CUR_ILL:
HISTORY:
Medical History/Concurrent Conditions: Localised itching; Localised maculopapular rash (during pregnancy of 38+2 weeks, erythematous maculopapular rash on abdomen and legs lasting 7 days); Premature rupture of membranes, antepartum; Preterm premature rupture of membranes; Pruritus (as conditions indicative of an allergy); Rash; Tonsillitis; Urticaria localised (not related to medications, foods or allergens); Weight (90kg in 2015 during pregnancy)
PRIOR_VAX:
SPLTTYPE:
ESPFIZER INC2020520830
FORM_VERS:
2
TODAYS_DATE:
02 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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