Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
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
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