VAERS ID: 1761178

Description

Visual changes/Not seeing well; Hypertension; Important neurological changes; Visual blurring/visual changes; pneumonia; bronchospasm; Abdominal pain; Headache; Chest pain; Diarrhea; Discomfort/Feeling uncomfortable; Somnolence/Sleepy; Convulsions/convulsed; Confused; Dilated ventricle; Encephalitis; encephalopathy; atypical primary immune thrombocytopenia; Abdominal discomfort; lowering of consciousness; primary DH was pericarditis; Electroencephalogram abnormal; Drunk-like; This is a spontaneous report from a contactable pharmacist received through agency portal and from Medical Information Team. A 12-year-old male patient received BNT162b2 (COMIRNATY), intramuscular, administered in right arm on 14Sep2021 at 15:00 (Batch/Lot Number: FF8844) as dose 1, single for COVID-19 immunisation. Vaccination facility type was Public Health Clinic facility. The patient's medical history and concomitant medications were not reported. The patient is not allergic to any medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not taking any other medications/products within 2 weeks of vaccination (including prescribed medicines, store bought medicines, dietary supplements and herbal remedies). Patient was previously healthy, without use of medications of chronical or acute use. On 14Sep2021, the same day of the administration of the vaccine, he started with headache and chest pain. With a diagnostic hypothesis (DH) of pneumonia and bronchospasm, did an X-ray and was introduced amoxicillin. Due to the discomfort and somnolence, he was taken to the health center that directed him to the emergency room of another hospital. Due to neurological changes and visual blurring, he was sent to another hospital where hypertension was verified and initiated with convulsions during examinations. He was medicated and remained confused. For safety measures, he was intubated and received Nipride that was replaced for Milrinone continuous infusion pump intravenous due to dilated ventricle. Currently the DH is encephalitis and opened to a clinical picture of atypical primary immune thrombocytopenia (ITP) due to the abdominal discomfort and nuclear magnetic resonance. The infectious tests of cerebrospinal fluid, toxicological and other markers were normal. Course of events was as follows: Patient of 12 years and 6 months old, male, took the 1st COVID-19 vaccine dose on 14Sep2021. On the same night of the vaccination, he started to experience headache and chest pain. The family did nothing because they thought it was normal. On the next day to the vaccination, started a clinical picture of abdominal pain and a more intense headache. The mother waited and on 16Sep2021, she took him to the health center, same place he had received the vaccine, where they did a diagnostic hypothesis (DH) of pneumonia. Started treatment with amoxicillin, but the patient was still very uncomfortable and with diarrhea. He remained sleepy and uncomfortable and on 17Sep2021 went back to the health center. On this day, the health center conducted him to an emergency room (ER) and there he became even more sleepy, and they observed important neurological changes and visual changes. He stayed 24 hours in this ER and asked for a place in the ICU of another hospital. He arrived on the hospital on 18Sep2021 and was diagnosed with hypertension, 17x9, but the pharmacist informed she does not have the exact record of this pressure, and informed that during the ER service the patient convulsed. They started Midazolam followed by anticonvulsant intravenous. The patient stabilized but was still presenting lowering of consciousness. The hypertension also remained. The patient was uncooperative and was intubated and an echocardiogram was performed. On examination, cardiac function was good, but the ventricle was dilated. At this moment, the primary DH was pericarditis, and the pharmacist (reporter) informed that the information on cases of pericarditis and myocarditis were very clear in the leaflet and literature. They changed the medication to "milrinone", due to the dilated ventricle. As the patient was a little more stable, he was extubated, and the liquor exams came out negative, hepatic markers were normal, his urine was sent to discard drug use, etc. The patient did an echocardiogram again that came out normal. The only thing that was abnormal was the electroencephalogram, also the patient is not seeing well. The current DH is encephalopathy to be clarified. The physicians are still investigating. She informed that today (21Sep2021) is the 2nd day the team is in discussion. As he was healthy, do not have history of allergy, they are attributing the possibility of these events to be related to the vaccine. She informed that the patient did not receive a vaccine during the last month and received the HPV vaccine on month 6 (June), last dose. The reporter was requesting to verify if it is possible that there are other reports and verify if there is any other marker to be evaluated. She referred that it seems the patient is drunk-like on the bed, what is not normal, so the urgency of this case. The reporter was asking for help to define the DH, as well as knowing if it is possible undergo other tests that help in the diagnosis of vaccine etiology. The adverse events resulted in Emergency room/department or urgent care visit. The patient was treated without success. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination on 19Sep2021, swab test (nasal); SARS-CoV-2 test: Negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events headache, diarrhea, and pericarditis were related to COMIRNATY use based on known drug safety profile. Based on the temporal relationship, the association between the other events with COMIRNATY use can not be fully excluded. 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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