Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | OT |
COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 24Jul2025, this case now contains all required information to be considered valid. This is a literature report. A 40-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 4 (booster), single and on 30Mar2023 as dose 5 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "chronic low back pain" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "gastroesophageal reflux disease" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "Migraine without aura" (unspecified if ongoing); "Nausea associated with migraines" (unspecified if ongoing); "Peripheral sensory neuropathy" (unspecified if ongoing); "Muscle pain" (unspecified if ongoing); "Headache" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease; PROCHLORPERAZINE taken for anxiety; SUMATRIPTAN taken for migraine without aura; CLONAZEPAM taken for depression; INTRAUTERINE CONTRACEPTIVE DEVICE taken for contraception; DESVENLAFAXINE taken for depression; GABAPENTIN taken for depression; EPTINEZUMAB taken for migraine without aura, headache; PARACETAMOL taken for myalgia; NAPROXEN taken for myalgia; BREXPIPRAZOLE taken for depression. Past drug history included: Bactrim, reaction(s): "bactrim allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Apr2023, outcome "recovered" (01May2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event covid-19 based on the known safety profile and temporal association.,Linked Report(s) : US-PFIZER INC-202500156631 Same article, drug, event and different patient;
Medical History/Concurrent Conditions: Anxiety; Bipolar disorder; Depression; Environmental allergy; Gastroesophageal reflux disease; Headache; Irritable bowel syndrome; Low back pain; Migraine without aura; Muscle pain; Nausea; Peripheral sensory neuropathy
FAMOTIDINE; PROCHLORPERAZINE; SUMATRIPTAN; CLONAZEPAM; INTRAUTERINE CONTRACEPTIVE DEVICE; DESVENLAFAXINE; GABAPENTIN; EPTINEZUMAB; PARACETAMOL; NAPROXEN; BREXPIPRAZOLE