Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Nausea, Paraesthesia oral, Skin test
Clinical narrative: Pt felt whoozy, off, the body felt "weird"/ Dizzy; Heaviness in the brain; Mild nausea; lips were tingling; This is a spontaneous report from a contactable Physician in response to HCP letter sent in cross reference case that included first dose. A 49-year-old female patient received second dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EL1283), via an unspecified route of administration on 13Jan2021 (at the age of 49-years) as 2nd dose, single for COVID-19 immunisation. The vaccine given in presence of MD (allergist) at cancer centre. Reportedly, skin test was done which was negative. It was not administered at military facility. Medical history included pernicious anaemia (Parietal Cell Ab+) (Onset date was reported as years), Hx anaphylactic reaction to contrast dye, Hx burning skin with gadolinium, HLD, PND, dysuria, seasonal allergy. Concomitant medications included (VITAMIN B12 [CYANOCOBALAMIN]) 1000 mcg daily SL (sublingual) for Pernicious anemia, Bupropion Hydrochloride (WELLBUTRIN) 150 mg PO (Per oral) BID (twice a day), Budesonide, Formoterol Fumarate (SYMBICORT), ALBUTEROL [SALBUTAMOL] PRN (As needed), Sertraline 75 QD (Once a day), Omeprazole PRN (As needed), Folic PRN (As needed) and vitamins. The patient previously took first dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EH9899), via an intramuscular route of administration, administered in deltoid left on 22Dec2020 at 10:00 for COVID-19 immunisation at hospital and after 10 minutes, patient experienced light-headed, 30 minutes heavyness, in the brain, lips were tingling. Patient was given epipen, felt in a fog and was taken to ER for observation. Patient felt nauseated before Epi, palp/SOB after Epi. Felt like throat was tight. Reportedly, reactions recurred on readministration of product. On 13Jan2021 (same day of vaccination), patient felt whoozy, off, the body felt weird/ dizzy, heaviness in the brain, mild nausea, lips were tingling. These symptoms occurred almost immediately. After second dose patient was under observation at cancer center. Patient was not admitted to hospital. Causal relationship was yes. Patient did not decease. Therapeutic measures were taken as a result events included Benadryl IV and the symptoms resolved in 30-minutes. Then Patient received completion of dose without symptoms. The patient underwent lab test which included unspecified Skin test: Negative on 13Jan2021, no other relevant tests were done. The reporter considered the Pfizer product had a casual effect to the adverse event. The outcome of all the events was recovered.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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.