Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Illness, Vomiting
Clinical narrative: severe allergic reaction/The caller is concerned about giving her the second dose Pfizer Covid Vaccine considering the anaphylactic like reaction the caller's daughter had after receiving the first dose Pfizer Covid Vaccine; started getting sick; vomiting; somewhat dizzy; shortness of breath; This is a spontaneous report received from a contactable physician (patient's father) reported for a patient. A 26-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date at around noon or 13:00 pm (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Nobody ever had that reaction in the family. The patient was allergic to sesame seeds. Concomitant medications included fluoxetine hydrochloride (PROZAC) (10 mg, daily, began taking about 10 years ago) and bupropion hydrochloride (WELLBUTRIN) (150 mg, 2x/day, began taking about a year ago). The Physician had called for her daughter who had received the first dose of the Pfizer COVID-19 vaccine. As soon as her daughter had received the vaccine in a drive through, she started to be sick. She started vomiting and she was dizzy. She also had shortness of breath. As soon as the caller's daughter got into the car, started getting sick, was vomiting and started getting somewhat dizzy. Clarified her daughter was already in the car, received the first dose Pfizer Covid Vaccine at a drive thru site. She was in the car, stayed in car and got the first dose Pfizer Covid Vaccine. The caller's daughter was sitting down. The vaccine site was notified and the caller's daughter stayed there until she felt a little better. The caller's daughter was fine now. The caller was concerned because the daughter is only allergic to sesame seeds, not any medications to the caller's knowledge. The caller was concerned whether the caller's daughter should get the second dose Pfizer Covid Vaccine or not. The caller would categorize her daughter's reaction as a severe allergic reaction. She mentioned that her daughter did not react to anything and she didn't vomit before. It lasted all day pretty much most of night by the next day the caller's daughter was okay. Her daughter was fine now. The caller stated she was concerned because usually the second dose Pfizer Covid Vaccine can have the most side effects. Caller wanted to know if agent recommends the caller receives the second dose Pfizer Covid Vaccine. The caller was concerned about giving her the second dose Pfizer Covid Vaccine considering the anaphylactic like reaction the caller's daughter had after receiving the first dose Pfizer Covid Vaccine. The caller was unable to provide the date the caller's daughter received the first dose Pfizer Covid Vaccine, stated it was about a month ago. No additional vaccines were administered on same date of the Pfizer suspect. No adverse events required a visit to Emergency Room or Physician Office and were treated at home. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no adverse events following prior vaccinations. No relevant tests were done. The outcome of the events was resolved on an unknown date in 2021.  Information about batch/lot number has been requested.  Follow-up (PRD 01Jun2021): This is a follow-up spontaneous report from a Pfizer sponsored program support via a consumer (patient's father) reported for the patient (reporter's daughter): Updated the Pfizer suspect vaccine and vaccination details and clinical course.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of anaphylactic reaction. The case will be reassessed once new information is available. 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