Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: fever; diarrhea; throwing up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "allergic to Sulfa" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER taken for diabetes mellitus. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6206), administration date: 19Mar2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "throwing up".  Additional information: The reporter reported that caller is calling about the Covid-19, she had her first booster at (pharmacy name) and states she had a reaction to it, she called her doctor and her doctor advised her to call Pfizer for further advice.  Caller reports that her arm swelled up where she received the injection and she had a fever of 102, itchiness everywhere reports that it was mostly on her head and back but it was everywhere. She was very itchy, also reports vomiting, and feeling very weak for 2 days. States she also had a lump under her arm, caller then clarifies and states the lump was under her left arm and she received the injection on her left arm. Caller then states that when she had her first shot she was fine. With the second shot she had fever, diarrhea and throwing up. States there was no lumps, swelling or rash. Caller confirms that this was her first booster, and her symptoms started a couple hours after the shot. She received the shot on Monday 16May2022 around 10:20 am, states that she came out of the pharmacy and said she must be mistaken, thought maybe she was having a reaction, states this was similar to the tetanus shot, it was a similar reaction. Her husband told her it was her mind playing games on her but then in a couple of hours they realized it was not. Dose: 1: Date: 19Mar2021, Lot: EN6206, NDC and Expiry: unknown, Dose and Route: unknown. Dose 2: Date: 04Apr2021. Lot: caller states that it could say PF8C or PFAC, and then there is a check mark after that. She is not sure if that is the lot number. Then below that is ER8727, which caller states could be the lot number too. Caller confirms she is reading this off her vaccination card. Additional Vaccines Administered on Same Date: no. NDC and Expiry: unknown, Dose and Route: unknown, Dose 3: Date: 16May2022. Lot: PF13ER and then under that it states FJ4989, caller not sure which is the lot number. Caller also states that below that it says hcp clinic site. NDC and Expiry: unknown. Dose and Route: unknown. Indication: well because she did not want to get covid and her granddaughter was having her 1st baby, this is her 1st great grandchild and she wanted to be well and when her granddaughter had the baby in March. And she did not want to give the baby covid. Tetanus shot: NDC, lot and expiry unknown, caller states that was 20 years ago. She had to get a tetanus shot to work in the school and she had a reaction and her doctor told her she would just need to have a chest x-ray if she ever needed to have a tetanus shot and not to take it. Emergency Room: No Physician office: no, caller states she called her primary care doctor, (Name withheld) and he said to do cold compresses and take Tylenol and Benadryl. No prior Vaccinations. AE(s) following prior vaccinations: Similar reaction with tetanus shot: NDC, lot and expiry unknown, Family Medical History: caller states her mom used to have reactions to medications and couldn't take a lot, caller states that she can't either. She is allergic to Sulfa. Relevant Tests: no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.