Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary mass, Body temperature, Pruritus, Pyrexia
Clinical narrative: her arm swelled up where she received the injection; had a fever of 102; itchiness everywhere reports that it was mostly on her head and back but it was everywhere; vomiting; feeling very weak for 2 days; had a lump under her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 16May2022 at 10:20 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2008 (unspecified if ongoing), notes: Diabetes diagnosed in 2008 or 2009. Concomitant medication(s) included: METFORMIN ER taken for diabetes mellitus, start date: 2008. Past drug history included: Sulfa, reaction(s): "allergic to Sulfa", notes: her mom used to have reactions to medications and could not take a lot. Vaccination history included: covid-19 vaccine (Dose: 1, Manufacturer Unknown, Lot: EN6206, NDC and Expiry: unknown, Dose and Route: unknown, After first shot she was fine), administration date: 19Mar2021, when the patient was 72-year-old, for COVID-19 immunization; covid-19 vaccine (Dose: 2, Lot: ER8727, Manufacturer Unknown, NDC and Expiry: unknown, Dose and Route: unknown, With the second shot she had fever, diarrhea and throwing up), administration date: 04Apr2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "fever", "throwing up"; covid-19 vaccine (Dose: 2, Lot: ER8727, Manufacturer Unknown, NDC and Expiry: unknown, Dose and Route: unknown, With the second shot she had fever, diarrhea and throwing up), administration date: 04Apr2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "diarrhea"; Tetanus shot (Similar reaction with tetanus shot: NDC, lot and expiry unknown.), for Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "her arm swelled up where she received the injection"; PYREXIA (non-serious), outcome "unknown", described as "had a fever of 102"; PRURITUS (non-serious), outcome "unknown", described as "itchiness everywhere reports that it was mostly on her head and back but it was everywhere"; VOMITING (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "feeling very weak for 2 days"; AXILLARY MASS (non-serious), outcome "unknown", described as "had a lump under her arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated 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. Stated she also had a lump under her arm, patient then clarifies and stated the lump was under her left arm and she received the injection on her left arm. Stated there was no lumps, swelling or rash on previous vaccination. Patient 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, stated that she came out of the pharmacy and said she must be mistaken, thought maybe she was having a reaction at 10:20 am, stated 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. Patient received the vaccine 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. The events were not required Physician office visit, patient stated she called her primary care doctor and he said to do cold compresses and take tylenol and benadryl. Regarding the booster dose Lot, patients states PF13ER and then under that it states FJ4989, patient not sure which was the lot number. No vaccines administered on same Date. The tetanus shot 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.