Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use, Pain, Pyrexia
Clinical narrative: swollen and puffy armpit; swollen and puffy armpit; arm pit on side of injection was kind of sore; soreness and fever/achiness; soreness and fever; received the second booster shot of the Pfizer-BioNTech Covid 19 on 11Apr2022; received the second booster shot of the Pfizer-BioNTech Covid 19 on 11Apr2022; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), 0.3 ml single (Lot number: FP4554) at the age of 58 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TIROSINT SOL taken for thyroid disorder; ALLOPURINOL [ALLOPURINOL SODIUM] taken for hyperuricaemia. Vaccination history included: BNT162b2 (First Dose: 17Mar2021, LOT: EP7534, NDC, EXP: Unknown), administration date: 17Mar2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (Second Dose: 8Apr2021, LOT: EW6153, NDC, EXP: Unknown), administration date: 08Apr2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (First Booster: 11Oct2021, LOT: FF2589, NDC, EXP: Unknown), administration date: 11Oct2021, when the patient was 57-year-old, for COVID-19 immunization.The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 11Apr2022, outcome "unknown" and all described as "received the second booster shot of the Pfizer-BioNTech Covid 19 on 11Apr2022"; PYREXIA (non-serious) with onset 12Apr2022, outcome "unknown", described as "soreness and fever"; PAIN (non-serious) with onset 12Apr2022, outcome "recovered" (Apr2022), described as "soreness and fever/achiness"; PAIN (non-serious) with onset 13Apr2022, outcome "unknown", described as "arm pit on side of injection was kind of sore"; SKIN SWELLING (non-serious), SWELLING (non-serious) all with onset 13Apr2022, outcome "unknown" and all described as "swollen and puffy armpit"; FATIGUE (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a 58 years old female patient that received the second booster shot of the Pfizer-BioNTech Covid 19 on 11Apr2022 and ever since she has had soreness and fever, but today she is experiencing a "swollen and puffy" armpit, in the side where she received the vaccine. She wants to know if this is a common side effect of the vaccine. Caller stated she was calling regarding the Pfizer booster, the second booster for the Covid-19 vaccine. She states she called the pharmacist to ask about side effects she had not had with previous doses of the Pfizer covid-19 vaccine. They had suggested that she call to report this with Pfizer. She got the shot Monday and had typical expected side effects. Yesterday, she had soreness and a little bit of a fever. Today, she noticed the arm pit on the side of the injection but not at the injection site, that arm pit was kind of sore. It looked swollen and ballooned up and was jiggly. She feels great otherwise and only has a mild temp of about 99. She does see an oncologist regularly. Caller stated she feel great and she was actually going to play golf if she is told she was not going to die from this. She stated she just has a low grade temp of about 99 degrees. She stated the soreness, tiredness and achiness are gone. Arm pit on side of injection was kind of sore, left arm pit looked swollen and ballooned up and was jiggly: Clarified that the caller just noticed today, 13Apr2022 this morning. She stated she felt sore but she played golf yesterday and thought it was just muscle soreness. In the shower, she could tell that it was really kind of swollen and puffed up. She looked in the mirror and the other side didn't have the same appearance. Clarified that this was the left arm, the same arm as she had the injection. She states the injection site was the shoulder, but this was in the arm pit. Prior Vaccinations (within 4 weeks): No. AE(s) following prior vaccinations: Nothing beyond chills and temperature. Family Medical History Relevant to AE(s): No. Caller states she will say and, does not know if this is relevant but, her husband came home just about 5 days prior to her receiving the vaccine. While he was away, he had come down with Covid-19 and recovered there and stayed there for the duration of the time. He was not having any symptoms when he came home. Clarified that the caller's husband tested positive for Covid 5 or 6 days before the caller went and got vaccinated.   No follow-up attempts are possible. No further information is expected.