Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Hypersensitivity, Investigation, Lip swelling, Lymphadenopathy
Clinical narrative: severe allergic reaction; throat was closing; o2 levels went down; her lips were swelling; She also had enlarged lymph nodes under her left armpit after the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 (Lot number: EW0191) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (ongoing); "High blood pressure" (unspecified if ongoing); "Cake allergy" (unspecified if ongoing); "lot of unknown allergies" (unspecified if ongoing); "Thyroid removed" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism (ongoing); DILT-XR taken for blood pressure increased (ongoing); AMILORIDE HCL taken for blood pressure increased. Vaccination history included: Bnt162b2 (Dose 1 BNT162B2, Lot number:EW0183, Anatomical location: Left arm, Patient was fine after dose 1), administration date: 08May2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "No reactions". The following information was reported: HYPERSENSITIVITY (medically significant) with onset Jun2021, outcome "unknown", described as "severe allergic reaction"; THROAT TIGHTNESS (medically significant) with onset Jun2021, outcome "unknown", described as "throat was closing"; OXYGEN SATURATION DECREASED (medically significant) with onset Jun2021, outcome "unknown", described as "o2 levels went down"; LIP SWELLING (medically significant) with onset Jun2021, outcome "unknown", described as "her lips were swelling"; LYMPHADENOPATHY (non-serious) with onset Jun2021, outcome "unknown", described as "She also had enlarged lymph nodes under her left armpit after the second dose". The event "severe allergic reaction" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy: (Jun2021) no cancer, notes: They did a biopsy, and there was no cancer; investigation: (Jun2021) went down, notes: Her 02 level went down; mammogram: (Oct2021) unknown results; ultrasound scan: (Oct2021) unknown results. Therapeutic measures were taken as a result of hypersensitivity, throat tightness, oxygen saturation decreased, lip swelling.  Clinical course: Warm transfer from (withheld) with Pfizer. Patient had a severe allergic reaction after a dose of the Pfizer COVID 19 vaccine. She would like to get the COVID booster dose. She was calling to ask for recommendation about getting the booster. The caller confirmed the details provided by the transferring agent. She did not have a prescribing doctor. She got it through (withheld) She got her first dose 08May2021, Pfizer lot number EW0183, and she got it in her left arm .She got the second dose 01Jun2021 with Pfizer lot number EW0191, and received it in her left arm.The allergic reaction occurred after her second dose. It happened seriously almost immediately. She has a lot of unknown allergies. As soon as the nurse gave the shot , she knew it wasn't going to be good. Her throat started closing. Her 02 level went down. She doesn't remember for sure, but she thinks she had swelling of her lips. The site did call 911. The ambulance took her to the Emergency room. She had to use her own Epi pen and prednisone. She did get better. She was not admitted. She was in the Emergency room for 3 hours. She asked her allergist about the COVID booster, and he said she would need to pre medicate with Benadryl and Prednisone if she did get it. She also had enlarged lymph nodes under her left armpit after the second dose. They did a biopsy , and there was no cancer. She is supposed to follow up in 6 months. She got her mammogram and ultrasound in Oct2021, and her last shot was in Jun 2021. They thought the swollen lymph nodes might be related between the two. She also has a history of high blood pressure and hyperthyroidism. She had her thyroid taken out, and she is on medication. Caller reported that she spoke with her allergist and he suggested that she pre medicate with Benadryl and prednisone if she gets it 2-3 days before. Time the Vaccination Was Given (24 hour clock) was reported as daytime morning time. Time of Onset (24 hour clock) was reported as immediately. Patient's Medical History (including any illness at time of vaccination): Other relevant medical history including but not limited to these conditions including diagnosed allergies, compromised immune status, respiratory illness, genetic/ chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as No. Relevant Tests including list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) was not reported  No follow-up attempts are possible. No further information is expected.