Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NJ6625 | RA |
her arm was swollen; she felt fatigue and lethargic; she felt fatigue and lethargic; nosebleeds/clots blowing nose, more like mucous with blood while blowing her nose; Reports a severe headache; Elevated blood pressure and Heart Rate; Elevated blood pressure and Heart Rate; Body aches; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19May2026 as dose 1, single (Lot number: NJ6625) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetic", start date: 1993 (unspecified if ongoing); "Obese" (unspecified if ongoing), notes: Since the 1980s; "sinus infection" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "Gained 50 pounds after hysterectomy" (unspecified if ongoing); "Acid indigestion" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN HCL; FAMOTIDINE oral taken for dyspepsia; TRESIBA; OZEMPIC. Vaccination history included: pfizer COVID-19 vaccines (DOSE 1; Lot EN6208; Exp: 30Jun2021), administration date: 10Mar2021, for Covid-19 Immunization; pfizer COVID-19 vaccines (DOSE 2; Lot EW0150; Exp: 31Jul2021), administration date: 31Mar2021, for Covid-19 Immunization; pfizer COVID-19 vaccines (DOSE 3 (booster); Lot FH8028; Exp: unknown), administration date: 13Nov2021, for Covid-19 Immunization; pfizer COVID-19 vaccines (DOSE 4; Lot FM0698; Exp: unknown), administration date: 05Apr2022, for Covid-19 Immunization; Covid-19 vaccine, administration date: 2023, for Covid-19 Immunization; Covid-19 vaccine, administration date: 2024, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset May2026, outcome "recovered" (21May2026), described as "Body aches"; BLOOD PRESSURE INCREASED (non-serious), HEART RATE INCREASED (non-serious) all with onset 19May2026, outcome "unknown" and all described as "Elevated blood pressure and Heart Rate"; HEADACHE (non-serious) with onset 19May2026, outcome "recovered" (21May2026), described as "Reports a severe headache"; EPISTAXIS (non-serious) with onset 20May2026, outcome "recovered" (21May2026), described as "nosebleeds/clots blowing nose, more like mucous with blood while blowing her nose"; PERIPHERAL SWELLING (non-serious) with onset 21May2026, outcome "unknown", described as "her arm was swollen"; LETHARGY (non-serious), FATIGUE (non-serious) all with onset 21May2026, outcome "unknown" and all described as "she felt fatigue and lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache Additional information: Caller was calling to report that she had severe side effects with the Pfizer Covid 19 vaccine, worst this time. Stated she gets one every since 2021, except 2025. Received a vaccine in 2022, 2023, 2024, skipped 2025, then 2026. Received Pfizer Covid 19 vaccine Tuesday, 19May2026. Reported a severe headache, nosebleeds/clots blowing nose, more like mucous with blood while blowing her nose; that started Wednesday morning during the headache and continued to Thursday morning. Event details: Headache started same day at night, Tuesday 19May2026; Took Tylenol for treatment that night. Stated she slept Tuesday night for about 10 hours off and on, Wednesday morning took another Tylenol and slept for another 10 hours off and on Wednesday during the day and Wednesday night slept solid without waking up and Thursday everything was gone, except she felt fatigue and lethargic, Thursday morning, and her arm was swollen. mucous with blood while blowing her nose: Started Wednesday morning during the headache and continued to Thursday morning. Caller said she may have had a sinus infection when she got the shot but it (mucous) wasn't green, it was just clear mucous. Fatigue and Lethargic: Started Thursday morning. Arm Swelling: Noticed Thursday morning. Elevated blood pressure and Heart Rate: Same day as the shot. Blood pressure usually runs between 110 and 120 over 60's but the day of the shot, her blood pressure was 135/77, Heart Rate 114 and she was sedentary; she had only walked into pharmacy got shot, came home and hadn't been doing anything else. Stated her heart rate hadn't been that high in months, or ever, unless with exercise. Stated she has a bicycle under her desk that she uses for half hour in the morning and half hour in the evening. Indication: Callers doctor has been bugging her to go get the shot. Said she gained 50 pounds after her hysterectomy. Test Results: Stated she just had a blood test A1c; Result was 5.7. Later in call, caller mentioned having body aches that started Tuesday night or Wednesday morning, that went away Thursday morning. Did the patient receive any other vaccines on the same date as the Pfizer vaccine? No. Did any AE require a visit to the Emergency Room? Or Physician's Office: No, but did call the doctor's office.
Medical History/Concurrent Conditions: Acid indigestion; Hysterectomy; Obesity (Since the 1980s); Sinus infection; Type 2 diabetes mellitus; Weight gain
METFORMIN HCL; FAMOTIDINE; TRESIBA; OZEMPIC
Test Date: 20260519; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/77 mmHg; Test Name: blood test A1c; Result Unstructured Data: Test Result:5.7; Test Date: 20260519; Test Name: heart rate; Result Unstructured Data: Test Result:114