Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Blood test, Erythema, Insomnia, Investigation
Clinical narrative: AUTOIMMUNE DISORDER; PROBLEM WITH LEG; LEFT ARM HURTS, PAINFUL; PAIN AT THE SITE, TENDERNESS; DIFFICULTY SLEEPING; MODERATE SWELLING OF LEFT ARM; INJECTION SITE HEAT; LEFT ARM RED; This spontaneous report received from a patient concerned a 69-year-old (elderly) female. The patient's weight 180-182 (unit not reported) and height was 163 centimeters. The patient's concurrent conditions included: stroke, blood pressure, cholesterol, and lot of allergies throughout life. The patient had visited the hospital on 07-FEB or 09-FEB. The patient had no history of previous immunization with the Pfizer vaccine. The patient had not administered additional vaccine on the same date of Pfizer vaccination, had no prior vaccinations (within 4 weeks). Before vaccination, the patient had some blood work done, result was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, expiry: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, lisinopril for blood pressure, and ezetimibe for cholesterol. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced problem with leg. She had testing done and never found a blood clot. Later she was diagnosed with autoimmune disorder (dose number in series 1). The subject reported having gotten blood work done "even before the COVID vaccine" so she could not definitively say if diagnosis was due to COVID vaccine or not so the event was conservatively captured after vaccination (dose number in series 1). On an unspecified date in NOV-2021 (5-10 minutes early to 13:00 hours), the patient received non-company suspect vaccine included: BNT 162 (dose number in series 2) (form of admin, route of admin, were not reported and batch number: FH8028, expiry: unknown) dose was not reported, administered on left arm for prophylactic vaccination. In NOV-2021 few hours after vaccinated with BNT 162, the patient experienced left arm pain (dose number in series 2). In NOV-2021, five days after vaccination with BNT 162, the patients arm was not huge but she was having moderate swelling (dose number in series 2). Her left arm hurts, painful and it was causing difficulty in sleeping but she slept great last night (from the day of reporting) (dose number in series 2). She was having pain at the site, heat and tenderness (dose number in series 2). Her arm was swollen and red (dose number in series 2). She confirmed that it was on her left arm. She was doing better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping in NOV-2021, was recovering from left arm hurts, painful, pain at the site, tenderness, moderate swelling of left arm, injection site heat, and left arm red. The outcome of problem with leg and autoimmune disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211201585-covid-19 vaccine ad26.cov2.s-Autoimmune disorder. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).