Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Immunisation, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: have swelling in her arm that is painful, tender and with heat; have swelling in her arm that is painful, tender and with heat/arm hurts, painful; redness; her cheeks are red even when she is not putting makeup and that may be a rash; her cheeks are red even when she is not putting makeup and that may be a rash; heat and tenderness; pain at the site; difficulty sleeping; heat and tenderness; receiving her booster dose; 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 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date Nov2021 (Lot number: FH8028) as dose number unknown (booster) 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Autoimmune issues" (unspecified if ongoing), notes: Autoimmune issues; "Stroke" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); AMLODIPINE taken for blood pressure abnormal (ongoing); EZETIMIBE taken for blood cholesterol abnormal (ongoing). Vaccination history included: Johnson & johnson covid vaccine (Caller's first dose was the Johnson & Johnson Covid Vaccine , 0.5ml . , Date 17Mar2021 , Lot-1805022 , Exp- Did not see to provide), administration date: 17Mar2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "receiving her booster dose"; PERIPHERAL SWELLING (non-serious), outcome "recovering", described as "have swelling in her arm that is painful, tender and with heat"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "have swelling in her arm that is painful, tender and with heat/arm hurts, painful"; ERYTHEMA (non-serious), outcome "recovering", described as "redness"; ERYTHEMA (non-serious), RASH (non-serious), outcome "unknown" and all described as "her cheeks are red even when she is not putting makeup and that may be a rash"; TENDERNESS (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovering" and all described as "heat and tenderness"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "pain at the site"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty sleeping".  Additional Information: Caller was a consumer who reported that after receiving her booster dose of the Pfizer Biontech COVID19 vaccine, she still have swelling in her arm that is painful, tender and with heat, it was also swollen and there was redness. It has been 5 days already when she got the booster shot. Caller wants to know if these are normal and if she should go see a doctor about it. Caller also said that her cheeks are red even when she was not putting makeup and that may be a rash. She also mentioned about two medications that she missed to give with the DSU agent, which were progesterone and low dose naltrexone. She was having a reaction that she was not concerned about initially, but now she was more so. She was doing better, but even 5 days later she was having these events. Her arm was not huge, but she was having swelling that she would consider as moderate. Her arm hurts, painful, and it was causing difficulty sleeping, but she slept great last night. She was having pain at the site, heat, and tenderness. Her arm was swollen, and red. She confirmed this was on her left arm. Had reaction to the other one, clarified as the Johnson & Johnson Covid Vaccine. She did not know if related to the vaccine, but she had a problem with her leg. They thought she had a blood clot, but she had testing done and never found a blood clot. Later she was diagnosed with autoimmune disorder. However, she was having some blood work done even before she had the Covid Vaccine, so she cannot say this was definitely from the vaccine.  No follow-up attempts are possible. No further information is expected.