Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Sarcoidosis" (unspecified if ongoing), notes: Other medical history: Sarcoidosis; "if Covid prior vaccination: Yes" (unspecified if ongoing), notes: if Covid prior vaccination: Yes; "Known allergies: NSAIDs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 23Dec2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 10Nov2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious) all with onset 15Jul2022, outcome "not recovered" and all described as "About 3 hours after shot, got headache & fatigue"; CHILLS (non-serious) with onset 15Jul2022, outcome "not recovered"; PYREXIA (non-serious) with onset 15Jul2022, outcome "not recovered", described as "fever"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE PRURITUS (non-serious), INJECTION SITE PAIN (non-serious), INJECTION SITE WARMTH (non-serious) all with onset 15Jul2022 at 13:00, outcome "not recovered" and all described as "About 5 minutes after shot, injection site got bright red, itchy, burny, & hot to touch"; INJECTION SITE MASS (non-serious) with onset 15Jul2022 at 13:00, outcome "not recovered", described as "Area was approx. size of baseball"; FEELING ABNORMAL (non-serious) with onset 15Jule2022 at 13:00, outcome "not recovered", described as "Feeling miserable"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Jul2022 at 13:00, outcome "not recovered" and all described as "Right arm became very painful from shoulder down into hand"; PAIN (non-serious) with onset 15Jul2022 at 13:00, outcome "not recovered", described as "body aches". The events "about 5 minutes after shot, injection site got bright red, itchy, burny, & hot to touch", "area was approx. size of baseball", "about 3 hours after shot, got headache & fatigue", "fever", "chills", "body aches", "right arm became very painful from shoulder down into hand" and "feeling miserable" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of injection site erythema, injection site pruritus, injection site pain, injection site warmth, injection site mass, headache, fatigue, pyrexia, chills, pain, pain in extremity, arthralgia, pain in extremity, feeling abnormal. Additional information: About 5 minutes after shot, injection site got bright red, itchy, burny, & hot to touch. Area was approx. size of baseball. Was given ice pack & then Benadryl. About 3 hours after shot, got headache & fatigue. Approx. 6 hours afterwards, fever, chills & body aches. Right arm became very painful from shoulder down into hand. Still have fever 101.6. Feeling  miserable. The patient was treated with Ice pack & Benadryl, plus Tylenol. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.