Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism; COZAAR taken for hypertension; INSULIN GLARGINE taken for diabetes mellitus; OZEMPIC taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease; BUSPAR taken for anxiety; CRESTOR taken for blood cholesterol increased; SINGULAIR taken for asthma; TOPROL XL taken for hypertension; ZETIA taken for blood cholesterol increased; MAXZIDE taken for hypertension. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "Pain in Arm".  Additional Information:  Consumer stated, "I had a Prevnar 20 vaccine on Saturday and today my arm has a swollen red hard lump, the size of an orange and I got the shot 2 days ago. I just took Benadryl because I do not know if its allergic reaction, I do not know what. I mean, is this normal? Has this been known to happen two days after the shot?". I got the COVID shot two weeks ago. Last week I got the flu shot (Suspect captured as unspecified flu shot) and this week I got the Prevnar 20." When probed for previous immunization with the Pfizer vaccine, consumer stated, "I just 2 weeks ago I took the Pfizer COVID-19 vaccine." When probed are there any vaccines administered on same date with the Pfizer vaccine: Consumer stated, "No. When probed for the Lot# and expiry date of Pfizer COVID-19 vaccine, consumer stated, "I do not have it either, they do not give you the card anymore. "Anatomical Location and route of administration of Pfizer COVID-19 vaccine: Consumer stated, "In the same arm, in the same muscle, left arm as the Prevnar but two weeks later." Consumer stated, "This may be the fifth one the fifth shot." When probed is the event required a visit to Emergency Room or Physician Office, consumer stated, "Not yet, may be tomorrow. I have not done it yet." When probed are there any other vaccinations within four weeks prior to the first administration date of Pfizer Covid Vaccine, consumer stated, "I got the Pfizer COVID vaccine on the 7th. On the 14th I got the flu shot and on the 21st I got the Prevnar." When probed is there any event following prior vaccination with Covid vaccine, consumer stated, "No, just some pain in my arms like two days, may be three days."   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.