Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Urticaria, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching around the site of injection; Hives; Received second dose of Pfizer COVID vaccine between shoulder and elbow instead of deltoid; Swelling around the site of injection; Pain around the site of injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 21Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FH8020), administration date: 01Nov2021, when the patient was 75-year-old, for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "Pain around the site of injection"; VACCINATION SITE SWELLING (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "Swelling around the site of injection"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 21Jun2022, outcome "unknown", described as "Received second dose of Pfizer COVID vaccine between shoulder and elbow instead of deltoid"; URTICARIA (non-serious) with onset 24Jun2022, outcome "not recovered", described as "Hives"; VACCINATION SITE PRURITUS (non-serious) with onset 24Jun2022, outcome "not recovered", described as "Itching around the site of injection". The events "swelling around the site of injection", "pain around the site of injection", "itching around the site of injection" and "hives" required physician office visit. Therapeutic measures were taken as a result of vaccination site pruritus, urticaria.  Additional information: 2nd booster dose administered to left arm pharmacist assumes attempted intramuscular but it was not close. It was reported that a pharmacist that injected the patient between the shoulder and elbow instead of deltoid so wondering if she needs another dose of the vaccine. States for serious criteria of this event of injecting the patient between the shoulder and elbow, it is not life threatening but the patient did experience symptoms of swelling, pain and itching around the site of injection and the swelling and pain went away after 1.5 weeks and began about a day or two after getting the vaccine; states the patient still has the itching and the hives and she tried to reach out to the patient in the past week but has not heard back from the patient and the caller is not sure what is going on; the itching and hives began about 3 days after the vaccine and the last time she spoke with the caller maybe a week or two ago, the itching and hives were still ongoing and the patient stated nothing was helping the itching or hives so she has no idea if the itching and hives are ongoing now or not. The patient tried and did not help the hives and itching except the patient stated the Claritin did not help and caller has no product details for lot, expiry date or NDC to provide for the Claritin. No additional vaccines administered on same date of the pfizer suspect. The patient was not hospitalized. The patient did not receive other vaccines within four weeks prior to COVID vaccine. No Investigations was conducted.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (21Jul2022): This is a spontaneous follow up report from a contactable pharmacist. This pharmacist reported for a female patient that:  Updated information included: Primary reporter full address added, Corresponding reporter added. Patient information (patient initials added, other medical history added, historical vaccines added), Suspect product information (coding updated, vaccination date added, lot number added, dose description added, anatomical location added, vaccination facility details added), Event information (New events, onset dates, outcomes, treatments added and physician office visit ticked) and Concomitant therapy added.