Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Sensory disturbance, Vaccination site pain
Clinical narrative: rash on the left side of her waist and upper part of her buttocks/rash was on her left side only and her hip; She had a rash, like blotches that were itchy; right hand started itching in the palm of it/left hand started itching in her palm and swelling.; the pain and swelling extended to her elbow on that right arm.; the pain and swelling extended to her elbow on that right arm.; the pain and swelling extended to her elbow on that right arm./left hand started itching in her palm and swelling.; the pain and swelling extended to her elbow on that right arm.; some kind of sensation in her right hand; right arm this time around the injection had a lot of soreness to the point it got where it was hard to raise her hand up and down; lot of soreness to the point it got where it was hard to hard to raise her hand up and down; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5, Pfizer BioNtech COVID Bivalent vaccine manufacturer: unspecified, Expiry Date and NDC number of Pfizer BioNtech COVID Bivalent vaccine: Unknown, Reason for no lot number: of Pfizer BioNtech COVID Bivalent vaccine: Complainant does not have the product with them at the time of call), on 03Oct2022 at 09:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "caller answered "the endocrinologist one"" (unspecified if ongoing), notes: Patient(s) Medical History:  answered "the endocrinologist one". Patient(s) Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: caller answered "the endocrinologist one". Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Covid-19 vaccine (Dose: 1st [She got the 2 initial ones, and then two boosters. She doesn't have their dates, NDC, lots or expirations]), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd [She got the 2 initial ones, and then two boosters. She doesn't have their dates, NDC, lots or expirations]), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd Booster [She got the 2 initial ones, and then two boosters. She doesn't have their dates, NDC, lots or expirations]), for Covid-19 immunization; Covid-19 vaccine (Dose: 4th Booster [She got the 2 initial ones, and then two boosters. She doesn't have their dates, NDC, lots or expirations]), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "lot of soreness to the point it got where it was hard to hard to raise her hand up and down"; VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "right arm this time around the injection had a lot of soreness to the point it got where it was hard to raise her hand up and down"; SENSORY DISTURBANCE (non-serious) with onset 2022, outcome "unknown", described as "some kind of sensation in her right hand"; PRURITUS (medically significant) with onset 06Oct2022, outcome "recovering", described as "right hand started itching in the palm of it/left hand started itching in her palm and swelling."; ARTHRALGIA (medically significant), PAIN IN EXTREMITY (medically significant), JOINT SWELLING (medically significant) all with onset 06Oct2022, outcome "recovering" and all described as "the pain and swelling extended to her elbow on that right arm."; PERIPHERAL SWELLING (medically significant) with onset 06Oct2022, outcome "recovering", described as "the pain and swelling extended to her elbow on that right arm./left hand started itching in her palm and swelling."; RASH MACULAR (medically significant) with onset 08Oct2022, outcome "recovering", described as "She had a rash, like blotches that were itchy"; RASH (medically significant) with onset 08Oct2022, outcome "recovering", described as "rash on the left side of her waist and upper part of her buttocks/rash was on her left side only and her hip". The events "right hand started itching in the palm of it/left hand started itching in her palm and swelling.", "the pain and swelling extended to her elbow on that right arm.", "the pain and swelling extended to her elbow on that right arm./left hand started itching in her palm and swelling.", "rash on the left side of her waist and upper part of her buttocks/rash was on her left side only and her hip" and "she had a rash, like blotches that were itchy" required physician office visit. Therapeutic measures were taken as a result of pruritus, arthralgia, pain in extremity, peripheral swelling, joint swelling, rash, rash macular. Caller got the vaccine on 03Oct2022, the Pfizer BioNtech COVID Bivalent vaccine. She had some side effects. She got the vaccine at (clinic name-withheld) which is also where she goes to the doctor. On 06Oct2022 is when she started to see side effects. Her right hand started itching in the palm of it. It started swelling up. Then, the pain and swelling extended to her elbow on that right arm. She woke up concerned during the night. She put alcohol on her arm and hand. Then next morning came Friday 07Oct2022, and her left hand started itching in her palm and swelling. But that side didn't extend into her arm like the right side. She decided to Monitor it. She contacted her doctor. She used to work as an Licensed practical nurse and then a registered nurse. On 08Oct2022, Saturday morning was when she talked to her doctor. She had a rash on the left side of her waist and upper part of her buttocks. They were like blotches that were itchy. The swelling looked like it was going down. Treatment: took Benadryl, hydrocortisone cream to rash. She was concerned so she wanted to get it reported. Her son was concerned she needed to go to urgent care, but she had an appointment scheduled the 17Oct2022 so she decided to monitor herself. Monday morning 10Oct2022, it seemed like the rash and side effects were diminishing. The rash was on her left side only and her hip. She had an appointment with the infusion department this morning so she walked over to the vaccine clinic to talk to them. She was upset no one followed up with her. She is better. She has improved. She was going to continue to monitor it. Her right hand especially because it was so swollen and painful. There was still some kind of sensation in her right hand. She had received 4 vaccines prior to this one. She got the 2 initial ones, and then two boosters. She doesn't have their dates, NDC, lots or expirations. She had no problem with the others. Her right arm this time around the injection had a lot of soreness to the point it got where it was hard to raise her hand up and down. Previously she had no issues. Two weeks before she did get the flu shot. She called to report to the FDA/ CDC vaccine reporting, but no one answered. Seriousness: medically significant, Causality: yes related. Vaccine Supplemental Form: Patient Age at Time of Vaccination in Months or Years: 71. Pfizer Suspect Vaccine and Vaccination Details:  Bivalent COVID vaccine. Time the Vaccination Was Given (24 hour clock): 09:30am. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm. For country Only: Vaccine Administered at private Facility: no. History of all previous immunization with the Pfizer vaccine considered as suspect: 4 previous doses, unknown dates. Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. Did any AE(s) require a visit to: Emergency Room: no, Physician Office: yes. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): no. Term highlighted by the reporter: yes, highlighted by the reporter, serious [right hand started itching in the palm of it; the pain and swelling extended to her elbow on that right arm; rash on the left side of her waist and upper part of her buttocks]. Relatedness of drug to reaction(s)/event(s): Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Result of Assessment: Yes.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "PRURITUS, PAIN IN EXTREMITY , PERIPHERAL SWELLING and RASH. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.