Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Pruritus, Urticaria, Urticaria chronic
Clinical narrative: Chronic urticaria or chronic hives; Chronic urticaria or chronic hives/hives have been everywhere, chest, breasts, buttocks, arms, thighs, hands, face, neck; A little bit of a sore arm; Itching; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol, start date: 06May2022; MELOXICAM oral taken for osteoarthritis, start date: 27Apr2022. Vaccination history included: BNT162b2 (booster shot), administration date: 01Nov2021, for Covid-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2022, outcome "not recovered", described as "A little bit of a sore arm"; URTICARIA CHRONIC (medically significant) with onset Apr2022, outcome "not recovered", described as "Chronic urticaria or chronic hives"; URTICARIA (medically significant) with onset Apr2022, outcome "not recovered", described as "Chronic urticaria or chronic hives/hives have been everywhere, chest, breasts, buttocks, arms, thighs, hands, face, neck"; PRURITUS (non-serious) with onset Apr2022, outcome "unknown", described as "Itching". Therapeutic measures were taken as a result of urticaria, pain in extremity, pruritus.  Clinical course: Patient had her Prevnar 20 vaccine on 20Apr2022. Patient had been working with a dermatologist and she think the Prevnar 20 is the only new thing'. Caller states that after vaccination, she had ''no problems the day of, a little bit of a sore arm and shortly after that hive developed and they became worse and worse to the point I've been working with a dermatologist" she has been treating them with ''twice daily antihistamines, hydroxyzine, and high-dose taper prednisone'' noting that she and her dermatologist ''are just racking our brains at this point. She have changed nothing whatsoever''. She states she saw her ''primary care on 12Apr and I know I had no rash that's who gave me the shot, and that's the only new thing.'' She also noted she couldn't find any information ''in system or places like that''. Provided there is no reason for the dermatologist to reach out to MI. Atorvastatin was being taken about a year. Meloxicam: started probably 10-15 years ago, taking a long time. Reason for no lot number of Prevnar 20 was Complainant does not have the product with them at the time of call. Caller states she is seeing her dermatologist and her dermatologist is considering her treatment options so she wanted to call and get some information, states she may have her dermatologist call as well. Caller states this may not be the cause, this is the only new thing she has had since before the hives started. Caller states she got the vaccine on 12Apr2022 at her PCP annual physical appointment, Caller states she is not sure when the hives exactly started but she knows that it was around a day or two after the vaccine and it has gotten progressively worse. States the hives have been basically everywhere, chest, breasts, buttocks, arms, thighs, hands, face, neck, when she first saw the dermatologist on 27Apr 2022, she had her take twice a day antihistamine and that provides relief, hydroxyzine for itching at night and that helps for a few hours and then has to take more, which helps the itching and now she is on a 16 day prednisone taper. States she is still functioning, treating with high dose antihistamines and high dose steroids and it is working to suppress the hives but it is not fully resolving. Caller states she has had no other vaccines in the last 4 weeks, states her most recent other vaccine was the Pfizer Covid vaccine on 1Nov2021, her booster shot. Caller does not provide Covid vaccine details. Caller states the only other medications she was taking around the time of the event were atorvastatin and meloxicam- caller states she has stopped both per her dermatologist's orders.  The information on the batch/lot number for [PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug PREVNAR 20 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product 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