Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Lip swelling, Odynophagia, Rash, Rash macular, Tongue blistering
Clinical narrative: reddened area left deloid where vaccine given; rash on hands, both arms and legs; shortness of breath upon exertion; blister on gums and tongue of mouth; blister on gums and tongue of mouth; swollen lips; hurts to swallow; face and neck red and blotchy; face and neck red and blotchy/left elbow red; left elbow red and sore; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 22Aug2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from Nurses and Other HCPs.  A 62-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Jul2024 as dose 1, 0.5 ml single (Lot number: HN5978, Expiration Date: 31Aug2025) at the age of 62 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "anxiety/depression" (unspecified if ongoing); "connective tissue disease" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "COPD with asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hidradenitis suppurativa" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraines" (unspecified if ongoing); "IBS with constipation" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "cochlear implant in place, right ear" (unspecified if ongoing), notes: over the age of 19; "seasonal allergies" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for insomnia; HYDROXYCHLOROQUINE taken for connective tissue disorder; MINOCYCLINE taken for hidradenitis; QUETIAPINE taken for mixed anxiety and depressive disorder; AMITRIPTYLINE taken for fibromyalgia; METHOTREXATE taken for connective tissue disorder; MONTELUKAST taken for rhinitis allergic; TRELEGY taken for asthma-chronic obstructive pulmonary disease overlap syndrome; DOXYCYCLINE MONOHYDRATE taken for hidradenitis; LORATADINE taken for seasonal allergy. The following information was reported: GINGIVAL BLISTER (medically significant), TONGUE BLISTERING (medically significant) all with onset 12Jul2024, outcome "unknown" and all described as "blister on gums and tongue of mouth"; RASH MACULAR (medically significant) with onset 12Jul2024, outcome "unknown", described as "face and neck red and blotchy"; ERYTHEMA (medically significant) with onset 12Jul2024, outcome "unknown", described as "face and neck red and blotchy/left elbow red"; ODYNOPHAGIA (medically significant) with onset 12Jul2024, outcome "unknown", described as "hurts to swallow"; ARTHRALGIA (medically significant) with onset 12Jul2024, outcome "unknown", described as "left elbow red and sore"; RASH (medically significant) with onset 12Jul2024, outcome "unknown", described as "rash on hands, both arms and legs"; VACCINATION SITE ERYTHEMA (medically significant) with onset 12Jul2024, outcome "unknown", described as "reddened area left deloid where vaccine given"; DYSPNOEA EXERTIONAL (medically significant) with onset 12Jul2024, outcome "unknown", described as "shortness of breath upon exertion"; LIP SWELLING (medically significant) with onset 12Jul2024, outcome "unknown", described as "swollen lips". The events "reddened area left deloid where vaccine given", "rash on hands, both arms and legs", "shortness of breath upon exertion", "blister on gums and tongue of mouth", "swollen lips", "hurts to swallow", "face and neck red and blotchy", "face and neck red and blotchy/left elbow red" and "left elbow red and sore" required emergency room visit. Therapeutic measures were taken as a result of vaccination site erythema, rash, dyspnoea exertional, gingival blister, tongue blistering, lip swelling, odynophagia, rash macular, erythema, arthralgia. Clinical courses: Patient complaint of reddened area left deltoid where vaccine given. Rash on hands, both arms and legs. Shortness of breath upon exertion, blisters to gums and tongue of mouth, swollen lips, hurts to swallow, face and neck red and blotchy, and left elbow red and sore. Event onset approximately 12Jul2024 after receiving Prevnar 20 vaccine. As for the treatment for reaction, patient sent to local ER for treatment where patient received iv steroids to continue prednisone and to follow up with her rheumotologiest. She was put on Prednisone and it was 60 milligrams on a paper. No other vaccine administered on the same date. When probed for the previous Immunization with Pfizer Vaccine, reporter stated, "Not as per my knowledge actually she hasn't had a, she hasn't had the same before if this one time. She hasn't had another Prevnar 20 before this is the only one." Reason for injection of Prevnar 20 is meeting criteria due to chronic medical conditions.; Sender's Comments: Based on known drug safety profile, and close temporal association the events vaccination site erythema, rash, rash macular, erythema, and arthralgia are assessed as related to the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN). The events dyspnoea exertional, gingival blister, tongue blistering, lip swelling, and odynophagia are conservatively assessed as related to the suspect drug based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.