Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, External ear cellulitis, Eye infection, Fatigue, Fungal infection
Clinical narrative: yeast infection; eye infection; Cellulitis; impetigo; cellulitis in ear; achy; tired; shingles; This is a solicited report from a contactable consumer (patient) from the marketing program FACILITATED COLLECT, based on information received by Pfizer from (manufacturer control number 21K-163-4088149-00).   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on 06Apr2021 (at 68-year-old) as dose 2, single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from Jun2018 (Batch/Lot number was not reported) to Jan2020, at 80 mg, 2x/week, subcutaneous from 23Jan2021 (Batch/Lot number was not reported) to 10Jun2021, at 80 mg, 2x/week, subcutaneous from 23Jul2021 (Batch/Lot number was not reported) to 03Sep2021, at 80 mg, 2x/week for moderate to severe rheumatoid arthritis. Medical history included alcoholic from 1972, shingles from 1973, tobacco user from an unknown date and stopped in 1978, latex allergy manifested by congestion and rash, bee stings allergy manifested by anaphylaxis, sulfa drugs allergy manifested by rash, hypothyroidism, ongoing rheumatoid arthritis, blood pressure, bone density. Concomitant medications included azathioprine taken for rheumatoid arthritis; levothyroxine taken for hypothyroidism; lisinopril taken for blood pressure; calcium taken for supplement; cyanocobalamin (VITAMIN B12) taken for supplement; denosumab (PROLIA) taken for bone density; vitamin D3 taken for supplement; probiotics taken for supplement. The patient has other concomitant therapy of unspecified antibiotic ointment and another oral antibiotic. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) intramuscular on 16Mar2021 (at 68-year-old) as dose 1, single for covid-19 immunisation, ibuprofen and experienced allergy manifested by swelling, acetylsalicylic acid (ASPIRIN) and experienced allergy manifested by gastrointestinal bleeding, zoster vaccine for immunization. The patient experienced cellulitis in ear (medically significant) on Jul2021, cellulitis on 10Sep2021, shingles on Jan2020, recurred shingles on Aug2021, tired on 2021, achy on 2021, impetigo on 10Sep2021, eye infection on 10Sep2021, yeast infection on 10Sep2021. Clinical details: Solicited report from the USA by a consumer of a 68 years old female with events of impetigo, yeast infection, eye infection and cellulitis and non-serious tired and achy due to covid vaccine, cellulitis in ear, shingles and recurred shingles with HUMIRA 80MG/0.8ML (adalimumab). In Jan2020, the patient experienced shingles. In 2021, the patient experienced tired and achy due to COVID vaccine. In Jan2021, the shingles resolved. In Jul2021, the patient experienced cellulitis in ear. In Jul2021, the cellulitis in ear resolved. In Aug2021, the patient experienced recurred shingles. On 13Sep2021, the patient was diagnosed with impetigo. On 16Sep2021, the patient was diagnosed with eye infection and cellulitis. On 19Sep2021, the patient was diagnosed with yeast infection. In Sep2021, the recurred shingles resolved. In 2021, the tired and achy due to COVID vaccine resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient stated that she had shingles exhibited by tiny red rashes on the left shoulder down to the arm and wrist with excruciating pain. She recovered after two to three weeks with Valtrex. She was diagnosed with cellulitis in her ear and recovered in fourteen days with Doxycycline. She again had shingles on the same area in Aug2021 and took a month to recover with Valtrex and Gabapentin. She mentioned there was no spot but there was shingle pain. She had been getting infections and had not been on medication since 03Sep2021. The physician stated to her that she could be back on medication two weeks after the antibiotics are done. She had gotten the Covid vaccine and was tired and achy. On 10Sep2021 she had developed crusty, weeping, oozing spots with swelling on the bridge of her nose to the right eye. She was diagnosed with impetigo and was given oral Keflex and an unspecified antibiotic ointment. She mentioned that it did not resolve therefore she visited a walk in clinic and was prescribed Erythromycin ophthalmic ointment and another oral antibiotic. The events did not resolve and she went to the emergency room last 16Sep2021 and was diagnosed with cellulitis and an eye infection. She mentioned that she was not given any treatment in the emergency room but was prescribed with Doxycycline. She went back to the emergency room last 19Sep2021 as the events were not resolved and her eyes were swollen shut with flaking of the eyelids and itchiness. She was also diagnosed with a yeast infection. She mentioned that she was treated in the emergency room and was given medication but she could not recall the name. She was prescribed Valtrex and prednisone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 16Mar2021, patient received 1st dose of COVID-19 Vaccine manufactured by Pfizer BioNTech, lot number unknown, expiration date unknown. On 06Apr2021, patient received 2nd dose of COVID-19 Vaccine manufactured by Pfizer BioNTech, lot number unknown, expiration date unknown. The patient was treated with valtrex, doxycycline, gabapentin, keflex, erythromycin and prednisone. The action taken in response to the events for adalimumab was permanently withdrawn on an unspecified date. The patient was recovered from event cellulitis in ear in Jul2021 (duration was 14 days), recovered from shingles in Jan2021, recovered from recurred shingles in Sep2021 (duration was 1 month), recovered from tired and achy in 2021; outcome of the other events was not recovered.  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the events of impetigo, yeast infection, eye infection, cellulitis, cellulitis in ear, shingles and recurred shingles was Not Reported. The reporter's causality for the events of tired and achy due to covid vaccine was Possible.   Causality for HUMIRA 80MG/0.8ML(adalimumab): The reporter's causality for the events of impetigo, yeast infection, eye infection, cellulitis and cellulitis in ear with HUMIRA 80MG/0.8ML (adalimumab) was Probable. The reporter's causality for the events of tired and achy due to covid vaccine was not provided. The reporter's causality for the events of shingles and recurred shingles with HUMIRA 80MG/0.8ML(ADALIMUMAB) was Not Related.  Causality Assessment: opinion is that there is a reasonable possibility that the events of impetigo, yeast infection, eye infection, cellulitis, cellulitis in ear, shingles and recurred shingles are related to HUMIRA 80MG/0.8ML(ADALIMUMAB). opinion is that there is no reasonable possibility that the event of tired and achy due to covid vaccine is related to HUMIRA 80MG/0.8ML(ADALIMUMAB).  The reporter's assessment of the causal relationship of the events impetigo, yeast infection, eye infection, cellulitis, cellulitis in ear, shingles and recurred shingles with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events impetigo, yeast infection, eye infection, cellulitis, cellulitis in ear, shingles, recurred shingles, tired and achy cannot be excluded.  The case will be reassessed if additional information becomes available. 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