Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ear haemorrhage, Ear lobe infection, Eye swelling, Herpes zoster, Pain
Clinical narrative: infection in ear lobe; ear infection/tissue inside his ear dried up and bleeding/infection started in his ear lobe that migrated to his whole left side of his face; Pain localised; Ear bleeding; Skin fissures; Shingles; Fluid discharge; Axillary abscess/substantial bubble of puss under arm; fever/Temp of 105; Chills; weakness; Swelling face; Eye swelling; This is a solicited report based on the information received by Pfizer.  A 73-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 intramuscular on 01Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot Number: 1132646) to an unspecified date, at unspecified dose, subcutaneous from an unspecified date (Batch/Lot Number: 1136949) to Mar2021, at unspecified dose for moderate to severe hidradenitis suppurativa.  The patient medical history includes ear infection. Concomitant medications were not reported. On unknown dates, the patient experienced tissue inside ear dried up and had bleeding, second infection in ears/painful when touched, felt pain on top of head, skin was cracking up, minor infections in ears, possible shingles and whole left side of face and eye swollen. In 2021, the patient experienced infection in ear lobe, feeling low energy and whole left side of face and eye swollen. On 02Mar2021, the patient experienced felt weakness and chills. On 08Apr2021, the patient experienced substantial bubble of pus under arm. On 10Apr2021, the patient experienced thick white odorous liquid almost syrup came pouring out of armpit. In Apr2021, the substantial bubble of pus under arm resolved. On unknown dates, felt pain on top of head, minor infections in ears and whole left side of face and eye swollen resolved. Covid-19 vaccine was also considered suspect. In Feb2021, the patient saw his physician twice for an ear infection. On 01Mar2021, the patient got his first vaccine shot. The next day he had chills and fever and feeling of weakness the next day. He went away after a short time and he felts better. He went to the physician twice in the past two weeks for minor infections especially in his ears. The tissue inside his ear dried up and bleeding. On the first visit he had a fever due to the infection in the ear. His physician prescribed antibiotic for a week. He got another infection in the same ears. He was painful when touched it. He went back to physician and physician prescribed another anitbiotic. The physician said the infections were to be expected with Humira because Humira weakens immune system. Partly because of his age. His age may be a contributing factor as well. He agrees to have physician contacted. On 29Mar2021 to 1Apr2021, he was in the hospital his infection started in his ear lobe that migrated to his whole left side of his face. His eye was swollen and felt pain on top of his head. His Temp of 105 when he went in. The patient was given intravenous antibiotics. He was tested to make sure infection had not spread to blood or bones. The Humira might have played a role because it lowers the bodies resistance to infection. They asked him not to take the Humira for two Saturdays. He did not take Humira on 09Apr2021 or before. He was stable. His skin was cracking up. Thought it might be shingles. He was prescribed an oral antibiotic first time, but then a week and a half later, it acted up again and he went back and got a different antibiotic and that worked until it. He was feeling completely better since he got out of the hospital. He had more energy than he had in a while. He had been feeling low energy for a while due to the infection. His physician did not think he should stop taking Humira but if he got a fever he needs to investigate immediately to see if he needs to hospitalized. In 08Apr2021, he had substantial bubble of puss under his arm. He gave him a steroid injection to control that. On 10Apr2021, he had thick white odorous liquid almost syrup came pouring out of his armpit and he thinks that was the end of it. On 11Apr2021, he had his second Covid vaccine manufactured by Moderna then after he was released from the hospital. He was no issues or reactions with either injection. He was careful when he went out around people. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events adalimumab was not applicable. The outcome of event infection in ear lobe, eye swelling and swelling face recovered in 2021, weakness and chills and fever recovered in Mar2021, ear infection and pain localised recovered on unspecified date, Axillary abscess/substantial bubble of puss under arm recovered in Apr2021; event ear bleeding was recovering; event fluid discharge, skin fissures and shingles was unknown.  The reporter's causality for adalimumab (Humira) on the events infection in ear lobe, tissue inside ear dried up and had bleeding unknown onset, tissue inside ear dried up and had bleeding unknown onset, second infection in ears/painful when touched, felt pain on top of head, minor infections in ears, substantial bubble of puss under arm, whole left side of face and eye swollen onset in 2021 and whole left side of face and eye swollen unknown onset with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt weakness and chills with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of feeling low energy, thick white odorous liquid almost syrup came pouring out of armpit, skin was cracking up and possible shingles was not provided.  Opinion is that there is a reasonable possibility that the events of infection in ear lobe, feeling low energy, thick white odorous liquid almost syrup came pouring out of armpit, second infection in ears/painful when touched, felt pain on top of head, skin was cracking up, minor infections in ears, possible shingles, substantial bubble of puss under arm, whole left side of face and eye swollen onset in 2021 and whole left side of face and eye swollen unknown onset are related to humira(adalimumab). Opinion is that there is no reasonable possibility that the events of felt weakness, chills, tissue inside ear dried up and had bleeding unknown onset and tissue inside ear dried up and had bleeding unknown onset are related to humira(adalimumab).; Sender's Comments: Pfizer comment: The serious events Ear lobe infection and Condition aggravated were considered as unlikely related to Pfizer BNT162b2 vaccine. A possible contributory role of BNT162b2 cannot be completely excluded for the non-serious asthenia, pyrexia and chills, which occurred in a close temporal relation, namely, one day after the  first dose BNT162B2 injection. The other reported events were confirmed as non-serious, while the causality was confounded by ADALIMUMAB administration. The infectious events were to be expected with co-suspect due an immunosuppression activity with increased infection susceptibility, such as Herpes zoster and Ear lobe infection aggravated, in this case. Furthermore, swelling face and eye swollen with unknown onset in 2021 may be attributable to the co-suspect and unrelated to the vaccine. 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.