Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Disease recurrence, Ear pain, Swollen tongue, Tongue pruritus
Clinical narrative: had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; Itching on the left side of her tongue; She had a little bit of swelling on the left side of her tongue; Other autoimmune type things going on; This is a spontaneous report from a contactable nurse reporting for herself. This 62 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246) on 19Jan2021 at 14:30 (at the age of 62 years old), in left arm, for COVID-19 immunisation. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing trigeminal neuralgia (she had nerve issues, clarifying she was diagnosed about 6-1/2 years ago with trigeminal neuralgia that caused right-sided pain in her head and in her right ear), Raynaud's in her hands and feet since she was a kid. The patient previously took a 7-day course of levofloxacin (LEVAQUIN) and after that she had a diagnosis of ongoing erythromelalgia in her hands and feet and permanent ringing in ears, both since 2014, after she took, saying she functioned fine with the permanent ringing in her ears, she had gotten used it. She also felt horrible and had a muscle tear in her right arm a week after taking Levaquin. Concomitant medication included nortriptyline 20 mg capsule once daily (at night), ongoing since about 6-1/2 years ago, for trigeminal neuralgia. On 19Jan2021, 3 hours after vaccination, the patient experienced itching on the left side of her tongue. On the same day she had a little bit of swelling on the left side of her tongue. She took 1 generic 25 mg tablet of diphenhydramine (BENADRYL) at 19:30 and was okay and slept fine. The next day it felt different but it wasn't itching. She had other autoimmune type things going on. Since an unspecified date in Feb2021 the patient had been having more ear pain and usually took medicine for this but had not had ear pain in awhile. The patient said the left side of her tongue itching and swelling was enough to make her concerned. She also said she was concerned that there may be something in the COVID-19 vaccine that will activate her nerve issue since her right ear had been hurting her since Feb2021. She said she thought that maybe the cold weather was causing her right ear pain, but she had been on medication for over 6 years now that had been taking care of her right ear pain. She said she did not want to have the second COVID-19 vaccine injection if it was going to set off her nerve issue. She stated the doctors were thinking that she should get it but staying there and be monitored and not get it on her day off. She would be getting it at the student health center where she worked so she could be monitored and would have access to medical treatment if needed. Relevant tests: none. The events did not require ER visit or physician office visit. Itching on the left side of her tongue resolved on 19Feb2021. Swelling of tongue resolved on 20Feb2021. The other events outcome was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  autoimmune disorder and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical condition in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including autoimmune panel, ANA and ESR, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.