Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain, Radiation associated pain, Ulnar neuritis, Vaccination site swelling
Clinical narrative: Ulnar neuritis; The pain continued and was described as burning, shooting; deltoid muscle swelled up; radiational pain; induration; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 04Oct2020 (Lot number: FF2389) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS-C", start date: 01Jan1989 (ongoing). Concomitant medication(s) included: LINZESS taken for irritable bowel syndrome, start date: 01Jan2020 (ongoing); MIRALAX taken for irritable bowel syndrome, start date: 01Jan2019 (ongoing). Vaccination history included: Bnt162b2 (Dose:1, Time (24hr): 18:00, Anatomical site of injection: left deltoid, Route of Administration: Intramuscular, Batch/lot number: FF2787), administration date: 13Sep2020, when the patient was 51 years old, for Covid-19 Immunization, reaction(s): "severe pain and swelling at the injection site", "severe pain and swelling at the injection site", "pain radiating down the posterior aspect", "burning sensation". The following information was reported: ULNAR NEURITIS (medically significant), outcome "not recovered", described as "Ulnar neuritis"; PAIN (non-serious), outcome "recovering", described as "The pain continued and was described as burning, shooting"; VACCINATION SITE SWELLING (non-serious), outcome "recovering", described as "deltoid muscle swelled up"; INDURATION (non-serious), outcome "recovered", described as "induration"; RADIATION ASSOCIATED PAIN (non-serious), outcome "recovering", described as "radiational pain". The events "ulnar neuritis", "the pain continued and was described as burning, shooting", "induration" and "radiational pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of ulnar neuritis, pain, vaccination site swelling, induration, radiation associated pain. Vaccination Facility Type: Doctors office/urgent care: Pharmacy or Drug store. Treatment: Methylprenisolone gabapentin. This patient complained that her deltoid muscle swelled up, was very tender to touch, and was indurated to palpation. Although the induration resolved after 48 hours, this patient complained of worsening of the radiational pain down the ulnar distribution Of her left upper arm. The pain continued and was described as burning, shooting, and continued to be triggered by the previously described motions, but now began to be triggered by pressure over the triceps and lateral aspect of her upper arm, such as while laying in bed, being hugged or applying any pressure to the area. Since the burning pain did not improve spontaneously, she was given 2 courses of Medrol dospak with minimal improvement. She was then placed on a month-long Medrol taper, from 24 mg down to O mg, reducing her dose every 3 days by 4 mg. She was also initiated on a up-titrating dose of gabapentin, beginning on 100 mg TID, and titrating up to 300 mg TID over the course of 2 weeks. This provided her with moderate to significant relief, but she had to discontinue the gabapentin after 2 weeks due to a viral gastroenteritis, and is slowly being up titrated again. At the present time, she has experienced mild improvement in her symptoms as compared with the initial presentation, but continues to be unable to use her left upper arm in the previously described movements as those movements trigger her burning, radiational pain.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported  events Ulnar neuritis , Pain , Vaccination site swelling , Induration , Radiation associated pain and the suspect drug BNT162B2 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