Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated, Headache, Injection site pain
Clinical narrative: vomiting; nausea/felt like she was going to vomit; headache/bad headache was reported as worsened; arm and joint pain in injection arm/Joint pain; arm and joint pain in injection arm; arm and joint pain, mostly in the left arm where she received the COVID vaccine/left arm pain at injection site; had a history of a pain conditions in her back/ but got worse after the shot"; This is a spontaneous report from a contactable nurse (reported for herself). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 22Dec2020 11:30 at single dose at arm for COVID-19 immunization. Medical history included complex regional pain syndrome from Dec2019 and ongoing, back pain ongoing. Concomitant medications included naproxen sodium (ALEVE) ongoing, duloxetine hydrochloride (CYMBALTA) from 20Dec2020 and ongoing. Caller wanted to know if she should receive the second dose of the Covid vaccine. She received the vaccine yesterday (22Dec2020) at 11:30 (11:30 a.m.) by 21:30 (9:30 p.m.) she was experiencing side effects of vomiting, nausea, headache, arm and joint pain in injection arm, and continued to feel as if she was going to throw up. HCP was called to get Zofran prescribed. Caller further reported that she got the COVID Vaccine yesterday, 22Dec2020, at 11:30 (11:30am). At 21:30 (9:30 pm) last night (22Dec2020), she started vomiting and has had nausea since that time. Caller also stated that she had a really bad headache. Caller stated that she also had arm and joint pain, mostly in the left arm where she received the COVID vaccine. She went to sleep at 8:30 last night and woke up vomiting at 9:30pm and then had had nausea and a headache since then. If she tried to get up, she felt like she was going to vomit. She had a history of a pain conditions in her back and "let" (as reported, pending clarification). Stated that she cannot say that this was entirely due to the shot, but got worse after the shot (Dec2020). Caller reported that last night, she took Zofran which help the vomiting. The vomiting stopped around 3 o'clock this morning (23Dec2020 03:00), but she was still having nausea that made her feel like she was going to throw up. She could not stop vomiting for a few hours during the night. Caller asked how she know if she should be taking the 2nd dose of the COVID vaccine. Events Vomiting, Nausea, bad headache, left arm pain at injection site, Joint pain all reported as started from 22Dec2020 (21:30). Patient recovered from vomiting with lasting effects of nausea which made her feel like she was going to vomit, started on 23Dec2020. Reporter seriousness for Vomiting, Nausea, bad headache was Medically significant and bad headache was reported as worsened. Reporter seriousness for left arm pain at injection site and Joint pain was not serious. No Investigation Assessment. The reporter considered events Vomiting, Nausea, bad headache, left arm pain at injection site, Joint pain were related to the suspect product. The outcome of the event vomiting was recovered on 23Dec2020 03:00. The outcome of "had a history of a pain conditions in her back/ but got worse after the shot" was unknown. The outcome of the other events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vomiting, nausea, headache and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics 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.