Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test negative
Clinical narrative: Arm at the site a little bit above the elbow where biceps are, were sore,; slight headache; exhausted; bad cold/cold type symptoms; upper respiratory infection with a sinus infection; upper respiratory infection with a sinus infection; mild respiratory infection; not feeling well; like a viral cold; nausea; This is a spontaneous report from a Pfizer sponsored program  via a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm) on 09Jan2021 at SINGLE DOSE for COVID-19 immunisation.  Patient's medical history included psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included paracetamol (TYLENOL). It was reported that patient wanted to know if she should get the second vaccine in the series. Patient mentioned that she had the first Pfizer Covid vaccine 09Jan2021. Approximately three weeks later, she developed a mild respiratory infection. It was mentioned that patient has psoriatic arthritis (one Dr told her she would experience more symptoms getting the second dose- another Dr told her she could die) and her physician wants her to start methotrexate, however, she is not currently taking this product. Patient is currently only taking paracetamol. Patient also mentioned that she had three friends who had the Pfizer Covid vaccine and they felt awful like they had the flu for 48 hours post vaccination. Patient asked if there was no allergic reaction to the first vaccine, will there be no allergic reaction to the second vaccine. Patient also asked if it is okay to start on methotrexate after having the vaccine and if this will decrease effectiveness. On an unknown date in Jan2021, patient stated she is not feeling well last night, something like a viral cold. Patient also stated "It was not bad at all. Arm at the site a little bit above the elbow where biceps are, were sore, slight headache the day after the 1st dose, after 3-4 hours I was exhausted, 2 days exhausted, maybe slightly nausea". Patient also mentioned Thursday night that she had a very bad cold from the beginning and has upper respiratory infection with a sinus infection. It was also reported that patient was not on immunosuppressants and has never had anaphylaxis. It was also reported that patient had swelling in her hand from the arthritis. On 21Jan2021, it was reported that patient went to urgent care with upper respiratory symptoms and a COVID test was performed which was negative. Patient stated that she is to have #2 covax this coming Saturday and is still dealing with some cold type symptoms and asks if she should get the second covax. Patient is not running a fever. Outcome of the event 'bad cold/cold type symptoms' was not recovered, outcome of the remaining events was unknown.  Information on lot number/batch number has been requested; Sender's Comments: Based on the temporal relationship, the association between the event upper respiratory tract infection with BNT162b2 can not be completely 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.