Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Skin tightness, Sleep disorder
Clinical narrative: Lymphadenopathy; Injection site pain/pain and tenderness under her arm; Lethargy; tired/did not feel like getting out of bed; Headache; arm was swollen/her sleeve was tighter, 1.5-2 inches bigger than her other arm; This is a spontaneous report from a contactable nurse reporting on behalf of herself.  This 50 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1685) on 19Dec2020 at 11:15, at single dose, in right deltoid, for COVID-19 immunization. No other vaccine was given on the same date or within 4 weeks before. Medical history included ongoing epilepsy, ongoing depression and anxiety, COVID in late Oct2020 early Nov2020 (so her manager advised her to get the vaccine), allergies as a child, ongoing allergy to penicillin that showed up on an allergy test, ongoing allergy to house dust and trees, things like that. She previously received influenza vaccine in Oct2020, for immunization. AE(s) following prior vaccinations: none. Family medical history relevant to AE(s): none. Concomitant medications included topiramate (TOPAMAX) and brivaracetam (BRIVIACT), both for years, for epilepsy and duloxetine HCl (CYMBALTA) from Aug2020, for depression and anxiety. The reporter related Cymbalta use to COVID. The patient experienced lymphadenopathy on 21Dec2020, headache on 20Dec2020, injection site pain on 20Dec2020 at 03:00, lethargy on 20Dec2020, tired on 20Dec2020, arm was swollen on an unspecified date in Dec2020. Lymphadenopathy was reported as medically significant. The other events were reported as non-serious. The reporter stated it was painful but everyone told her it would be so she expected that. At about 3 A.M. on 20Sun2020 she woke up to her arm hurting when she tried to turn on her right side. She had taken 2 of the arthritis strength paracetamol (TYLENOL) the night before because she was told it was going to hurt, that might have been the reason she did not notice it before then. This was just injection site pain. At this point, she still had some injections site pain and it was tender if bumped but it was better than before. On 20Dec2020 she did not go to church because she felt tired and did not feel like getting out of bed, she also had a headache but these things were expected by her. She stayed in bed till noon. She went to work on 21Dec2020 and in that morning when she went to apply deodorant she noticed pain and tenderness under her arm. Her arm was swollen and she noticed that her sleeve was tighter so she had her husband measured her arm and it was 1.5-2 inches bigger than her other arm. It was tight and tender, actually at this point it was more than tender when she put her deodorant on. She was also giving the vaccine. No other treatments were given and she had not called her doctor about this. No emergency room or physician office visit were not required. Relevant tests: none. Headache and lethargy resolved on 20Dec2020. Injection site pain was resolving. Lymphadenopathy had not yet resolved and was reported as aggravated. The outcome of the other events was unknown. The reporter considered there was a reasonable possibility that headache, injection site pain, lymphadenopathy, lethargy were related to BNT162B2 vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject drug cannot be excluded for the lymphadenopathy and the 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, 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.