Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: pain; Armpit is swollen/ left lymph gland in my armpit was swollen felt like a pebble; Armpit hurts/ lymph gland, and it hurts; swelling in the shot arm; They gave it higher than the first one; This is a spontaneous report from a contactable consumer (patient herself). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0172), via an intramuscular route of administration in the left arm on 01May2021 10:00 (on Saturday) (age at vaccination: 74 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing insomnia which she had for 20 years. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EW0151, Everything was fine with the first shot, 1st Dose, Time: 10:00 AM) on 10Apr2021 (age at vaccination: 74 years) for COVID-19 Immunization, reaction(s): "No adverse event". Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for insomnia, she went on it again about 8 months or a year ago. She was off it for a long time; clonazepam taken for insomnia, has been on it for a year or 2 years; calcium, had been on it for at least 2 years; cholecalciferol (D3), had been on it for at least 2 years; vitamin c (ascorbic acid), had been on it for at least 2 years; zinc, started it last year and magnesium. She may have left something out. They have nothing to do with it. She has kept switching them for years and sometimes adds one. On 01May2021, the patient experienced armpit was swollen. The patient's left lymph gland in her armpit was swollen felt like a pebble. It went away after 7 to 10 days. It appeared to be a lymph gland, and it hurts. On an unknown date, the patient had pain, few hours after the vaccine. On an unknown date in May2021, they gave it higher than the first one and there was swelling in the shot arm after few hours of the vaccine. The patient does not remember the time of onset of event, it maybe 1600 to 2000. She was a little bit vague on that. She took Advil (Lot: WJ21524, expiration date: Jun2023), which helped a little bit, but then it comes back. She has the bottle. They were 200mg and she took 2. She had 400mg total. She wanted to know approximately how long it may last, and does she need it to be drained or if there was anything to do. She can tell her doctor, or will it go away by itself. When she puts her arm down, she feels it press against it. It was not the worst thing, but it was there. She said it was just annoying, but it was there. She doesn't know if she should do anything about it or let it go and it will dilute itself. Her doctor doesn't seem to know. The patient did not have any investigations. She had an annual visit in January, and everything was fine. Her symptoms didn't start until hours after the shot. The patient did not have emergency room or physician office visit. The outcome of Lymphadenopathy (Armpit is swollen/ left lymph gland in my armpit was swollen felt like a pebble) was recovered on May2021, Lymphadenopathy (Lymph node disorder) was recovered on 2021, pain was not recovered; product administered at inappropriate site, peripheral swelling was unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up (27Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non HCP letter sent that included: Updated information: Batch/Lot Number of dose 2 was updated, Route of administration and Anatomical Site of injection were added, historical vaccination's details updated and event verbatim was updated to Armpit is swollen/ left lymph gland in my armpit was swollen felt like a pebble (previously Armpit is swollen), event outcome and stop date updated.  No follow-up attempts are possible. No further information is expected.