Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Swelling around mouth; Aching in my mid back; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Batch/Lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included montelukast, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); colecalciferol (vitamin D), and bumetanide (BUMEX). The nurse stated that she got the Pfizer COVID Vaccine yesterday (28Dec2020) and she didn't know if she should report the side effects but she didn't yesterday and she was going to today (29Dec2020). It didn't happen right away, it was like throughout the day, her eyes started swelling around them, she had swelling around her mouth, she still has it actually. She didn't have any breathing issues but there was a lot of aching in her mid back which was gone now, the aching part, but it was the swelling that concerned her. They were around her eye, the left one. She had a question herself though because this was just her first vaccine. She meant it wasn't bad enough that she had breathing issues because she monitored it and it's already in there now. She asks if it would it be okay to get the next one. As treatment, the patient took Tylenol and a Benadryl. The patient also mentioned that she has been extremely tired too. What she meant was she was sitting at her desk at work yesterday and she was nodding off. According to her, it was just offered through work and they went to a hospital to get it. The patient said that she did not have to seek medical treatment for it, so it was not like life threatening. When clarified if the swelling around eyes was still there, the patient stated that it was not as prominent, it was more around the eyes it's worse. She further stated that it has improved, she was still tired but the swelling had improved. The patient was also asked regarding the route of administration and she stated that she believes it was long enough to be, it looked like IM, she was not sure. It might have been a SubQ but she means it wasn't like a huge long needle but it wasn't like the real short ones either. Outcome of the events "Eyes started swelling, around my eye the left one, it is more around the eyes it's worse", "Swelling around mouth", "Aching in my mid back", was recovering/resolving; for the event 'Fatigue' was not recovered, while for 'Somnolence' was unknown. Causality assessment of the reporter between the events 'eye swelling', 'swelling around mouth', 'aching in my mid back', and 'I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of' and BNT162B2 was reported as related.