Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Drug ineffective, Ear discomfort, Headache, Influenza
Clinical narrative: could have had COVID that's why I had severe allergic reaction; could have had COVID that's why I had severe allergic reaction; neck was swollen; felt like the back of her eyeballs were poking/feeling of the eyeball outward/like to the front, like they would pop out of her eye; severe headache; lymphadenopathy/appeared neck was swollen, probably lymph nodes, swollen to the back and side; neck pain feeling of the eye ball outward lasted 1-4 days/severe neck pain; ear burning in ear drums/burning in eardrums, both ears; I thought a severe allergic reaction was like anaphylaxis; little reaction on her left forearm, of a rash; bad flu; This is a spontaneous report from a contactable nurse (patient). This nurse reported different events for different vaccine doses for the same patient. This is one of the two reports.  A 62-years-old female patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 08Jun2021 at 15:00 (Batch/Lot Number: EW1071) single; and dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot Number: EW0183) single, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from Jun2021 to 09Jun2021. It was reported that with the first Pfizer vaccine dose on 19May2021, she developed chills, had severe headache, feeling of ants crawling in her throat, and shooting pain in the calves and left calf shot down to the big toe, it was shooting pain, but both calves were involved. The patient experienced rash on 08Jun2021; anaphylactic reaction on 09Jun2021; severe headache, 'lymphadenopathy', 'neck pain', 'ear discomfort', 'swelling', 'ocular discomfort' on 09Jun2021 at 15:00; and bad flu in 2021. After what the patient experienced with the first vaccine dose, she was indicated to take Benadryl thirty minutes before the second vaccine. She was however told that it could mask potential side effects. Due to the masking potential, she stopped taking it and reported adverse events. The patient reported lymphadenopathy, headache, neck pain, feeling of the eye ball outward which lasted 1-4 days, and ear burning in ear drums. The patient stated that these (unspecified) stopped on Sunday. Stated that the headache was most severe. Also stated that "I thought a severe allergic reaction was like anaphylaxis". The patient was at another doctor's office and was indicated that she could also have had COVID that's why she had a severe allergic reaction. According to her, she had never been mask less, and was double masking. She works from home. Second vaccination was two weeks post. She could have possibly gotten it, bad flu, that would be the only time she could have. The patient had called on 09Jun2021 as she got her second dose of the Pfizer vaccine on 08Jun2021 and someone was supposed to call her back from the department, whoever handled Adverse Events, but no one ever returned the call or sent an email. She took the first Pfizer vaccine on 19May2021 and had severe headache, feeling of ants crawling in her throat, shooting pain in calves and left calf shot down to the big toe, it was shooting pain, but both calves were involved, and she had spoken to an employee health nurse, who suggested she take a Benadryl 30 minutes before the second vaccine. As they were concerned about the crawling in her throat, they feared anaphylactic reaction to the second, as people said the second was worse, and she called her doctor to confirm, who was also in agreement for her to take it. Her doctor said to take it and take it every 4-6 hours for the first 24 hours, and she had the vaccine on the 8th at around 3PM, and had a little reaction on her left forearm, of a rash. It lasted about 10 minutes and went away. At the vaccine site, they let her go, and she took the Benadryl twice more, her last dose was at 0130. On 09Jun2021, she called Pfizer, who said they don't recommend to take Benadryl, that it could be masking potential side effects that can lead to anaphylaxis, so she stopped taking her last dose at 0130, and at 3PM on the 9th, she had severe headache, neck pain, it appeared her neck was swollen, stated it was probably lymph nodes that were swollen to the back and side, she had burning in her eardrums, both ears, and she felt like the back of her eyeballs were poking, like to the front, like they would pop out of her eye (she thought that was the most predominant symptoms she had). It lasted for 3 days. She spoke to someone on 09Jun2021 in the morning. and stopped taking Benadryl, and they said she would get a call from Pfizer and she thought she would report those side effects after the second dose because they happened in the afternoon, and now she has a day off from work, so she thought to call and say what happened with the second dose. The patient stated that she works from home, but she was not clinical. Confirmed it was the COVID 19 Pfizer vaccine that she received. The severe headache started after 3PM on 09Jun 2021, it was not ongoing and it went away on Sunday, which the reporter provided as "12Jun2021" The patient stated that she has had intermittent headaches ever since, so has recovered with lasting effects, they are not as severe as the original, but she had some lasting effects. The patient was inquiring if she should receive a booster. According to the patient, they were talking about the potential of having to give boosters, and with everything she had been through with the first two (the second was worse than the first), she was ambivalent about getting the booster. Outcome of the event 'rash' was recovered on 08Jun2021; for 'lymphadenopathy', 'swelling', and 'ocular discomfort' was recovered on 10Jun2021; for 'neck pain' and 'ear discomfort' was recovered on 11Jun2021; for 'headache' was recovered with sequela on 12Jun2021; while for the other events was unknown. Seriousness criteria for the severe neck pain was reported as disabling; for the "burning in eardrums, both ears" was not serious; while for the initial headache, to the 12th was severely debilitating, she couldn't do anything, it was horrible, but the lasting effects were tolerable, she took Tylenol and it resolved. For the severe neck pain that ended in the morning and was no longer present (appeared neck was swollen: ended in the evening) seriousness was reported as just mild discomfort, not disabling. For the burning in eardrums that started in the evening, at hour of sleep, at night, was bilateral, burning, inner ear pain, and it was intermittent, and lasted until 11Jun2021, and she went to the ear doctor today, who said her eardrums were ok, but she was concerned, so this was reported as not serious. For the eyeballs poking that happened at the same time as burning eardrums, only at hour of sleep at night, and woke up on the 10th and it was gone, seriousness was reported that since it was intermittent, not disabling, but was annoying. Also stated that it was frightening, but she was worried if it continued, she would go to the eye doctor, but it went away. Causality for the events was reported as follows: severe headache: Yes (Related), severe neck pain: Yes (Related), "appeared neck was swollen, probably lymph nodes, swollen to the back and side": Yes (Related), burning in eardrums, both ears: Yes (Related), and "felt like the back of her eyeballs were poking, like to the front, like they would pop out of her eye": Yes (Related).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677809 Same patient, same product, different events/vaccine dose