Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sneezing, Swelling face
Clinical narrative: eyes were so bad, so swollen; Diagnosed with conjunctivitis; slight headache; soreness in her arm; Sneezing; face was so swollen/Face Puffy; Eye red; Eyes goopy; This is a spontaneous report received from a non-contactable consumer (Patient). This 62-Year old female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry Date, NDC nuber: not reported), via an unspecified route of administration, administered in left arm on 20Mar2021 at 09:00 (at the age of 62 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing hypothyroidism, seasonal Allergies (From: started about 10 years ago To: Ongoing), Shellfish allergy (From: Unknown To: Ongoing). She had ongoing dry eye. She stated that she last saw her eye doctor on 10Mar2021 and was being treated for dry eyes already. Stated she had complained of for years. Received formal diagnosis on 10Mar2021. She was told there was a loss of mucous in the eyes, abrasions in the eyes, and clogged glands. She was told that she had rosacea in her eyes (10Mar2021). It started when she was 11 and found was unable to eat scallops. Then in her 30's she became itchy while eating shrimp, then tried again and her tongue swelled, tried another time and her throat became itchy; at the time of report she broke out into hives if she was around it. Then found out she was allergic to crab also. Family medical history relevant to AE(s) was none, caller only mentioned her own allergies and hypothyroid. Stated there was a million little things wrong with her. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY) 10 mg, 1x/day, taken for seasonal allergies, started a couple of months ago, 4-5 months ago and stop date were not reported; doxycycline (DOXYCYCLINE) 60 mg, 1x/day taken for severe dry eyes, abrasions on eyes, clogged glands from 10Mar2021 to an unspecified stop date; levothyroxine sodium (SYNTHROID) 80 mCi, 1x/day taken for hypothyroid, unknown start date and ongoing (it was recently decreased to 6 days a week from 7 days a week). Past drug included Claritin was not working anymore better for her seasonal allergies. Investigation assessment was not done. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations was not available) was none. Additional vaccines administered on same date of the Pfizer suspect was none. Prior vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. The patient took Covid 19 vaccine as she did not want to get sick. On 20Mar2021, she got vaccine and stood outside under tree waiting on husband for about 15 minutes. She stated that after she received it, she felt fine except for some soreness in her arm at the injection site on 20Mar2021 that came on slowly. She then stated that later in the day she started getting what felt like seasonal allergies, saying her eyes were red and her face started getting puffy. She experienced red eyes, sneezing, and a puffy face on 20Mar2021; she thought it was a seasonal allergy experience. The patient experienced slight headache on 21Mar2021. Mentioned that she was prone to headaches. Stated that she had one the day after the vaccine and that she didn't think it was related as she usually wakes up with a headache. This particular headache started the day after the vaccine 21Mar2021, stated it was a slight headache. Caller stated she was just headachey. She reported that on 21Mar2021, Sunday it got progressively worse. On Monday 22Mar2021, she stated that she took Advil (200mg, took 2 pills; mentioned that the package said to take one but she always took two because one did not do anything. Lot: R85574/Expiration: Feb2023) for the headache. Then she decided to take Sudafed which got rid of the headache. On same day, Monday she had to call her eye doctor because her eyes were so bad, so swollen, eyes red, goopy; face puffy. She was diagnosed with pink eye in both eyes and was prescribed drops (Tobramycin and Dexamethasone Ophthalmic Suspension: 4 drops in eyes a day, for one week; then 3 drops in eyes a day, until bottle was gone) for her dry eyes and for pink eye and reported that a couple of days later her eyes started to get better. She was diagnosed with conjunctivitis on 22Mar2021. On an unspecified date in Mar2021, she had eyes goopy. On an unspecified date, her face was so swollen. She reported that she also had to start taking Sudafed (Sudafed Head Congestion and Pain, over the counter) because her face was so swollen, stating she took 3 pills a day for 2 days but then stopped because it started affecting her dry eyes again. Stated that her symptoms have not gone away completely but were a lot better. Mentioned that her eye was no longer goopy but was still red. She reported that at the time of report her face was back to normal. Caller said that she had made an appointment with an allergist; but it was after the scheduled date for her second shot. She would like to know if her side effects could be related to the vaccine. Caller went online, and it said if a patient had any swelling, they should not get the second vaccine and her second one was coming up. She was worried about getting the second vaccine. Wanted to know if this was something anyone else had experienced. Caller would like to know if it was recommended, she take the second dose of the Pfizer BioNTech COVID-19 vaccine because of her facial swelling after the first dose. She stated that she read online on the CDCD website that if there was any swelling after the vaccine then the second dose should not be taken. Spoke from the fact sheet for recipients/caregivers regarding the contraindications to receiving a dose of the vaccine and what a severe allergic reaction could include. Let caller know that it would be up to her HCP to help her decide if her reaction was a severe allergic reaction. The outcome of event Eyes goopy was recovered in Mar2021, events eye red, sneezing and face was so swollen/Face Puffy was recovering while the outcome of other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.