Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Photophobia, Swollen tongue, Throat tightness
Clinical narrative: She awoke and realized her tongue was swelling; She awoke and realized her throat felt like it was closing; had pain go through to the top of her head, and she thought her head was going to explode; she closed her eyes because the light was giving her severe pain in her eyes; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 08Mar2021 at 15:00 (batch/lot number: EN6205) as a single dose for COVID-19 immunisation. Medical history included pityriasis rubra pilaris from Oct2012 and ongoing - she was in remission since Sep2015 and it wouldn't ever go away fully; an ablation of all 4 heart chambers, and then was put on apixaban (ELIQUIS); back surgery, and now had no feeling in her right leg from the right knee down; her heart had stopped 3 times in the past, and she was brought back each time; had to use a 4-prong cane for the rest of her life; premature ventricular contractions (PVCs); and sinus problems. Concomitant medication included atenolol (50 mg tablet; manufacturer: Zydus Pharmaceuticals) taken as heart medication, start and stop date were not reported. The patient previously took methotrexate, steroids, and adalimumab (HUMIRA) for pityriasis rubra pilaris from Jan2014 to Sep2015 and experienced atrial fibrillation (AFIB). She clarified she did not have the adalimumab NDC, lot, and expiration that caused the AFIB. She stated pityriasis rubra pilaris (PRP) was a rare dermatological autoimmune disease and she was in remission since Sep2015 and it wouldn't ever go away fully. She took methotrexate, steroids and adalimumab. She said it took 3 doctors before she found a dermatologist who saved her life. She said the "PRP" covered 99% of her body at the time she was diagnosed. She said she was on adalimumab from Jan2014 until she went into remission in Sep2015. The patient received the first dose on 08Mar2021, when returned on 29Mar2021, unable to receive second dose. Stated primary care physician ordered blood work to test for antibodies, asking if this was the only way to indicate immunity. She got the first COVID-19 vaccine, and they will not let her have the second COVID-19 vaccine because she had such an adverse reaction to the first COVID-19 vaccine. She said no one would give her any information about the COVID-19 vaccine or answer any of her questions. She said her problem with the COVID-19 vaccine was she had an underlying condition. She said she was 71 years old, and had been through it all. She reported she was in remission for her autoimmune disease. She said she was put on adalimumab for her autoimmune disease, and the adalimumab sent her into AFIB. She said she had to have an ablation of all 4 heart chambers, and then was put on apixaban. She said she then had back surgery, and now had no feeling in her right leg from the right knee down. She said her heart had stopped 3 times in the past, and she was brought back each time. She said she was lucky to be alive, and didn't want to complain because she knows there are other that have it worse than her. She tried to get her second COVID-19 vaccine on Monday, 29Mar2021. She said after she told the COVID-19 vaccination staff what happened after her first COVID-19 vaccine, the vaccination staff all freaked out. She said the COVID-19 vaccination staff told her she couldn't get the second COVID-19 vaccine dose. She and her husband went through a drive-thru COVID-19 vaccination facility, and she was on the passenger side of the car. She said she got her COVID-19 vaccine in her left arm. She said because of her issue with her right leg, she had physical therapy for 3 years, and now had to use a 4-prong cane for the rest of her life. She said a male nurse at the COVID-19 vaccination facility helped her out of the car, and administered the COVID-19 vaccine in her left arm. She said she had an immediate reaction to the COVID-19 vaccine. On 08Mar2021, she said she had pain go through to the top of her head, and she thought her head was going to explode. She said the pain in her head hurt so bad. She said she closed her eyes because the light was giving her severe pain in her eyes. She said the male nurse made her husband move their car into another lane, and she had to wait for 30-45 minutes in the car. She said her headache got worse, and the male nurse made her lay down in the car while she waited. She said she didn't have any further adverse reaction while she was at the (name). She said when she got home, 2 hours later, her husband made her lay down because he didn't want her to go into AFIB. She clarified she had PVCs, and knew when her heart was OK, and when it was not. She said she didn't want to go into AFIB. She said she took her heart medication (Atenolol 50 mg). She clarified she took Atenolol 50 mg 3 times a day. She clarified she arrived home at 4:00PM, when she would normally take her second daily dose of Atenolol 50 mg. She clarified after she got home she laid in bed in the dark, and put a cold wash rag over her eyes. She said she must have dozed off, and when she awoke realized her tongue was swelling and her throat felt like it was closing. She said it was about an hour later, at 5:00PM. She said her husband wanted to take her to the emergency room of a hospital that was about 40 minutes away in (name), but she felt the emergency room was too far away. She said her husband gave her 2 doses of Benadryl (25 mg tablets). She clarified she took 1 Benadryl 25 mg tablet, and waited about a half an hour before she took the second Benadryl 25 mg tablet. She said she took another dose of Atenolol 50 mg because the Atenolol brings her blood pressure right down. She said she was fine after 2 hours.  She clarified her tongue swelling and throat closing resolved by 10:00PM on 08Mar2021. She said her husband gave her that length of time to recover before deciding if he had to take her to the hospital in (name). Treatment was Benadryl 25 mg pink tablet (stated she took 1 Benadryl 25 mg tablet twice, about a half hour between doses) (NDC Number: 50580-226-50, Lot Number: KHL0000; Expiration Date: Jul2022). Stated she can't take generic medication because it doesn't do anything. Reported because her eyes were so bad, so can't drive anymore, and needed a magnifying glass to read the Benadryl NDC Number on the product label. Reported the Atenolol 50 mg tablet was dispensed in a pharmacy bottle and had no NDC, Lot, and Expiration Date. She said the Atenolol 50 mg tablet manufacturer was Zydus Pharmaceuticals. Reported she had headaches for 2 weeks after receiving her COVID-19 vaccine. She said the headache happened between 3:00PM-4:00PM every afternoon at the top of her head. She said the headaches would last until 11:00PM when she went to bed. She said the headaches were not bad, but a dull ache. She said she had sinus problems, and knew the difference between a sinus headache, and a headache at the top of her head. She declined any headache treatment, saying she didn't take over-the-counter medications, like Advil, because over-the-counter medications were bad for her heart. Reported she knew Pfizer had done clinical trials for the COVID-19 vaccine with 60,000 people, and she knew she was going to be the exception with her pityriasis rubra pilaris. Events did not require emergency room visit and physician office visit. No prior vaccinations within 4 weeks. The outcome was recovered on 08Mar2021 for the events "tongue was swelling and her throat felt like it was closing"; and recovered on Mar2021 for the rest of the events.