Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Dehydration, Ear discomfort, Eye pain
Clinical narrative: wound up in the emergency; eye pain; Nausea; my ears are just muffled, like the sound of everything is muffled; dehydrated; neck pain; vomiting; excruciating headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:15 (Lot number: EN6206) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid vaccine" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for autoimmune thyroiditis, start date: 2012 (ongoing); CYTOMEL taken for autoimmune thyroiditis, start date: 2012 (ongoing); CYCLESSA taken for contraception (ongoing). The following information was reported: WOUND (non-serious), outcome "unknown", described as "wound up in the emergency"; VOMITING (non-serious) with onset 24Mar2021, outcome "recovered" (26Mar2021), described as "vomiting"; HEADACHE (non-serious) with onset 23Mar2021, outcome "recovering", described as "excruciating headache"; EYE PAIN (non-serious), outcome "not recovered", described as "eye pain"; NECK PAIN (non-serious) with onset 24Mar2021, outcome "recovering", described as "neck pain"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DEHYDRATION (non-serious) with onset 26Mar2021, outcome "unknown", described as "dehydrated"; EAR DISCOMFORT (non-serious), outcome "recovering", described as "my ears are just muffled, like the sound of everything is muffled". The events "vomiting" and "dehydrated" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, eye pain, neck pain, nausea.  Additional information: The patient would like to know if she has to return on 9Apr2021 for her 2nd dose of the covid vaccine as scheduled due to her symptoms from the 1st dose. The patient had a violent reaction where she was vomiting for 3 days, excruciating headache, eye pain, neck pain. It has been almost 2 weeks since she got the vaccine and was supposed to get the next dose on 9Apr2021. She also reported that she wound up in the emergency. She saw her primary care physician who asked if she could get some advice from Pfizer. The patient would like to know if it would be okay to show up on 16 Apr 2021 at the vaccination site although her vaccination card notes 9 Apr 2021. The patient would like to tell what happened after her vaccine and get some advice. On 19Mar2021, she had the 1st dose in City name and felt fine that day and felt totally fine through 22Mar20221. On 23Mar2021, she developed out of nowhere the most excruciating headache of her life and thought she would sleep it off, but it was too much pain. She started vomiting every 10-15 minutes and was vomiting nothing as she could not eat anything. She went to a walk-in clinic because she did not know what to do and they gave her a shot of Zofran to stop the vomiting and she was able to drink a little but could not eat as she was so nauseas. When the Zofran wore off, she started vomiting again, and the next day she had a lot of vomiting. She did a Covid test, and it was negative, and she was still unable to eat or drink without throwing up. On Friday 26Mar2021, she went to the ER because she was completely dehydrated and still had the headache real terrible 3 days later and had the same symptoms and thought something else was wrong and she did not know what to do. States the ER did a CAT scan of her head, blood work, urine and another Covid test and a flu test. States all of these were negative and fine, and she got another Zofran shot to stop throwing up. Caller states she was in the ER 7-8 hours, and they gave her Tylenol and that was the only pain medication she was taking, and it really did not do anything. States she was sent home because she had a cup of water and a cracker and kept that down and that was the last time she threw up. The next day was a little better and each day the nausea subsided, and the headache subsided, and she started to feel like a human being. 9 days since her first symptoms and her head still hurts, not like it was that she was about 80% better. Her neck now hurts, and her eyes hurt really really bad. She went to her primary care doctor yesterday and they looked over the test results and said everything looked fine and looked in her eyes. Her ears and her hearing were muffled, that it was getting less and less each day. Her healthcare provider had no advice, told her it could be from the shot or be some weird virus. She was 100% healthy and people have said why 3 days later but why. Her doctor told her to call and report and also to find out what she should do about the second half of the vaccine. The vomiting started in the middle of the night so technically on 24Mar2021 and she vomited 50 times over the 3 days. It stopped 26Mar2021. Caller clarifies the 1st Covid test was at pharmacy drive through and was self-administered and the put it in a portal and this was on 25Mar2021. The hospital did a rapid Covid and a Covid PCR and both were negative, and this was 26Mar2021. She got Tylenol in the hospital that did not work she thought it was extra strength. States they gave her 3 pills. Caller does not have NDC, lot, expiry to provide. Caller states they just handed to them to her to take. The neck pain started last week and was excruciating, and the headache took over and she noted the neck pain at the hospital, and they were worried about meningitis and ruled that out and it was getting better and was still there and states it could be from throwing up 50 times. The eye pain started Saturday or Sunday and was still going on, kind of the same as it has been. States it was both eyes. Provides that it was when she looks up, down, left, or right. The neck pain started after the vomiting started on the same day, maybe later that day. The ears and muffled hearing started Wednesday, or Thursday and it was still there but was improving. The patient stated that she called # and pressed 3 and got DSU after being on hold for 48 minutes. She had called another number and she gave her information and said she wanted to talk about specifics and was given this number. States she also got the Covid line hours for USMI. The patient stated, "So, she got the first dose of the vaccine on 19th March, and she was fine on March 20th, she was fine on 21st, March 22nd fine. March 23rd, 3 days later she started experiencing an excruciating headache and then nonstop vomiting for 3 days. She had to go to the emergency room to get the vomiting to stop because she could not, she could not even take a sip of water. She was very, very dehydrated because she kept throwing up. And now it's a week later from there and I'm still experiencing like head, neck pain, my ears are just muffled, like the sound of everything was muffled, my eyes hurt. And she went to my primary care doctor. When she went to the emergency room, they did all kinds of tests on me, they did a CAT scan, blood work and everything and everything was totally fine. And so, she went to my primary care doctor yesterday, just to follow-up and you know, they could not find anything wrong with me was what I'm trying to say. Thank God. So, in my opinion, she felt like the vaccine was doing this to me. She still feeling awful. So, she just wanted to speak with someone about what happened, and she also wanted to get some advice on what she should do about the second shot. She stated that she takes birth control, Cyclessa, one pill a day, she did not know. She stated that it was like a thyroid disease, an auto immune thyroid disease, called Hashimoto's. She stated that they gave me a CAT scan of my head because my head hurts so bad. They did blood work, urine analysis, everything was negative. She stated that the only thing she took was Tylenol and anti-nausea pills that they gave me in the hospital. She stated that she was taking 3 pills, 1000 mg of Tylenol but it did not do anything. It did not help her. She stated that it was called Zofran, as far as in mg, she thought it was like 8 mg. They gave it to me intravenously, so I'm not exactly sure. She stated that it was the Pfizer BioNTech Covid 19 vaccine, 1st dose. She did not have NDC, expiry date or dose to provide. The patient declined to provide information prescribing Healthcare Professional. There was a Product Complaint. Investigation Assessment was yes. The report was not related to a study or programme. Why was the patient taking Covid 19 vaccine (Verbatim): so she did not get Covid and die. She did not know dose of Cyclessa and stated that she has been taking for about 10 years. Vaccine was not administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was 1st dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were no.  No follow-up attempts are possible. No further information is expected.