Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Vaccination site pain
Clinical narrative: pain in the spot the vaccine was given; 1st dose was 22MAR2021 and 2nd dose was 31OCT2021; 1st dose was 22MAR2021 and 2nd dose was 31OCT2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 31Oct2021 (Lot number: 32030BD, Expiration Date: 28Feb2022) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune disease", start date: 11Jan1960 (ongoing), notes: Caller states she has an autoimmune disease and asthma.; "asthma", start date: 2017 (ongoing), notes: Caller states she has an autoimmune disease and asthma.; "Arthritis", start date: 1980 (ongoing); "Allergies", start date: 11Jan1960 (ongoing). Concomitant medication(s) included: ADVILCAPS taken for inflammation; CLARITIN [LORATADINE]. Vaccination history included: Bnt162b2 (dose 1, expiry date: Jun2021, Caller states after the first dose, within 4 hours she couldn't breathe and had to do inhalers every 4 hours), administration date: 22Mar2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "she couldn't breathe and had to do inhalers every 4 hours", "she has never had a vaccine without a fever", "couldn't drive for 3 weeks", "Fuzzy", "Floating", "Floating", "Sore throat", "swollen glands", "Headache", "Tender arm", "Vertigo", "Double vision", "Taste", "Smell", "nauseated", "Diarrhoea", "Hot flashes", "Chills"; Bnt162b2 (dose 1, expiry date: Jun2021), administration date: 22Mar2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "Body aches"; Tetanus shots (Caller states she has always had severe reactions even to the tetanus shots it took her 3 weeks to recover), reaction(s): "she has always had severe reactions". The following information was reported: VACCINATION SITE PAIN (non-serious s) with onset 31Oct2021, outcome "recovered" (2021), described as "pain in the spot the vaccine was given"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OFF LABEL USE (non-serious) all with onset 31Oct2021, outcome "unknown" and all described as "1st dose was 22MAR2021 and 2nd dose was 31OCT2021".  Additional Information: The caller was calling because she had her 2nd dose yesterday and said that she is not having side effects and she is concerned because with her 1st dose of the vaccine she had so many side effects that went on for months. She has an autoimmune disease and asthma. She has previously had severe reactions even to a tetanus shot that took her 3 weeks to recover from. With the first dose of the COVID vaccine it took her 5 months to recover. Within 5 minutes of the first dose she experienced symptoms. She couldn't drive for 3 weeks. After the 2nd dose, within 4 hours she couldn't breathe and was using her inhalers every 4 hours and the doctor put her on steroids. With the 2nd dose she had no side effects but had pain in the spot where she had the vaccine. The lot number is 32030BD. Caller clarifies and confirms that it was after the 1st dose that she couldn't breathe and was using her inhalers every 4 hours, not after the 2nd dose as provided by transfer agent. With her 2nd dose she had nothing and she has never had that happen in her life because of her autoimmune disease that she was born with. She usually will at least get a fever and this time she had nothing so she was wondering if she had an expired vaccine or one that was not stored properly. The doctor wanted to make sure that she had everything, including steroids at home. The doctor gave her a 6 day pack of the steroids in advance even though normally they would only give those afterwards but previously the caller couldn't drive and once she got home the symptoms had kicked in so she needed to have that on hand. She also had to make sure that she had her inhalers on hand since she was using both every 4 hours after the 1st dose. They make you sit there for 15 minutes after the vaccine and she just thought, uh oh here we go, it is all expected when she has a vaccine. Mentally she was very conscious and aware of what was going on but she can only describe it like she felt like she was floating and then sounds became amplified and light became so bright and everything was getting fuzzy and she thought that she better get home where she has her medications. When she stood up and looked down she thought, okay she is standing now, and when she was trying to make herself walk it was weird. She only had to drive 2.5 miles to get home and when she did she had started with a sore throat, fever, swollen glands and then she felt like she had ran a mile and she only walked from her car into the house. She laid down and took a nap and she woke up 4 hours later. She also had body aches, chills, and she was sweating and then freezing which was like hot flashes she had when she was going through menopause. The reason that she woke up at 4 hours was because she was having problems with her breathing and her asthma has been under control for 2 months before this. She began using her inhalers and when she was getting off of the sofa she was out of breath. She thought well her asthma has just flared and that's possible. She also was nauseated and had diarrhea and thought good Lord. The next day she couldn't taste or smell anything and then that lasted the whole day but she still had all the other symptoms too. When she woke up from her nap the lights were still really bright and sounds were still amplified and then she was starting to have double vision and that was kicking up her vertigo. She has suffered from vertigo her whole life. Eventually, later that week, she figured out that if she covers her right eye, then she could see everything normal out of her left eye, but out of her right eye everything was at a 45 degree angle. It was brutal and she couldn't drive for 3 weeks. When she was able to get to the doctor's office they had prescribed her steroids to see if a dose of steroids for a week would get it under control and it didn't. The doctor said that she was surprised with the vison issues. The caller also had severe headaches. Finally after all of this the fever broke after 5 days and then the headache went away but the double vison continued and the other side effects were starting to dissipate. The sound and light sensitivity, nausea and weakness had all continued. Then the doctor had gave her the prescription for steroids and after a week, finally, the double vison started getting better but the steroids didn't resolve it. The doctor sent the caller to an ophthalmologist who said that there was no medical reason for her double vision and referred her to a neurologist and when she was eventually able to go to see the neurologist, months later since she was a new patient, he diagnosed it an as BPPV migraine that was triggered. He asked the caller why she didn't recognize her own migraine and she said that she had never had one in her life. After 5 months she had the okay to get the 2nd dose but she decided to get her flu shot first since she knew she would recover faster from that. Now she was wondering when she should get her booster.  No follow-up attempts are possible. No further information is expected.