Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nasal congestion, Rhinorrhoea, Sinus congestion, Sudden hearing loss
Clinical narrative: upper sinus congestion/nasal congestion; upper sinus congestion/nasal congestion; sudden hearing loss; tight feeling in neck and jaw; fullness or weird feeling in her head and ears; fullness or weird feeling in her head and ears/odd feeling in ears/ears felt clogged up; fullness or weird feeling in her head and ears; nasal runny nose; This is a spontaneous report from a contactable consumer. This consumer reported for a 68-year-old female patient (family member) that who received first dose of BNT162B2 (COMIRNATY) at the age of 68-years, via an unspecified route of administration on 18Aug2021 at single dose for COVID-19 immunization. Medica history included patient was allergic to corn, spicy food, sunflower products, cumin, rye, caraway seeds. Concomitant medications were none. The patient received her first dose of the Pfizer covid vaccine. Right after she had a list of adverse reactions: on 18Aug2021, tight feeling in neck and jaw, fullness or weird feeling in her head and ears, they tested her on blood pressure and other things but no explanation on her head sensation and stated it should get better. About 5-7 days after that, on 26Aug2021, she felt were her ears were clogged up (like when you change elevation); odd feeling in her ears and that feeling didn't go away. Then went to the HCP to ENT. She had a sudden hearing loss on 26Aug2021 and regardless of treatment. She had multiple hearing tests and then get worse each time instead of better and no prior hearing issues/loss prior to the Pfizer covid vaccine. She also got side effects with upper sinus congestion/nasal congestion. She had a nasal runny nose immediately after the vaccine; within 35 minutes of the vaccine and continued with her since that time and no OTC or medicine clears up the congestion. She was at the doctor today. Consumer wanted reports about hearing loss and sinus congestion, asked about nuts in the vaccine, asked about gluten in the vaccine. They had reported the tight feeling in neck and jaw and a fullness or weird feeling in head and ears to the person that gave the vaccine and was looked at following and then they were cleared he guesses. Then a week or so later ears felt clogged up, like from an elevation change or something like that, and had since been diagnosed with sudden hearing loss. It was getting very severe and had had treatment for that and there was no other explanation other than the vaccine with having the experience with this scenario. They were still seeking treatment. Consumer said any information at this point would be helpful to them since this was something brand new. He was not entirely sure that an ENT or ear specialist were entirely familiar with what can be done to treat this other than what they may would do in for sudden hearing loss but since its quite possibly drug related this may be a totally different animal. The patient then continued having the feelings for days after the vaccine and then she also got a lot of nasal congestion that wouldn't clear and it still hadn't cleared. Consumer thought that the jaw tightness and the neck feeling may of gotten better but the ear fullness and tightness never went away. Then it worsened and went into sudden hearing loss with hearing tests confirming that. The patient had not had any type of hearing loss or issues prior to the vaccine. Consumer thought that the first sign of sudden hearing loss was within 5 to 7 days following the vaccine, and then put 26Aug2021 for when the side effects such as the fullness and the ear problems started, it was approximately a week after getting the vaccine that these occurred. Consumer confirmed that these side effects were ongoing and were getting worse very quickly, even with treatments. The patient had to see her primary care provider and then three days later was able to get an appointment and get scheduled with the ear doctor and then there was an additional 2 more days so it was probably into the first part of Sep2021 for the hearing test. The patient underwent lab tests and procedures, which included hearing test in Sep2021 confirmed sudden hearing loss. Outcome of tight feeling in their neck and jaw was recovering/resolving while of remain was not recovered/ not resolved.   The lot number for BNT162b2 was not provided and will be requested during follow up.