Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: tinnitus; hard to sleep; This is a spontaneous report received from a contactable female consumer (patient) via a Pfizer-Sponsored Program. A 52-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8272; Expiration Date: 21Jul2021) via an unspecified route of administration on 29Mar2021 in the afternoon (at the age of 52-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included connective tissue disorder from an unspecified date and ongoing (sticker syndrome. It was diagnosed officially after genetic testing. She always had it, but did not find out about until 5-6 years ago), Hashimoto's thyroiditis from an unspecified date and ongoing, multiple brain cavernomas from an unspecified date and ongoing (cluster of capillaries form in the brain), fibromyalgia from an unspecified date and ongoing, possible long QT syndrome from an unspecified date and unspecified if ongoing, thimerosal allergy from an unspecified date and unspecified if ongoing, seasonal allergies from an unspecified date and unspecified if ongoing, arrhythmia from an unspecified date and unspecified if ongoing, anxiety from an unspecified date and unspecified if ongoing and hearing loss from an unspecified date and unspecified if ongoing. Concomitant medications included metoprolol tartrate taken for arrhythmia from an unspecified date and ongoing at 25mg, 1x/day, lorazepam (ATIVAN; strength: 0.5mg) taken for anxiety from an unspecified date and ongoing at 0.5mg, as needed (usually take one once a day), mometasone furoate (NASONEX) taken for season allergies from an unspecified date and ongoing and vitamins NOS taken for an unspecified indication on unspecified dates. Prior vaccinations within 4 weeks and additional vaccines administered on the same date as the COVID-19 vaccine were both reported as none. The patient previously received the flu vaccine (INFLUENZA VACCINE) on an unspecified date taken for immunization and experienced allergic reaction (two different occasions, it was at the site of injection, due to the Thimerosal preservative in it). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6208; Expiration Date: 21Jun2021) via an unspecified route of administration on 10Mar2021 as a single dose in the left arm for COVID-19 immunization. On an unspecified date, the patient experienced tinnitus and hard to seep. The event tinnitus required a visit to the physician's office. The patient reported that she received both doses of the Pfizer COVID-19 vaccine and after the second dose she experienced tinnitus. She stated that it was really severe tinnitus. She still had it and it was not gone. She still had some ringing in the ears. She already previously had the tinnitus and ringing in the ears, but it was not very bad; however, immediately after the second dose she noticed it. It was to the point where she could not hear anything. Her husband asked her why she had things turned up so loud, it was that significant. It was a little better now, but overall, it was worse than what she had before she got the second dose. She had noticed within a couple of days after she received the second dose. She had ringing in ears previously, but it came and went. There would be times where it would be worse for a day or so, but she did not realize right away. It later got so bad, and it was noticeable. They were wondering why she was turning everything up. She could not hear her husband when he was talking. This feeling made it hard to sleep. She saw her otologist not long after this. She had already had an appointment scheduled because she had hearing loss and mentioned these details to the otologist. It was determined her hearing was not affected. She compared results to a previous hearing test and her hearing was still similar. It was nothing super noticeable. The tinnitus was slightly better than it was. It was not until Aug2021 when it started to get better. Therefore, for four months it was pretty bad.  The otologist told her that she had a number of patients who had also experienced this as a side effect. The patient stated she also informed her primary care provider of this. She stated that she was informed that they would notify Pfizer of this, but she did not know if Pfizer was notified. She had had reactions to other medications. She had an allergic reaction to the flu vaccine on two different occasions. It was at the site of injection. It was due to the Thimerosal preservative in it. She confirmed she did not have any details to provide lot/exp from the two different flu vaccines. She still received the flu vaccine, she just got one for this year and she was fine because it did not have the Thimerosal preservative. The patient wanted to know if it was safe for her to receive the booster dose. She asked if she should get it again due to tinnitus. She said her tinnitus had gotten better to what it was few months ago and she did not want it to worsen. She stated it slowly seemed to have gotten better. She wanted to find out about other cases of individuals who had this event. Her doctor commented that other patients had this event. She wanted more details on what their experience had been. She wanted to know if it would go away, or would this be more of a transient thing? Would it go away, did it get worse or better over time? The clinical outcome of the event tinnitus was recovering/resolving while hard to sleep was unknown.