Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Sleep disorder, Tinnitus
Clinical narrative: symptom seemed to had increased last night./ Tinnitus Spike/Sometimes it just goes up. It went up a little last night; wasn't sleeping; I will not be taking the second shot; This is a spontaneous report from a contactable female consumer (patient) reported for herself received via medical information team. A 65-year-old female (who was not pregnant at the time of vaccination) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6208, Expiration date: not provided), dose 1 via an unspecified route of administration, in arm left on 17Mar2021 15:00 (at the age of 65-year-old) as single for COVID-19 immunisation at hospital. The patient medical history included tinnitus from 1997 and ongoing (she has tinnitus for about 30 years), No known allergies to medications, food, or other products. The patient concomitant medication was included ginger capsules received within two weeks. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was stated that caller received her first Pfizer Covid vaccine on 17March2021. Patient has been diagnosed with tinnitus for around 30 years. Patient reported that the symptom seemed to had increased last night on an unspecified date in Mar2021. She was asking if tinnitus has been reported as a reaction? Yesterday she had her first shot. It was crazy and might not have anything to do with the shot. She has had tinnitus, ringing in the ear, since 1997. Sometimes it just goes up. It went up a little last night. Has Pfizer had any reports of that? They have been doing road work around there so she has been putting ear plugs in and out. Have there been any complaints of tinnitus going up. First Vaccine in March. Side effects were normal. A spike in my tinnitus, gone back done. Reluctant to take the second shout. It was so loud. I think I am going to stick with the one dose. Why? Is it gonna be spike or be temporary? Too nervous it could happen. Is it something to be worried about. Why is it spiking? States that after the first shot of the Covid Vaccine she had a tinnitus spike. States she has been reading that some people have a spike in tinnitus after the vaccine and some of them don't; states there is no rhyme or reason to it. Says that this all occurred back in March 2021. States the tinnitus was frightening, it was so loud in her head.  She could not tune it out, even with her sound machine and was not sleeping on an unspecified date in 2021. States that it has been about 5 weeks and she is back to normal now. She does not think she will get the second shot. She is afraid to go through that again and stated that she does not know why it happened to her or if it may happen again. States she is thinking she will just go with the first dose of the shot that she already had. Then next year when a vaccine comes out for the variance she may get that one. Patient did not received any treatment for the adverse events. The events was reported as non-serious. Outcome of the events was not sleeping, she will not be taking the second shot was unknown and symptom seemed to had increased last night/tinnitus spike/sometimes it just goes up. It went up a little last night was recovered on an unspecified date in 2021.  Follow-up #01 (18Apr2021): This is a follow up spontaneous report from a contactable consumer. The consumer (patient) reported that: medical history (onset date of tinnitus, ringing in the ear: on an unspecified date in 1997) was added.  Follow-up #02 (19Apr2021): This is a follow up spontaneous report from a contactable consumer. The consumer (patient) reported that: patient details (age at vaccination: 65), she was not pregnant, concomitant medication (ginger capsules), event (increased tinnitus start date: on an unspecified date in Mar2021) were added, clinical information was updated.  Follow-up #03 (21Apr2021): This is a follow up spontaneous report from a contactable consumer. The consumer (patient) reported that: seriousness was reported as no, product details (administration date: on an unspecified date in Mar2021, administration time: 03:00 PM, vaccine location: left arm) were added.  Follow-up #04 (23Apr2021):  This is a follow up spontaneous report from a contactable consumer. The consumer (patient) reported that: event details (outcome of the event spike in my tinnitus, gone back done: recovered on an unspecified date in 2021) was added.  Follow-up #05 (23Apr2021):  This is a follow up spontaneous report from a contactable consumer. The consumer (patient) reported that: product details (lot/batch number: EN6208, administration date: 17Mar2021, administration time: 15:00), events (wasn't sleeping, I will not be taking the second shot) were added.  No follow-up attempts are needed. No further information is expected.