Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Ear pain, Frustration tolerance decreased, Headache, Hypoacusis
Clinical narrative: I feel like killing myself; He said he can't sleep flat without headaches; I couldn't hear on my left ear; frustrated; I could hear fine and shortly after that some little pain was cleaning it; sleep apnea; then it got worse; He said the ringing in his ears has been nonstop from 1NOV2021 until now; In July/August, he started getting headaches/constant headaches; 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 64 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 01Apr2021 (Lot number: EP7533, Expiration Date: 30Jun2021) at the age of 63 years as dose 2, 0.3 ml single for covid-19 immunisation; zoledronic acid (ZOLEDRONIC), intravenous since 11Aug2021 (Batch/Lot number: unknown) at 5 mg/100 mg for bone density abnormal. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, administration date 25Oct2021; TD-TDAP, administration date 07Jun2021; VITAMIN D [VITAMIN D NOS], MULTIVITAMINS [VITAMINS NOS], his 1st shingles shot on 24Aug2021, and his 2nd shingles shot on 19Nov2021, cholesterol pills of 20 mg (unspecified). Vaccination history included: Bnt162b2 (Lot: EN6204, Expiration date: 30Jun2021), administered on 11Mar2021, when the patient was 63 years old, for COVID-19 immunization at outdoor drives near hospital. The following information was reported: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "I feel like killing myself"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "In July/August, he started getting headaches/constant headaches"; INSOMNIA (non-serious), outcome "unknown", described as "He said he can't sleep flat without headaches"; TINNITUS (non-serious) with onset 01Nov2021, outcome "not recovered", described as "He said the ringing in his ears has been nonstop from 1NOV2021 until now"; HYPOACUSIS (non-serious), outcome "unknown", described as "I couldn't hear on my left ear"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "frustrated"; EAR PAIN (non-serious), outcome "unknown", described as "I could hear fine and shortly after that some little pain was cleaning it"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "sleep apnea"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "then it got worse". The action taken for zoledronic acid was unknown. Therapeutic measures were taken as a result of tinnitus. It was reported that, patient did not know what was going on he have been seeing the doctors and stuff and 05:30 morning the patient had been struggling to get over three months of constant headache, which started out with mild and been trying different sleeping patterns but could not figure out what was going on. He went to his primary doctor he thought around November to get his ear kind of cleaned out and because he could not hear on his left ear, because it was waxed pulled up or something and cleaning out it was fine. After that patient could hear fine and shortly after that some little pain was cleaning it but, he was having the headaches and shortly after that his ear on the left side started ringing like severe like it was just like a light switch, then in his right ear too patient had a little bit of ringing a tiny bit for a while and it never bothered him but, this was like a 'Richter scale' where he just cannot. Patient was frustrated and it was driving him nuts and he was trying to figure out. He felt like killing himself because it's that bad, he never had any issues like this just hit him a like aa ton of bricks, he was dealing with this for three months. The patient used to be a marathon cycle and the doctors put him on a bone density shot (zoledronic acid) on 11Aug2021 and it was supposed to stay in his system for a year but after that, he started getting the headaches. 2 days after the patient got, he bone density infusion he got his ears cleaned out. He had been having headaches since August and thought it was the CPAP, he took the harness off his CPAP and it got a little better. He took some Tylenol and it didn't work. He initially didn't have the ringing and when they cleaned the ear from the little bit of wax build up on 01Nov2021 it started after that and now he had this ringing that was crazy. During the hearing test the patient's left side failed terrible, he could still hear a little bit but not like he used to. The ringing in the ears has been going on over a month. He had been trying different sleep patterns and he couldn't figure out; hard time sleeping in a normal bed; sleeping in a chair for about a month. It helped a little bit but then it got worse and had some wave music to keep him from his head blowing up which did not help. The patient said ringing in his ears was like clicked out like a bomb. He said it always has the same intensity and was loud. He said the ringing in his right ear is starting to kick in as well but was mild. He said he was given Amoxicillin but said it did not work. He said it was getting worse. He said it was wearing him down, and he couldn't sleep. The patient had been having the headache since August and was on and off and was still going on even at the time of report but it's not severe, but just enough where it's aggravating. Then the patient cleaned out his ears and the ringing/ticking started. The patient always had a little bit of tinnitus in the way back. When the patient's brain blew up, he was put on Amoxycillin Northstar (Amoxy-Clav 125 mg: NDC 16714-0477-01, lot and expiration date unknown) and steroids Methylprednisolone (4 mg dose pack: NDC 42806-0400-21, lot and expiration date unknown) on 06Dec2021 and was told that if it doesn't clear up after 10 days get the ear test. They didn't help and so, he stopped with last two or three pills of Amoxycillin and three or four the first day with Methylprednisolone. When his headache started, he thought it was his sleep apnea machine and did a sleep study and they said it was nothing to do with that. The patient received all 3 doses of the Pfizer-BioNTech Covid-19 Vaccine. Patient received booster shot of Pfizer-BioNTech Covid-19 Vaccine on 14Dec2021 (dosage on booster: 0.3 ml lot: FE3594, expiration date: 31Jan2022) at pharmacy. He went to an ear, eyes and throat doctor and they wanted him to see a different doctor on the 12th but he was losing his mind. He wanted to know if this is a side effect of the vaccine, and how long it would last. He also wanted to know if it was normal to experience headache 3 or 4 months after receiving the vaccine. He was unsure if it's a reaction to something else another vaccines he got and he was suffering.   No follow-up attempts are possible. No further information is expected.