SLEPT A LOT; UNHAPPY; HEARING LOSS; ACHING/DULL ACHE; NIGHT SWEATS; FEELING BURNING HOT; COULDN'T DO DAILY ACTIVITIES; FEELING VERY SICK; COULDN'T GET WARM; CHILLS; HEADACHE; TINNITUS FROM NERVE DAMAGE; FATIGUE / VERY TIRED; NAUSEA; FEVER; DIARRHEA; This spontaneous report received from a patient concerned a 64-year-old female. The patient's weight was 239 pounds, and height was 62.5 inches. The patient's past medical history included: laminectomy (l4), and lazy eye surgery of the left eye, and concurrent conditions included: hypothyroidism, and hypertension, and Patient had no known allergies. The patient noted that codeine makes her nauseated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine, levothyroxine, lisinopril, and pregabalin all for an unknown indication. It was reported that the patient did not had any issues or arm soreness on the 12-MAR-2021 and 13-MAR-2021. On 14-MAR-2021, the patient started feeling sick on the night and by the morning of 15-MAR-2021, patient was very sick. Patient experienced a headache, head pressure, tinnitus, fatigue, nausea (on and off, not causing vomiting), aching, chills, fever (unknown temperature), night sweating, could not get warm then felt burning hot and some diarrhea. Patient stated that, she did not change out of her pajamas for 7 days and only got out of bed to use the bathroom and to made soup. After 7 days, patient started to feel better, and called the clinic to ask why she felt so sick. It was suggested for her to do a Covid-19 test (date unspecified), which was negative. The patient did not recall the date of the phone call or the date of the test. Patient stated that, these symptoms faded away one by one over 6 weeks in total (after the initial 7 days), except for the tinnitus, headache and head pressure, at the end of the 6 weeks she had done her daily activities again but she still did not felt all that great, still felt very tired and slept a lot over the next 6 weeks. Patient slept 4-5 hours in the day and 7-8 hours at night. Patient noted that, initially the headache was minor, off and on throughout the day, then it subsided to where it was evening only. Then around July or August she went without headaches for a short time (maybe for days or a week). The headaches then returned in the evening but worse and took Ibuprofen daily for weeks. At the time of reporting (26-OCT-2021), patient experienced at evening 17:00 temple to temple headaches and headaches across the top of her forehead which were 2-6/10 pain scale and described as a dull ache. Patient stated that, she currently was not taking medications for the headaches as they were tolerable but annoying. The tinnitus still affects both ears and that she had less ringing in her right ear than the left in July/August during the time when her headaches went away. In the last week, patient just noticed, experienced times when she heard a higher pitch sound that came instantly and acutely louder than the baseline ringing more in the right ear than the left ear and it lasts few seconds then goes away, the tinnitus made her an unhappy person to be around and she could not be around her grandkids due to noise levels. Loud noises set her off and made her nervous and panicked like she needs to leave the area due to the noise. Patient stated that, the feeling of pressure in her head was general and present constantly/all the time. The patient followed up with a nurse practitioner from the for the tinnitus, headache and head pressure. She was referred for a Magnetic Resonance Imaging (MRI) of the head and results were inconclusive. Patient was then referred to a neurologist. The patient switched insurance and healthcare providers in APR-2021. Patient contacted her new doctor and asked to be referred to an ENT (Ears, nose and throat) specialist. On 19-OCT-2021, patient saw the ENT and had a hearing test done and result was hearing loss, which was not new for her. However, the patient wants to compare with old records to see the change. Patient was disappointed with the ENT's diagnosis which was hearing loss and tinnitus from nerve damage. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative, MRI (NR: not provided) Inconclusive, and Pain scale (NR: not provided) 2-6/10.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, feeling burning hot, couldn't do daily activities, couldn't get warm, chills, nausea, fever, and diarrhea, had not recovered from headache, tinnitus from nerve damage, fatigue / very tired, aching/dull ache, feeling very sick, and hearing loss, and the outcome of slept a lot and unhappy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211053453 and 20211053779.; Sender's Comments: V0: 20211051846-COVID-19 vaccine Ad26.CoV2.S-Deafness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).