Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tinnitus
Clinical narrative: aching ears and ringing in my ears something awful; aching ears and ringing in my ears something awful; my arms and legs were so achy, really bad achy; couldn't walk; felt like she couldn't stand; itching behind the eyes; itching on her scalp; Bowel movement each time after she ate; sleepy; exhausted and tired; I was so dizzy; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 27May2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable nurse (patient).  A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 06May2021 09:30 (at the age of 47-years-old) (Batch/Lot Number: EW0182) as single dose for covid-19 immunization. Medical history included vertigo, happened a couple of years ago, happened once or twice but not frequent, she thought happened when she had sinus thing and during the pandemic, she gained weight, 10 pounds. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations (within 4 weeks) and Usually the patient did not get vaccinations. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Left on 14Apr2021 09:30 (Lot number: EP7533) as single dose for covid-19 immunization. The patient received her second Pfizer vaccine dose on 06May2021. Beginning on 12May2021 she began having side effects. The patient googled the side effects information and it said the side effects would start 1-3 days after the vaccine dose. Her symptoms started 7 days later. On 12May2021, her arms and legs were so achy, really bad achy, she took tylenol because there was a lot of pain and aching in both arms and both legs. She took tylenol and it help a lot. Then the next day, it all came back and the tylenol didn't help. That really scared her. She still was aching around the clock even with taking tylenol all day. Then the 3rd or 4th day, no more aching in her arms and only in her legs. On 14May2021, She then began having aching ears and ringing in her ears something awful and she was so dizzy in May2021. The dizziness and ringing were still happening today but it got better each day. The patient said 7 days after the shot, she had severe aching in the arms and legs, bilaterally. She felt like she had done a hard work out for 5 hour and couldn't walk on 12May2021. Tylenol helped. The next day it came back. Tylenol didn't help, but may have taken the edge off. On the third day, it happened again in just the legs and not the arms, the arms were not aching. Then she had aching in the ears and ringing in the ears. She was very dizzy. The ringing and dizziness continued, but it was getting better each day. Confirmed that it was the Pfizer Covid vaccine. She was sleepy, real sleepy at first on 06May2021. She didn't think this was a side effect, but now she thinks so. She did not have diarrhea, but she had to go to the bathroom every time she ate on 06May2021. Usually she went only once a day, but after getting the shot she going 3 times per day. That was not her usual. That started the day of the shot. She clarified that she had pain, it was in her arms and legs. She woke up all 3 days with aching. It came out of nowhere. She had bowel movements 3 times per day on 06May2021. She was sleepier. She felt like she needed to rest. On day 7 or day 6, she woke up in so much pain. Her arms and legs hurt. She stood up and felt like she couldn't stand on 12May2021. She wasn't thinking of shot at first. She talked to her family. Then she thought maybe it was the shot. Tylenol worked. The next day the Tylenol did not work. It helped deal with the pain. It made it tolerable. It dealt with the pain. Then it seemed like it was getting worse. The Tylenol wasn't working. The third day she got real afraid. She was really in pain. She was really exhausted and tired in May2021. She went to sleep. She had pain. She took Tylenol. She was ready to go to the ER. She talked to nurses. She talked to her PCP (Primary Care Physician). PCP did not think it sounded like vaccine. She took test for Covid on 17May2021. The test was negative. She wasn't around anyone. She didn't get the test that same day, not until the third day when her legs were hurting. She was in so much pain that day. Her arms were not hurting. She felt a sigh of relief. It was late after the news was on TV. It was after 11:00 at night. She started taking 2 Tylenol at once. Then she thought the Tylenol was making it worse. Her body was fighting with the Tylenol. The pain in her legs and arms started 12May2021. She felt like it was in her bones and muscles. It gradually went away. When the ringing in the ears first started, her ears felt like what was happening in her legs. It felt like nerves. It was the same signals. She didn't have chills. Caller described that it almost mimicked and felt like it sounded, like circulation. It felt like when you lay on your arm and it falls asleep and it felt like the shaking you do to wake it up. It felt like tingling. Caller said that it is improving but lingering. It occasionally happens and is scary. Everyday it felt better. Later on 09May2021, she had itching behind the eyes. This went away. She also had itching on her scalp on 09May2021 which was still going but improved. The event severe aching in arms and legs required a visit to Physician Office by Tele-visit and did not require a visit to Emergency Room. Tylenol did not work at times for the severe pain in her arms and legs. The seriousness of event Aching and ringing in ears was reported as disabling and the events severe aching in arms and legs, Bowel movement each time after she ate, Sleepy, Itching behind eyes and Scalp itching was not serious. The outcome of the event arms and legs were so achy was recovered on 17May2021, the outcome of the event itching behind the eyes was recovered on 18May2021, the outcome of the event sleepy was recovered on 20May2021, the outcome of the events aching ears and ringing in ears and itching on her scalp was recovering and the outcome of the other events was unknown. The reporter considered the events Severe aching in arms and legs, Bowel movement each time after she ate, Aching and ringing in ears, Sleepy, Itching behind eyes and Scalp itching were related to Pfizer Covid Vaccine.; Sender's Comments: Based on available information a contributory  role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.