Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Magnetic resonance imaging, Muscular weakness, Neuralgia, Neuropathy peripheral
Clinical narrative: feels like a neuropathy, a nerve pain; nerve pain in the right leg; Right Leg weak and painful when he stands; Right Leg weak and painful when he stands; Has been in bed for two weeks; This is a spontaneous report received from a contactable 63-year-old male consumer (Pharmacist). This consumer (patient) reported for himself. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date was unknown), via unspecified route on 17Apr2021 at 13:00 (patient was 63-year-old at the time of vaccination) at a single dose for COVID-19 immunisation. The patient's medical history included bad back which was ongoing he had this issue since he was 20. He has been going on for about 45 years. The patient received first dose of BNT162b2 (Lot number: EN6200), and patient didn't have any problems with the first dose of the Covid Vaccine. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient had not received any additional Vaccines on Same Date of the Pfizer Suspect. On 27Mar2021 The patient's concomitant medications were not reported. On 17Apr2021, 8 hours after vaccination, the patient experienced right leg went very weak and became very painful when he stood up. He stated this is something he has never felt before, he has been in bed for 2 weeks now. He can get up, but if he does he will have about an hour of pain afterwards. He was putting ice on his leg for about 2 hours at a time but he doesn't have to do that anymore. He can walk for about 2 minutes, then has to lay down, Then he will feel back to normal, then he can walk two more minutes, then he has to lay back down. Reporter stated the pain is only in his right lower leg and good. Reporter stated it feels like a neuropathy, a nerve pain. Reporter stated that 8 hours after his second dose of the Covid Vaccine his right leg went very weak and became very painful when he stood up. He stated this is something he has never felt before. He has been in the bed since then. His right leg went numb and is very painful when he walks but not as much when he in bed; he never experienced this before. Reporter wanted to know about any reports of neuropathy or autoimmune disease reported with the covid vaccine and how it might be treated. On an unspecified date, the patient visited physician's office. Reporter stated that his doctor doesn't know what is wrong with his leg. He also stated he had a MRI yesterday, no results from that known yet. The patient asked has anyone else reported neuropathy. Offered transfer to and initially declines. He doesn't think they can help him. When asked what kind of help he was looking for states that he wants to know if anyone else has reported neuropathy. Informed to reporter that has the most recent product information for the Vaccine. The patient was referred for hcp for further guidance. The outcome of the event muscular weakness and bedridden were recovering, while outcome of the other events were unknown.  Follow-up #1 (30Apr2021):This is a  Follow-up spontaneous report received from a contactable 63-year-old male consumer (Pharmacist). This consumer (patient) reported for himself that: Relevant medical history (Historical vaccine, medical history), suspect details, new events (neuropathy and neuropathic pain), outcome and lab data added.  Follow-up attempts are needed. Further information is expected; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Muscular weakness, bedridden, neuropathy and nerve pain cannot be excluded. 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.