Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: BURNING SENSATION IN THE THUMBS; PAIN IN KNEES; NUMB/ KNEES FEEL NUMB; COULD NOT SLEEP; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; TINGLINGS ON THE OUTSIDE OF HEAD/FEET/HANDS; SEVERE PAINS ALSO INVOLVING NERVE PAINS/NERVE PAIN IN THE FEET TO LOWER  LEGS; This spontaneous report received from a patient via a company representative concerned a 52 year old of unspecified sex, race and ethnicity. The patient's weight was 91 kilograms, and height was not reported. The patient's concurrent conditions included: diabetes. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-JUL-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 03-JAN-2022 for covid-19 prophylaxis. Age at time of vaccination 52 years old. No concomitant medications were reported.  Since JAN-2022 patient suffered from tingling on the outside of his head, since February patient also experienced tingling in his feet which was getting more and more present and more spread over toes, legs, and arms and patient at the time of reporting had severe pains which involved nerve pains (Dose number in series 2). Patient had covid symptoms at the end of FEB-2022 (17-FEB-2022) and tested positive (confirmed covid-19 infection) on 18-FEB-2022 which resulted to confirmed clinical vaccination failure (Dose number in series 2). On APR-2022, Laboratory data included: Blood glucose was higher than it should be. On MAY-2022, Laboratory data included: Blood glucose something like 170. while it must had to be between 80 and 120. Something like above 200 is really much too high, according to the physician. Got some pills, and started measuring, and left sugars behind (Dose number in series 2) From the beginning of JUN-2022 it started to seed further in the feet. At the end of June it was so bad that patient often couldnot sleep and at mid JUL-2022 spread to whole feet, and first tingling in the hands, but almost negligible and patient took Gabapentin for nerve pain, 100 mg 2 times a day (Dose number in series 2). On JUL-2022, Laboratory data included: Blood test all looks fine. On AUG-2022, the patient experienced pain in knees, and numb/ knees feel numb (Dose number in series 2). On 16-AUG-2022, the patient experienced burning sensation in the thumbs (Dose number in series 2).  On 20-AUG-2022, patient had extension of nerve pain in the feet to lower legs, the following week also pain in knees (severe pains also involving nerve pains/nerve pain in the feet to lower legs) and It was not totally numb, on the contrary, the feet were very sensitive. Patient knees felt numb, but they were not (patient don't know how to describe this)(Dose number in series 2).  On SEP-2022, Laboratory data included: Blood glucose At the moment most values are between 80 and 120, only when stressed it goes towards 150. Blood got drawn at the beginning of July, and that all looked fine. But at the time of reporting patient had pain in the feet which  increased enormously since July and the last 2-3 weeks also pulled further into patient legs, and hands were started to hurt. The pain starts to get so bad that it almost starts to define your day. Things like oxycodone and tramadol still work, but that's not the solution either. As patient mentioned, this all was started in January or February. Treatment medications (dates unspecified) included: gabapentin (600 mg, 3 times a day), tramadol (50 mg 2 times a day), and oxycodone. If patient do not take it,it can barely got through the day and event patient suffered from lower legs and feet, hands, and the occasional nerve shoots randomly in patient body. The patient also visited emergency room and physician office for the adverse events. Patient scheduled visit to neurologist on 07-SEP-2022 (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pains also involving nerve pains/nerve pain in the feet to lower legs, and pain in knees, and the outcome of tinglings on the outside of head/feet/hands, could not sleep, burning sensation in the thumbs, numb/ knees feel numb, confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220909740-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.