Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Burning sensation, COVID-19, Drug ineffective
Clinical narrative: Vaccine attack every weak point in his body; Whole arm is on fire; Spinal arthritis; Burning sensation; Pain in his left shoulder; Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times; Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times; Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series; Lack of drug effect; Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day; Left foot, left shoulder and entire right arm pain; Have a queasy fainting feeling, phlegm in chest and cough; phlegm in chest and cough; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day), COVID-19 (Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series), MUSCLE SPASMS (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times), PAIN (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times) and VACCINATION COMPLICATION (Vaccine attack every weak point in his body) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history of the patient was reported by the reporter.  Concomitant products included OMEPRAZOLE, FLUTICASONE, GABAPENTIN, TETRACYCLINE, FINASTERIDE, PSEUDOEPHEDRINE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PARAESTHESIA (Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day), PAIN IN EXTREMITY (Left foot, left shoulder and entire right arm pain), PRESYNCOPE (Have a queasy fainting feeling, phlegm in chest and cough) and PRODUCTIVE COUGH (phlegm in chest and cough). On 10-Jul-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series). 10-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 12-Jul-2021, the patient experienced MUSCLE SPASMS (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times) and PAIN (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine attack every weak point in his body), LIMB DISCOMFORT (Whole arm is on fire), SPINAL OSTEOARTHRITIS (Spinal arthritis), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Pain in his left shoulder). At the time of the report, PARAESTHESIA (Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day), COVID-19 (Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series), MUSCLE SPASMS (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times), VACCINATION COMPLICATION (Vaccine attack every weak point in his body), LIMB DISCOMFORT (Whole arm is on fire), SPINAL OSTEOARTHRITIS (Spinal arthritis), PAIN IN EXTREMITY (Left foot, left shoulder and entire right arm pain), PRESYNCOPE (Have a queasy fainting feeling, phlegm in chest and cough), PRODUCTIVE COUGH (phlegm in chest and cough), BURNING SENSATION (Burning sensation), DRUG INEFFECTIVE (Lack of drug effect) and ARTHRALGIA (Pain in his left shoulder) outcome was unknown and PAIN (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 103 f (High) 103 F.         Treatment medications were not provided.   This case was linked to MOD-2021-280006 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received contains significant information and additional events are added.; Sender's Comments: This case concerns a 54-year-old, male subject with no relevant medical history reported, who experienced the unexpected, non-serious and AESI event of COVID-19. The event occurred approximately two and a half months after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.