Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Insomnia, Neuropathy peripheral, Therapeutic response unexpected
Clinical narrative: (moderate) neuropathy, he used to have neuropathy at the end of his toes but now it got worsen/ got intense again; had to end of sleeping with legs below chests to get any sleep; History or osteoporosis, was getting better when got the booster shot, it started effecting; received an expired Moderna booster dose; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL ((moderate) neuropathy, he used to have neuropathy at the end of his toes but now it got worsen/ got intense again) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 030M20A and 041L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not had COVID test of diagnosis in past. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Broken foot (prior to vaccine) and Neuropathy (used to have neuropathy at the end of his toes.). Concurrent medical conditions included Penicillin allergy and Osteoporosis. Concomitant products included COLESTIPOL, LISINOPRIL, THIOCTIC ACID (ALPHA LIPOIC ACID), AZELASTINE, FLUTICASONE, LINUM USITATISSIMUM SEED (FLAXSEED), EZETIMIBE, DENOSUMAB (PROLIA), CALCIUM, MULTIVITAMIN [VITAMINS NOS] and CETIRIZINE HYDROCHLORIDE (ZYRTEK) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired Moderna booster dose). On 30-Oct-2021, the patient experienced NEUROPATHY PERIPHERAL ((moderate) neuropathy, he used to have neuropathy at the end of his toes but now it got worsen/ got intense again) (seriousness criterion medically significant), INSOMNIA (had to end of sleeping with legs below chests to get any sleep) and THERAPEUTIC RESPONSE UNEXPECTED (History or osteoporosis, was getting better when got the booster shot, it started effecting). At the time of the report, NEUROPATHY PERIPHERAL ((moderate) neuropathy, he used to have neuropathy at the end of his toes but now it got worsen/ got intense again), THERAPEUTIC RESPONSE UNEXPECTED (History or osteoporosis, was getting better when got the booster shot, it started effecting) and EXPIRED PRODUCT ADMINISTERED (received an expired Moderna booster dose) outcome was unknown and INSOMNIA (had to end of sleeping with legs below chests to get any sleep) had not resolved.            Patient received the first Moderna COVID-19 booster vaccine on 29-Oct-2021. Everything started on 30- Oct-2021, numbness in legs, tingling in legs, affected muscles, muscles ached and felt like when touched them, they're bruised. Both legs ached (when work out too much and got a muscle strain) and could barely walk a mile. He had a test of stick the needles in (moderate) neuropathy. The physician advised him not to get another booster dose. He had visited vascular surgeon, neurologist and various other, he cut off all medications (after adverse reactions began) and it was to moderate but got intense again. Feet, arches, ankles feel were totally numb. Treatment medication was not reported.  Company Comment: This spontaneous case concerns a 74-year-old male patient with relevant medical history of neuropathy, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as (moderate) neuropathy, he used to have neuropathy at the end of his toes but now it got worsen/ got intense again), 1 day after receiving booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series.  Patient presented with numbness, tingling and pain in the legs for which moderate neuropathy was assessed based on needle examination. Additionally, Therapeutic response unexpected (History or osteoporosis, was getting better when got the booster shot, it started effecting) and Expired product administered were also noted. Patient previously received a 2 dose-primary series of mRNA-1273 vaccine given 28 days apart, the last dose of which was administered approximately 8.5 months prior to current mRNA-1273 vaccine.  Neuropathy could be triggered, cause flare ups or progress due to degeneration, thus, remains a confounder. The advanced age of the patient could be considered a predisposing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2022: Significant live follow-up: Onset date for first dose and second dose, Expiration Date, batch number and Patient Route of Administration were added. Expired vaccine used added as a new event.; Sender's Comments: This spontaneous case concerns a 74-year-old male patient with relevant medical history of neuropathy, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as (moderate) neuropathy, he used to have neuropathy at the end of his toes but now it got worsen/ got intense again), 1 day after receiving booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series.  Patient presented with numbness, tingling and pain in the legs for which moderate neuropathy was assessed based on needle examination. Additionally, Therapeutic response unexpected (History or osteoporosis, was getting better when got the booster shot, it started effecting) and Expired product administered were also noted. Patient previously received a 2 dose-primary series of mRNA-1273 vaccine given 28 days apart, the last dose of which was administered approximately 8.5 months prior to current mRNA-1273 vaccine.  Neuropathy could be triggered, cause flare ups or progress due to degeneration, thus, remains a confounder. The advanced age of the patient could be considered a predisposing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.