Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy testes, Feeling abnormal, Inappropriate schedule of product administration, Pruritus
Clinical narrative: itching skin feeling skyrocketed through roof; feeling skyrocketed through roof/ strange; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching skin feeling skyrocketed through roof) and FEELING ABNORMAL (feeling skyrocketed through roof/ strange) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine (BOTH WRISTS BELOW THUMBS HAD) on 05-Jun-2021, Janssen COVID-19 Vaccine (10-Jun-2021, batch  number: 205A2) on 05-Jun-2021, Janssen COVID-19 Vaccine (10-Jun-2021) on 05-Jun-2021, Janssen COVID-19 Vaccine (10-Jun-2021) on 05-Jun-2021, Janssen COVID-19 Vaccine (??-Sep-2021) on 05-Jun-2021 and Janssen COVID-19 Vaccine (10-Jun-2021) on 05-Jun-2021. Past adverse reactions to the above products included Crawling sensation of skin with Janssen COVID-19 Vaccine; Goose bumps with Janssen COVID-19 Vaccine; Itchy skin with Janssen COVID-19 Vaccine; Swollen wrists with Janssen COVID-19 Vaccine; Tingling with Janssen COVID-19 Vaccine; and Wrist pain with Janssen COVID-19 Vaccine. Concurrent medical conditions included Bipolar disorder and Attention deficit hyperactivity disorder. Concomitant products included DEXAMFETAMINE and LITHIUM for ADHD and Bipolar disorder, VALACICLOVIR HYDROCHLORIDE for an unknown indication.    On 24-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 26-Nov-2021, the patient experienced PRURITUS (itching skin feeling skyrocketed through roof) (seriousness criterion medically significant) and FEELING ABNORMAL (feeling skyrocketed through roof/ strange) (seriousness criterion medically significant). The patient was treated with GABAPENTIN for Adverse event, at a dose of UNK, qd, 12001500 mg. At the time of the report, PRURITUS (itching skin feeling skyrocketed through roof), FEELING ABNORMAL (feeling skyrocketed through roof/ strange) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy testes: results not provided (Inconclusive) results not provided.         With janssen covid vaccine patient experienced a strange itch not like a rash, scratching it resulted in tingling feeling mostly alternating between his legs all over the whole body except his head, and there was no rash, just like goosebumps, like skin was crawling, tingly, and itchy. He went to an urgent care clinic. The patient was given a steroid, but it did not work. The patient went to dermatologist, who did a biopsy. Biopsy results not reported. Dermatologist stated this could be from medications, neurologic or psychiatric related. Patient went to his psychiatric practitioner because he was being treated for attention deficit hyperactivity disorder (ADHD) and bipolar disorder. The patient was started on 600mg per day Gabapentin prescribed by his psychiatric practitioner. Gabapentin provided him some relief, but no HCP could explain the cause. He was on 1200mg Gabapentin, increased by his primary HCP, which helped the unusual s kin sensations. The patient stated he looked up J&J side effects and was wondering if he was possibly developing Guillain Barre Syndrome (GBS).  This is a case of Inappropriate Schedule of Product Administration that concerns a 55-year-old male patient with no relevant medical history, who experienced the unexpected serious events of Pruritus and Feeling Abnormal, all events were reported as medically significant by the regulatory authority. The events of occurred 3 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. The patient was treated with Gabapentin for the adverse event, Biopsy Tests yielded Inconclusive Results, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Inappropriate Schedule of Product Administration that concerns a 55-year-old male patient with no relevant medical history, who experienced the unexpected serious events of Pruritus and Feeling Abnormal, all events were reported as medically significant by the regulatory authority. The events of occurred 3 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. The patient was treated with Gabapentin for the adverse event, Biopsy Tests yielded Inconclusive Results, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.