Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blister, Device issue, Injection site haemorrhage, Pruritus
Clinical narrative: PEN MISFIRE/SOLUTION PRESENT IN SKIN; WATER BLISTER ON SKIN; SKIN ITCHY ON CHEST SHOULDERS AND LEGS; recurring injection site blood/injection site blood in belly; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (WATER BLISTER ON SKIN), PRURITUS (SKIN ITCHY ON CHEST SHOULDERS AND LEGS), INJECTION SITE HAEMORRHAGE (recurring injection site blood/injection site blood in belly) and DEVICE ISSUE (PEN MISFIRE/SOLUTION PRESENT IN SKIN) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049121a) for COVID-19 vaccination.        The patient's past medical history included Cholesterol, Heart attack in 2018 and Bypass surgery in 2019. Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (Dose 1, intramuscular, Lot number: 1805022) on 07-Mar-2021, JANSSEN COVID-19 vaccine (Dose 2, intramuscular and Lot number: 1855194) on 04-Nov-2021; for Drug use for unknown indication: PEPTO BISMOL. Past adverse reactions to the above products included Hives with PEPTO BISMOL; and No adverse event with JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 vaccine. Concurrent medical conditions included Psoriasis, Insomnia, Vitamin D3 deficiency, Vitamin B12 deficiency, Heart disease, unspecified since December 2018, Alcoholic (FOUR DRINKS A NIGHT RHUM) since 1980 and Non-tobacco user. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) for Inflammation and Supplementation therapy, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Vitamin B12 deficiency, VITAMIN D3 for Vitamin D3 deficiency.   In 2020, the patient started (HUMIRA) (Subcutaneous) 40 milligram. On 15-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced INJECTION SITE HAEMORRHAGE (recurring injection site blood/injection site blood in belly). On 16-May-2022, the patient experienced BLISTER (WATER BLISTER ON SKIN) and PRURITUS (SKIN ITCHY ON CHEST SHOULDERS AND LEGS). On 02-Sep-2022, the patient experienced DEVICE ISSUE (PEN MISFIRE/SOLUTION PRESENT IN SKIN). On 18-May-2022, PRURITUS (SKIN ITCHY ON CHEST SHOULDERS AND LEGS) had resolved. In 2022, BLISTER (WATER BLISTER ON SKIN) and INJECTION SITE HAEMORRHAGE (recurring injection site blood/injection site blood in belly) had resolved. At the time of the report, DEVICE ISSUE (PEN MISFIRE/SOLUTION PRESENT IN SKIN) outcome was unknown.            On 19 Aug 2022, the patient experienced HUMIRA pen misfire.  Patient had cardio therapy for 6 weeks. Patient also took some unspecified statins for cholesterol.   The reporter's causality for the event(s) of WATER BLISTER ON SKIN, SKIN ITCHY ON CHEST SHOULDERS AND LEGS and RECURRING INJECTION SITE BLOOD/INJECTION SITE BLOOD IN BELLY with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of PEN MISFIRE/SOLUTION PRESENT IN SKIN and HUMIRA PEN MISFIRE was not provided. No treatment drug information was provided.