Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Product dose omission issue, Pruritus, Rash, Rash erythematous
Clinical narrative: red rash all over my body; Rash on both legs, red rash all over my body; Redness; Missed dose; Prickling / Tingling; Severe burning; Feeling of doom; Panic attack like symtoms; Hives on leg; Severe itching; Anaphylactic reaction; Feeling hot; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Hives and rash) since 2006, Drug allergy (Hives, rash and breathing) since 2006 and Shellfish allergy (Hives and rash) since 2012.    On 23-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced FEELING HOT (Feeling hot). On 23-Jan-2021 at 3:00 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced PARAESTHESIA (Prickling / Tingling), SKIN BURNING SENSATION (Severe burning), FEELING ABNORMAL (Feeling of doom), PANIC ATTACK (Panic attack like symtoms), URTICARIA (Hives on leg), PRURITUS (Severe itching), RASH ERYTHEMATOUS (red rash all over my body), RASH (Rash on both legs, red rash all over my body), ERYTHEMA (Redness) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 75 milligram. On 25-Jan-2021 at 10:00 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. At the time of the report, PARAESTHESIA (Prickling / Tingling), PANIC ATTACK (Panic attack like symtoms), FEELING HOT (Feeling hot) and ERYTHEMA (Redness) outcome was unknown and SKIN BURNING SENSATION (Severe burning), FEELING ABNORMAL (Feeling of doom), URTICARIA (Hives on leg), PRURITUS (Severe itching), RASH ERYTHEMATOUS (red rash all over my body), RASH (Rash on both legs, red rash all over my body) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event Anaphylactic reaction was automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria, it was classified as Non-serious. Patient´s medical history of allergies (drug and food allergies) could be a potential confounder to the events, which seem to be related to each other (Anaphylactic reaction with Tingling,  Skin burning sensation, Feeling abnormal, Hives, Feeling hot, Itching, Rash erythematous, Rash all over and Redness).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information received included reporter details, anatomical location of vaccine administration and new events added and medical history was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event Anaphylactic reaction was automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria, it was classified as Non-serious. Patient´s medical history of allergies (drug and food allergies) could be a potential confounder to the events, which seem to be related to each other (Anaphylactic reaction with Tingling,  Skin burning sensation, Feeling abnormal, Hives, Feeling hot, Itching, Rash erythematous, Rash all over and Redness).