Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Pruritus, Rash, Skin mass, Urticaria
Clinical narrative: trouble with Benadryl and had to go to the Hospital; Hives all over his body except the trunk; lumps all over his body except the trunk; started itching terribly; rash on thighs, legs, and arms/covered with a rash all over his body except the trunk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) and URTICARIA (Hives all over his body except the trunk) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) (seriousness criterion hospitalization). On 23-Aug-2021, the patient experienced RASH (rash on thighs, legs, and arms/covered with a rash all over his body except the trunk). On 24-Aug-2021, the patient experienced URTICARIA (Hives all over his body except the trunk) (seriousness criterion medically significant), SKIN MASS (lumps all over his body except the trunk) and PRURITUS (started itching terribly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) outcome was unknown and URTICARIA (Hives all over his body except the trunk), SKIN MASS (lumps all over his body except the trunk), PRURITUS (started itching terribly) and RASH (rash on thighs, legs, and arms/covered with a rash all over his body except the trunk) was resolving.            Concomitant medications were not reported.  The patient did not have any adverse events following the first two doses of the vaccine.   On 25-Aug-2021, the doctor started the patient on steroid injections. The patient had trouble with Benadryl and had to go to the hospital and was released (had nothing to do with the vaccine).  His reaction was 90% cleared, however, it was reported that he still had some red bumps.  The wife of the patient stated that she also received the 3 shots at the same time as her husband and with the same lot number. She denied having had any adverse reactions.  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. However, more information is required for further assessment. For the event adverse reaction: Reporter's causality assessment considered the event unlikely related to the vaccine. Treatment drug Benadryl is a confounding factor. However, very limited information is available to assess causality.  This case refers to a case of third dose of Moderna. Clarification regarding patient´s history of immunodeficiency has been requested.; 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. However, more information is required for further assessment. For the event adverse reaction: Reporter's causality assessment considered the event unlikely related to the vaccine. Treatment drug Benadryl is a confounding factor. However, very limited information is available to assess causality.  This case refers to a case of third dose of Moderna. Clarification regarding patient´s history of immunodeficiency has been requested.