Adverse Event Reporting

VAERS ID 1001424
Gender Male
Age
StateCode NJ
Pharmaceutical Company MODERNA
Lot Number 011L20A
Number of vaccinations 1
Vaccinated 2021-01-01
Onset 2021-01-01
Condition Life Threatening
Symptoms
  • Chills
  • Pruritus
  • Anaphylactic reaction

Current Illness

Preexisting Conditions

Medical History/Concurrent Conditions: No adverse event (No medical history reported)

Other Medications

TAMSULOSIN; PRILOSEC [OMEPRAZOLE]; SIMVASTATIN; AMLODIPINE; FINASTERIDE

Previous Vaccinations

Allergies

Laboratory Data

Write-up

Anaphylactic reaction; Had severe itching in the whole body; chills; A spontaneous report was received from a physician concerning a 80-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic reaction, severe itching in the whole body and chills.
The patient's medical history was not provided.
Concomitant medications reported included tamsulosin, omperazole, simvastatin, amlodipine and finasteride all for unknown indications.
On an unknown date, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 01120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.
On an unknown date, the patient experienced severe itching and chills for about a day following vaccination.
2 days following vaccination, the subject experienced an anaphylactic reaction.
He sought medical attention from his dermatologist who gave him the diagnosis.
Treatment for the event included sertac at night, claritin in the morning, and betamethasone 0.
05% cream.
Action taken with mRNA-1273 in response to the events was not reported.
The outcome of the events anaphylactic reaction, severe itching in the whole body and chills were unknown.
; Reporter's Comments: This case concerns a 80-year old, male patient, who experienced a serious unexpected event of anaphylactic reaction and pruritus (had severe itching in the whole body), and a non-serious expected event of chills.
The event of anaphylactic reaction occurred 2 days after first dose of mRNA-1273, lot # 011L20A.
The event of, pruritus and chills occurred on an unspecified date after first dose of mRNA-1273, lot # 011L20A.
Treatment included Sertac-one pill at night, Claritin- one pill in the morning and Betamethasone dipropionate 0.
05% cream.
Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.