Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, COVID-19, Product dose omission issue, Pruritus, SARS-CoV-2 test
Clinical narrative: Received the first dose of the Moderna covid-19 vaccine in 29JAN2021/not able to get the second dose; Contracted covid-19/tested positive for covid/had covid for 5 days; Itching/alot of itchiness; Had an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching/alot of itchiness), ALLERGY TO VACCINE (Had an allergic reaction), COVID-19 (Contracted covid-19/tested positive for covid/had covid for 5 days) and PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna covid-19 vaccine in 29JAN2021/not able to get the second dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Epilepsy. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ALLERGY TO VACCINE (Had an allergic reaction). On 29-Jan-2021, the patient experienced PRURITUS (Itching/alot of itchiness). On 01-Jul-2021, the patient experienced COVID-19 (Contracted covid-19/tested positive for covid/had covid for 5 days). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna covid-19 vaccine in 29JAN2021/not able to get the second dose). The patient was treated with METHYLPREDNISOLONE for COVID-19, at an unspecified dose and frequency; AZITHROMYCIN for COVID-19, at an unspecified dose and frequency; DEXAMETHASONE ACETATE (DECADRON A) for COVID-19, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 05-Jul-2021, COVID-19 (Contracted covid-19/tested positive for covid/had covid for 5 days) had resolved. At the time of the report, PRURITUS (Itching/alot of itchiness) and ALLERGY TO VACCINE (Had an allergic reaction) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna covid-19 vaccine in 29JAN2021/not able to get the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Contracted COVID-19, 2 months after the first dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had prescribed with a blood thinner, an antihistamine for COVID-1  Patient entered a clinical trial on 01JUL2021 for antibodies with AstraZeneca, it was a double blinded study. ON 05JUL2021 and drew blood and urine, and a couple days after, they came back and gave her a shot in each cheek so she is not sure if she received the monoclonal antibody or saline. When the trail was over, she was told to get the second dose of the vaccine. She contacted the CDC, and she was told not to restart the vaccination series but to go ahead and get the second dose.  This is a case of Product Dose Omission Issue that concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred approximately 6 months after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up included no new information. On 09-Nov-2021: Follow-up received and does not contain any new information. (Added start and stop date for event COVID-19); Sender's Comments: This is a case of Product Dose Omission Issue that concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred approximately 6 months after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.