Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, COVID-19, Cough, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of COVID-19 (Got a positive test for covid19), PARAESTHESIA (little bit of tingling), COUGH (Dry cough), THROAT CLEARING (had to clear my throat a lot) and NASAL CONGESTION (stuffiness/little congestion) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PARAESTHESIA (little bit of tingling). On 11-Feb-2021, the patient experienced ARTHRALGIA (left shoulder was very sore/left shoulder was hard to the touch). On 23-Feb-2021, the patient experienced COVID-19 (Got a positive test for covid19), COUGH (Dry cough), THROAT CLEARING (had to clear my throat a lot), NASAL CONGESTION (stuffiness/little congestion), RHINORRHOEA (runny nose) and UPPER-AIRWAY COUGH SYNDROME (post nasal drip). On 24-Feb-2021, the patient experienced ASTHENIA (was very weak). On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine have not been received for over 90 days now). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine have not been received for over 90 days now) had resolved. At the time of the report, COVID-19 (Got a positive test for covid19), PARAESTHESIA (little bit of tingling), COUGH (Dry cough), THROAT CLEARING (had to clear my throat a lot), NASAL CONGESTION (stuffiness/little congestion), RHINORRHOEA (runny nose), ASTHENIA (was very weak), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and ARTHRALGIA (left shoulder was very sore/left shoulder was hard to the touch) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No medical history or concomitant medications provided. Consumer stated that he took his first shot of Moderna Covid 19 vaccine 3 months ago and then contracted Covid 13 days after dose 1st dose. Consumer went to the ER and the doctor advised him not to take the second dose of the vaccine until after 90 days (Inappropriate schedule of vaccine administered) because he was already producing antibodies. 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. The mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Email id of Reporter is added On 14-May-2021: New event added as Inappropriate schedule of vaccine administered.; 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. The mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.