Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result; I felt miserable after my second Moderna covid-19 vaccination; Lying in bed in the fetal position; Chills; Fever/Fever of 100 degrees Farenheight; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result), FEELING ABNORMAL (I felt miserable after my second Moderna covid-19 vaccination), BEDRIDDEN (Lying in bed in the fetal position), DRUG INEFFECTIVE (Lack of drug effect) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FEELING ABNORMAL (I felt miserable after my second Moderna covid-19 vaccination), BEDRIDDEN (Lying in bed in the fetal position), CHILLS (Chills), PYREXIA (Fever/Fever of 100 degrees Farenheight) and HEADACHE (Headache). On 30-Sep-2021, the patient experienced COVID-19 (Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result). 30-Sep-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid-19 on 30 Sep 2021/Positive COVID result), FEELING ABNORMAL (I felt miserable after my second Moderna covid-19 vaccination), BEDRIDDEN (Lying in bed in the fetal position), DRUG INEFFECTIVE (Lack of drug effect), CHILLS (Chills), PYREXIA (Fever/Fever of 100 degrees Farenheight) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for Covid-19 on 30 Sep 2021. On an unknown date, Body temperature: 100 (High) Fever of 100 degrees Farenheight.         Concomitant medication were not reported.  Treatment medication was not reported.  Patient reported that she had no adverse reaction with the first dose and she received her second dose in left arm shoulder deltoid muscle and experienced a loss of smell and taste but she regain smell and taste on day 8 of covid-19 infection. patient experienced another episode of headache on an unknown date in SEP-2021 and another episode of Pyrexia on an unknown date in SEP-2021.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-Significant follow up Updated  reporter contact information includes reporter's address and email. On 05-Oct-2021: Added patient demographics(gender, date of birth, weight, pregnant information), lab data, suspect product details(dose one and dose  two) and new events(case upgraded from non serious to serious as per follow up document- other medically important condition for a few events).; Sender's Comments: This case of drug ineffective concerns a 27-year-old female patient with no relevant medical history reported, who experienced  non-serious unexpected event of special interest COVID-19. The event occurred approximately 5 months after the second dose of Spikevax. Rechallenge was not applicable as the event occurred after the second dose.  The benefit-risk relationship of drug is not affected by this report