Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Head discomfort, Inappropriate schedule of product administration, Malaise
Clinical narrative: extremely tired; fever/low grade temperature; chills; Patient was worried she also has COVID-19; cant keep my head up past the time; under the weather for 6 weeks; Shots weren't given between the proper time period; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Patient was worried she also has COVID-19), HEAD DISCOMFORT (cant keep my head up past the time), MALAISE (under the weather for 6 weeks), FATIGUE (extremely tired) and PYREXIA (fever/low grade temperature) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 004B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shots weren't given between the proper time period). In November 2021, the patient experienced SUSPECTED COVID-19 (Patient was worried she also has COVID-19), HEAD DISCOMFORT (cant keep my head up past the time), MALAISE (under the weather for 6 weeks), PYREXIA (fever/low grade temperature) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (extremely tired). On 20-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shots weren't given between the proper time period) had resolved. At the time of the report, SUSPECTED COVID-19 (Patient was worried she also has COVID-19), HEAD DISCOMFORT (cant keep my head up past the time), MALAISE (under the weather for 6 weeks), PYREXIA (fever/low grade temperature) and CHILLS (chills) outcome was unknown and FATIGUE (extremely tired) had not resolved.            The patient stated that she got the first and second shots but they weren't given between the proper time period (unsure of how many days).  The patient was worried she had COVID-19 because she had been under the weather for 6 weeks, fever, chills, low grade temperature. She was also extremely tired. She cant keep her head up past the time. It was reported that patient was due for booster on 20-Dec-2021 and was reported that patient was at high risk. No treatment information was provided.  Company comment: This spontaneous case concerns a 77-year-old female patient with no medical history reported, who experienced the unexpected non serious event/AESI of Suspected COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred approximately 4 months and 14 days after the second dose of mRNA- 1273 vaccine. Inappropriate schedule of vaccine administered was also captured since the time window between the first and second dose was 59 days. Clinical manifestations included Malaise, Fatigue, Pyrexia, Chills and Head discomfort with a duration of 6 weeks. It is unknown if SARS-CoV-2 test was performed. Very limited information was provided regarding diagnostic work-up and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old female patient with no medical history reported, who experienced the unexpected non serious event/AESI of Suspected COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred approximately 4 months and 14 days after the second dose of mRNA- 1273 vaccine. Inappropriate schedule of vaccine administered was also captured since the time window between the first and second dose was 59 days. Clinical manifestations included Malaise, Fatigue, Pyrexia, Chills and Head discomfort with a duration of 6 weeks. It is unknown if SARS-CoV-2 test was performed. Very limited information was provided regarding diagnostic work-up and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.