Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Ear discomfort, Ear pain, Head discomfort
Clinical narrative: inappropriate schedule of vaccine administration; tested for Covid-19 on 20Mar2021, and the test was positive; Congestion in head; Ear canals blocked; Ear canals blocked and extremely painful; Feels like flu; No appetite; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested for Covid-19 on 20Mar2021, and the test was positive), HEAD DISCOMFORT (Congestion in head), EAR DISCOMFORT (Ear canals blocked), EAR PAIN (Ear canals blocked and extremely painful) and INFLUENZA LIKE ILLNESS (Feels like flu) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 03BB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced HEAD DISCOMFORT (Congestion in head), EAR DISCOMFORT (Ear canals blocked), EAR PAIN (Ear canals blocked and extremely painful), INFLUENZA LIKE ILLNESS (Feels like flu), DECREASED APPETITE (No appetite), MYALGIA (Body aches) and PYREXIA (Fever). On 20-Mar-2021, the patient experienced COVID-19 (tested for Covid-19 on 20Mar2021, and the test was positive). On 07-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration). The patient was treated with IBUPROFEN for Swelling, at a dose of 800 mg once an hour. On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved. At the time of the report, COVID-19 (tested for Covid-19 on 20Mar2021, and the test was positive), HEAD DISCOMFORT (Congestion in head), EAR DISCOMFORT (Ear canals blocked), EAR PAIN (Ear canals blocked and extremely painful), INFLUENZA LIKE ILLNESS (Feels like flu), DECREASED APPETITE (No appetite) and MYALGIA (Body aches) outcome was unknown and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: Positive. On 02-Apr-2021, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The consumer stated that she believes she had Covid-19 before receiving her first dose. She stated that she was exposed to Covid-19 four days prior to her first dose. The consumer wanted to note that all the symptoms reported following her first dose were possibly due to her Covid-19 diagnosis rather than the Moderna Covid-19 vaccine.The consumer was advised not receive her second dose of the Moderna Covid-19 vaccine until the second week of June by a HCP at the Urgent Care facility where she received her Covid-19 test.  Reportedly, the patient was going to see her ENT specialist for blocked ear canals.  No concomitant medications were reported.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. The other events are in consistence with the COVID-19 infection. The other events are in consistence with the COVID-19 infection.  The event of inappropriate schedule of product administration is assessed as not applicable.   This case was linked to MOD-2021-046198, mod-2021-216620, MOD-2021-216620 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Upon internal review on 10Aug2021, an event of 'inappropriate schedule of vaccine administered', was added.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. The other events are in consistence with the COVID-19 infection. The other events are in consistence with the COVID-19 infection.  The event of inappropriate schedule of product administration is assessed as not applicable.