Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product use in unapproved indication, Pyrexia, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (can't taste anything), ANOSMIA (nor can I smell anything), PRODUCT USE IN UNAPPROVED INDICATION (received second booster, patient not over 50 year old, not immunocompromised), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second booster, patient not over 50 year old, not immunocompromised) and FATIGUE (Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 014F21A, 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 21-Jan-2020, Eye injury (From a bad car accident several years ago and had to have a prosthetic lens in one eye) and Motor vehicle accident. Previously administered products included for Drug use for unknown indication: Benadryl. Past adverse reactions to the above products included No adverse event with Benadryl. Concurrent medical conditions included Asthma and Injury to trigeminal nerve (and takes Botox). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Injury to trigeminal nerve. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced PRODUCT USE IN UNAPPROVED INDICATION (received second booster, patient not over 50 year old, not immunocompromised), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second booster, patient not over 50 year old, not immunocompromised) and PYREXIA (fever ,temperature of 104.7). On 22-Apr-2022, the patient experienced AGEUSIA (cant taste anything) and ANOSMIA (nor can I smell anything). On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. In April 2022, PYREXIA (fever, temperature of 104.7) had resolved. At the time of the report, AGEUSIA (can't taste anything), ANOSMIA (nor can I smell anything), PRODUCT USE IN UNAPPROVED INDICATION (received second booster, patient not over 50 year old, not immunocompromised), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second booster, patient not over 50 year old, not immunocompromised), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2019, SARS-CoV-2 test: negative (Negative) negative. On 31-Dec-2019, SARS-CoV-2 test: negative (Negative) negative. On 04-Jan-2020, SARS-CoV-2 test: negative (Negative) negative. On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) positive. On  11-Apr-2022, Body temperature: 104.7 104.7. On 22-Apr-2022, SARS-CoV-2 test: negative (Negative) negative. The patient stated that early in the evening after the second booster the patient had a temperature. The patient kept an eye on it and lasted for a few hours. In the morning, on the day of reporting the patient woke up, the patient  was unable to taste anything or smell anything. Company Comment: This spontaneous case concerns a 43 year old female patient, with no relevant medical history, who experienced unexpected, non-serious AESIs of ageusia and anosmia approximately 11 days after receiving a fourth dose (second booster) of mRNA-1273. She also had symptoms of fever, fatigue, headache, myalgia, arthralgia, chills, and nausea for which she took paracetamol. She tested negative for SARS-CoV-2 test. The outcome of the events is unknown. Additionally, product use in unapproved indication and inappropriate schedule of vaccine administration (received second booster, patient not over 50 years old, not immunocompromised) was noted in this case. The benefit risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-547082 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up contains no new information. Sender's Comments: This spontaneous case concerns a 43 year old female patient, with no relevant medical history, who experienced unexpected, non-serious AESIs of ageusia and anosmia approximately 11 days after receiving a fourth dose (second booster) of mRNA-1273. She also had symptoms of fever, fatigue, headache, myalgia, arthralgia, chills, and nausea for which she took paracetamol. She tested negative for SARS-CoV-2 test. The outcome of the events is unknown. Additionally, product use in unapproved indication and inappropriate schedule of vaccine administration (received second booster, patient not over 50 years old, not immunocompromised) was noted in this case. The benefit risk relationship of mRNA-1273 is not affected by this report.