Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eyes are red), EYE IRRITATION (Eyes are burning/Eyes feels like hot water), DIZZINESS (Dizzy), BALANCE DISORDER (Loses his balance when stands up) and AGEUSIA (Had a loss of taste) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. On 09-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced OCULAR HYPERAEMIA (Eyes are red), EYE IRRITATION (Eyes are burning/Eyes feels like hot water), DIZZINESS (Dizzy), BALANCE DISORDER (Loses his balance when stands up), AGEUSIA (Had a loss of taste), ARTHRALGIA (Joints hurting), NAUSEA (Very nauseous) and VOMITING (Feels like he wants to throw up). 02-Dec-2021, the patient experienced HEADACHE (Severe headache/headache is unbelievable). At the time of the report, OCULAR HYPERAEMIA (Eyes are red), EYE IRRITATION (Eyes are burning/Eyes feels like hot water), DIZZINESS (Dizzy), BALANCE DISORDER (Loses his balance when stands up), AGEUSIA (Had a loss of taste), ARTHRALGIA (Joints hurting), HEADACHE (Severe headache/headache is unbelievable), NAUSEA (Very nauseous) and VOMITING (Feels like he wants to throw up) outcome was unknown. The patient weight was reported as 300 (unspecified). Concomitant medication included blood pressure medicine (unspecified). No Treatment information was reported. Company comment: This case concerns a 65-year-old, male patient, with no medical history reported in this case, previously vaccinated with JANSSEN COVID-19 VACCINE, who experienced the non-serious AESI of Ageusia. Additionally, other non-serious events have also been reported. The event occurred approximately one day after the administration of the third dose of the mRNA-1273 Vaccine.  The outcome of the event was reported as unknown.  No further information on clinical course, diagnostic tests or treatments was disclosed.  The rechallenge is not applicable since the event occurred after the third dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 65-year-old, male patient, with no medical history reported in this case, previously vaccinated with JANSSEN COVID-19 VACCINE, who experienced the non-serious Ageusia. Additionally, other non-serious events have also been reported. The event occurred approximately one day after the administration of the third dose of the mRNA-1273 Vaccine.  The outcome of the event was reported as unknown.  No further information on clinical course, diagnostic tests or treatments was disclosed.  The rechallenge is not applicable since the event occurred after the third dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.