Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash pruritic, Urticaria
Clinical narrative: Hearing loss 2 weeks after 2nd dose; frequent urination (every 10 minutes); Diarrhea; In the last week - all of a sudden I'll get an itchy spot and it could be anywhere, it's very very itchy, and what happens is a thing comes up, almost like a hive.; In the last week - all of a sudden I'll get an itchy spot and it could be anywhere, it's very very itchy, and what happens is a thing comes up, almost like a hive.; tired; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss 2 weeks after 2nd dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included SIMVASTATIN, AMLODIPINE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN / HIDROCLOROTIAZIDA) and METOPROLOL for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced DEAFNESS (Hearing loss 2 weeks after 2nd dose) (seriousness criterion medically significant), POLLAKIURIA (frequent urination (every 10 minutes)), DIARRHOEA (Diarrhea), URTICARIA (In the last week - all of a sudden I'll get an itchy spot and it could be anywhere, it's very very itchy, and what happens is a thing comes up, almost like a hive.) and RASH PRURITIC (In the last week - all of a sudden I'll get an itchy spot and it could be anywhere, it's very very itchy, and what happens is a thing comes up, almost like a hive.). The patient was treated with HYDROGEN PEROXIDE for Discomfort, at an unspecified dose and frequency. At the time of the report, DEAFNESS (Hearing loss 2 weeks after 2nd dose) had resolved and POLLAKIURIA (frequent urination (every 10 minutes)), DIARRHOEA (Diarrhea), URTICARIA (In the last week - all of a sudden I'll get an itchy spot and it could be anywhere, it's very very itchy, and what happens is a thing comes up, almost like a hive.), RASH PRURITIC (In the last week - all of a sudden I'll get an itchy spot and it could be anywhere, it's very very itchy, and what happens is a thing comes up, almost like a hive.), FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Patient asked about booster shots.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: added patient's demographic, Event and concomitant medication. On 25-May-2021: Follow-up information received on 25-May-2021 contains non-significant information. On 05-Aug-2021: Follow-up received and newevent- hearing loss 2 weeks after second dose. outcome of event recovered/resolved was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.