Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Tinnitus, Urticaria
Clinical narrative: debilitating chronic hives; Patient has tinnitus in the left ear/going to be hearing sounds for the rest of her life not a moment of silence; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (debilitating chronic hives) and TINNITUS (Patient has tinnitus in the left ear/going to be hearing sounds for the rest of her life not a moment of silence) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MOMETASONE FUROATE (NASONEX) for Rhinitis, PROCATEROL HYDROCHLORIDE (PRO-AIR) for an unknown indication.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced URTICARIA (debilitating chronic hives) (seriousness criterion disability) and TINNITUS (Patient has tinnitus in the left ear/going to be hearing sounds for the rest of her life not a moment of silence) (seriousness criterion disability). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (debilitating chronic hives) and TINNITUS (Patient has tinnitus in the left ear/going to be hearing sounds for the rest of her life not a moment of silence) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: showed her ig's are over the top (Inconclusive) showed her Ig's are over the top.         Races given as:   Patient reported that she's been on antihistamines for a while and she has gone to a Dermatologist, an Immunologist and a GP.  She also mentioned that she went to the doctor to get an MRI when she developed the tinnitus to rule out a brain tumor.  Nasonex for when she has stuffy nose and a ProAir pump but that she hardly uses it, and that 7-8 years ago she had an allergy shot because she had some allergies and since then she hasn't had any health problems and that her lab records can prove it.  Company comment: This case concerns a 62-year-old, female patient with no medical history reported, who experienced the unexpected serious events urticaria and tinnitus 29days after receiving the second dose of mRNA-1273 vaccine. Patient had some allergies and had allergy shot 7-8 years ago and since then she hasn't had any health problems. Blood tests showed IG's were high (Details not provided) The benefit-risk relationship of mRNA-1273 vaccine  is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient with no medical history reported, who experienced the unexpected serious events of urticaria and tinnitus 29days after receiving the second dose of mRNA-1273 vaccine. Patient had some allergies and had allergy shot 7-8 years ago and since then she hasn't had any health problems. Blood tests showed IG's were high (Details not provided) The benefit-risk relationship of mRNA-1273 vaccine  is not affected by this report.