Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, COVID-19 immunisation, Ear pain, Ear swelling, Hypoacusis
Clinical narrative: COVID-19 immunization; interchange of vaccine products; There was more facial swelling; RIGHT ear began to swell and hurt like last time/My ears were swollen/LEFT ear followed suit; RIGHT ear began to swell and hurt like last time /LEFT ear followed suit; started to lose hearing mildly in both ears; allergic reaction to the second booster; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (There was more facial swelling), EAR SWELLING (RIGHT ear began to swell and hurt like last time/My ears were swollen/LEFT ear followed suit), EAR PAIN (RIGHT ear began to swell and hurt like last time /LEFT ear followed suit), HYPOACUSIS (started to lose hearing mildly in both ears) and ALLERGY TO VACCINE (allergic reaction to the second booster) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131322A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus in November 2021. Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Timing 12:00, intramuscular at arm, lot number ER8730, Dose 1, sore arm and extremely tired, lasted 24 hours.) on 25-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Timing 14:30, intramuscular at arm, lot number EW0171, Dose 2, sore arm, low grade fever, chills, aches, headache, Felt like bad flu lasting 48 plus hours) on 22-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Timing 11:40, intramuscular at arm, lot number FH8028, Dose 3, sore arm, achy and extremely tired. 13-Nov-2021, Swelling and pain on both ears.) on 12-Nov-2021, NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (on 14-Nov-2021, Neo/Poly/HC 1 percent otic green (ear) on 19-Nov-2021, Neo/Poly/HC 1 percent otic green (ear)), ciprofloxacin (on 14-Nov-2021, ciprofloxacin 500 mg tablet on 19-Nov-2021 and ciprofloxacin 500 mg tablet). Past adverse reactions to the above products included Adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE; and No adverse event with NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE and ciprofloxacin.    On 31-Jul-2022 at 10:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2022, the patient experienced SWELLING FACE (There was more facial swelling) (seriousness criteria disability and medically significant), EAR SWELLING (RIGHT ear began to swell and hurt like last time/My ears were swollen/LEFT ear followed suit) (seriousness criteria disability and medically significant), EAR PAIN (RIGHT ear began to swell and hurt like last time /LEFT ear followed suit) (seriousness criteria disability and congenital anomaly), HYPOACUSIS (started to lose hearing mildly in both ears) (seriousness criteria disability and medically significant) and ALLERGY TO VACCINE (allergic reaction to the second booster) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced COVID-19 IMMUNISATION (COVID-19 immunization) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). The patient was treated with METHYLPREDNISOLONE on 02-Aug-2022 at a dose of 4 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (There was more facial swelling), EAR SWELLING (RIGHT ear began to swell and hurt like last time/My ears were swollen/LEFT ear followed suit), EAR PAIN (RIGHT ear began to swell and hurt like last time /LEFT ear followed suit), HYPOACUSIS (started to lose hearing mildly in both ears) and ALLERGY TO VACCINE (allergic reaction to the second booster) had resolved and COVID-19 IMMUNISATION (COVID-19 immunization) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2022, SARS-CoV-2 test: (Negative) Negative. On 24-Feb-2022, SARS-CoV-2 test: (Positive) Positive. On 03-Mar-2022, SARS-CoV-2 test: (Positive) Positive. On 08-Mar-2022, SARS-CoV-2 test: (Negative) Negative.         Concomitant medication list was not provided. Age of the patient was reported was reported as 53 years old at time of Pfizer vaccine and 54 years old at moderna vaccine. On 13-Nov-2021 at 7 pm, swelling and pain on both ears. Both ears were swollen so much that could not see into either ear canal. Head was throbbing at this point and face starting to swell. On 14-Nov-2021, patient visit emergency room. Doctor treated as this as tinnitus. On 26-Nov-2021, patient recovered from events. Covid status was confirmed positive on 25-Feb-2022. Lasted 13 days before testing negative on 09-Mar-2022.  Company comment: This spontaneous case concerns a 54-years-old female patient with past medical history of Tinnitus reported, who experienced the unexpected serious (medically significant) Swelling face, Ear pain, Ear swelling, Hypoacusis and Allergy to vaccine that occurred after 2 days after the fourth dose of mRNA-1273 vaccination. The patient was treated with METHYLPREDNISOLONE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). The events outcome was not resolved. It was noted that patient received 3 doses with PFIZER BIONTECH COVID-19 VACCINE  different COVID-19 vaccine  prior to current vaccination (interchange of vaccine products and COVID-19 immunization). No additional information is available regarding medical history and treatment details. The event outcome was resolved. Patient's past medical history of Tinnitus remain a confunder for the events Ear pain,Ear swelling and Hypoacusis.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 54-years-old female patient with past medical history of Tinnitus reported, who experienced the unexpected serious (medically significant) Swelling face, Ear pain, Ear swelling, Hypoacusis and Allergy to vaccine that occurred after 2 days after the fourth dose of mRNA-1273 vaccination. The patient was treated with METHYLPREDNISOLONE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). The events outcome was not resolved. It was noted that patient received 3 doses with PFIZER BIONTECH COVID-19 VACCINE  different COVID-19 vaccine  prior to current vaccination (interchange of vaccine products and COVID-19 immunization). No additional information is available regarding medical history and treatment details. The event outcome was resolved. Patient's past medical history of Tinnitus remain a confunder for the events Ear pain,Ear swelling and Hypoacusis.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.