Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: PCR test yesterday (14NOV2022) which resulted positive today; Voice has dropped a few octaves and is now husky; Achy; Immediately after receiving this dose his arm hurt; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Achy), DYSPHONIA (Voice has dropped a few octaves and is now husky), COVID-19 (PCR test yesterday (14NOV2022) which resulted positive today) and VACCINATION SITE PAIN (Immediately after receiving this dose his arm hurt) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. UT77733CA) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (took robitussin DM by day and scotch whiskey by night for his symptoms, but there were no lab tests available at that time) from 02-Jan-2022 to 15-Jan-2022. Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine on 16-Dec-2020, Pfizer COVID-19 vaccine on 06-Jan-2021, Pfizer COVID-19 vaccine on 13-Jan-2022 and Robitussin DM since an unknown date. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Robitussin DM. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 07-Nov-2022 at 3:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Nov-2022, the patient experienced VACCINATION SITE PAIN (Immediately after receiving this dose his arm hurt). On 08-Nov-2022, the patient experienced PAIN (Achy). On 13-Nov-2022, the patient experienced DYSPHONIA (Voice has dropped a few octaves and is now husky). On 14-Nov-2022, the patient experienced COVID-19 (PCR test yesterday (14NOV2022) which resulted positive today). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM) at an unspecified dose and frequency. On 09-Nov-2022, PAIN (Achy) had resolved. On 14-Nov-2022, VACCINATION SITE PAIN (Immediately after receiving this dose his arm hurt) had resolved. At the time of the report, DYSPHONIA (Voice has dropped a few octaves and is now husky) and COVID-19 (PCR test yesterday (14NOV2022) which resulted positive today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Antibody test: (Positive) showed strongly positive for COVID-19 vaccine antibodies.. On 14-Nov-2022, Polymerase chain reaction: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   The patient received mRNA-1273 BIVALENT .222 vaccine in upper right arm. On 08-Nov-2022, the patient was out walking his dog and upon returning home he felt profoundly weak, fatigued, tired, achy, and had flu-like symptoms. The patient laid down and slept for 18 of the next 24 hours only rising for 2 meals. The patient experienced dry cough and it was persisted at the time of this report though it was very intermittent. The patient's throat only hurt for one night. His dry cough has persisted today (15-NOV-2022) though it was very intermittent. The patient was taking Robitussin DM for his symptoms during the day and scotch whiskey for it at night. Due to COVID-19 patient experienced  laid down and slept for 18 of the next 24 hours only rising for 2 meals, Profoundly weak, Dry coughing that woke him up, Fatigued/tired, Sore throat and dry coughing that woke him up and Flu-like symptoms.  Company comment: This spontaneous case concerns a 78-years-old male patient with no medical history reported, who experienced the unexpected non-serious event of COVID-19, Vaccination site pain and Dysphonia which occurred in context to fourth dose of mRNA-1273 bivalent BA.4/BA.5 vaccine. The events occurred in about 1 to 7 days after the current vaccination with positive Polymerase chain reaction 7 days after vaccination. The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM). The event Dysphonia outcome was unknown and other events were resolved. It was noted that patient received a dose with Pfizer COVID-19 approximately 10 months prior to current vaccination (Revaccination with different COVID-19 vaccine and interchange of vaccine products). The causality of the event of COVID-19 was assessed as not applicable, due to lack of biological plausibility. The events might be explained by COVID-19 pandemic outbreak.   Nurse who worked in the emergency room stated patients are getting the Moderna vaccine and coming in with more frequency than the Pfizer vaccines.; Sender's Comments: This spontaneous case concerns a 78-years-old male patient with no medical history reported, who experienced the unexpected non-serious event of COVID-19, Vaccination site pain and Dysphonia which occurred in context to fourth dose of mRNA-1273 bivalent BA.4/BA.5 vaccine. The events occurred in about 1 to 7 days after the current vaccination with positive Polymerase chain reaction 7 days after vaccination. The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM). The event Dysphonia outcome was unknown and other events were resolved. It was noted that patient received a dose with Pfizer COVID-19 approximately 10 months prior to current vaccination (Revaccination with different COVID-19 vaccine and interchange of vaccine products). The causality of the event of COVID-19 was assessed as not applicable, due to lack of biological plausibility. The events might be explained by COVID-19 pandemic outbreak.