Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had a sore throat and dry coughing that woke him up. voice had dropped a few octaves and was now "husky"/ PCR test yesterday (14Nov2022) resulted positive; Had a sore throat and dry coughing that woke him up. voice had dropped a few octaves and was now "husky"/ PCR test yesterday (14Nov2022) resulted positive; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): MOD22-029370 (Moderna).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown), on 06Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 13Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Nov2022 at 15:00 as dose 4 (booster), single (Lot number: UT77733CA) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 02Jan2022, stop date: 15Jan2022, notes: He believes he had a history of COVID-19 which occurred from 02Jan2022-15Jan2022. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 03Nov2022 as dose number unknown, single.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Nov2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2022, outcome "unknown" and all described as "Had a sore throat and dry coughing that woke him up. voice had dropped a few octaves and was now "husky"/ PCR test yesterday (14Nov2022) resulted positive". The patient underwent the following laboratory tests and procedures: Antibody test: (Dec2020) positive, notes: He later received an antibody test in Dec2020 which showed strongly positive for COVID-19 vaccine antibodies; SARS-CoV-2 test: (14Nov2022) Positive, notes: PCR test yesterday (14Nov2022) which resulted positive today. Therapeutic measures were taken as a result of interchange of vaccine products, vaccination failure, covid-19.  Clinical course: Patient had received 3 doses of the Pfizer COVID-19 vaccines on 16Dec2020, 06Jan2021, and 13Jan2022. He then received a dose of the Moderna COVID-19 Bivalent vaccine by intramuscular injection to the upper right arm on 07Nov2022 at 3:00 PM (Lot number: UT77733CA, expiration date unknown). Immediately after receiving this dose his arm hurt. The next day (08Nov2022) he was out walking his dog and upon returning home he felt profoundly weak, fatigued, tired, achy, and had flu-like symptoms. He laid down and slept for 18 of the next 24 hours only rising for 2 meals. His wife started experiencing symptoms on 09Nov2022 and tested positive for COVID-19 by PCR on 11Nov2022 after having tested negative with 2 at home tests. Sunday (13Nov2022) night he started to have a sore throat and dry coughing that woke him up. His voice has dropped a few octaves and is now "husky." He went to receive a PCR test yesterday (14Nov2022) which resulted positive today. His throat only hurt for one night. His dry cough has persisted today though it is very intermittent. His sore arm stopped hurting yesterday. He has been taking Robitussin DM for his symptoms during the day and scotch whiskey for it at night. He believed he had a history of COVID-19 which ocurred from 02Jan2022-15Jan2022. He took robitussin DM by day and scotch whiskey by night for his symptoms, but there were no lab tests available at that time. He later received an antibody test in Dec2020 which showed strongly positive for COVID-19 vaccine antibodies. He also received a flu shot a week prior to his dose of the Moderna vaccine on 03Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure, Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.