Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Some pain in the heart; Received dose 1 and dose 2 of Moderna Covid-19 Vaccine before receiving Novavax as a first booster; Dry throat; Covid; COVID-19; Had a reaction; Huge reaction; Throat ache; Injected the whole 1.5 ml instead of the .5 ml. So in one shot I got 3 boosters; Muscle aches; Fatigue; This non-serious initial spontaneous safety report PRIVATE was received by Novavax on 10-JAN-2023 from a consumer via the contact center.  A male of 83 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 3 (reported as first booster) on 04-JAN-2023 in the left upper arm at a pharmacy.  The following medical history was reported: Cardiac disorder, Coronary artery bypass, stems (have a heart situation, triple bypass, and stems), Drug hypersensitivity, dose 1 (10-AUG-2021) and dose 2 (16-SEP-2021) of Moderna Covid-19 Vaccine (elasomeran) in the upper left arm.  The following concomitant medications were reported: losartan.  On 04-JAN-2023, the individual received Novavax as a first booster after reportedly receiving dose 1 and dose 2 of Moderna Covid-19 Vaccine last year (PT: COVID-19 immunisation). On 04-JAN-2023, the individual reported that that the pharmacy assistant did not get the right instruction and injected the whole 1.5 ml instead of the 0.5 ml., so in one shot, the individual got 3 boosters (PT: Incorrect dose administered). Subsequently, the individual had a reaction (PT: Adverse drug reaction).  On an unspecified day in JAN-2023, reported as 2-3 days after the shot, the individual had a throat ache (PT: Oropharyngeal pain). On 06-JAN-2023, reported as 2 days after the shot, the individual had a dry throat (PT: Dry throat), muscle aches (PT: Myalgia) and fatigue (PT: Fatigue). Subsequently, the individual took an at home rapid antigen test and it was positive for Covid (PT: Breakthrough COVID-19).  Treatment included Paxlovid (nirmatrelvir/ritonavir).  Relevant lab tests included: SARS-CoV-2 test (Result: positive; 06-JAN-2023) and SARS-CoV-2 test (Result: positive; 10-JAN-2023).  At the time of reporting, the event outcomes of COVID-19 immunization and Incorrect dose administered were recovered/resolved and event stop date was 04-JAN-2023, and the event outcomes of Adverse drug reaction, Breakthrough COVID-19, Oropharyngeal pain, Myalgia, Dry throat and Fatigue were not recovered/not resolved.  On 31-JAN-2023, significant additional information was received by Novavax from a consumer via the contact center. The consumer reported an additional significant event, "Some pain (on and off) in the heart," (PT: Angina pectoris) with onset date of an unspecified date in JAN-2023 and outcome recovered/resolved. Additionally, the individual described two existing events in more detail, stating they had a huge reaction two days after the vaccination and around three days after, and then found out they had COVID-19.  A discrepancy in the source documents was identified. The individual initially reported the date of vaccination to be Wednesday 04-JAN-2023, in the follow-up information he reported it to be 02-JAN-2023. Based on details in the initial source document the individual mentioned multiple times that they received the vaccination on a Wednesday therefore it was recorded as 04-JAN-2023.; Sender's Comments: This 83 year-old male experienced: Angina pectoris, COVID-19 immunisation, Incorrect dose administered, Breakthrough COVID-19, Dry throat, Fatigue, Myalgia, Adverse drug reaction and Oropharyngeal pain after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Angina pectoris was assessed as serious. The events COVID-19 immunisation, Incorrect dose administered, Breakthrough COVID-19, Dry throat, Fatigue, Myalgia, Adverse drug reaction and Oropharyngeal pain were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.