Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 6024MF014A | OT / RA |
I had a second flare in May; Right knee swelled; Right knee...was hot; Right knee...I could not bend it; I had CPPD flare; Fever; Cold-like symptoms; Uncomfortable; I got COVID after getting vaccinated with Novavax's COVID vaccine; Extreme fatigue/Extremely tired; Achiness all over; Skin sensitivity; Your vaccine did not work; This serious initial Spontaneous safety report was received by Novavax via web portal (Adverse Event Submission No.US-1000000501-NVAX) on 09-Jun-2025 from a Consumer or other non-health professional. A 56-year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (Intramuscular) (Lot number was not provided in the report.) on 26-Oct-2024. The following medical history was reported: COUGH VARIANT ASTHMA. No concomitant medications were reported. On 26-Oct-2024, 1 Day after vaccination, the patient reported "Your vaccine did not work"(Vaccination failure)(Serious: Other Medically Important Condition), On 24-Dec-2024, 60 Day after vaccination the patient reported "I got COVID after getting vaccinated with Novavax's COVID vaccine" (Breakthrough COVID-19). Treatment included Paxlovid. On unknown date in Dec-2024, after vaccination the patient reported "I was a week in bed" (Adverse event). Relevant lab tests included: COVID-19 RAPID POC TEST (Result: Positive, Test Date: 24-Dec-2024) and COVID-19 RAPID POC TEST (Result: Positive, Test Date: 21-Jun-2022). At the time of reporting, the event outcome of Vaccination failure was Recovered/Resolved on 26-Oct-2024, Adverse event was Unknown and Breakthrough COVID-19 was Recovering/Resolving. Few discrepancies were identified in the source document: For the event of vaccination failure, event onset date was captured as the date of vaccine administration and event cessation was captured to match the event start date with an outcome of recovered/resolved as it is a special situation, Other Medically Important Condition event. The reporter indicated that the Novavax vaccine was administered as a booster dose; however, it was also stated that only one COVID-19 vaccination dose has been received to date. On 18-Jun-2025, significant information was received from consumer via a query response with the following updates: CPPD (Pseudogout) (Calcium Pyrophosphate Dihydrate deposition disease) and Severe Osteoarthritis were added to patient's medical history. Patient's past therapy was updated with 2 administrations of Pfizer Covid-19 vaccines (reported as full course) followed by Moderna Covid-19 vaccine booster. Novavax vaccine therapy start and end dates were updated from 26-Oct-2024 to 07-Oct-2024, and lot number 6024MF014A was reported with an expiration date of 31-Oct-2024. The onset and cessation dates of the event Vaccination failure were updated from 26-Oct-2024 to 07-Oct-2024. The following events were added: On unspecified date in Dec-2024, the patient experienced "Extreme fatigue/Extremely tired" (Fatigue), "Achiness all over" (Pain), "Skin sensitivity" (Sensitive skin), "Fever" (Pyrexia), "Cold-like symptoms" (Nasopharyngitis), "Uncomfortable" (Discomfort). On 05-Jan-2025, the patient experienced "Right knee swelled" (Joint swelling), "Right knee... was hot" (Joint warmth), "Right knee... I could not bend it" (Joint range of motion decreased), and "I had CPPD flare" (Condition aggravated). On an unspecified date in May-2025, the patient experienced "I had a second flare in May" (Condition aggravated). At the time of reporting, the outcome of the events Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated (second flare) was Unknown. The outcome of the event Condition aggravated (first flare) was Recovered/Resolved (on an unknown date). Discrepancies were identified in the source document: For the event of vaccination failure, event onset date was captured as the date of vaccine administration and event cessation was captured to match the event start date with an outcome of recovered/resolved as it is a special situation, Other Medically Important Condition event. The outcome of the event "I had CPPD flare" (Condition aggravated) was not reported but was captured as Recovered/Resolved due to reported second episode of the same event. On 28-Jun-2025, significant information was received from consumer via a query response with the following updates: Primary physician was added as another reporter. Patient's date of birth was added. The following medical history was added: Bursitis of the shoulders (left+right). The previously reported patient's medical history was updated: CPPD: the start date was updated from unknown to 05-Jan-2025, severe osteoarthritis onset date was updated from unknown to 2015 (reported as: "started 10 years ago"), cough variant asthma was updated from continuing to No and the onset was updated from unknown to 2015. The previously reported patient's past therapies were updated: Comirnaty (previously reported as Pfizer vaccine) with the therapy start and stop date on 02-Apr-2021 for the first dose (Lot number: EW0150, left arm), 23-Apr-2021 for the second dose (Lot number: EW0171, left arm), and 29-Nov-2021 for the booster dose (Lot number: FH8030, right arm). Moderna vaccine was updated to Spikevax (Lot number: 013H22A, right arm) with the therapy start and stop date on 05-Nov-2022. The following details were updated for the reported events: The onset dates of the following events were updated from an unspecified date in Dec-2024 to 25-Dec-2024: Fever (PT: Pyrexia), Cold-like symptoms (PT: Nasopharyngitis), Uncomfortable (PT: Discomfort). The outcome of the event Right knee swelled (PT: Joint swelling) was Recovering/Resolving. The outcome of the events "Right knee was hot" (PT: Joint warmth), "Right knee I could not bend it" (PT: Joint range of motion decreased) was Recovered/Resolved with Sequelae, on an unknown date. The outcome of the event Skin sensitivity (PT: Sensitive skin) was Recovered/Resolved on an unknown date. The outcome of the event Fever (PT: Pyrexia) was Recovered/Resolved on 29-Dec-2024. The outcome of the events Cold-like symptoms (PT: Nasopharyngitis) and Uncomfortable (PT: Discomfort) were Recovered/Resolved on 03-Jan-2025. The outcome of the events of "I got COVID after getting vaccinated with Novavax COVID vaccine" (PT: Breakthrough COVID-19)" was Recovered/resolved on 04-Jan-2025, "I had a second flare in May (PT: Condition aggravated) was Recovered/Resolved on 15-Jun-2025. The cessation date for the event of "I had CPPD flare" (PT: Condition aggravated) (first flare) was updated to 20-Jan-2025.; Sender's Comments: This 56 year-old Female experienced Vaccination failure, Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Breakthrough COVID-19, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated and Condition aggravated after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Vaccination failure was reported as serious. The events Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Breakthrough COVID-19, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated and Condition aggravated were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Vaccination failure is considered Related, and the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Breakthrough COVID-19, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated and Condition aggravated is considered Possible.
Calcium pyrophosphate dihydrate deposition disease; Osteoarthritis; Shoulder bursitis
Medical History/Concurrent Conditions: Cough variant asthma
Test Date: 20241224; Test Name: COVID-19 RAPID POC TEST; Test Result: Positive ; Test Date: 20220621; Test Name: COVID-19 RAPID POC TEST; Test Result: Positive