Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Brain fog, COVID-19, Fatigue, Malaise
Clinical narrative: I start shaking; Got a light case of Covid 19; I took a test and it was positive; I felt like little cold like symptoms and with a little sore throat; I felt like little cold like symptoms and with a little sore throat; I still have the fatigue and some brain symptoms; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down; I still have the fatigue and some brain symptoms; I start shaking; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down; I still have the fatigue and some brain symptoms; Feeling a little under the weather; Sore arm; I had minimal side effects; Brain fog; I still have long covid symptoms; This serious initial spontaneous safety report was received by Novavax on 09-Oct-2024 from a consumer via Novavax Medical Information (NOV24-00567 and NOV24-00609). A female of unspecified age was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)(Intramuscular) (Lot number was not provided in the report) in 2023.  The following medical history was reported: ALLERGIC ASTHMA.   No concomitant medications were reported.  On an unspecified date after vaccination the patient experienced Feeling a little under the weather (Malaise) and Sore arm (Pain in extremity). In Nov-2023 the patient experienced I felt like little cold like symptoms and with a little sore throat (Nasopharyngitis) (Oropharyngeal pain), I took a test and it was positive (Vaccination failure) (Serious: Other Medically Important Condition), Got a light case of Covid 19 (COVID-19), I still have long covid symptoms (Post-acute COVID-19 syndrome), I still have the fatigue and some brain symptoms (fatigue) (Nervous system disorder).  Treatment for COVID-19 included Paxlovid.  Relevant lab tests included: COVID-19 TEST(Result: Positive, Test Date: Nov-2023).  At the time of reporting, the event outcome of Fatigue and Nervous system disorder was Recovering/Resolving; the event outcome of Malaise, Pain in extremity, COVID-19 was Unknown; the event outcome of Post-acute COVID-19 syndrome was Not Recovered/Not Resolved/Ongoing, the event outcome of Nasopharyngitis, Oropharyngeal pain and Vaccination failure was Recovered/Resolved.  On 15-Oct-2024, significant information was received from PQC via a follow-up query - added 2 new reporters, updated therapy start and end date from --2023 to 29-Oct-2023, and lot number to 5683MF012, vaccination facility telephone, added 1 new event: I had minimal side effects (PT: Adverse event) with the outcome as Recovered/Resolved. Patient's past therapy was added: Nuvaxovid COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) administered on 15-Oct-2024, with associated events Pain, Headache and Fever.  On 14-Nov-2024, significant information was received from a consumer via a query response: Added reporter's middle name Added 1 new patient past therapy (Moderna in 2021 with reported event: Severe reaction to my 2nd Moderna shot). Added 2 new events in the patient past therapy for Nuvaxovid received in 2024: Not nearly as bad as my severe reaction to my 2nd Moderna shot in 2021, but definitely uncomfortable (PT: Adverse event), Worse since my booster (PT: Condition aggravated) Added body temperature increased in patient medical history Updated COVID test date from -Nov-2023 to 23-Nov-2023 Updated event onset date of I took a test and it was positive (PT: Vaccination failure) to 23-Nov-2023, added Paxlovid as treatment started on 23-Nov-2023. Added 2 new events - On an unknown date, the patient experienced Brain fog (PT: Brain fog); On an unknown date in Nov-2023, the patient experienced I start shaking (Tremor). The outcome of the events Brain fog and Tremor were Not Recovered/Not Resolved/Ongoing. The reported term for the event PT: Fatigue was updated from "I still have the fatigue and some brain symptoms" to "I still have the fatigue and some brain symptoms; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down".  Updated event outcome of PT: Fatigue to Not recovered/Not resolved/Ongoing.  On 21-Nov-2024, the product quality complaint (PQC) investigation results were received. Per the investigation summary, the vaccine was expected ti meet all critical quality attributes at the time of vaccine administration. PQC was added as Report classification.  On 20-Dec-2024, non-significant information was received from a consumer - No new information was received.  On 25-Jan-2025, significant information was received from a consumer via a query response:    History of Allergic asthma estimated start was provided as 25 years ago, and classified as current condition as response to whether condition is ongoing was "unknown/sometimes". Added Flu vaccine to past therapy. Other COVID-19 vaccines site of administration for Moderna and Johnson & Johnson received in 2022 was updated to left arm. Dose number in series of two moderna doses received in 2022 was confirmed as Doses 1 and 2 while dose of Johnson & Johnson was in 2022 was confirmed as booster dose.  The following events were upgraded to serious: fatigue (serious: disability), Nervous system disorder (serious: disability), COVID-19 (serious: disability), Adverse event (serious: disability), brain fog (serious: disability),   Onset date of the event of PT: COVID-19 was updated to 23-Nov-2023 and outcome was updated recovered/resolved with sequelae. Onset date of the event of PT: Nasopharyngitis was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Oropharyngeal pain was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Malaise was updated to 23-Nov-2023 and outcome was updated recovered/resolved.  Onset date of the event of PT: Pain in extremity was updated to 23-Nov-2023 and outcome was updated to recovered/resolved.  Onset date of the event of PT: Adverse event was updated to 23-Nov-2023, and outcome was updated to recovered/resolved with sequelae.  Onset date of the event of PT: Brain fog was updated to 23-Nov-2023. Onset date of the event of PTs: Fatigue and Nervous system disorder was updated to 23-Nov-2023, and outcome of the events were updated to not recovered/not resolved. Start date of the event of PT: Tremor was updated to 15-Dec-2023.   Discrepancies were identified in the source document - Flu vaccine was reported as concomitant medication, but it was also stated that it was received a few weeks - 45 days, thus not captured as concomitant medication as it was beyond 30 days in the structured field. This was instead captured as past therapy. Start dates captured as 23-Nov-2023 as no month corresponds to 23 if the format of DD/MMM/YYYY is followed. Patient's age was reported as 70 years, however age at the time of the event was retained (69 years).; Sender's Comments: This 69 years old female experienced Malaise, Pain in extremity, Adverse event, Brain fog, Tremor, COVID-19, Post-acute COVID-19 syndrome, Nasopharyngitis, Oropharyngeal pain, Nervous system disorder, Fatigue and Vaccination failure after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (4).  The event Vaccination failure was assessed as serious. The events of Fatigue, Nervous system disorder, COVID-19, Adverse event, and brain fog were reported as serious. The event Malaise, Pain in extremity, Tremor, Post-acute COVID-19 syndrome, Nasopharyngitis, Oropharyngeal pain were reported as non-serious.    Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and COVID-19, Post-acute COVID-19 syndrome, Tremor, Nasopharyngitis, Oropharyngeal pain, Nervous system disorder, Fatigue, Malaise, Pain in extremity, Adverse event and Brain fog is considered Possible; and the event of Vaccination failure is considered Related.