chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood potassium normal, Blood sodium decreased, Blood test, Blood triglycerides normal, Blood urea normal
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood urine absent, Carbon dioxide normal, Cerebral atrophy, Cerebral ventricle dilatation, Cerebrovascular accident
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram head abnormal, Culture urine negative, Differential white blood cell count abnormal, Disorganised speech, Eosinophil percentage decreased
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Full blood count abnormal, Fungal test negative, Glomerular filtration rate normal, Glucose urine absent, Glycosylated haemoglobin normal
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Haematocrit normal, Haemoglobin normal, Headache, High density lipoprotein normal, International normalised ratio normal
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Intervertebral disc space narrowing, Low density lipoprotein normal, Lymphocyte percentage decreased, Magnetic resonance imaging head normal, Mean cell haemoglobin concentration normal
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal, Metabolic function test abnormal, Monocyte percentage increased
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Neutrophil percentage increased, Nitrite urine absent, Osteoarthritis, Platelet count decreased
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Protein total normal, Protein urine absent, Prothrombin time prolonged, Red blood cell count decreased, Red blood cell nucleated morphology
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Red blood cells urine negative, Red cell distribution width, Scan, Scan with contrast abnormal, Sleep disorder
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Specific gravity urine normal, Spinal osteoarthritis, Spinal retrolisthesis, Transient ischaemic attack, Troponin T increased
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urinary sediment present, Urine analysis abnormal, Urine ketone body present, Urobilinogen urine, Vertebral foraminal stenosis
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: White blood cell count normal, White blood cells urine negative, pH urine normal
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Mobility decreased, Muscular weakness
Clinical narrative: GENERAL FEELINGS LIKE I HAD FLUE, LOST STRENGTH IN MY LEGS AND HAD PROBLEMS MOVING ABOUT
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE and no PQC; Pharmacist calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 08/30/2023; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies.  On 30-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #W004863, expiration date: 21-AUG-2023 (expired vaccine administered), administered for prophylaxis (strength, and route of administration were not provided).  No adverse symptoms were reported.
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient is not experiencing any side effects at this time; 12 month old female patient was accidently given GARDASIL 9 vaccine this morning; This spontaneous report has been received from a nurse and refers to a 12-month-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 21-SEP-2023, the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis at 12 months of age (Product administered to patient of inappropriate age). (strength, lot #, expiry date, and route of administration were not provided). The patient had not experienced any adverse events.
Age: 0.33
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC.; HCP calling to report a child received VARIVAX inadvertently at 4 months of age instead of 12 months. No side effects were reported. No additional information was provided. No additional AE/no PQC.; This spontaneous report has been received from a nurse and refers to a 4-month-old male patient.  The patient's pertinent medical history, other drug reactions or allergies, and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 12-JUN-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml), at 4 months of age instead of 12 months (product administered to patient of inappropriate age), administered for prophylaxis (lot number W039967 has been determined to be an invalid number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date was reported as 13-DEC-2024) (strength, and route of administration were not provided). However, no side effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site swelling
Clinical narrative: swelling at injection site; Headache; dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 17-SEP-2023, the patient received the 2nd dose of Shingles vaccine. On 17-SEP-2023, less than a day after receiving Shingles vaccine, the patient experienced injection site swelling (Verbatim: swelling at injection site), headache (Verbatim: Headache) and dizziness (Verbatim: dizziness).  The outcome of the injection site swelling, headache and dizziness were not resolved.   It was unknown if the reporter considered the injection site swelling, headache and dizziness to be related to Shingles vaccine.     It was unknown if the company considered the injection site swelling, headache and dizziness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 and 18-Sept-2023 The case was received from the patient via interactive digital media. The patient got the second shot on the day of reporting and had some swelling at injection site, headache and dizziness. The physician stated that the patient will never get shingles again and they will see.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: injection site reaction of tenderness, soreness/tender to the touch; she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down; myalgia/muscle achiness "on and off; significant fatigue; swelling at the injection site swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down/large, a little puffy like an enormous welt; very itchy; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA287385(cluster).  This case involves a 69 year old female patient who experienced injection site reaction of tenderness, soreness/tender to the touch, she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down, myalgia/muscle achiness "on and off, significant fatigue, a little puffy like an enormous welt and very itchy after receiving vaccine Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Penicillin allergy.  On 12-Sep-2023, the patient received a dose of 0.7 ml suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, formulation, expiry date and lot number not reported) via intramuscular route in unknown administration site as immunization.  On 12-Sep-2023 the patient developed injection site reaction of tenderness, soreness/tender to the touch (vaccination site pain)she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down/large, a little puffy like an enormous welt (vaccination site swelling), (vaccination site erythema), soreness/tender to the touch (vaccination site pain), myalgia/muscle achiness "on and off (myalgia), significant fatigue (fatigue) and very itchy (vaccination site pruritus) (latency: same day).  Reportedly: also have felt itchiness on the injection site. In addition I have had myalgia and fatigue for the last five days from that shot. No fever was experienced. She states that the achiness has resolved, that was only for "a couple of days". The fatigue lasted "a number of days" but is also better. Her arm remains "red and itchy and not a happy camper.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for the event  vaccination site pain, vaccination site swelling;  was Not Recovered / Not Resolved for the event  vaccination site erythema, vaccination site pruritus and was Recovered / Resolved on an unknown date in 2023 for the event myalgia,  was Recovering / Resolving for the event fatigue; Sender's Comments:  US-SA-2023SA287395:01770285
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site reaction of tenderness, soreness/tender to the touch; she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down; myalgia/muscle achiness "on and off; significant fatigue; swelling at the injection site swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down/large, a little puffy like an enormous welt; very itchy; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA287385(cluster).  This case involves a 69 year old female patient who experienced injection site reaction of tenderness, soreness/tender to the touch, she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down, myalgia/muscle achiness "on and off, significant fatigue, a little puffy like an enormous welt and very itchy after receiving vaccine Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Penicillin allergy.  On 12-Sep-2023, the patient received a dose of 0.7 ml suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, formulation, expiry date and lot number not reported) via intramuscular route in unknown administration site as immunization.  On 12-Sep-2023 the patient developed injection site reaction of tenderness, soreness/tender to the touch (vaccination site pain)she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down/large, a little puffy like an enormous welt (vaccination site swelling), (vaccination site erythema), soreness/tender to the touch (vaccination site pain), myalgia/muscle achiness "on and off (myalgia), significant fatigue (fatigue) and very itchy (vaccination site pruritus) (latency: same day).  Reportedly: also have felt itchiness on the injection site. In addition I have had myalgia and fatigue for the last five days from that shot. No fever was experienced. She states that the achiness has resolved, that was only for "a couple of days". The fatigue lasted "a number of days" but is also better. Her arm remains "red and itchy and not a happy camper.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for the event  vaccination site pain, vaccination site swelling;  was Not Recovered / Not Resolved for the event  vaccination site erythema, vaccination site pruritus and was Recovered / Resolved on an unknown date in 2023 for the event myalgia,  was Recovering / Resolving for the event fatigue; Sender's Comments:  US-SA-2023SA287395:01770285
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received improperly stored vaccine; This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # U022983 exp date 22-JUL-2023) (dose and route not reported). The temperature of excursion was 49.3°F for a time frame of 3 hour 11 minutes. There was no previous temperature excursion.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: No additional AE/No PQC; HCP reported a pregnant woman was given MMR II and VARIVAX.; This spontaneous report has been received from a medical assistant and refers to a 41-year-old pregnant female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the pregnant patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number w031812 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 05-OCT-2024) (strength was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number w036931 has been determined to be an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date has been reported as 19-MAY-2023) (maternal exposure during pregnancy) (strength, and indication were not provided); both vaccines were administered intramuscularly for immunization. No adverse events were reported.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site of less than 20mm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at the injection site of less than 20mm).  The outcome of the injection site erythema was resolved (duration 48 hrs).   It was unknown if the reporter considered the injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site erythema to be related to Arexvy.   Additional Information: GSK Receipt date: 18-SEP-2023 A pharmacist reported that a patient experienced redness at the injection site of less than 20 mm, which remained for about 48 hours post injection. The reporter agree to follow up from GSK.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 054A22A) for COVID-19 prophylaxis.     Patient had no known allergies. It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19.     On 08-Apr-2023 at 2:33 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) .5 dosage form. On 08-Apr-2023 at 2:33 PM,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial did not undergo any temperature excursions.  Vial size given as 10 dose vial.  Vial was initially stored in the refrigerator on 07 Apr 2023 and Date of administration of vaccine on 08 Apr 2023.  Treatment medication not reported.  This case was for patient 1 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-738752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Significant follow up received contains reporter details, medical history, patient details and product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738752:Patient 2
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Cholesterol.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: not go down 96.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took some medication for Cholesterol.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741466 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741466:Same reporter Wife case
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: No adverse event; During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm; During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm; This spontaneous case was reported by a patient and describes the occurrence of DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm), UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Patient had received 5 doses of the Pfizer COVID-19 vaccine previously.). Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Soft tissue infection, Swelling
Clinical narrative: Swelling and redness of skin and soft tissue started 6 hours after the injection
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Note from client that administered vaccine:  THIS PATIENT GIVEN HIGH DOSE FLU VACCINE BY ME TODAY. I HAVE CALLED EMPLOYEE IN BILLING DEPARTMENT TO ADJUST THE AGE PARAMETERS SO I CAN PUT THE VACCINE IN FOR THIS PATIENT AS I WAS NOT ABLE TO BECAUSE OF AGE PARAMETERS. ALSO, THE BILLING WAS REMOVED SO THIS PATIENT WILL NOT BE CHARGED FOR THIS VACCINE. HER INSURANCE WILL DENY PAYMENT DUE TO HER AGE. I CALLED THE PATIENT TO NOTIFY HER OF THE MEDICATION ERROR. I APOLOGIZED AND INFORMED HER THAT SHE WILL NOT BE CHARGED FOR THE VACCINE NOR WILL HER INSURANCE BE BILLED. PATIENT UNDERSTOOD ALL. I WILL PUT AN INCIDENT REPORT IN FILE CABINET AND UPDATE PROGRESS NOTE AS NEEDED.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: NO ISSUES TOLERATED WELL
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: no issues - tolerated well
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site mass, Injection site nodule
Clinical narrative: Right thigh nodule/lump
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Reactivated oral herpes (HSV1) that had been dormant for 10+ years.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to pt in office. Issue is with labeling as the label writing very minute, label and cap color exactly the same as Moderna. Due to this reason, 5-11yo vaccine of Pfizer was given to adult, due to the similarities in coloring of bottle. Pt also has c/o very sore arms a few hours after having the vaccine. No VIS is able to be obtained from CDC or online except for ages younger than 11 yo. Pts requesting more information as to side effects for adults being a new variant of vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Chills, Dyspnoea, Pyrexia
Clinical narrative: Presented to the ED due to chest pain, shortness of breath, fevers and chills.  Reports COVID-19 infection found outpatient.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Watery diarrhea lasting about 1 hr.
Age: 13.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock, unspecified, initial encounter on 2023-08-02.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: I took COVID-19 vaccination and the influenza vaccination in the same left arm. The shot site for the Covid vaccination was approximately 1 inch higher than the site of the flu injection vaccination. I have recovered completely, however, there is a persisting nagging cough that continues.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pyrexia, Rash, Swelling
Clinical narrative: Patient contact triage nurse on 9/26/2023 and advised of lump, redness, swelling, rash, feverish after pneumonia shot to the left arm. Patient was advised to utilize our same day clinic for evaluation and treatment. Patient presented to same day clinic on 9/26/2023 and was evaluated by NP and was scripted triamcinolone cream and famotidine.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 80 year old patient was given Vaxelis vaccine but should have been given Tdap. Patient had no reaction or adverse outcome to vaccine.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Noticeable Erythematous patch about 50-70mm, slightly raised, warm and tender to touch on 09/24/2023