chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Bartonellosis, Dysbiosis, Electric shock sensation, Haematological infection
Clinical narrative: 1) Myalgic Encephamyolitis,  2) Reactivated Lyme Disease, 3) Furry Tongue Disease, 4) Bartonella Blood Infection  5) Melanoma skin cancer  6) Muscle Twitching and Electric Shocks 7) Auto Immune Disease 8) Gut Dysbiosis
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Lyme disease, Malignant melanoma, Muscle twitching, Post viral fatigue syndrome
Clinical narrative: 1) Myalgic Encephamyolitis,  2) Reactivated Lyme Disease, 3) Furry Tongue Disease, 4) Bartonella Blood Infection  5) Melanoma skin cancer  6) Muscle Twitching and Electric Shocks 7) Auto Immune Disease 8) Gut Dysbiosis
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tongue disorder
Clinical narrative: 1) Myalgic Encephamyolitis,  2) Reactivated Lyme Disease, 3) Furry Tongue Disease, 4) Bartonella Blood Infection  5) Melanoma skin cancer  6) Muscle Twitching and Electric Shocks 7) Auto Immune Disease 8) Gut Dysbiosis
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: Pentacel and RotaTeq were expired
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Developed high blood pressure after having second booster shot of Moderna Covid vaccine. Started blood pressure medication on 11/22/2022.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Dose was not diluted with saline at all. It was the original vial from the refrigerator (2 - 8 degrees Celsius). Patient was given 0.2 mL of the concentrated vial. Patient did not seem to have any reactions 30 minutes after the vaccination and tolerated the original series fine.  Patient was notified and called 2 hours later about the possible side effects and to follow up on the patient per the guardian (mother). The immunizer and pharmacist will personally follow up in 24, 48, and 72 hours from the time of the vaccination.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: Patient was given Pentacel vaccine that did not get reconstituted thus ended up getting the Dtap and IPV only and missing the ActHib.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: I developed ?Covid arm? with red, hot lumps under the injection site.
Age: 1.5
Sex: M
Vaccine: COVID19-2, HEPA
Symptoms: Extra dose administered
Clinical narrative: There were no symptoms, patient got a 4th dose of Pfizer Bivalent even though it is not authorized as a booster yet.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Patient said that they experience high fever.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: I received the Moderna Bivalent booster on 9/12/2022. On 11/28/2022, I developed a sore throat, nasal congestion, chest congestion, and cough, but they weren't severe. I was also more fatigued than usual, but it wasn't severe at that point. I took a 12-hour nasal decongestant with pseudoephedrine and menthol cough drops. I started taking another OTC medicine that contained dextromethorphan and guaifenesin, but I don't know if I started taking it on 11/28/2022 or 11/29/2022. On 11/29/2022, my symptoms worsened. The sore throat and coughing became moderate to severe. The fatigue worsened. The nasal and chest congestion also worsened, and I developed a headache and body aches. I took ibuprofen in conjunction with the aforementioned medicines. They didn't get rid of the symptoms, but they lessened their intensity. On 11/30/2022, all of the symptoms worsened, and the severity reached its peak. I had a low-grade fever of 99.4(?); my body temperature is usually about 98 degrees. I took a home antigen test, which yielded a positive result. On 11/30/2022, I had a telehealth appointment with a doctor, who prescribed PAXLOVID, which I began taking on 12/1/2022. On 12/1/2022, my throat was still sore, but it didn't hurt as much. My other symptoms, though, just reached a plateau. During the duration of my illness, I continued to take the aforementioned OTC medicines in conjunction with the PAXLOVID. On 12/2/2022, I no longer had a fever, and though I still felt bad, my symptoms had improved overall. On 12/3/2022, the overall improvement of my symptoms continued. This trend continued for the next several days. On 12/6/2022, I felt well enough to work; I work remotely, so I did not have to go far. At around this time, the majority of the symptoms had decreased in their intensity and they were similar to those of a moderate cold. The sore throat persisted, and since the other symptoms had become milder, most of my attention was drawn to my sore throat. At this point, I stopped taking the nasal decongestant, but I continued to take the cough suppressant and non-menthol cough drops. The rest of the symptoms tapered off gradually, but a mild cough and an intermittent mild sore throat have continued to the time of this writing. On 12/7/2022, I tested negative on a home antigen test at around 5 AM. On 12/10/2022, I had another negative test result at around 2 AM. The persistent cough I continue to deal with does not cause any discomfort, but it's more like I have to frequently clear my throat.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: I received the Moderna Bivalent booster on 9/12/2022. On 11/28/2022, I developed a sore throat, nasal congestion, chest congestion, and cough, but they weren't severe. I was also more fatigued than usual, but it wasn't severe at that point. I took a 12-hour nasal decongestant with pseudoephedrine and menthol cough drops. I started taking another OTC medicine that contained dextromethorphan and guaifenesin, but I don't know if I started taking it on 11/28/2022 or 11/29/2022. On 11/29/2022, my symptoms worsened. The sore throat and coughing became moderate to severe. The fatigue worsened. The nasal and chest congestion also worsened, and I developed a headache and body aches. I took ibuprofen in conjunction with the aforementioned medicines. They didn't get rid of the symptoms, but they lessened their intensity. On 11/30/2022, all of the symptoms worsened, and the severity reached its peak. I had a low-grade fever of 99.4(?); my body temperature is usually about 98 degrees. I took a home antigen test, which yielded a positive result. On 11/30/2022, I had a telehealth appointment with a doctor, who prescribed PAXLOVID, which I began taking on 12/1/2022. On 12/1/2022, my throat was still sore, but it didn't hurt as much. My other symptoms, though, just reached a plateau. During the duration of my illness, I continued to take the aforementioned OTC medicines in conjunction with the PAXLOVID. On 12/2/2022, I no longer had a fever, and though I still felt bad, my symptoms had improved overall. On 12/3/2022, the overall improvement of my symptoms continued. This trend continued for the next several days. On 12/6/2022, I felt well enough to work; I work remotely, so I did not have to go far. At around this time, the majority of the symptoms had decreased in their intensity and they were similar to those of a moderate cold. The sore throat persisted, and since the other symptoms had become milder, most of my attention was drawn to my sore throat. At this point, I stopped taking the nasal decongestant, but I continued to take the cough suppressant and non-menthol cough drops. The rest of the symptoms tapered off gradually, but a mild cough and an intermittent mild sore throat have continued to the time of this writing. On 12/7/2022, I tested negative on a home antigen test at around 5 AM. On 12/10/2022, I had another negative test result at around 2 AM. The persistent cough I continue to deal with does not cause any discomfort, but it's more like I have to frequently clear my throat.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat clearing
Clinical narrative: I received the Moderna Bivalent booster on 9/12/2022. On 11/28/2022, I developed a sore throat, nasal congestion, chest congestion, and cough, but they weren't severe. I was also more fatigued than usual, but it wasn't severe at that point. I took a 12-hour nasal decongestant with pseudoephedrine and menthol cough drops. I started taking another OTC medicine that contained dextromethorphan and guaifenesin, but I don't know if I started taking it on 11/28/2022 or 11/29/2022. On 11/29/2022, my symptoms worsened. The sore throat and coughing became moderate to severe. The fatigue worsened. The nasal and chest congestion also worsened, and I developed a headache and body aches. I took ibuprofen in conjunction with the aforementioned medicines. They didn't get rid of the symptoms, but they lessened their intensity. On 11/30/2022, all of the symptoms worsened, and the severity reached its peak. I had a low-grade fever of 99.4(?); my body temperature is usually about 98 degrees. I took a home antigen test, which yielded a positive result. On 11/30/2022, I had a telehealth appointment with a doctor, who prescribed PAXLOVID, which I began taking on 12/1/2022. On 12/1/2022, my throat was still sore, but it didn't hurt as much. My other symptoms, though, just reached a plateau. During the duration of my illness, I continued to take the aforementioned OTC medicines in conjunction with the PAXLOVID. On 12/2/2022, I no longer had a fever, and though I still felt bad, my symptoms had improved overall. On 12/3/2022, the overall improvement of my symptoms continued. This trend continued for the next several days. On 12/6/2022, I felt well enough to work; I work remotely, so I did not have to go far. At around this time, the majority of the symptoms had decreased in their intensity and they were similar to those of a moderate cold. The sore throat persisted, and since the other symptoms had become milder, most of my attention was drawn to my sore throat. At this point, I stopped taking the nasal decongestant, but I continued to take the cough suppressant and non-menthol cough drops. The rest of the symptoms tapered off gradually, but a mild cough and an intermittent mild sore throat have continued to the time of this writing. On 12/7/2022, I tested negative on a home antigen test at around 5 AM. On 12/10/2022, I had another negative test result at around 2 AM. The persistent cough I continue to deal with does not cause any discomfort, but it's more like I have to frequently clear my throat.
Age: 2.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: There were no symptoms, patient got a 4th dose of Pfizer Bivalent even though it is not authorized as a booster yet.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: 63 year old patient had 3 vaccines administered, Fluzone Quad, Prevnar-20 and Pfizer Bivalent.  About 2 hours later patient started with aches and  fever.   About 12 hours later patient started Vomiting.  Patients daughter is bringing her to provider, or emergency Dept
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Feeling cold, Muscle tightness, Speech disorder
Clinical narrative: I finished a hot bath as I do every evening.  When getting into bed, a chill started in my shoulder blades and quickly swept across my back and down my front.  I felt freezing cold and crawled into bed.  Almost immediately the muscles running from my head to my body seized shut.  The muscles were pulled taught under my skin and my throat narrowed.  I could barely get a single word out as I struggled for breath.  I asked my to get me warm.  She was frantic and wanted to call an ambulance.  I couldn't guide her thru a tracheotomy and if it worsened I wouldn't live to see an ambulance.  I felt if I stayed calm and could get warm it would pass.  In about five minutes the muscles unfroze and I could breath freely again.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: I finished a hot bath as I do every evening.  When getting into bed, a chill started in my shoulder blades and quickly swept across my back and down my front.  I felt freezing cold and crawled into bed.  Almost immediately the muscles running from my head to my body seized shut.  The muscles were pulled taught under my skin and my throat narrowed.  I could barely get a single word out as I struggled for breath.  I asked my to get me warm.  She was frantic and wanted to call an ambulance.  I couldn't guide her thru a tracheotomy and if it worsened I wouldn't live to see an ambulance.  I felt if I stayed calm and could get warm it would pass.  In about five minutes the muscles unfroze and I could breath freely again.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired Pfizer vaccine. The vaccine expired on 12/16/22 and was given to the patient three days later on 12/19/22.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic vascular thrombosis, Ophthalmological examination abnormal
Clinical narrative: Blood c lot in right eye
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Depression, Dyspnoea, Fatigue
Clinical narrative: heart was fine before 5th vaccine, going to gym exercising, very active after vaccine   shortness of breath  exhaustion, depression
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Echocardiogram normal, Ventricular extrasystoles
Clinical narrative: Irregular Heart Beat (PVCs) off and on all day.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Lethargy, Oropharyngeal pain
Clinical narrative: developed cold like symptoms...sinus congestion, mild H/A, non-prod cough, sore throat, lethargy
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: developed cold like symptoms...sinus congestion, mild H/A, non-prod cough, sore throat, lethargy
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Condition aggravated, Pyrexia, Seizure
Clinical narrative: Patient experienced a seizure after developing a fever in the morning after getting the flu vaccine the evening before. The seizure resolved on its own and the patient recovered without seeking  further medical attention. The mother informed us that the patient  had a seizure a few years ago after developing a high fever.
Age: 53.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt had red, painful, warm-to-touch injection site. She went to a doctor's office to have it examined on 12/19/2022, two days after vaccination. Per the patient, doctor diagnosed her with cellulitis. Physician prescribed patient Medrol dose pack and amoxicillin 500mg  three times daily for 10 days.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Muscular weakness
Clinical narrative: About 15 minutes after vaccine patient felt dizzy and legs felt "rubbery".  Patient was seated and drank water and felt find about 25 minutes after vaccination.  Patient was called at home 5 hours later and she said she was find.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Pericarditis
Clinical narrative: Pericarditis
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Tightness and discomfort in chest when exercising
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dermatitis acneiform, Rash erythematous
Clinical narrative: Patient states they began to get a red pimple-like rash across different sections of the body, starting with the chest. He stated it looked like shingles compare to what he had seen online, but was not localized to a single area like shingles. He was unsure if the reaction was due to the shot or something else. He plans on following up at his next regular dermatology appointment.
Age: 30.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Bacterial vaginosis, Blood test normal, Candida infection, Candida test positive, Chlamydia test negative
Clinical narrative: Recurring yeast infections, 4 weeks apart. First symptoms occurred around October 12. Over-the-counter treatment initially resolved infection but recurred about 4 weeks later. Went to doctor and was prescribed 2 rounds of Diflucan for yeast infection and metronidazole for bacterial vaginosis, which fully resolved the symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fungal infection, Gardnerella test negative
Clinical narrative: Recurring yeast infections, 4 weeks apart. First symptoms occurred around October 12. Over-the-counter treatment initially resolved infection but recurred about 4 weeks later. Went to doctor and was prescribed 2 rounds of Diflucan for yeast infection and metronidazole for bacterial vaginosis, which fully resolved the symptoms.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis systems started with a peak in symptoms in April. Confirmed diagnosis in November. No symptoms prior to vaccination.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient had present to the pharmacy to receive his 2nd dose of the monovalent Pfizer Covid-19 vaccine 12yrs +, but was accidentally administered the Pfizer bivalent vaccine product 12yrs+. Error was not realized until patient had left the pharmacy, patient was contacted and notified of error, and he reported no adverse reaction or symptoms. Was notified to reach out to pharmacy or healthcare provider in the event of any symptoms or adverse reactions.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: PT RECEIVED MONOVALENT INSTEAD OF BIVALNT, NO ADVERESE EVENTS AT ALL, PT WILL GET VACCINATED WITH BIVALENT IN 8 WEEKS
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Laboratory test, Pemphigus
Clinical narrative: I have been recently diagnosed with pemphigus. A very rare autoimmune condition and the symptoms started right after getting vaccinated for covid.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I have had increasing pain in my left shoulder since vaccination with limited range of motion.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Blood test, Chest pain
Clinical narrative: After my second dose, within 8 hours I had muscle construction throughout my body, fever, severe migraine, extreme fatigue. Within a few days I could not move my head, lymph nodes in my neck, trouble from pain lifting my head. I was in bed 13 days and over three months I was having chronic fatigue, rashes, muscle pain from my hips to my feet with stiffness, difficulty breathing, pain in my thorax, heart racing, vertigo. Four months later rt upper quadrant pain, crossing over under my ribs. Difficulty swallowing pain in my neck. I spoke with a different doctor office 1 month post second vaccine was told to take Motrin and warm packs and that was all. I?ve never regained my energy and still have body stiffness and arthritis type symptoms and overall unwell.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dysphagia, Dyspnoea, Fatigue, Malaise
Clinical narrative: After my second dose, within 8 hours I had muscle construction throughout my body, fever, severe migraine, extreme fatigue. Within a few days I could not move my head, lymph nodes in my neck, trouble from pain lifting my head. I was in bed 13 days and over three months I was having chronic fatigue, rashes, muscle pain from my hips to my feet with stiffness, difficulty breathing, pain in my thorax, heart racing, vertigo. Four months later rt upper quadrant pain, crossing over under my ribs. Difficulty swallowing pain in my neck. I spoke with a different doctor office 1 month post second vaccine was told to take Motrin and warm packs and that was all. I?ve never regained my energy and still have body stiffness and arthritis type symptoms and overall unwell.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Movement disorder, Muscle disorder, Musculoskeletal chest pain, Musculoskeletal stiffness
Clinical narrative: After my second dose, within 8 hours I had muscle construction throughout my body, fever, severe migraine, extreme fatigue. Within a few days I could not move my head, lymph nodes in my neck, trouble from pain lifting my head. I was in bed 13 days and over three months I was having chronic fatigue, rashes, muscle pain from my hips to my feet with stiffness, difficulty breathing, pain in my thorax, heart racing, vertigo. Four months later rt upper quadrant pain, crossing over under my ribs. Difficulty swallowing pain in my neck. I spoke with a different doctor office 1 month post second vaccine was told to take Motrin and warm packs and that was all. I?ve never regained my energy and still have body stiffness and arthritis type symptoms and overall unwell.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Neck pain, Pain, Pain in extremity, Palpitations
Clinical narrative: After my second dose, within 8 hours I had muscle construction throughout my body, fever, severe migraine, extreme fatigue. Within a few days I could not move my head, lymph nodes in my neck, trouble from pain lifting my head. I was in bed 13 days and over three months I was having chronic fatigue, rashes, muscle pain from my hips to my feet with stiffness, difficulty breathing, pain in my thorax, heart racing, vertigo. Four months later rt upper quadrant pain, crossing over under my ribs. Difficulty swallowing pain in my neck. I spoke with a different doctor office 1 month post second vaccine was told to take Motrin and warm packs and that was all. I?ve never regained my energy and still have body stiffness and arthritis type symptoms and overall unwell.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Vertigo
Clinical narrative: After my second dose, within 8 hours I had muscle construction throughout my body, fever, severe migraine, extreme fatigue. Within a few days I could not move my head, lymph nodes in my neck, trouble from pain lifting my head. I was in bed 13 days and over three months I was having chronic fatigue, rashes, muscle pain from my hips to my feet with stiffness, difficulty breathing, pain in my thorax, heart racing, vertigo. Four months later rt upper quadrant pain, crossing over under my ribs. Difficulty swallowing pain in my neck. I spoke with a different doctor office 1 month post second vaccine was told to take Motrin and warm packs and that was all. I?ve never regained my energy and still have body stiffness and arthritis type symptoms and overall unwell.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Cardiac stress test normal, Chest discomfort, Chest pain, Discomfort
Clinical narrative: Nov. 27-2AM: Chest pain, 10 minutes, subsided with nitroglycerin tablet. Nov. 27-Noon: Chest pain, palpitations, blood pressure 100/90 with 120 heart beat rate, subsided after two glycerin tablets, time elapsed about 10 minutes. Nov. 28-1AM: Strong Chest Pain, traveled up shoulder, left arm and neck with feeling of ground glass pressure, painful. Took two glycerin tablets 5 minutes apart and pain subsided. Experienced slight fever (Temperature 99.7 degrees F) from Nov. 25-28. Since November 29, no further ill effects from vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Pain, Pain in extremity, Palpitations
Clinical narrative: Nov. 27-2AM: Chest pain, 10 minutes, subsided with nitroglycerin tablet. Nov. 27-Noon: Chest pain, palpitations, blood pressure 100/90 with 120 heart beat rate, subsided after two glycerin tablets, time elapsed about 10 minutes. Nov. 28-1AM: Strong Chest Pain, traveled up shoulder, left arm and neck with feeling of ground glass pressure, painful. Took two glycerin tablets 5 minutes apart and pain subsided. Experienced slight fever (Temperature 99.7 degrees F) from Nov. 25-28. Since November 29, no further ill effects from vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Antinuclear antibody negative, Arthralgia, Full blood count normal, Joint swelling, Joint warmth
Clinical narrative: Vaccine given on 11/17/22. First 15 min - OK. Nothing that day - no sore arm. Some lethargy. Woke up next day - right hip soreness 2nd day - both knees - sore. 3d later - woke up with (R) elbows, (B) knees, (R) hip hot, painful to touch, swollen, edematous went to urgent care on 11/21 (Treated with prednisone by me later on 11/21) Now on 11/29 - has
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lethargy, Oedema
Clinical narrative: Vaccine given on 11/17/22. First 15 min - OK. Nothing that day - no sore arm. Some lethargy. Woke up next day - right hip soreness 2nd day - both knees - sore. 3d later - woke up with (R) elbows, (B) knees, (R) hip hot, painful to touch, swollen, edematous went to urgent care on 11/21 (Treated with prednisone by me later on 11/21) Now on 11/29 - has
Age: 14.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Syncope
Clinical narrative: Syncope
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Albumin globulin ratio, Anion gap, Aspartate aminotransferase normal, Bacterial test negative
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Basophil percentage decreased, Bilirubin urine, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin decreased
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Blood calcium decreased, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood magnesium increased
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Blood phosphorus normal, Blood potassium normal, Blood sodium normal, Blood urea increased, Blood urea nitrogen/creatinine ratio
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Blood urine present, Carbon dioxide normal, Chromaturia, Condition aggravated, Culture urine positive
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count abnormal, Eosinophil percentage, Escherichia test positive, Full blood count abnormal, Globulins decreased
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Glomerular filtration rate normal, Glucose urine absent, Haematocrit decreased, Haemoglobin decreased, Lymphocyte count decreased
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Metabolic function test abnormal
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Metamyelocyte percentage, Monocyte count normal, Monocyte percentage, Myelitis transverse, Neutrophil count increased
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Neutrophil percentage increased, Nitrite urine absent, Nucleated red cells, Platelet count normal, Protein total decreased
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Protein urine absent, Quadriplegia, Red blood cell count decreased, Red blood cells urine negative, Red cell distribution width normal
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative, Specific gravity urine normal, Urinary sediment present, Urine abnormality, Urine analysis abnormal
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count increased, White blood cells urine positive
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: pH urine normal
Clinical narrative: Transverse Myelitis onset 9/27/2022 Quadriplegic Hospitalization PT
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Feeling hot, Immediate post-injection reaction, Posture abnormal, Staring, Unresponsive to stimuli
Clinical narrative: Patient was to receive HPV, Flu, Menningitis & TDAP. He was given HPV & Menningitis in Lt Deltoid then flu in Rt Deltoid. Immediately after 3rd injection he had blank stare, became unresponsive & went limp into Mothers arms as she was standing behind him. I called for help & as Dr. and PA came into room patient was coming to. Vitals were taken and were within acceptable limits. Patient complained of being hot so I placed fan in room which he stated helped. Within 10 minutes patient's color had improved, he was talking and responding appropriately. He remained in room sitting in chair talking & laughing with mother & sister as she was waiting her post vaccine shot time. Patient was then discharged in care of mother with normal vital signs and no appearnt distress.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive for Covid-19
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizures". Clinical course: Caused seizures after flipping poison. Data that CEO's don't like. Study: out of 100,000 people followed after their first poison shot 3,190 had their first seizure within 1 month. Now a friend's daughter who also had her very first seizure after poison shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Child is 3 yr old and received 5-11 covid-19 dosing accidentally.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Child is 3 yr old and received 5-11 covid-19 dosing accidentally.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Accidental underdose, No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No additional AE reported; during administration of  MMR II dose, patient moved her leg and she only received about half the dose; This spontaneous report was received from a medical assistant student and refers to a 2-year-old female patient.   The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 28-NOV-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) subcutaneous injection, 0.5 ml, lot # U017524, expiration date: 03-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) reconstituted with a sterile diluent (Inappropriate age at vaccine administration). During administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) dose, the patient moved her leg and she only received about half the dose (Accidental underdose). Agent confirmed there was nothing wrong with the product. No additional AE reported.   This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA000351:
Sex: F
Vaccine: PNC, PPV
Symptoms: COVID-19, COVID-19 pneumonia, Pneumonia
Clinical narrative: contracted COVID last year and ended up with double pneumonia; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's concurrent conditions included diabetes. Information regarding her medical history, or concomitant medications was not provided.  On an unknown date in 2014, the patient was vaccinated with pneumococcal vaccine conj 7v (crm197) (PREVNAR) administered for infection prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported/unknown by the reporter); and on an unknown date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection administered for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).  On an unknown date in 2021, the patient experienced contracted coronavirus disease (COVID) last year and ended up with double pneumonia (COVID-19 pneumonia). The patient sought medical attention and was treated with antibiotics (unspecified). It was not reported if the patient had laboratory diagnostics or studies performed for this adverse event.  The outcome of the event and the causal relationship between the event and the suspect therapies were not reported.  Upon internal review, the event contracted COVID last year and ended up with double pneumonia was determined to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: HCP reported RECOMBIVAX HB was administered to a patient on 09DEC2022 after the expiry date of 21NOV2022. No additional AE or PQC reported. No additional information provided.; HCP reported RECOMBIVAX HB was administered to a patient on 09DEC2022 after the expiry date of 21NOV2022. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 09-DEC-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number U005271, with an expiration date of 21-NOV-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No symptomatic side effects reported. No additional AE details.; Inbound call from HCP who stated a 1 year old was inadvertently administered PROQUAD and VARIVAX concomitantl.y; This spontaneous report was received from a Registered Nurse regarding a 12-month-old patient, of an unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 14-DEC-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W010527, expiration date: 25-SEP-2023, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis; and varicella virus vaccine live (oka/merck) (VARIVAX) lot #U027326, expiration date: 02-SEP-2023, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (Accidental overdose) which were reconstituted with sterile diluent, lot #W000452 and expiration date: 23-JUL-2024. No adverse events were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: 1 BIG BLOOD CLOT IN LEFT LUNG/LITTLE ONES (CLOTS) IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via medi concerned a patient of an unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s  (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 01 total, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, 01 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 8 months after vaccination, the patient had to go to ER (emergency room). The patient experienced 1 big blood clot in left lung and little ones (clots) in right lung and was hospitalized (dose number in series 2). The number of days hospitalized was 5. It was reported that, "I had 2 shots.8 mo after I had to go to ER.Had 1 big blood clot in left lung and little ones in right lung.Said it was 1 side effect of the shot. 5 days in hospital." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 1 big blood clot in left lung/little ones (clots) in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20221236007, 20221236261 and 20221236691.  It was determined that 20221236007, 20221236261 and 20221236691 was a duplicate of this case. All relevant information regarding this case will be submitted under 20221236114.; Sender's Comments: V0:20221236114- 1 big blood clot in left lung/little ones (clots) in right lung . The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: REALLY SICK; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced really sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots (Dose number in series 2). Reporter stated that, "I got the blood clots too after one of the shots" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221237140-blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: autoimmune disease (3 autoimmune diseases). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis.  It was reported that, the patient did not have any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). It was reported that, "3 autoimmune diseases here. I chose J and J for initial Vax without problems, which really surprised me. Then one booster and got so ill...like Covid all over again. I can't go yhrough that again". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case is a duplicate of 20221237180.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: TEMPORARILY ILL AFTERWARD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced temporarily ill afterward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporarily ill afterward. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication information provided.  It was reported that HCP had called to inform that 4 or 5 adult patients were accidentally administered Moderna COVID-19 Bivalent after 30 day use by date.  No treatment information provided.   This case was linked to MOD-2022-687538, MOD-2022-687539, MOD-2022-687540, MOD-2022-687454, MOD-2022-687542 (Linked Report).; Sender's Comments:  MOD-2022-687454:Original Case : MOD-2022-687454 MOD-2022-687540:Original Case : MOD-2022-687454 MOD-2022-687539:Original Case : MOD-2022-687454 MOD-2022-687542:Original Case : MOD-2022-687454 MOD-2022-687538:Original Case : MOD-2022-687454
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccines given after the BUD; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD).    Concomitant product use was not provided by the reporter.   Vaccine was given after the BUD. Moderna vaccines was stored in the freezer of storage unit which was a dorm style refrigerator with a separate freezer compartment. Individual vial of the vaccine was thawed out the day of use and disposed of if not completely used. No treatment information was provided.