chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Pyrexia
Clinical narrative: Woke up  with fever the next morning. Sunday around 4pm complained of chest pains . was admitted to hospital and stayed 5 days . Heart inflammation. Myocarditis
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Myocarditis, Pericarditis
Clinical narrative: Patient is a 15-year-old boy with history of ADHD who presented to ED with left-sided chest pain. He has been having chest pain over the last 3 weeks. The pain initially started after his first dose of COVID vaccine. It has been intermittent, worse with deep inspiration, non-radiating and mainly located to the mid-left sternal border, and well responsive to ibuprofen. Three days prior to presentation he had his second COVID shot and the pain progressively worsened and started waking him up at night. The quality of the pain is the same as previously described. No recent fevers, cough, congestion or increased work of breathing. ER work-up significant for elevated troponin level and elevated CK-MB. CXR demonstrated normal cardiac cillhouette and no significant lung pathology. EKG with sinus rhythm, normal axis, non-specific T wave changes (negative T waves in V1 and V2) and no significant ST segment changes.   06/13: Complaining of chest pain this AM, 6/10, worse with inspiration. Also reporting nausea, given zofran. At 10:52 monomorphic PVCs (triplets) noted on telometry, asymptomatic at time of event, normal BP. Normal EKG. Troponin this AM up to 9.  06/14: Reports improvement of chest pain, absent this AM. No SOB, dizziness. EKG yesterday showing no PVCs or ST changes, qustionable PR depression (minimal). ECHO showed normal systolic function and no structural abnormalities. Troponin fluctuating since last AM, last level up to 23.46 at 3AM (highest so far). Afebrile.   06/15: Remained hemodynamically stable, no chest pain in the morning. EKG remained stable.ECHO done yesterday wtih normal function. Troponins downtrending, down to 15.6 this AM and 11 at noon. RPP negative, pending Mycoplasma antibodies.  Deemed stable for discharge today to follow-up with Dr. in 1 week. Might require MRI in 6m to evalute for cardiac scaring.. Should continue Ibuprofen 600mg q8hr for 2 weeks. Refrain from physical activity for 2 weeks and from competitive sports for 3-6m.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood calcium, Blood creatine phosphokinase MB increased, Blood creatinine decreased, Blood glucose normal, Blood sodium normal
Clinical narrative: Patient is a 15-year-old boy with history of ADHD who presented to ED with left-sided chest pain. He has been having chest pain over the last 3 weeks. The pain initially started after his first dose of COVID vaccine. It has been intermittent, worse with deep inspiration, non-radiating and mainly located to the mid-left sternal border, and well responsive to ibuprofen. Three days prior to presentation he had his second COVID shot and the pain progressively worsened and started waking him up at night. The quality of the pain is the same as previously described. No recent fevers, cough, congestion or increased work of breathing. ER work-up significant for elevated troponin level and elevated CK-MB. CXR demonstrated normal cardiac cillhouette and no significant lung pathology. EKG with sinus rhythm, normal axis, non-specific T wave changes (negative T waves in V1 and V2) and no significant ST segment changes.   06/13: Complaining of chest pain this AM, 6/10, worse with inspiration. Also reporting nausea, given zofran. At 10:52 monomorphic PVCs (triplets) noted on telometry, asymptomatic at time of event, normal BP. Normal EKG. Troponin this AM up to 9.  06/14: Reports improvement of chest pain, absent this AM. No SOB, dizziness. EKG yesterday showing no PVCs or ST changes, qustionable PR depression (minimal). ECHO showed normal systolic function and no structural abnormalities. Troponin fluctuating since last AM, last level up to 23.46 at 3AM (highest so far). Afebrile.   06/15: Remained hemodynamically stable, no chest pain in the morning. EKG remained stable.ECHO done yesterday wtih normal function. Troponins downtrending, down to 15.6 this AM and 11 at noon. RPP negative, pending Mycoplasma antibodies.  Deemed stable for discharge today to follow-up with Dr. in 1 week. Might require MRI in 6m to evalute for cardiac scaring.. Should continue Ibuprofen 600mg q8hr for 2 weeks. Refrain from physical activity for 2 weeks and from competitive sports for 3-6m.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood urea normal, Carbon dioxide increased, Cardiac telemetry abnormal, Chest X-ray normal, Chest pain
Clinical narrative: Patient is a 15-year-old boy with history of ADHD who presented to ED with left-sided chest pain. He has been having chest pain over the last 3 weeks. The pain initially started after his first dose of COVID vaccine. It has been intermittent, worse with deep inspiration, non-radiating and mainly located to the mid-left sternal border, and well responsive to ibuprofen. Three days prior to presentation he had his second COVID shot and the pain progressively worsened and started waking him up at night. The quality of the pain is the same as previously described. No recent fevers, cough, congestion or increased work of breathing. ER work-up significant for elevated troponin level and elevated CK-MB. CXR demonstrated normal cardiac cillhouette and no significant lung pathology. EKG with sinus rhythm, normal axis, non-specific T wave changes (negative T waves in V1 and V2) and no significant ST segment changes.   06/13: Complaining of chest pain this AM, 6/10, worse with inspiration. Also reporting nausea, given zofran. At 10:52 monomorphic PVCs (triplets) noted on telometry, asymptomatic at time of event, normal BP. Normal EKG. Troponin this AM up to 9.  06/14: Reports improvement of chest pain, absent this AM. No SOB, dizziness. EKG yesterday showing no PVCs or ST changes, qustionable PR depression (minimal). ECHO showed normal systolic function and no structural abnormalities. Troponin fluctuating since last AM, last level up to 23.46 at 3AM (highest so far). Afebrile.   06/15: Remained hemodynamically stable, no chest pain in the morning. EKG remained stable.ECHO done yesterday wtih normal function. Troponins downtrending, down to 15.6 this AM and 11 at noon. RPP negative, pending Mycoplasma antibodies.  Deemed stable for discharge today to follow-up with Dr. in 1 week. Might require MRI in 6m to evalute for cardiac scaring.. Should continue Ibuprofen 600mg q8hr for 2 weeks. Refrain from physical activity for 2 weeks and from competitive sports for 3-6m.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram T wave inversion, Haematocrit normal, Haemoglobin normal, Myocarditis
Clinical narrative: Patient is a 15-year-old boy with history of ADHD who presented to ED with left-sided chest pain. He has been having chest pain over the last 3 weeks. The pain initially started after his first dose of COVID vaccine. It has been intermittent, worse with deep inspiration, non-radiating and mainly located to the mid-left sternal border, and well responsive to ibuprofen. Three days prior to presentation he had his second COVID shot and the pain progressively worsened and started waking him up at night. The quality of the pain is the same as previously described. No recent fevers, cough, congestion or increased work of breathing. ER work-up significant for elevated troponin level and elevated CK-MB. CXR demonstrated normal cardiac cillhouette and no significant lung pathology. EKG with sinus rhythm, normal axis, non-specific T wave changes (negative T waves in V1 and V2) and no significant ST segment changes.   06/13: Complaining of chest pain this AM, 6/10, worse with inspiration. Also reporting nausea, given zofran. At 10:52 monomorphic PVCs (triplets) noted on telometry, asymptomatic at time of event, normal BP. Normal EKG. Troponin this AM up to 9.  06/14: Reports improvement of chest pain, absent this AM. No SOB, dizziness. EKG yesterday showing no PVCs or ST changes, qustionable PR depression (minimal). ECHO showed normal systolic function and no structural abnormalities. Troponin fluctuating since last AM, last level up to 23.46 at 3AM (highest so far). Afebrile.   06/15: Remained hemodynamically stable, no chest pain in the morning. EKG remained stable.ECHO done yesterday wtih normal function. Troponins downtrending, down to 15.6 this AM and 11 at noon. RPP negative, pending Mycoplasma antibodies.  Deemed stable for discharge today to follow-up with Dr. in 1 week. Might require MRI in 6m to evalute for cardiac scaring.. Should continue Ibuprofen 600mg q8hr for 2 weeks. Refrain from physical activity for 2 weeks and from competitive sports for 3-6m.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Platelet count normal, Sleep disorder, Troponin increased, Vaccine positive rechallenge
Clinical narrative: Patient is a 15-year-old boy with history of ADHD who presented to ED with left-sided chest pain. He has been having chest pain over the last 3 weeks. The pain initially started after his first dose of COVID vaccine. It has been intermittent, worse with deep inspiration, non-radiating and mainly located to the mid-left sternal border, and well responsive to ibuprofen. Three days prior to presentation he had his second COVID shot and the pain progressively worsened and started waking him up at night. The quality of the pain is the same as previously described. No recent fevers, cough, congestion or increased work of breathing. ER work-up significant for elevated troponin level and elevated CK-MB. CXR demonstrated normal cardiac cillhouette and no significant lung pathology. EKG with sinus rhythm, normal axis, non-specific T wave changes (negative T waves in V1 and V2) and no significant ST segment changes.   06/13: Complaining of chest pain this AM, 6/10, worse with inspiration. Also reporting nausea, given zofran. At 10:52 monomorphic PVCs (triplets) noted on telometry, asymptomatic at time of event, normal BP. Normal EKG. Troponin this AM up to 9.  06/14: Reports improvement of chest pain, absent this AM. No SOB, dizziness. EKG yesterday showing no PVCs or ST changes, qustionable PR depression (minimal). ECHO showed normal systolic function and no structural abnormalities. Troponin fluctuating since last AM, last level up to 23.46 at 3AM (highest so far). Afebrile.   06/15: Remained hemodynamically stable, no chest pain in the morning. EKG remained stable.ECHO done yesterday wtih normal function. Troponins downtrending, down to 15.6 this AM and 11 at noon. RPP negative, pending Mycoplasma antibodies.  Deemed stable for discharge today to follow-up with Dr. in 1 week. Might require MRI in 6m to evalute for cardiac scaring.. Should continue Ibuprofen 600mg q8hr for 2 weeks. Refrain from physical activity for 2 weeks and from competitive sports for 3-6m.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles, White blood cell count normal
Clinical narrative: Patient is a 15-year-old boy with history of ADHD who presented to ED with left-sided chest pain. He has been having chest pain over the last 3 weeks. The pain initially started after his first dose of COVID vaccine. It has been intermittent, worse with deep inspiration, non-radiating and mainly located to the mid-left sternal border, and well responsive to ibuprofen. Three days prior to presentation he had his second COVID shot and the pain progressively worsened and started waking him up at night. The quality of the pain is the same as previously described. No recent fevers, cough, congestion or increased work of breathing. ER work-up significant for elevated troponin level and elevated CK-MB. CXR demonstrated normal cardiac cillhouette and no significant lung pathology. EKG with sinus rhythm, normal axis, non-specific T wave changes (negative T waves in V1 and V2) and no significant ST segment changes.   06/13: Complaining of chest pain this AM, 6/10, worse with inspiration. Also reporting nausea, given zofran. At 10:52 monomorphic PVCs (triplets) noted on telometry, asymptomatic at time of event, normal BP. Normal EKG. Troponin this AM up to 9.  06/14: Reports improvement of chest pain, absent this AM. No SOB, dizziness. EKG yesterday showing no PVCs or ST changes, qustionable PR depression (minimal). ECHO showed normal systolic function and no structural abnormalities. Troponin fluctuating since last AM, last level up to 23.46 at 3AM (highest so far). Afebrile.   06/15: Remained hemodynamically stable, no chest pain in the morning. EKG remained stable.ECHO done yesterday wtih normal function. Troponins downtrending, down to 15.6 this AM and 11 at noon. RPP negative, pending Mycoplasma antibodies.  Deemed stable for discharge today to follow-up with Dr. in 1 week. Might require MRI in 6m to evalute for cardiac scaring.. Should continue Ibuprofen 600mg q8hr for 2 weeks. Refrain from physical activity for 2 weeks and from competitive sports for 3-6m.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Antiacetylcholine receptor antibody, Bulbar palsy, Computerised tomogram head, Computerised tomogram neck
Clinical narrative: Myasthenia gravis-like presentation. Serum MG panel still outstanding (send out). Started on IVIG, prednisone, pyridostigmine with some improvement though currently w/ persistent bulbar symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Myasthenic syndrome
Clinical narrative: Myasthenia gravis-like presentation. Serum MG panel still outstanding (send out). Started on IVIG, prednisone, pyridostigmine with some improvement though currently w/ persistent bulbar symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bulbar palsy, Immunoglobulin therapy, Laboratory test, Myasthenic syndrome
Clinical narrative: Myasthenia gravis-like presentation. Serum MG panel still outstanding (send out). Started on IVIG, prednisone, pyridostigmine with some improvement though currently w/ persistent bulbar symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Antiacetylcholine receptor antibody, Dysarthria, Dysphagia, Eyelid ptosis
Clinical narrative: Myasthenia gravis-like presentation. Serum MG panel still outstanding (send out). Started on IVIG, prednisone, pyridostigmine with some improvement though currently w/ persistent bulbar symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Full blood count, Immunoglobulin therapy, International normalised ratio normal, Laboratory test normal
Clinical narrative: Myasthenia gravis-like presentation. Serum MG panel still outstanding (send out). Started on IVIG, prednisone, pyridostigmine with some improvement though currently w/ persistent bulbar symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Liver function test, Myasthenia gravis
Clinical narrative: Myasthenia gravis-like presentation. Serum MG panel still outstanding (send out). Started on IVIG, prednisone, pyridostigmine with some improvement though currently w/ persistent bulbar symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Antiacetylcholine receptor antibody, Bulbar palsy, Computerised tomogram head, Computerised tomogram neck
Clinical narrative: Two days after Vaccination patient reported right eye drooping. Following that he had progressive bilateral ptosis followed by progressive dysphasia and dysarthria. He was admitted to the hospital on 6/30/21 and treated as myasthenia gravis. He has promising clinical response to IVIG 2g/kg, steroids and pyridostigmine however he is still in the hospital for dysphasia.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Myasthenic syndrome
Clinical narrative: Two days after Vaccination patient reported right eye drooping. Following that he had progressive bilateral ptosis followed by progressive dysphasia and dysarthria. He was admitted to the hospital on 6/30/21 and treated as myasthenia gravis. He has promising clinical response to IVIG 2g/kg, steroids and pyridostigmine however he is still in the hospital for dysphasia.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bulbar palsy, Immunoglobulin therapy, Laboratory test, Myasthenic syndrome
Clinical narrative: Two days after Vaccination patient reported right eye drooping. Following that he had progressive bilateral ptosis followed by progressive dysphasia and dysarthria. He was admitted to the hospital on 6/30/21 and treated as myasthenia gravis. He has promising clinical response to IVIG 2g/kg, steroids and pyridostigmine however he is still in the hospital for dysphasia.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Antiacetylcholine receptor antibody, Dysarthria, Dysphagia, Eyelid ptosis
Clinical narrative: Two days after Vaccination patient reported right eye drooping. Following that he had progressive bilateral ptosis followed by progressive dysphasia and dysarthria. He was admitted to the hospital on 6/30/21 and treated as myasthenia gravis. He has promising clinical response to IVIG 2g/kg, steroids and pyridostigmine however he is still in the hospital for dysphasia.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Full blood count, Immunoglobulin therapy, International normalised ratio normal, Laboratory test normal
Clinical narrative: Two days after Vaccination patient reported right eye drooping. Following that he had progressive bilateral ptosis followed by progressive dysphasia and dysarthria. He was admitted to the hospital on 6/30/21 and treated as myasthenia gravis. He has promising clinical response to IVIG 2g/kg, steroids and pyridostigmine however he is still in the hospital for dysphasia.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Liver function test, Myasthenia gravis
Clinical narrative: Two days after Vaccination patient reported right eye drooping. Following that he had progressive bilateral ptosis followed by progressive dysphasia and dysarthria. He was admitted to the hospital on 6/30/21 and treated as myasthenia gravis. He has promising clinical response to IVIG 2g/kg, steroids and pyridostigmine however he is still in the hospital for dysphasia.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram normal, Troponin increased
Clinical narrative: myocarditis
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cytomegalovirus test, Echocardiogram, Electrocardiogram, Enterovirus test, Epstein-Barr virus test
Clinical narrative: myocarditis
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Diarrhoea
Clinical narrative: 07/04/2021 at approx. 3:00 AM  I woke up with severe chills .  At approx. 6:00 AM I experienced abdominal pain and diarrhea.   The diarrhea persisted for approx.  2 hours.  I was very weak  for the rest of the day .   At approx. 7:00pm diarrhea persisted.  07/05/2021  approx. 8:00 PM abdominal pain and  diarrhea started again.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Within a few days to one week of receiving the 2nd dose of the COVID-19 vaccine, I noticed a sudden and sharp pain down my left arm, upon movement.  The pain was intense, and I could feel it from my shoulder down through my arm.  It lasted about 20-30 seconds.  This same pain has continued to recur on a regular basis, without improvement.  It occurs when I stretch my arm in certain directions, and as a result I have limited my arm movements to avoid triggering the pain.  It also occurs at night while I am sleeping, sometimes keeping me awake or disturbing my sleep.  And at times it occurs as I am getting out of bed in the morning.    I have not been treated for this condition yet, as I have been waiting to see whether it would reduce or resolve on its own.  It has now been just over two months, however, with no improvement.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Blood albumin increased, Blood glucose normal, Blood sodium decreased, Laboratory test
Clinical narrative: Experienced a bad case of vertigo.  Urgent Care doctor prescribed Meclizine.  Meclizine had no affect so I discontinued use,
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vertigo, Vitamin D
Clinical narrative: Experienced a bad case of vertigo.  Urgent Care doctor prescribed Meclizine.  Meclizine had no affect so I discontinued use,
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Dizziness, Electrocardiogram normal, Immobile
Clinical narrative: Patient received the Covid-19 vaccine and within 1 minute  started to slump over with weakness and immobility. He had dizziness and was lightheaded. He complained of blurred vision. His mother was by his side. Pharmacist called 911 and paramedics arrived in about 5 minutes. Patient started feeling better but was pale and his vision was bad. Mom said he was dehydrated and at the lake all weekend. Paramedics took him out on stretcher to emergency room.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Pallor, Vision blurred
Clinical narrative: Patient received the Covid-19 vaccine and within 1 minute  started to slump over with weakness and immobility. He had dizziness and was lightheaded. He complained of blurred vision. His mother was by his side. Pharmacist called 911 and paramedics arrived in about 5 minutes. Patient started feeling better but was pale and his vision was bad. Mom said he was dehydrated and at the lake all weekend. Paramedics took him out on stretcher to emergency room.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstruation irregular, Pain in extremity
Clinical narrative: Early mental cycle not typical and early by 2weeks. Sharp pain in outer legs.  Headaches.  Fatigue.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Gastrointestinal pain, Hot flush, Muscle spasms, Nasopharyngitis
Clinical narrative: Digestive pains and issues, hot and cold flashes, muscle spasms. I didn?t even want to get this vaccine but my school requires it. I?m sure this will get chalked up to a coincidence when in fact every doctor and pharmacist that is misrepresenting the pros/cons of this vaccine should be held criminally  and civilly liable. I?m a healthy 23 year old who had covid 4 months ago. It was easier than the flu. There?s no reason why it should be suggested let alone required to get this vaccine without proper informed consent. It?s my body my choice until the government can wield some power and it?s trust the science until the science doesn?t support a political narrative
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood thyroid stimulating hormone, Full blood count, Lip swelling, Metabolic function test
Clinical narrative: 1st dose Hives+lip swelling 2nd dose diffuse hives and facial swelling
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Swelling face, Tryptase, Urticaria, White blood cell count
Clinical narrative: 1st dose Hives+lip swelling 2nd dose diffuse hives and facial swelling
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Post menopausal bleeding? I have not had a menstrual  cycle for 2 plus years
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Urticaria
Clinical narrative: Hives / large red raised rash on left arm near the site  Appeared on 7/4 still there today
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Rash, Skin discolouration
Clinical narrative: Started with rash around belly and spread so went to ER.  They gave him steroid shot, Benadryl, and one other thing he could t remember. things got worse. Blood pressure got very low, dizzy, nurse couldn?t get a pulse ox reading, fingers turning blue. They thought he was having allergic reaction to shot. Gave him Epipen. He said things got better then
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: 1) There were no side effects after taking the first vaccine (except for pain on the left arm for 2 days) 2)  Until yesterday, there were no side effects after taking the second vaccine (except for pain on the left arm for 2-3 days) 3) Last night when I went to bed, I felt distinct pulling sensation of nerve on right side of the chin/jaw area. The pulling sensation is still present after 20 hours and can clearly be seen when I look at the mirror. I am not sure if this is early symptom of Bell's Palsy. 4) As of now, I do not seem to have any other side effects.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: mild lip swelling (both doses)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: The day after receiving the COVID19 shot (upper left arm), I experienced swelling with a dull, insistent pain that seemingly moves down the back of my arm to my elbow and forearm and will occasionally cause the back of my hand and fingers to tingle or go numb.  While the swelling went down within 3 days, the uncomfortable pains have persisted and somewhat worsened.  I occasionally will feel a slight pain in my chest, which made me initially think it was due to my HBP, but my pressure was normal and I have taken my pills during this time.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: The day after receiving the COVID19 shot (upper left arm), I experienced swelling with a dull, insistent pain that seemingly moves down the back of my arm to my elbow and forearm and will occasionally cause the back of my hand and fingers to tingle or go numb.  While the swelling went down within 3 days, the uncomfortable pains have persisted and somewhat worsened.  I occasionally will feel a slight pain in my chest, which made me initially think it was due to my HBP, but my pressure was normal and I have taken my pills during this time.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sudden vomiting. Was sitting down feeling normal one minute, next minute in the bathroom vomiting for about 15 minutes.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 on 02/05/2021 Became sick with influenza like symptoms accompanied by high fever April, May and June.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Electrocardiogram normal, Electromyogram normal, Fibrin D dimer, Neurological examination normal
Clinical narrative: Paresthesia in hands, feet and legs, high d dimer from blood test at 5 and 9 days after first jab, at 12 days was almost normal, diarrhoea the week following the injection. I underwent also neurological examination, electromyography, electrocardiogram, which were all negative.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Paresthesia in hands, feet and legs, high d dimer from blood test at 5 and 9 days after first jab, at 12 days was almost normal, diarrhoea the week following the injection. I underwent also neurological examination, electromyography, electrocardiogram, which were all negative.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt was given Moderna COVID vaccine on 18 Mar 2021 for his first dose, however this vaccine was no longer available at the clinic after April 2021.   The clinic switched to using the Pfizer vaccine.  Due to the exceptional situation/unavailability of the same series vaccines for both doses,  pt was given Pfizer for his second dose.    "In exceptional situations in which the mRNA vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. Such persons are considered fully vaccinated against COVID-19 ?2 weeks after receipt of the second dose of an mRNA vaccine."  Pt tolerated well/No reported side effects.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Musculoskeletal chest pain, Pruritus
Clinical narrative: Patient received Shingrix #1 on 14Dec20, COVID (Pfizer) #1 on 21Dec20, COVID (Pfizer) #2 on 8Jan21, and Zoster #2 on 11Jun21.  Around Feb/Mar, the patient developed pain near his right costal margin near the midline.  No skin disruption, no mass, just pain.  Over the last few months in addition to pain, the patient developed burning and itching.  Symptoms come/go. The patient questions shingles, now post-herpetic neuralgia as a possible complication of vaccinations.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itchy, sunburn-like rash appeared near elastic area of undergarment after dose 1 (not at vaccine site on arm).  It seemed to be improving until after second dose, when it spread farther and began to itch more again.  Benadryl helps some, as do aloe and zinc oxide, but rash has not yet resolved.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt was given Moderna COVID vaccine on 18 Mar 2021 for his first dose, however this vaccine was no longer available at the clinic after April 2021.   The clinic switched to using the Pfizer vaccine.  Due to the exceptional situation/unavailability of the same series vaccines for both doses,  pt was given Pfizer for his second dose.    "In exceptional situations in which the mRNA vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. Such persons are considered fully vaccinated against COVID-19 ?2 weeks after receipt of the second dose of an mRNA vaccine."  Pt tolerated well/No reported side effects.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation delayed
Clinical narrative: Loss of menstrual cycle. Previous regular, now skips every other month since receiving vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles left leg outbreak burning and itching
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness near injection site weeks after second dose administered on 5/20/21. Becomes more noticable at night time. Perhaps worse after laying on it.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol normal, Myocardial infarction
Clinical narrative: Heart attack within 1.5 months of receiving final dose. 38 year old, physically fit patient has excellent cholesterol, blood pressure, and resting heart rate numbers.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Confirmed with customer no additional AE.; Dose of GARDASIL 9 that was administered early/Patient who received their first dose of GARDASIL 9 on 1/29/2021, and the patient received their second dose of GARDASIL 9 on 6/2/2021; This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 29-JAN-2021, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)(dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided).  On 02-JUN-2021, the patient received an early second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in a 2 dose series regimen (inappropriate schedule of product administration) (dose, route of administration and anatomical location of vaccination were not provided; lot number T008152 has been verified to be a valid lot number and expiration date reported and established as 21-JUN-2022). No additional adverse events were confirmed. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; 1st PROQUAD dose via intramuscular route instead of and not by subcutaneous route; This spontaneous report was received from a nurse and refers to a 11-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-JUN-2021, the patient was improperly vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), via an intramuscular route instead of subcutaneous route (lot# T013602 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date: 15-MAR-2022) (formulation, strength, frequency, lot # and expiration date were not reported) for prophylaxis. No adverse event was reported. The reporter requested measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) medical information.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; When the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator. It was discovered yesterday that 5 bad doses were given, and 6 potential patients were involved.; 5 bad doses were given, and 6 potential patients were involved; back in April we had a delivery of GARDASIL 9 that did not arrive for more than 5 days; This spontaneous report was received from an office manager referring to a patient of unknown age and gender.  Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was not provided.  On an unspecified date in April 2021, the reporter had a delivery of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days (product distribution issue), when the product was received it was supposed to be returned to the wholesaler, instead it was placed in the refrigerator (product storage error). Information about the temperature storage or a time frame was unknown by the reporter. There wasn't a previous temperature excursion.  On 13-MAY-2021, the patient was vaccinated with a bad dose HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (poor quality product administered) pre-filled syringe, 1 time dose as prophylaxis (dose, route of administration, anatomical location and vaccine scheme were not reported; lot number T026168 has been verified to be valid, expiration date reported and validated as 04-DEC-2022) as prophylaxis. No additional adverse events occurred.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA005001: US-009507513-2106USA005005: US-009507513-2106USA005150: US-009507513-2106USA005047: US-009507513-2106USA005081:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion that occurred on MMR II which underwent temperature excursion was administered to multiple patients; This spontaneous report was received from an healthcare business professional, concerning to a patient's of unknown age and gender. No information was provided regarding the patients' pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 18-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) as prophylaxis (lot number S039313 has been verified to be valid, expiration date was reported and validated as 04-DEC-2021 (dose, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error). The administered vaccine experienced two temperature excursion of -50 degrees Celsius (C) to 8 degrees C (9.5 degrees C) during a time frame of 0 hour, 40 minutes and 0 seconds, as recorded by data logger. There was not a previous temperature excursion. No additional adverse events (AE's) were reported.   This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA006395: US-009507513-2106USA006408:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 06-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 07-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 03-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 15-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 17-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 21-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 23-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355: