chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac telemetry, Chest X-ray abnormal, Death, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: The patient presented with severe fatigue and weakness which began 2 days after receiving her third COVID-19 booster shot. She had reduced oral intake over the preceding 1 to 2 days before admission. She did not report chest pain or chest pressure or shortness of breath. She had an elevated troponin level greater than 90 with EKG changes consistent with diffuse anterior wall ischemia. She also had acute renal insufficiency. She was hemodynamically stable and was not experiencing chest pain. Her echocardiogram showed wall motion abnormalities consistent with stress cardiomyopathy or takotsubo syndrome. She was admitted to the intensive care unit and treated with intravenous fluid as well as intravenous unfractionated heparin and Plavix. She developed paroxysmal rapid atrial fibrillation and was treated with amiodarone and subsequently converted to sinus rhythm. She developed hypotension and was treated with low-dose phenylephrine. She remained stable and was transferred out of intensive care to telemetry and was treated with Eliquis and bisoprolol and amiodarone. She was showing signs of improvement but then took a turn for the worse with the development of respiratory failure. She was treated with intravenous Lasix and nitroglycerin paste. A repeat echocardiogram showed no new changes. Her chest x-ray showed worsening infiltrates which were multi focal as well as leukocytosis. Hospital-acquired pneumonia was suspected. At this point the patient's family opted to transition her to full comfort measures only and stopped all medications.  The patient subsequently passed away on comfort measures with family at the bedside on September 12, 2021.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypophagia, Hypotension, Intensive care, Leukocytosis
Clinical narrative: The patient presented with severe fatigue and weakness which began 2 days after receiving her third COVID-19 booster shot. She had reduced oral intake over the preceding 1 to 2 days before admission. She did not report chest pain or chest pressure or shortness of breath. She had an elevated troponin level greater than 90 with EKG changes consistent with diffuse anterior wall ischemia. She also had acute renal insufficiency. She was hemodynamically stable and was not experiencing chest pain. Her echocardiogram showed wall motion abnormalities consistent with stress cardiomyopathy or takotsubo syndrome. She was admitted to the intensive care unit and treated with intravenous fluid as well as intravenous unfractionated heparin and Plavix. She developed paroxysmal rapid atrial fibrillation and was treated with amiodarone and subsequently converted to sinus rhythm. She developed hypotension and was treated with low-dose phenylephrine. She remained stable and was transferred out of intensive care to telemetry and was treated with Eliquis and bisoprolol and amiodarone. She was showing signs of improvement but then took a turn for the worse with the development of respiratory failure. She was treated with intravenous Lasix and nitroglycerin paste. A repeat echocardiogram showed no new changes. Her chest x-ray showed worsening infiltrates which were multi focal as well as leukocytosis. Hospital-acquired pneumonia was suspected. At this point the patient's family opted to transition her to full comfort measures only and stopped all medications.  The patient subsequently passed away on comfort measures with family at the bedside on September 12, 2021.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung infiltration, Myocardial ischaemia, Pneumonia, Respiratory failure, Stress cardiomyopathy
Clinical narrative: The patient presented with severe fatigue and weakness which began 2 days after receiving her third COVID-19 booster shot. She had reduced oral intake over the preceding 1 to 2 days before admission. She did not report chest pain or chest pressure or shortness of breath. She had an elevated troponin level greater than 90 with EKG changes consistent with diffuse anterior wall ischemia. She also had acute renal insufficiency. She was hemodynamically stable and was not experiencing chest pain. Her echocardiogram showed wall motion abnormalities consistent with stress cardiomyopathy or takotsubo syndrome. She was admitted to the intensive care unit and treated with intravenous fluid as well as intravenous unfractionated heparin and Plavix. She developed paroxysmal rapid atrial fibrillation and was treated with amiodarone and subsequently converted to sinus rhythm. She developed hypotension and was treated with low-dose phenylephrine. She remained stable and was transferred out of intensive care to telemetry and was treated with Eliquis and bisoprolol and amiodarone. She was showing signs of improvement but then took a turn for the worse with the development of respiratory failure. She was treated with intravenous Lasix and nitroglycerin paste. A repeat echocardiogram showed no new changes. Her chest x-ray showed worsening infiltrates which were multi focal as well as leukocytosis. Hospital-acquired pneumonia was suspected. At this point the patient's family opted to transition her to full comfort measures only and stopped all medications.  The patient subsequently passed away on comfort measures with family at the bedside on September 12, 2021.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Wall motion score index abnormal
Clinical narrative: The patient presented with severe fatigue and weakness which began 2 days after receiving her third COVID-19 booster shot. She had reduced oral intake over the preceding 1 to 2 days before admission. She did not report chest pain or chest pressure or shortness of breath. She had an elevated troponin level greater than 90 with EKG changes consistent with diffuse anterior wall ischemia. She also had acute renal insufficiency. She was hemodynamically stable and was not experiencing chest pain. Her echocardiogram showed wall motion abnormalities consistent with stress cardiomyopathy or takotsubo syndrome. She was admitted to the intensive care unit and treated with intravenous fluid as well as intravenous unfractionated heparin and Plavix. She developed paroxysmal rapid atrial fibrillation and was treated with amiodarone and subsequently converted to sinus rhythm. She developed hypotension and was treated with low-dose phenylephrine. She remained stable and was transferred out of intensive care to telemetry and was treated with Eliquis and bisoprolol and amiodarone. She was showing signs of improvement but then took a turn for the worse with the development of respiratory failure. She was treated with intravenous Lasix and nitroglycerin paste. A repeat echocardiogram showed no new changes. Her chest x-ray showed worsening infiltrates which were multi focal as well as leukocytosis. Hospital-acquired pneumonia was suspected. At this point the patient's family opted to transition her to full comfort measures only and stopped all medications.  The patient subsequently passed away on comfort measures with family at the bedside on September 12, 2021.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in lung within 30 days of vaccine booster
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: blood clot in lung within 30 days of vaccine booster
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrooesophageal reflux disease, Non-cardiac chest pain, SARS-CoV-2 test, Vomiting
Clinical narrative: Within 24 hours of receiving first dose of Pfizer-BioNTech shot, started experiencing increased, exacerbated symptoms of GERD and Acid Reflux, including vomiting, chest pain, shortness of breath, diarrhea, and abdominal pain.  Increased dosing of PPI (Omeprizole) 20 MG (2x a day). Was recommended by PCM to conduct holistic therapy, such as Apple Cider Vinegar to neutralize acidity with very little to no relief.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Condition aggravated, Diarrhoea, Dyspnoea
Clinical narrative: Within 24 hours of receiving first dose of Pfizer-BioNTech shot, started experiencing increased, exacerbated symptoms of GERD and Acid Reflux, including vomiting, chest pain, shortness of breath, diarrhea, and abdominal pain.  Increased dosing of PPI (Omeprizole) 20 MG (2x a day). Was recommended by PCM to conduct holistic therapy, such as Apple Cider Vinegar to neutralize acidity with very little to no relief.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrooesophageal reflux disease, Vomiting
Clinical narrative: Within 24 hours of receiving first dose of Pfizer-BioNTech shot, started experiencing increased, exacerbated symptoms of GERD and Acid Reflux, including vomiting, chest pain, shortness of breath, diarrhea, and abdominal pain.  Increased dosing of PPI (Omeprizole) 20 MG (2x a day). Was recommended by PCM to conduct holistic therapy, such as Apple Cider Vinegar to neutralize acidity with very little to no relief.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Condition aggravated, Diarrhoea, Dyspnoea, Headache
Clinical narrative: This case meets criteria for vaccine breakthrough review.  SxS include cough, HA, eye pain, fatigue, fever.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Productive cough, Pruritus, Respiratory disorder
Clinical narrative: This case meets criteria for vaccine breakthrough review.  SxS include cough, HA, eye pain, fatigue, fever.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: This case meets criteria for vaccine breakthrough review.  SxS include cough, HA, eye pain, fatigue, fever.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Eye pain, Fatigue, Headache, Pyrexia
Clinical narrative: This case meets criteria for vaccine breakthrough review.  SxS include cough, HA, eye pain, fatigue, fever.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: This case meets criteria for vaccine breakthrough review.  SxS include cough, HA, eye pain, fatigue, fever.
Sex: U
Vaccine: COVID19, UNK, UNK
Symptoms: COVID-19, COVID-19 pneumonia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Link with VAERS #661321, updated only with patient death.
Sex: U
Vaccine: COVID19, UNK, UNK
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Link with VAERS #661321, updated only with patient death.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Fatigue, Headache
Clinical narrative: Injection site redness; Tiredness; Nausea; Loss of appetite; Stomach pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2021, several hours after receiving Shingrix, the patient experienced injection site erythema, tiredness, nausea, appetite lost and stomach pain. On an unknown date, the outcome of the injection site erythema, tiredness, nausea and appetite lost were recovered/resolved and the outcome of the stomach pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, tiredness, nausea, appetite lost and stomach pain to be related to Shingrix.  Additional information was provided as follows: The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Nausea, Pain in extremity
Clinical narrative: Injection site redness; Tiredness; Nausea; Loss of appetite; Stomach pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2021, several hours after receiving Shingrix, the patient experienced injection site erythema, tiredness, nausea, appetite lost and stomach pain. On an unknown date, the outcome of the injection site erythema, tiredness, nausea and appetite lost were recovered/resolved and the outcome of the stomach pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, tiredness, nausea, appetite lost and stomach pain to be related to Shingrix.  Additional information was provided as follows: The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Injection site erythema, Nausea
Clinical narrative: Injection site redness; Tiredness; Nausea; Loss of appetite; Stomach pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2021, several hours after receiving Shingrix, the patient experienced injection site erythema, tiredness, nausea, appetite lost and stomach pain. On an unknown date, the outcome of the injection site erythema, tiredness, nausea and appetite lost were recovered/resolved and the outcome of the stomach pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, tiredness, nausea, appetite lost and stomach pain to be related to Shingrix.  Additional information was provided as follows: The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Erythema
Clinical narrative: patient developed an infection on the injection site. she was given an antibiotic course per MD. Rash and discoloration present
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discolouration, Injection site infection, Injection site rash
Clinical narrative: patient developed an infection on the injection site. she was given an antibiotic course per MD. Rash and discoloration present
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Troponin I increased
Clinical narrative: The patient had the second pfizer covid vaccine three days ago, followed by muscle ache and fever for two days, and chest pain which started one day ago. He visited the ER and was admitted to the ICU due to elevated troponin. The chest pain subsided by pain medication, but he presented another chest pain this afternoon. EKG taken at the time showed ST elevation in 2,3,aVF accompanied with a reciprocal change in V2-V6. He was suspected of myocarditis or STEMI, and transferred to hospital.   Cardiac CT done; final Dx was myocarditis.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Chest pain, Computerised tomogram thorax abnormal, Electrocardiogram ST segment elevation, Intensive care
Clinical narrative: The patient had the second pfizer covid vaccine three days ago, followed by muscle ache and fever for two days, and chest pain which started one day ago. He visited the ER and was admitted to the ICU due to elevated troponin. The chest pain subsided by pain medication, but he presented another chest pain this afternoon. EKG taken at the time showed ST elevation in 2,3,aVF accompanied with a reciprocal change in V2-V6. He was suspected of myocarditis or STEMI, and transferred to hospital.   Cardiac CT done; final Dx was myocarditis.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: The patient had the second pfizer covid vaccine three days ago, followed by muscle ache and fever for two days, and chest pain which started one day ago. He visited the ER and was admitted to the ICU due to elevated troponin. The chest pain subsided by pain medication, but he presented another chest pain this afternoon. EKG taken at the time showed ST elevation in 2,3,aVF accompanied with a reciprocal change in V2-V6. He was suspected of myocarditis or STEMI, and transferred to hospital.   Cardiac CT done; final Dx was myocarditis.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 29-09-2021 and contains no new information
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy, Mass, Supraclavicular fossa pain
Clinical narrative: Injection was administered somewhat posteriorly and high up in the arm, most likely missing the majority of the deltoid muscle.  No pain occurred, however concern over the effectiveness of the vaccine was a concern.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Injection was administered somewhat posteriorly and high up in the arm, most likely missing the majority of the deltoid muscle.  No pain occurred, however concern over the effectiveness of the vaccine was a concern.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned 3 patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006798 and 20211006371.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Patient positive for Covid on 10/04/21 and is now hospitalized.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Respiratory viral panel, SARS-CoV-2 test positive
Clinical narrative: Patient positive for Covid on 10/04/21 and is now hospitalized.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest pain, Discomfort, Dizziness, Electrocardiogram
Clinical narrative: Fast heart rate, chest discomfort about 5 minutes after the shot was given.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Palpitations, Tachycardia
Clinical narrative: Fast heart rate, chest discomfort about 5 minutes after the shot was given.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Electrocardiogram normal, Heart rate increased
Clinical narrative: Fast heart rate, chest discomfort about 5 minutes after the shot was given.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer (Patient is reporter's wife). A female patient of unknown age received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 1 on unknown date as Dose 1 SINGLE for covid-19 immunization (Age of vaccination was unknown). The patient medical history and concomitant medications were not reported. On an unknown date the patient had Allergic reaction. The reporter clarified that his wife had the Pfizer Covid-19 Vaccine, and she did not have a severe reaction, but she had an allergic reaction to the Pfizer Covid-19 Vaccine. The outcome of the event was unknown. No follow-up attempts are possible information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal discomfort, Pyrexia
Clinical narrative: Swollen lymph node in left armpit; Discomfort in joints; fever; This is a spontaneous report received from a contactable consumer or other non-HCP (patient reported for himself). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 11:00 AM (at the age of 48-year-old), as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Crustacean allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included Levothyroxine sodium (Sintroid 112) (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Mar2021, as single for covid-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021, the patient experienced swollen lymph node in left armpit tennis ball sized, discomfort in joints and fever. No treatment was received for the adverse events. The events did not result into death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The case was reported as non-serious. The patient outcome of the events was Resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Pain, Sensory disturbance
Clinical narrative: The injection itself was very smooth and almost painless.  The next day, however, I experienced extreme pain in left shoulder, inability to move upper arm without significant pain.  This pain got increasingly worse over the next few days and for the most part, has not improved since.   Ibuprofen seems to make little difference.  I saw my PCP 10 days after the injection and I am scheduled to see an orthopedic doctor tomorrow to see what treatment path is advised.  The injection site itself was the normal kind of pain- in other words, just a minor bit of soreness.  The shoulder pain is a very different sort of pain.  It sometimes feels like there is broken glass in my shoulder joing.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19 infection
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Mastitis
Clinical narrative: Within 4 months of receiving the J and J vaccine, I developed a kidney infection. I have never had any sort of infection in my life. I'm a healthy 37 year old. I don't smoke or do drugs. I drink alcohol very minimally on occasion. I'm reporting this because I know my body. The only change I've had recently is the fact that I got the shot. I believe it is something to look into: If these vaccines are linked to kidney or other infections in individuals. I have no proof the vaccination caused my infection but it is highly suspicious. Also, I'm on antibiotics again for an infection in my right breast. So why all of a sudden is my body not fighting infection? Please look into this!
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Syncope
Clinical narrative: Fainted about a minute after receiving vaccination. Nothing major, just want to make sure it is known in case related to lot or similar.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Venous oxygen saturation decreased
Clinical narrative: Shortness of breath and increased heart rate - resting heart rate jumped from avg 54 to 65-70 on 8/13, day after first dose and now nine weeks later my rhr avg is 65. My VO2 max was consistently above average for years, since mid August it has steadily declined to below average. I was in excellent health, with an extremely healthy heart and now my heart health is rapidly declining.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis, SARS-CoV-2 test
Clinical narrative: Shortness of breath and increased heart rate - resting heart rate jumped from avg 54 to 65-70 on 8/13, day after first dose and now nine weeks later my rhr avg is 65. My VO2 max was consistently above average for years, since mid August it has steadily declined to below average. I was in excellent health, with an extremely healthy heart and now my heart health is rapidly declining.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations for 4-5 days.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Extra dose administered, Neuralgia
Clinical narrative: Developed severe nerve pain over entire body. History of Shingles shortly after second dose of vaccine, at the time assumed to be unrelated with intermittent residual nerve pain localized to L arm. Received booster in AM, ~12hrs later sudden intense onset of severe nerve pain over entire body, unrelieved so far.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: pt verbally attest to needing pfizer booster and showed on phone vaccine history and dates to technician.  dose 1 :3/10/21, dose 2 : 4/7/21.  Pharmacist verified with patient that pfizer was being administered and asked pt to bring physical card next day to fill out for pt since they only had a digital image available. Later in day when billing insurance and get rejection, saying different manufacturer.  After checking state registery discovered pt had moderna dose 1 and 2 and was not due for a booster.  Pharmacist attempt to call pt to discuss and had to leave a voicemail
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Tachycardia
Clinical narrative: Patient initially experienced tachycardia (HR >110 bpm). She reported that she's not feeling too well and that her heart is beating so fast. This occurred within the 15 min monitoring period post vaccination. Checked her bp and reading was 199/100. checked it once again after 15 mins and it was at 188/89.  15 mins after paramedics came, her bp was still at 190/89 and HR of 117bpm, O2 sat 99%. Patient was still not feeling too well, although conscious and was able to communicate with me and the paramedics.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Hypopnoea, Myalgia
Clinical narrative: Severe fatigue, muscles aches and weakness, joint pain, swelling of throat, shallow breathing.  Persisted form 6/27/21 to 6/30/21.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Severe fatigue, muscles aches and weakness, joint pain, swelling of throat, shallow breathing.  Persisted form 6/27/21 to 6/30/21.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Palpitations, Stem cell therapy
Clinical narrative: severe fatigue, dizzy, palpitations, breathing issues Holistic treatment -stem cell supplements Cellorane #3 27 days
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Laboratory test, Pain
Clinical narrative: Light headed, vertigo, vision issues, headache, body aches and feeling very tired
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Visual impairment
Clinical narrative: Light headed, vertigo, vision issues, headache, body aches and feeling very tired
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Malaise, Mobility decreased, Stent malfunction
Clinical narrative: I felt very sick could not get out of bed. Then I started to have chest pain. On June 10th i had a stent out in my LED. Freak incident with no explanation
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Laboratory test normal
Clinical narrative: Stomach discomfort and constant watery diarrhea that has not stop since Pfizer second dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing heartbeat at 12 hours post vaccine
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysarthria, Electrocardiogram, Gait disturbance, Hypoaesthesia
Clinical narrative: During visit to  store returning some items around 10 am. Had numbness of face and legs, blurry vision and had slurred speech could not walk very well. Store employee help me to sit and called my daughter and took me to ER.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vision blurred
Clinical narrative: During visit to  store returning some items around 10 am. Had numbness of face and legs, blurry vision and had slurred speech could not walk very well. Store employee help me to sit and called my daughter and took me to ER.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Chest pain, left sided.  Patient went to the ED, two times, 9/22 and 9/25.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Immediate post-injection reaction, Injection site pain
Clinical narrative: Sore arm starting immediately after shot and lasting more than 3 days. Acne breakout on face starting the day after the shot.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy
Clinical narrative: Within less than three hours of injection.  Every arthritic joint (From previous injury or strains) was alternating between aching and numbing.  Took Tylenol as advise, but the aching persisted.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Malaise, Mass, Neck pain
Clinical narrative: Evening of the vaccination( 10/4/2021  malaise, soreness   (9/10 pain)  LUE @ injection site .  0300, early next morning 9/10 pain  continued through tonight  in LUE.   1100 AM Tuesday : pain/tenderness in Left axillary.  Noted a soft moveable lump upon assessment.  Malaise, ache in neck noted throughout today and into the 6th.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Evening of the vaccination( 10/4/2021  malaise, soreness   (9/10 pain)  LUE @ injection site .  0300, early next morning 9/10 pain  continued through tonight  in LUE.   1100 AM Tuesday : pain/tenderness in Left axillary.  Noted a soft moveable lump upon assessment.  Malaise, ache in neck noted throughout today and into the 6th.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Contusion, Haemorrhage
Clinical narrative: Bleeding right after shot. Then I discovered bruised in the shower around 8pm. Woke up at 4am with tingling and burning sensation from Left shoulder radiating to arm and fingers. Elevated arm with a pillow. Symptoms have not improved yet.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Exposure to SARS-CoV-2
Clinical narrative: Patient fully vaccinated and died due to Covid related causes. Patient believes was exposed from husband
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Patient fully vaccinated and died due to Covid related causes
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia, Paralysis
Clinical narrative: Paresthesias pins needles feelings of neuropathy and pain traveled up and down my right arm and hand. My thumb and first two fingers went numb with very little feeling. After several days had moderate to severe pain in my right hand and numbness and paralysis to the extent I could not close my fingers and make a fist. This hand paralysis went away after about a week and a half.  The paresthesias continued in my hand and arms for about two months and then gradually improved. To date about 95 percent better but still continue experiencing occasional paresthesias in  a couple fingers
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Swollen under left arm  Swollen tender arm around injection site  Red  swollen area around injection site
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Initial response normal- injection site sore (as for first, two doses).   Then, on day 5 (Monday, October 4), late at night, I was woken up by serious (level 3-5? out of 10) THROBBING pain: absolutely no swelling or redness (i.e. nothing visible).  Throbbing has stopped but a consistent, low-grade pain, UNDER the skin (not external) persists.    ?! (Everything I have read on internet suggestion symptoms should diminish and/or disappear after ~24 hours).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Brain oedema, Cerebral artery stenosis, Cerebral infarction, Hydrocephalus
Clinical narrative: Cerebral infarction. Acute hydrocephalus. Cerebral edema. Stenosis of the lower cerebral artery.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Super long and  heavy period after second dose. Period also came 5 days early.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Exposure during pregnancy, Gestational hypertension, Magnetic resonance imaging head, Ultrasound head
Clinical narrative: Baby diagnosed with severe communicating hydrocephalus requiring a VP shunt (most likely present at 4 months but diagnosed at 6 months)   Vaccinated at approx 31 and 34 weeks pregnant   EDD 2/26/2021 Delivery on 2/9/2021 for gestational hypertension  Birth weight 6lbs 9oz
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: Dry mouth right after injection; This spontaneous case was reported by a pharmacist and describes the occurrence of DRY MOUTH (Dry mouth right after injection) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: NSAIDS (Long term use of NSAIDs) on 19-Aug-2021. Concurrent medical conditions included Foot callus since 19-Aug-2021, Pain in hip since 19-Aug-2021 and Leg pain since 19-Aug-2021.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter once. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRY MOUTH (Dry mouth right after injection). At the time of the report, DRY MOUTH (Dry mouth right after injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.  Reporter states that two different patients, one male and one female, given the vaccine reported severe dry mouth right after injection.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Added patient demographics, medical history
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion for GARDASIL/Vaccines were administered to patients; This spontaneous report has been received from a medical assistant, referring to an 11-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 30-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) intramuscularly (IM) (anatomical site of vaccination and vaccine scheme was not provided; lot number T026323 has been verified to be valid, expiration date reported and established as 22-FEB-2023) as prophylaxis.   The vaccine experienced a temperature excursion of 47 degrees Fahrenheit during a time frame of 47 minutes (product storage error). There was no previous temperature excursion.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 13-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, vaccine scheme, dose number, route of administration and anatomical site of vaccination were not reported; lot number T030746 has been verified to be valid, expiration date reported and established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9 F) during a time frame of 90 hours (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA003185:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant medications were provided.   On 13-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, vaccine scheme, dose number, route of administration and anatomical site of vaccination were not reported; lot number T030746 has been verified to be valid, expiration date reported and established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9F) during a time frame of 90 hours (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA003185:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported. No other AE reported; temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021; temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021; This spontaneous report was received from a medical assistant referring to an unreported age and gender patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.    The medical assistant reported that a temperature excursion occurred on 03-AUG-2021 and 05-AUG-2021 involving hepatitis A vaccine, inactivated (VAQTA) lot number T037788, verified to be valid for prefilled syringe formulation, with expiration date 30-APR-2022. The vaccine underwent a temperature excursion of 35.4 and 35.8 degrees Fahrenheit (F) for a cumulative timeframe of 15 minutes (product storage error). There was not a previous temperature excursion.   The 1-time dose vaccine was administered to the patient on an unspecified subsequent date in 2021 for prophylaxis (route and anatomical location of vaccination were not reported).  No signs or symptoms nor other adverse events (AE) were reported (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA002589:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2102USA001220), concerning a 74-year-old female patient. The patient's medical history and concurrent condition were not provided. .  On approximately 04-NOV-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis in a medical center.   On approximately 27-OCT-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis in a medical center (inappropriate schedule of product administration). There was no adverse reaction or side effects experienced.; Sender's Comments:  US-009507513-2102USA001220:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; incorrect product storage; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 22-SEP-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707496, expiration date 29-MAR-2022) at a dose of 2 milliliter, orally and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T037650, expiration date 21-JUL-2023) at a dose of 0.5 milliliter, both vaccines for prophylaxis. The vaccines had a temperature excursion of 46.9 F for 25 minutes. No previous temperature excursions were reported. no additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Expired vaccine used; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On 23-SEP-2021 (also reported as today), the patient was vaccinated with an expired dose of  varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose (strength, formulation, indication, vaccination scheme, route and anatomical location of administration were not provided; lot # S020464 upon internal review determined as valid, and expiration date established as 02-JUL-2021) for prophylaxis (expired product administered).  No additional adverse events reported
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: the patient received a dose of Gardasil ten years ago, when she was eleven years old, without completing the vaccine series for coverage; a patient approach her about receiving a Gardasil 9; no additional AE; This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. Her pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date in 2011, reported as 10 years ago, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (exact dose, dose #, route, anatomical location, lot # and expiration date were not reported). She did not completing the vaccine series for coverage. No adverse events were reported.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion, temperature (48.7F); This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender.   On unspecified date in September 2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026961 and expiration date on 02-APR-2023 for prophylaxis with an improperly stored vaccine after temperature excursion on 10-SEP-2021 (product storage error). The temperature was 48.7F and lasted 10 minutes. There was no previous temperature excursion reported. No product quality complaint was reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Crohn's disease, Drug ineffective, Haematochezia, Inflammation, Malaise
Clinical narrative: Caller stated he was on HUMARA but it did not work. Caller did not specify why the HUMIRA did not work.; Caller stated if she would have been told about side effects she would not have got the vaccine for her son.; Caller stated end of February 2018, a few months after receiving the vaccine, her son got bloody stools. Caller stated he was diagnosed with Chron's disease and his inflammation was so bad.now he is really sick because of this vaccine.; This spontaneous report has been received from the patient's mother, concerning to a currently 17-year-old male. It was stated that the patient was very healthy, no medications or allergies. Information regarding the patient's pertinent medical history and concurrent conditions reported as none.  On an unspecified date of 2018 (also reported as: "therapy end date: March 2018"; conflicting information), the patient was vaccinated with the first dose injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis of human papilloma virus (HPV) (route of administration reported as injection) (exact dose, vaccination scheme frequency, anatomical location of vaccination, lot number and expiration date were not reported).   In February 2018, reported as a few months after the first dose of the vaccine (conflicting information as the date of the vaccination was reported on an unspecified date in 2018), the patient was sick, and was not able to join the military; the patient's mother stated he got bloody stools. Indeed, he was diagnosed with Chron's disease and his inflammation was so bad. In addition, the patient was constantly at the hospital (no hospitalization reported) and had "800 pages of medical records" and the reported said that if she would know about the side effects (adverse event) she would not got the vaccination to his son, the pediatrician only stated the benefits of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but did not mentioned the outcomes of the things could happen, he was always healthy and now he was really sick because of the vaccine.   On an unspecified date, the patient started as a treatment therapy adalimumab (HUMIRA) (formulation, dose, frequency, route of administration, indication, lot number and expiration date were nor reported), but did not worked (drug ineffective), and had to be chanced for infusions of infliximab (REMICADE) every month. At the time of this report the patient had not recovered from the event.   The causality assessment between Crohn's disease, the adverse event, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as related; and with the drug ineffective was not provided. The causality assessment between the drug ineffective and adalimumab (HUMIRA) was reported as related.  Upon an internal review, Chron's disease was determined to be medically significant.