chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69yr old male arrived to ED via clinic in wheelchair. He was brought to ED and clinic staff stated he was having irregular heart rate ranging 30's -107. He was being seen in the clinic for "body pain". He points to right leg and thought it was sciatica, but the pain is moving to the front of his leg.    ED chart:  1.  elevate troponin level 2. Cough Acute 3. Fasting hyperglycemia  4. Type 2 diabetes mellitus with stage 3a chronic kidney disease, with long-term current use of insulin (HCC)  5. Hypercalcemia    Per chart Acute Problems 1. Acute asthma/COPD exacerbation 2. Hypertensive urgency 3. Mild hypercalcemia 4. Elevated troponin 5. Asymptomatic bacteriuria 6. Suspected non-oliguric AKI 7. Type 2 DM with hyperglycemia 8. Right thigh discomfort
Pt said she received second dose pfizer covid-19 vaccine on 5/14/21. Per pt, she's had a stiff neck for about 4days now. Advised to contact PCP.
He took 1st oral typhoid last nite at 2130. Woke up this a.m. with itching neck and upper chest and 1 lesion (R) upper arm.
Soreness at injection site for both doses after 4 hours of dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 08:30 (Lot number: EN6206) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Citrus foods" (unspecified if ongoing), notes: known allergies: Citrus foods. Concomitant medication(s) included: PHENTERMINE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021 12:30, outcome "recovered", described as "Soreness at injection site for both doses after 4 hours of dose". Therapeutic measures were taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Complained of redness & swelling in bicep of right arm (injection site of PNEUMOVAX 23). Follow up: spoke with pt via phone 9/10/11 11:39am CDT reaction resolving nicely.
Patient reported that after receiving the second dose of SHINGRIX he experienced vomiting, body aches and pains, and fever. These symptoms prevented him from attending work for two days. His condition is improving at this time but he does not feel back to his usual self.
Severely sore arm-hot-swollen-painful fever of 101.8, cramping in feet, severe headache which decreased proportionally as the fever reduced. This lasted until today. I am left with a head cold and sinus infection.
Tested positive for Covid-19 on 7/29/2021. On 8/19/2021 pt was admitted to hospital, not for Covid-19 s/s.
Above vaccine given @ 9:45am on 9/1/21 and vaccine expired on 8/31/21. Reported to moderna awaiting further instruction.
This case was reported by a physician via call center representative and described the occurrence of nausea in a 64-year-old female patient who received SHINGRIX. Concomitant products included LEVOXYL. On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, 9 hrs after receiving SHINGRIX, the patient experienced nausea, decreased appetite, general body pain, malaise, fever, chills, fatigue and vomiting. In April 2018, the outcome of the nausea, general body pain, malaise, fever, chills and vomiting were recovered/resolved. On an unknown date, the outcome of the decreased appetite and fatigue were recovering/resolving. It was unknown if the reporter considered the nausea, decreased appetite, general body pain, malaise, fever, chills, fatigue and vomiting to be related to SHINGRIX. Additional details were reported as follows: The patient was a retired physician. The patient received SHINGRIX at 14:00 hours. Less than a day after receiving SHINGRIX, the patient experienced decreased appetite and vomiting. The patient planned to follow-up with her physician on an unknown date.
Nausea; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 05-Jan-2021, NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
The patient came to the pharmacy to report an adverse event she called "Covid Arm" about 06:00 Monday evening 8/15/2022. The evening after vaccination, the area around the vaccine site became a raised area. By the next morning, it became large, swollen, itchy, and discolored. The swelling felt deep. The patient felt like passing out especially Saturday, so she spent most of Saturday sleeping  and a good portion of Sunday sleeping. The patient took Advil Sunday evening to feel better. Her blood sugar was in the low 200s over the whole weekend according to her Dexcom meter. Today, most of the reaction has self-resolved and only feels swollen if it is messed with.
01/01/2022 Vaccination. I had trouble breathing. Tightness in chest. I drank a really cold electrolyte water and double dose of Benadryl. I had been taking Allegra 2x a day for 14 days prior to shot and 14 days after. I went to an immunologist prior to vaccination due to past medical history with vaccinations.  I was having lower back pain since my first shot and this continued.  06/07/2022 CT Scan  06/20/2022 Ultra Sound  07/13/2022 Polyp removed
Initial information regarding unsolicited case received from pharmacist on 12-Dec-2013: This case involves female patient. Medical history and concomitant medication was unknown. Patient started therapy FLUZONE HD (batch number: and expiry date: unknown). Consumer experienced muscle pain. The therapy was unknown at the time of the report. At the time of the report event outcome was recovered. No further relevant information reported.
Arm was red from shoulder down to crease of elbow & warm to touch. Chest pains come and go.
Patient received pfizer vaccine on 10/19/21 and 11/9/21. Presented to ER on 7/11/22 and found to be COVID positive. Received ceftriaxone and doxy. Was on room air at all times. Discharged on 7/13/22.
Case number PHEH2013US015777, is an initial spontaneous report received from a nurse on 18 Jul 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A12011, expiry date: Feb 2014) at dose of 0.5 ml intramuscularly on 17 Jul 2013. On 18 Jul 2013, his parent called and reported that, he experienced redness, heat and swelling at MENVEO injection site, low grade fever and headache (onset exact date of reactions was not known). The outcome, seriousness and causality of the events were not reported. Following an internal review received on 06 Aug 2013, the case number PHEH2013US016372 was identified to be a duplicate of PHEH2013US015777 and hence all the information from PHEH2013US016372 was merged into PHEH2013US015777 and the case PHEH2013US016372 would be deactivated.
Rash in both arms; Red-blurred petechiae that are so uniforms and skin looks very red; Red-blurred petechiae that are so uniforms and skin looks very red; This is a spontaneous report from a contactable consumer (patient) and other-health care professional. A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm right on 01Apr2021 16:15 (at the age of 46-year-old) as dose 1, single for covid-19 immunisation at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient medical history concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not have any known allergies to medications, food, or other products. On 03Apr2021 at 14:00, the patient experienced rash on both arms, red-blurred petechiae that are so uniforms and skin looks very red. The patient did not receive any treatment for the reported adverse event. As per the reporter, the seriousness criteria of the reported events were non-serious. The event does not lead to any of the seriousness criteria such death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient inadvertently given Moderna 0.25 ml booster dose instead of Pfizer Adult booster dose. Patient was not eligible for Moderna due to age restrictions. No other adverse reactions.
Horrible bitter taste in mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Horrible bitter taste in mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Long COVID in November 2020. Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Compazine), Allergy to antibiotic (erythromycin) and Adhesive tape allergy. Concomitant products included PREDNISONE, ESOMEPRAZOLE, FAMOTIDINE (PEPCID [FAMOTIDINE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 18-May-2022, the patient experienced DYSGEUSIA (Horrible bitter taste in mouth). At the time of the report, DYSGEUSIA (Horrible bitter taste in mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was also on Actemra infusion since 06-May-2022.  It was reported that the patient had horrible bitter taste in mouth since 18-May-2022 and had not received any treatment.
Patient reported injection site pain, throbbing, redness for 2 days. No fever. Family doctor indicated possible skin infection, was treated with antibiotics and ibuprofen. 4 days later reports no symptoms.
Information has been received from a physician concerning a pt who on approx 05Jul06 was vaccinated PO with a dose of ROTATEQ. The physician reported that on approx 19Jul06, his office received a call from the pt's parents indicating their child had diarrhea. On approx 26Jul06, the physician's office received another call from the pt's parents noting that the diarrhea continued. At the time of this report, no lab/diagnostic tests had been performed and the pt's diarrhea persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/10/2006.  Information has been received from a physician and a woman in the physician's office concerning a 9-month-old male who on 07-JUL-2006 (previously reported as approximately 05-JUL-2006) was vaccinated PO with the second dose of ROTATEQ.  It was reported that on 07-JUL-2006 (previously reported as approximately 19-JUL-2006), the physician's office received a call from the patient's parents indicating their child had diarrhea.  On approximately 26-JUL-2006, the physician's office received another call from the patient's parents noting that the diarrhea continued.  No laboratory/diagnostic tests were performed.  On 01-AUG-2006, patient's diarrhea resolved.  Additional information has been requested.
9/11/21 PMH of Granulomatous Polyangiitis, CKD, CVA, Hypertension and Polymyalgia Rheumatica; presented for shortness of breath
Starting less than 12 hours from the injection, the adverse effects started with a bad headache and light sensitivity. Within an hour the adverse effects evolves to severe chills, fever, body aches, fatigue and nausea. A few hours later all symptoms continued and worsened. Fever spiked to 102, nausea turned to vomiting, chills made the skin hurt from any touch/pressure, muscles aches made pain continually radiate all throughout the body, headache turned to a migraine. Symptoms persisted throughout the night and into the next day resulting in no sleep. The following day ibuprofen was able to manage symptoms enough where patient was able to sleep. Fever decreased, but chills, headache, fatigue, and vomiting continued. Patient was forcefully vomiting bile after not being able to keep anything down. Patient broke capillaries across the face. Extreme tiredness pursued, but symptoms dwindled over the course of three days.
Mom state lt thigh has large red knot from HIB vax given 1 wk ago; no elevated temp reported; Tylenol given;
rash; 1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0119l1a and 041l20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021). On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RASH (rash) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021).    No concomitant medications were reported.     Following vaccination patient started to experience not right after, in Feb or March 2021 a terrible rash. Patient went to the dermatologist, had several creams and treatments Patient received the booster dose of Moderna COVID-19 vaccine on 11-Nov-2021 (lot number: 013f21a) and booster dose of Moderna COVID-19 vaccine, Bivalent on 22-Dec-2022 (lot number: 043h22a). Patient believed it was related to the vaccine as she never had that before.
Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too; Something was off; Weird effect on his vision; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too), FEELING ABNORMAL (Something was off) and VISUAL IMPAIRMENT (Weird effect on his vision) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID 19 vaccine (Arm of injection: Not sure but guess right arm Lot #: 002A21A) on 11-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID 19 vaccine.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Nov-2021, the patient experienced OCULAR DISCOMFORT (Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too), FEELING ABNORMAL (Something was off) and VISUAL IMPAIRMENT (Weird effect on his vision). At the time of the report, OCULAR DISCOMFORT (Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too), FEELING ABNORMAL (Something was off) and VISUAL IMPAIRMENT (Weird effect on his vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Within hours of patient's HepB vaccination her bilirubin score went from perfectly normal to 19. Bili-light treatment and nursing would bring it down only for it to spike again...up to a score of 23 3 days after vaccination.
4 Month old infant developed injection site reactionwithin 24 hrs after DTP/OPV immunization.
Pt reports confusion, memory loss lasting approximately 1 hour occurring after leaving physicians office. S/P receiving vaccination.
Patient sitting in lobby for recommended 15 min observation time. He burped loudly, vomited (green/yellow vomitus), slumped to his right in the chair. Patient was diaphoretic and slow to respond to verbal stimuli.
Fever of 99.8 for almost 48 hours even with Tylenol every 4 hours, body aches, chills, fatigue, headache
Member was given Vaccine at Day 16 versus recommended 21 days after first dose.  No adverse reaction was noted while onsite and member was interviewed over the phone and he reported that he had no adverse reaction.
Information has been received from a woman in a physician's office concerning a 7 year old male who was vaccinated with a dose of Varivax. The reporter noted that the patient was not vaccinated at her facility. On 21-APR-2006, the patient developed chickenpox and subsequently recovered. Additional information is not expected.
fainted; diarrhea; vomiting; nausea; Knees buckled; severe gastrointestinal effects; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder. On an unknown date, the outcome of the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder were recovered/resolved.   It was unknown if the reporter considered the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. 2 weeks ago, from reporting date, the patient received 1st dose of Shingles and 8 hours after vaccination experienced knees buckled, fainted, and had severe gastrointestinal effects including nausea, vomiting and diarrhea. The patient did not provide vaccine facility details and enquired if he should receive 2nd dose of Shingles vaccine. The patient also enquired if he could have the flu vaccine at the same time as the shingles vaccine.
Headache; body aches; fever; stuffy nose; fatigue; muscle twitching in lower limbs mostly in the first 24 hours. 3 weeks later, and the muscle twitching has not stopped; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date: not reported), via an unspecified route of administration in left arm on 25Feb2021 15:30 (at age of 40-years-old) as single dose for COVID-19 immunisation in hospital. Medical history was reported as none. The patient had no known allergies. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date: Not reported), via an unspecified route of administration in right arm on 04Feb2021 15:30 (at age of 40-year-old) as single dose for COVID-19 immunisation. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 25Feb2021 at 23:00, the patient experienced headache, body aches, fever, stuffy nose, fatigue, muscle twitching in lower limbs mostly in the first 24 hours. 3 weeks later, and the muscle twitching has not stopped. Headache, body aches, fever, stuffy nose, and fatigue in the first 36 hours. Also, muscle twitching in lower limbs mostly in the first 24 hours. 3 weeks later, and the muscle twitching has not stopped, throughout various parts of the body. Legs, feet, stomach, hands, etc. Adverse events resulted in none. No therapeutic measures were taken as result of the adverse events. The outcome of all events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching and rash noticed on Jan 22.  By Jan 24 itching had subsided. Mild rash remains.  Rash centered around the site of the injection on the right deltoid.  Rash diameter approximately 3 inches.  No pain noted past the initial 2-3 days post injection.  Initial post injection pain was mild as would be expected and not thought to be at all unusual.  At the time of this report filing the rash persists but to a lessor extent and is considered mild.
This case is linked with the case number 2014USA046378 with same product and reporter. Initial misuse report received from a healthcare professional on 24 January 2014. The cases were received on 21 March 2014 at GPV. A '09-month-old' patient (No information was provided regarding the patient) had received dose of FLUZONE 0.5 ml, on an unspecified date i.e. overdose. No adverse event was reported. List of documents held by sender: none.
Swollen glands, feverish, feeling nausea, threw up the next morning.