chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 83 y.o. male with a history of chronic hypotension (unknown etiology), adrenal insufficiency, melanoma s/p resection/immunotherapy (2016) who presented to Hospital on 12/11/2022 for progressive malaise, lethargy, confusion, and tested +COVID at SNF. Labs notable for AKI Cr 2, elevated trop 154, elevated BNP 5100s on admit.   1. COVID-19 infection: Presented with URI symptoms, lives in assisted living. Positive test 12/11/2022. Symptoms began roughly 12/9. Vaccinated. ID followed, s/p 5 days of dex. Improved.  2. Acute hypoxic respiratory failure: Pt required 3L nasal cannula on admit, weaned to room air. Resolved. 3. AKI: Cr 2.0 on admit, up from baseline ~1. Possibly from hypovolemia given general illness. Noted elevated BNP, but not overtly volume overloaded on exam. Improved with IVF. Creatinine 0.9 on day of discharge. 4. Acute/Subacute cerebral infarct: Presented with acute encephalopathy, no localizing neurological defect. CTH 12/11/22: small lacunar infarct. MRI Brain 12/13/22: multifocal late acute/subacute infarcts concerning for embolic process. CT angio head/neck: with intracranial atherosclerosis. MRV 12/16 without contrast cannot rule out thrombus. CTV negative for thrombus. 30 day event monitor. Started Aspirin. Neurology followed. 5. Acute encephalopathy: Suspect due to COVID, subacute CVA and possible UTI. Improved.  6. Acute hyponatremia: likely secondary to poor oral intake and IV fluids, stopped on 12/19. TSH normal on admit. Sodium mildly decreased at 126 12/21/2022 , restarted salt tablets, improved to 128 at time of discharge  7. Suspected UTI: UA 12/13 suggestive of infection. Urine cx contaminated. S/p empiric rocephin x3 days ended 12/17/22 8. Elevated troponin: Trop 154 on admit. No prior CAD history per chart. EKG on admit with poor R wave progression, but otherwise no ST changes or TWIs. Denied chest pain. 12/12/22 Echo: LVEF 68%, grade I diastolic dysfunction. 9. Chronic hypotension: Unclear etiology (possibly from adrenal insufficiency), but has chronically been on midodrine. Notably blood pressure sufficient off midodrine for several days on admit  10. Adrenal insufficiency: Per chart, due to prolonged steroid use for melanoma treatment. Tapered down to 1 mg daily prednisone in 4/2022 by Oncology. s/p Decadron for COVID hypoxia, resumed home prednisone 11. Severe malnutrition: related to acute on chronic illness. Not eating much but unfortunately do not think further hospitalization will with this.  12. Code status: DNRCC-Arrest
The day after his injections, he experienced pain and fever (up to 102 degrees), followed by the swelling and redness.  His fever had subsided a little but his swelling and redness was still severe enough to go to the urgent care on 9/19/20.  They discussed adverse reactions to immunizations with him and sent him home without additional treatment.
Face flushed/ cheeks warm to the touch/red in color Left side of face , slightly swollen anxious/headache  Patient given Benadryl 25 mg cap x 1 dose - effective , patient observed for 30 minutes more , symptoms improved , Patient discharged
Headache; Neck Pain from top of shoulder to neck on left side; Neck Stiffness; Really Dry Mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via intramuscular, administered in left arm on 03Mar2021 at 09:30 (at a age of 65-year-old during vaccination) as 1st dose, 0.3ml, single dose for covid-19 immunisation. The patient's medical history and family medical history were reported as none. The patient's concomitant medications were not reported. The patient had not undergone any investigation assessment prior or post vaccination. The patient had not taken any other vaccine 4 weeks prior to Covid vaccine. The patient no adverse events prior to Covid vaccination. On 03Mar2021, the patient almost immediately within 5 mins of vaccination experienced headache. He stated that he went home, and headache still lasting and then within a half hour after the vaccination the patient had neck pain from the top of his shoulder up to his neck and his neck was really stiff, and really dry mouth. He wanted to report his effects, he assumes he had a reaction to the shot. He stated that he was finally starting to feel better. He stated that he has his next one shot in three weeks. The patient had neither visited emergency room nor physician. He stated that his doctor may tell him to go to the ER if events worsened and it was not. The patient took Tylenol as treatment medications for the resulted events. The outcome of the event headache was not recovered and for the rest of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 vaccine EUA I had generalized body pain within 24 hours. I developed redness below the site of injection. The site of redness is very sensitive  and warm to touch. I have also developed a sore throat within 48 hours of the vaccination.
7 PM - started with hives on her legs, torso, and face. Subsided after an hour. Went to sleep. Woke up at 6AM, red rash present on legs, torso, & chest. Had coughing throughout night needed nebulizer. Pt did not need hospitalization; she did develop a headache and mood changes resulting in frequent doctors visits. Patient also now is going through testing for auto-immune encephalitis.
Information has been received from a registered nurse concerning an adult patient with a history of chickenpox in the past but her titers still being negative after having the disease who on 06-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 669408/1384Z, expiring on 19-JAN-2012) instead of the second dose of VARIVAX (Merck) (MSD). The patient had received a first dose of VARIVAX (Merck) on 11-NOV-2010. No adverse effect reported. It was unspecified if the patient sought medical attention. Follow up information has been received from the registered nurse stated that it was a case of the wrong product was pulled off the shelf by mistake. It was not a case of product confusion. Additional information is not expected.
Syncope, tachycardia, shortness of breath, chest pain/tightness, throat tightness. Resolved in 10 minutes. No treatment needed.
Moderna COVID-19 Vaccine EUA  Woke up May 12 7 AM with chills, fatigue, full body aches including strong headache. Symptoms eased with migraine medication (2 tablets, each with 250mg acetaminophen, 250mg aspirin, 65mg caffeine). Symptoms came back 2-3 PM. Took just aspirin (3 tablets, each with 325mg aspirin), and symptoms got better after dinner at 5:30.
I am experiencing an irregular menstrual cycle; Severe cramping in my lower back and lower abdomen; Severe cramping in "my" lower back and lower abdomen.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 at 09:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to kiwi (fruit allergy). Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included levonorgestrel (MIRENA) and salbutamol (ALBUTEROL); all used for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 08:00, the patient experienced an irregular menstrual cycle. She normally had only spot if anything at all. Not this time and it was at least 2 weeks early. She also reported for severe cramping in patient lower back and lower abdomen. Normally she had nothing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstrual cycle and severe cramping in her lower back and lower abdomen was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
low grade fever, body and joint aches, headache. Used OTC motrin and tylenol. Unable to work
STAGE 3 KIDNEY DISEASE; This spontaneous report received from a consumer concerned multiple patients of unspecified sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  As per the reporter, on an unspecified date, "many other people were complaining of stage 3 kidney disease after getting the J and J vaccine" (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 3 kidney disease was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220100154.; Sender's Comments: V0: 20220104344 -Covid-19 vaccine ad26.cov2.s- Stage 3 kidney disease. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This is a spontaneous report from a contactable nurse. An 18-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for Meningitis B. The patient's medical history and concomitant medications were not reported. The patient had no known history of allergies. On an unspecified date, the patient had adverse effect reported as left deltoid was swollen; the complete deltoid was swollen with an approximate size of 3 inches wide and 5 inches tall. Extremely hard to touch and it was very tender he was unable to raise his left arm at 90 degrees. The patient denied headache. The patient had feeling fatigue, very weak and was very tired. Vital signs on an unspecified date included temperature of 99.1, blood pressure 137/66 (units were not provided). The outcome of the events was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in arm left on 08Apr2021 14:30 (batch/lot number EW0153 and expiry date unknown) at 53 years of age as 1st dose, single for COVID-19 immunization in other facility. Medical history included known allergies many but did not react to vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included meloxicam, omeprazole, levocetirizine; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he was quite sick after the 1st dose and he suffered from exhaustion and sleeping 15 to 17 hours a day, and a heavy cough, and a minor sinus pressure, for the first 2.5 weeks after the 1st dose. The patient noticed a very faint high pitch in his ears a few days before the 2nd shot but dismissed it as an aberration. The adverse events were reported serious which caused disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
9 days after receiving injection I awoke with red rash (like hives) extending approximately 1-3 inches around the injection site.  The area was warm to the touch but not painful.  The day before the rash appeared I noticed the muscle appeared slightly larger and firmer than that of the uninjected arm.  I showed the rash to my primary care physician, who asked me to tell her if it spread, in case it was an infection.  The next day (today) it has not spread, and appears to be slightly less red.  Doctor has advised me that she has now seen another patient with a similar apparent delayed reaction to the Moderna COVID-19 vaccine, and suggests I report it.
Sore arm with first 3 injections; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm with first 3 injections) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with first 3 injections). At the time of the report, PAIN IN EXTREMITY (Sore arm with first 3 injections) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2022-650769 (Patient Link).   Reporter did not allow further contact
72-year-old female with insignificant past medical history here as a transfer from outside facility. Patient went in for 2 days of worsening fatigue and some mild urinary incontinence. She was found to be positive for COVID19 infection was found to have a new frontal brain mass with large amount of vasogenic edema. Was transferred here for higher level of care. Patient denies recent fevers, chills, chest pain, shortness of breath, cough, abdominal pain, nausea, vomiting, diarrhea, dysuria, blood in her urine. Ambulatory. 8/23/22- Pt feels well. Deneis CP, SOB or dizziness. MRI completed and reviewed. Per neurosurg, pt cleared for discharge on decadron and keppra and to follow up with them OP for elective surgery in 2 weeks. Pt to f/u with pcp and specialists and continue current medication regimen.
Pt. complained of an itchy throat, initially. Spoke to medical doctor about - gave 50mg BENADRYL PO and .3mg epi 30 min later.
8/14 pt. received Tdap & IPV in right deltoid, varicella right arm.  Developed large area of erythema, pain, swelling, pruritus on 8/15.
This case involves a 17-year-old female patient who was vaccinated with a second dose of MENACTRA (Batch number: U5835AB, expiry date was not reported), in deltoid left via intramuscular route on 31-Aug-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): BACTRIM Allergy. The patient's concomitant medications were not reported. On 5-Sep-2017, five day following the vaccination, the patient experienced pain lifting the left arm in which had the injection. The patient had received first dose of MENACTRA on an unknown date. The patient required ER visit. The patient's laboratory data and corrective treatment were not reported. The patient was not recovered from event. List of documents held by sender: none.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 16-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II recombinant human albumin (rHA) status (lot# L009213, expiration date, dose, anatomical location and route of administration were not reported). On 16-NOV-2015, the patient was vaccinated with another improperly stored dose of M-M-R II recombinant human albumin (rHA) status (lot# L009213, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because of the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected, as no further information was available.
Slight fever; I have been checking my temperature and it is like 99.5; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 61-years), on 09Feb2021 as dose 1, single for COVID-19 immunization. Medical history included high blood pressure and diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported. On 10Feb2021, the patient experienced slight fever; i have been checking my temperature and it is like 99.5. The patient stated, I was calling because I had the Covid vaccine, the Pfizer shot, the first shot on Monday and today I have a slight fever so, I am trying to figure out, should I just take Tylenol or what should I do. She stated that I am a social worker. She stated for the lot number that E and then it looks like a M9309. She stated about expiration date that I do not know, it does not say. She stated about date of vaccination, 09Feb. She stated about start date that this evening and was not clarified further. She further stated that I have been checking my temperature and it is like 99.5. She stated about treatment that I took the Tylenol and I am eating ice chips. The treatment was received for the adverse event with drug Tylenol. The patient underwent lab tests and procedures which included body temperature: 99.5 on an unspecified date noted as slight fever. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Patient became pale, diaphoretic, nauseous, and hypotensive. 0.3 mg of epinephrine administered, ambulance called; patient transported via ambulance to ER.
This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with PEDVAXHIB, intramuscular. Route, dose, dose number, frequency and lot number were not reported. The nurse reported that improperly stored PEDVAXHIB may have been administered to unspecified patients. PEDVAXHIB was exposed to temperatures of 31.5F for 4 hours and 31.5F for 1.5 hours. No adverse effects were reported. This case is linked to 1308USA014798, 1309USA013283 and 1309USA013284 (same reporter link). Additional information is expected.
passed out; convulsions; Her HCP said not to get the second dose.; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 10Jun2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the Pfizer covid 19 vaccine and had complications. She passed out and had convulsions on an unspecified date. The patient stated her HCP said not to get the second dose. The patient asked what she could do going forward with that and about her vaccination card. The patient disconnected before agent could ask caller demographics and phone number. Outcome of the events was unknown.
Vertigo, tinnitus, dizziness, faint, fatigue, ache, swelling, anxiety, depression, irritation, unusual period, heart palpitations.
irritated; puffy; red; hot; swollen; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (irritated), SKIN SWELLING (puffy), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and SWELLING (swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SKIN IRRITATION (irritated), SKIN SWELLING (puffy), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and SWELLING (swollen). At the time of the report, SKIN IRRITATION (irritated), SKIN SWELLING (puffy), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.