chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states she started experiencing a rapid heart beat (135bpm) the evening after she received the vaccination that lasted about 30 minutes, then subsided. Pt also states she continues to experience rapid heart rate 1 to 2 times daily for "a couple of minutes" and reports heart flutters as well. Pt states if she coughs hard, or hits her chest, she feels it helps the flutters.
Starting 01/13/2022, I got up and started my normal morning routine when I suddenly started to get lightheaded. I went back to bed and started getting very nauseous. I went to the bathroom and vomited. I went through the routine of dry heaving again. I called my PCP and spoke with a nurse. The nurse recommended I took a COVID test, and I explained to her I had COVID in December 2021, but she insisted you can get it twice. By the end of the day, I felt better (not lightheaded), but the next day I had the same episode. I called the doctor again and they told me to take the COVID test. IT was negative and I continued to sip Gatorade throughout the day. The doctor called me and said it was likely a reaction to the vaccine.
Inappropriate schedule of vaccine administered; This spontaneous report as received from a physician refers to a 6-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-DEC-2022, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On 20-FEB-2023, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of product administration).  This i one of two reports of the same patient.
Developed pruritic rash at injection site about 8 hours after vaccination ; subsequent spread to trunk. No other symptoms.
Soreness in injection site, surrounding muscle. Fever of 101 degrees F, chills, general body aches for about 24 hours.  Treated with Tylenol per vaccinator recommendation.  Arm soreness persisting into 2d day but fever resolved.
This spontaneous report as received from a currently (at the time of the report) 31 year old non pregnant female consumer via a company representative, refers to herself. The patient's relevant medical history was not reported. On 04-JAN-2008 the patient was vaccinated with a third dose of GARDASIL (intramuscular as per prescribing information, dose, lot # and expiration date were not reported). Information about the patient's concomitant medication was not reported. On an unknown date, after the patient's third dose of GARDASIL, the patient tested positive for an unspecified strain of HPV. On an unknown date, the patient underwent a procedure known as loop electrosurgical excision procedure as a treatment for the event. The patient's current status was unspecified regarding the diagnoses of HPV. The patient sought medical attention via visiting a physician (date unspecified). The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
patient went ahead and got a second dose somewhere else a week later after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient went ahead and got a second dose somewhere else a week later after first dose) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient went ahead and got a second dose somewhere else a week later after first dose). In May 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient went ahead and got a second dose somewhere else a week later after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  The patient was supposed to have the second dose on 02-Jun-2021.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Father states that son has hives due to the injection.-Mild
body aches; Stomach aches; 7 to 10 reddish brown pea sized spots; This spontaneous case was reported by a consumer and describes the occurrence of RASH (7 to 10 reddish brown pea sized spots), PAIN (body aches) and ABDOMINAL PAIN UPPER (Stomach aches) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (7 to 10 reddish brown pea sized spots). On an unknown date, the patient experienced PAIN (body aches) and ABDOMINAL PAIN UPPER (Stomach aches). At the time of the report, RASH (7 to 10 reddish brown pea sized spots) outcome was unknown and PAIN (body aches) and ABDOMINAL PAIN UPPER (Stomach aches) had resolved.            No concomitant medication was not reported. No treatment medication was not reported
She felt feverish later in the evening after receiving her vaccination, but this resolved. At approximately 2300-000 that night she had an "extreme headache" lasting  approximately one hour. She took Tylenol with little relief. She states at the time of the headache, she immediately experienced numbness from her left temple to her chin that has not resolved. She continues to experience pressure, tingling, and a loss of taste on the left side only. She denies facial drooping, difficulty swallowing, changes in facial movements, or any other concerns.
Intense non stop high pitched crying for 2 hrs. Fever of 101 F (R) 1st DTP, no hx of convulsions in pt or family.
pt recvd vax 10OCT95 & 11OCT95, pt devel an inj site rxn characterized by redness & swelling;no other details known as of the date of this report
WARM; ARM HURTS UPON TOUCH; INJECTION SITE PAIN; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 10-MAR-2021in left arm for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced warm. On MAR-2021, the subject experienced arm hurts upon touch. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm hurts upon touch, and injection site pain, and the outcome of injection site redness and warm was not reported. This report was non-serious.
shingles; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 24Feb2021 (Lot Number: EN6201) as single for COVID-19 immunization. Medical history included hypertension and known allergies: sulpha from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide taken for hypertension; lisinopril; calcium carbonate, colecalciferol (VITAMIN D); calcium; cyanocobalamin (B12) and unspecified multivitamin; start and stop date of all medications were not reported. The patient has not received other vaccine in four weeks. The patient experienced shingles on 18Mar2021 with outcome of recovering. Therapeutic measures include gabapentin. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of covid prior vaccination. The patient has not been tested for covid post vaccination.  No follow-up attempts are needed. No further information is expected.
After four days from receiving first dose burning pain feeling in chest what felt like really bad heartburn lasting for hours at a time and eventually went away after some rest later in the evening. Had another burning feeling two days after but mild and went away quickly. No other symptoms so far.
On Thursday last week my boss tested positive with Covid. I had been around him so I took a test that was negative. Saturday woke up feeling crummy with a sore throat and headache. I ended up taking a test again and it was positive. My symptoms have been mostly those consistent with a head cold and not really present or giving me issues in my lungs.
Severe neck and shoulder pain.  Limited movement of arms, not able to put above the head.
Individual administering the vaccine shot placed it too high causing an instant stiff neck on the side of the injections and a slight headache. Later that day, I had a bruise and a stiff arm. Injections was administered in the Left Arm Joint and not in the Muscle, causing symptoms listed above.
ARM FELT LIKE DEAD LEG; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm felt like dead leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm felt like dead leg was not reported. This report was non-serious.
Patient presented to the ED after a mechanical fall resulting in left hip pain. She was found to have a fracture and underwent a left hip hemiarthroplasty. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
nausea; Vomiting; This is a spontaneous report from a contactable other health professional (also reported as a consumer; patient); via specialty pharmacy. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN 5 mg/ml), intravenously from 10Mar2017 (Batch/Lot number was not reported) to an unspecified date, at 0.094 ug/kg, continuous for primary pulmonary arterial hypertension.  Medical history included primary pulmonary arterial hypertension from an unknown date and unknown if ongoing. Concomitant medications included macitentan (OPSUMIT) taken for an unspecified indication, start and stop date were not reported. On 21Mar2021, the patient experienced nausea and vomiting.  The patient was hospitalized for nausea and vomiting from 21Mar2021 to an unknown date. The patient began therapy with treprostinil sodium (REMODULIN, concentration of 5 mg/ml), on 10Mar2017 for primary pulmonary arterial hypertension. The current dose was reported as 0.094 ug/kg, continuous via intravenous (IV) route. On 21Mar2021, the patient was hospitalized due to nausea and vomiting after getting the COVID vaccine. The action taken in response to the events for treprostinil sodium was unknown. The clinical outcome of the events was unknown. The reporter did not provide causality for the events of nausea and vomiting.  Case Comment/Senders Comment: The company has assessed the serious adverse events of nausea and vomiting as possibly related to IV treprostinil based on the known safety profile of the suspect drug even though there was a lack of temporal relationship. The events could also have been caused by the recent administration of the COVID vaccine.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of nausea and vomiting due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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, and Investigators, as appropriate.
Patient presented to medical clinic for his scheduled second dose of vaccine. Vaccine administered was the expired vaccine that was not pulled from the vaccine fridge after Saturday clinic on 10/8/22. Dose was expired by 4 days. Manufacturer instructed clinic to administer a third dose as soon as possible. Patient still deciding if he wants a third dose. Patient had no adverse reactions to expired second dose. Patient was instructed to call if he experienced and adverse events or side effects. Patient has been in several times since that administration and has had no side effects.
I had the vaccine and got the shingles within a year/suspected vaccination failure; I had the vaccine and got the shingles within a year; they hurt; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient had the vaccine and got the shingles within a year. The patient was shocked and stated that they hurt. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
At 1535 nurses in observation noted that patient was itching.  Pt reported she had long-standing untreated hypertension and did not take medication for it.  Pt reported anaphylaxis to PCN in the past.  Pt reported itching in arm and throat.  No respiratory distress noted at this time.  VS: 170/147,  103, 98%, 16.  Pt reports 170-200 systolic is baseline BP and that she did not feel sick or any other symptoms at this time.  Pt declined any emergency services to be called at this time.  Continued to monitor patient closely.  No further escalation of itching or other sx's were reported.  Vitals taken again at 1600 before patient was released from 30 min observation time. VS: 173/118, 91, 100%, 16.  Pt was educated on blood pressure management and encouraged to follow up with PCP.  No further adverse effects noted. Pt remained in the facility until staff departure at 1645.
THE VACCINE EXPIRED ON 10/03/2021 AND WAS GIVEN ON 10/07/2021
Patient presents to ED and reports that for the past 3 weeks he has progressive shortness of breath
Patient noted low back pain - over the course of weeks noted progressive lower extremity weakness associated with the low back pain which radiates to legs and across buttocks. 11/11/13 - numbness sensation in hands. Admitted to hospital 11/11/13 - 11/21/13. Re-admitted 11/27/13 - 12/4/13. Treated with plasmapheresis x 5 during first hosp stay. Treated with same x 5 during second hosp. stay.
administered infanrix after a temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.    Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Infanrix vaccine after a temperature excursion in right arm. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Infanrix vaccine after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093640:Same patient, same reporter, different product US-GLAXOSMITHKLINE-US2022093600:Same reporter US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter.
Pt exp feeling light headed. Nurse checked pt b/p 59/39 pallor lips bluish skin dry;resp ok;laid on exam table-ate crackers-pt stated had not had breakfast; pt was better after 10 minutes.
Low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 26Sep2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (It's the same number for the first and the second FF2588), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Low grade fever".  No follow-up attempts are possible. No further information is expected.
rash on torso and arm. went to urgent care on 8/21/19. Prescribed prednisone 20mg - 2 tabs daily for 5 days
Bells palsy; Pregnancy; A spontaneous report was received from a physician, who was also a 32-year-old female patient who received Moderna's COVID-19 vaccine (mRNA- 1273) during pregnancy and the patient has been diagnosed with Bell's palsy after delivery.  The patient's medical history included exercise induced asthma. Products known to have been used by the patient, within two weeks prior to the event, included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide and omeprazole.  On 23 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) for the prophylaxis of COVID-19 infection. On 20 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) for the prophylaxis of COVID-19 infection.  On an unknown date, an ultrasound and quad screen (levels of alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), estriol and inhibin A in pregnant women's blood) were performed, and the results were normal. There were no complications during the pregnancy.  On 01 Feb 2021, the patient delivered the baby. No other delivery or infant details were reported.   On 10 Feb 2021, the patient was diagnosed with Bell's palsy. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the reported event, Bell's Palsy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A patient received an improperly stored PNEUMOVAX 23; Information has been received from a certified medical assistant, concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, previously drug reactions, allergies and concomitant medications were not reported.   On 15-AUG-2019, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number R025297 with expiration date on 08-JUN-2020 (strength, dose number, anatomical location and route of administration were not provided), for prophylaxis.   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 9 degrees Fahrenheit (°F) for the time frame of 5 days. There was no previous temperature excursion and the call was because of a data logger.
On May 4th, I woke with pain and stiffness in the joints of my fingers on both hands.  No swelling or redness.  The pain persists throughout the day but is worse in the mornings.  It is slowly improving, but I still  have stiffness and pain.
SOB, cough, pneumonitis. Was admitted and was in critical care for 8 days.
been sick as a dog; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and gender patient who had been sick as a dog after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, formulation, Expiry date was not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious been sick as a dog, no more shots will go in my body (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.