chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client  was seen by PCP on 10/9/2023 for initial medical exam. During exam client collected urine for HCG test, test results read negative. When getting ready to discard the pregnancy test it showed positive and minor had been administered all vaccines including live vaccines by PCP staff. PCP staff advised us of the incident.
Hard nodule around injection site, redness, itching, swelling, under arm lymph node pain and swelling
Information has been received from a physician via a field employee referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unknown number of doses of GARDASIL (dose, strength, route, and lot# were not reported). On unknown dates the patients experienced chronic headaches. The outcome of the event was not reported. The causality was not reported. This is one of several cases from the same reporter. Additional information has been requested.
The pt experienced induration, erythema, pain, and heat in the right deltoid area. Treated with dicloxocillin.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 30-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Allergic urticaria, swollen throat, hands, feet, face, hives, fever 5 days. Clinic on 10/20, 10/21/2012. Diphendyramine 25mg, Prednisone 10mg 10 days. 10/23/12 Dr. injection BENADRYL.
Mom reports patient's eyes started crossing within an hour of receiving vaccine. She was seen in ED the next day and by ophthalmology on 5/11. They were concerned for papilledema so she was admitted to hospital, had MRI and LP. Dx pseudopapilledema.
Spondylitis ankylosing aggravated; Pressure in limbs; Leg pain/leg achy; Chills; Headache; Fatigue;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4161789-00 (RA).  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (TOZINAMERAN), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single and intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing aggravated"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Pressure in limbs"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Leg pain/leg achy"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue". The action taken for adalimumab was dosage not changed.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of ankylosing spondylitis flare up with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of pressure in legs and leg achy was not provided. The reporter's causality for the event(s) of chills, headache and fatigue with Humira (adalimumab) was no reasonable possibility.  Causality for BNT162B2 (TOZINAMERAN): The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out.  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.
pt recvd vax & exp red cellulitis following vax; treated w/DPH/ice pack; pt recovered;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, the patient did not received other medications in two weeks. The patient received Paxlovid on 19Jul2022 to 24Jul2022 for treatment of COVID-19. Known allergies oral Sulfa and other medical history none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Started on 11/5/15 left arm weakness with throbbing. Denies loss of ROM, denies tingling and numbness in fingers. No redness or swelling at injection site. Did not seek medical care for. Also had flu-like symptoms start on this date too of diarrhea, nausea, stomach cramps, vertigo, headache. Encourage to see PCP or walk in clinic if weakness in arm persists. Told to use warm pack and ice as needed take TYLENOL or ibuprofen if needed. Avoid laying on (L) arm.
Admitted to hospital on 2/24/15 sepsis.  Varicella verified on PCR with subsequent progressive multi-organ failure. Autopsy:  Cause of death 3/5/15  disseminated varicella - final histology pending as of 4/6/15.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/12/21 2nd dose02/03/21 Diagnosed covid positive:08/25/21 Symptom onset:08/24/21 Exposure Symptoms:fever, chills.
HAD BELLS PALSY 8 YEARS AGO MODERNA VACCINE 1ST DOSE 2/12/2021 3/6/2021 HAD TINGLING LIP THAT PROGRESSED TO DROOPING FACE AND EYE TO CENTER ON 3/8/2021 AND RECIEVED PRED PACK AND ACYCLOVAIR
With both dose # 1 and dose #2 I got deep fatigue, headaches, nausea, body aches , and some chills.
Rash under both arms after second dose. Started the day of the vaccine and went away by 5/9. Was not painful or itchy for patient.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (lot number and expiry date unknown0 (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. This is one of the many reports from the same source. Additional information has been requested.
Information has been received from a physician concerning a 16 year old female with no reported medical history who on 09-MAR-2007 was vaccinated with Gardasil intramuscularly. There was no concomitant medication. On 09-MAR-2007 the patient experienced a pale face. Subsequently, the patient recovered from pale face. Additional information has been requested.
Severe headache, severe nausea to almost vomiting, severe diarrhea, inability to eat, exhaustion, dizziness/lightheadedness, inability to lie on or touch the injection site (right upper arm), fever up to 103 for extended period of time, fever over 101 for 2+ days now, body and bone aches and pain.
Patient is a 19-year-old, who reports to urgent care with complaint of left-sided facial paralysis. Reports he feels like his face is tight. Noticed yesterday that he could not puff out his cheek on the left side and his left ear was sensitive to sound. Reports that he received his first Covid vaccination  7 days ago. Denies any stressors, illness, sick contacts.
No adverse event; was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.; was accidentally given 6 yr old dose of 0.5mL; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.), INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 15-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Oct-2022, the patient experienced ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.) and INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.), INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.) and INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL).    No concomitant medication were reported.   Reporter stated that they had a 15-month-old patient here on Monday (24Oct2022) that was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.      No treatment information was provided by the reporter.
pt was 8 years old at time vaccine was given. Wrong formulation was given. No symptoms were reported
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received Paxlovid, treatment from 03Jul2022 to 08Jul2022 for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Bell's Palsy-Medium, Additional Details: Wife reported Paralysis of left side of face, watery left eye and left side of mouth.
This spontaneous report was received from a licensed practical nurse, concerning a 23-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse symptoms or further information was provided. Additional information has been requested.
HCP calling to report administration of ROTATEQ during temperature excursion on 7/14/22; This spontaneous report has been received from a nurse, regarding a 4-months-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-JUL-2022, the patient was vaccinated with an improperly storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml orally, 3 doses every 4-10 week intervals, as prophylaxis (strength, lot number, and expiration date were not provided) (product storage error). Temperature and period of time of the temperature excursion were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005211: US-009507513-2207USA005319: US-009507513-2207USA005454:
Dizzy; Loopy; Body aches; Running a low grade fever; Woke up 2:30 am with chills; Muscle aches; Joint ache; Feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever) and CHILLS (Woke up 2:30 am with chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-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) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.6 f (Borderline) 99.6 F.         Concomitant product used was not provided by the reporter.   Treatment information was not provided by the reporter.
Patient received ZOSTAVAX on 10/24/13. She came in 10/26/13 and showed me her arm. Red, little swollen, hot to the touch - from injection site to elbow on her right arm. There was little white bump at injection site. I recommend she see a doctor. Suggested urgent care.
Tired, headache, body ache, blurred vision, arm itching. Body ache worsened when resting.
Shortness of breath and feeling of pressure on sternum began on the evening of Sunday, May 8th and continued through Monday May 9th. Went to clinic on Monday evening (5/9/21). Slightly elevated troponin levels detected (0.14 ng/mL) and waas subsequently transferred to Hospital. After 2 days of testing in cardiac unit final diagnosis was mycarditis with no determined cause.
Adverse Event Description: I developed an Eye infection around 01/26/2023 I had a lot of eye discharge. I saw the doctor on January 30, 2023. It appeared to be an infection of the right eye only with increased discharge at times. At times my eye felt sticky across the surface. The doctor looked at it with slit microscope treated it with TobraDex antibiotic drops. After 10 days all symptoms had dissolved.
COVID-19; Patient had one dose of J & J and one Moderna and no booster dose; Patient had one dose of J & J and one Moderna and no booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Patient had one dose of J & J and one Moderna and no booster dose) and COVID-19 IMMUNISATION (Patient had one dose of J & J and one Moderna and no booster dose) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Patient had one dose of J & J and one Moderna and no booster dose) and COVID-19 IMMUNISATION (Patient had one dose of J & J and one Moderna and no booster dose). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Patient had one dose of J & J and one Moderna and no booster dose) and COVID-19 IMMUNISATION (Patient had one dose of J & J and one Moderna and no booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  Patient was experiencing the exact same rebound like patient's wife and the rebound symptoms were diarrhea, upper and lower colds.  Patient thought patient had just gotten post-covid colds until tested.  Device Date was reported as 10-Oct-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657738 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: The  live follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657738:MOD-2022-657738 - Wife's Case
10/4/21 2:48pm called patient, no answer left message to return call. Second dose not received yet per vaccine portal appointment on 9/1/21.  10/18/21 1:24 pm called patient, no answer left message to return call. Text message and email sent via vaccine portal.  12/23/21 10:34 am called patient, no answer left message to return call.
Arm was swollen and red.  Patient had chills, fever, nausea, vomiting, diarrhea.  Admitted to hospital and received steroids and antibiotics for severe inflammatory reaction.
whiteness on both hands, specifically on the fingers.; a sore arm down to her hand; This is a report from a Pfizer sponsored program received via a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 22Jun2021 (at the age of 15-year-old), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization .The patient's medical history and concomitant medications were not reported. After the vaccination, the patient experienced sore arm down to her hand and whiteness on both hands, specifically on the fingers on Jun2021. Reporter would like to know, what that is. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Got the shot and got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received shingles vaccine and still experienced shingles which are terrible. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pain and fever; Pain and fever; This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative.  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced pain and fever. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Diagnosed with shingles recently.; This is a spontaneous report from contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles (recently diagnosed, as reported) on an unspecified date. It was reported that "Had first pfizer covid shot. Due for 08Feb". Outcome of the event was unknown.     No follow-up attempts are possible; information about batch number cannot be obtained.