chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, dose number series of 1, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that "a friend of mine had JJ vaccine he got covid and he died 3 month ago" (suspected clinical vaccination failure). On SEP-2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on SEP-2021, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000207827.; Sender's Comments: V0: 20211244971-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event 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. 20211244971-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Diagnosed as shingles; Was in so much pain / Right flank pain; Rash; Discoloration; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced skin discoloration. On 22nd July 2020, the patient experienced shingles, flank pain and rash. The patient was treated with prednisone, gabapentin and antivirals nos. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the flank pain was recovering/resolving and the outcome of the rash was recovered/resolved and the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the shingles, flank pain, rash and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was in so much pain she was taken to an emergency room facility to treat her for right flank pain and rash which was diagnosed as Shingles. The rash was gone but there was something was there described as discoloration and that her pain was a lot better but not gone in the right flank area of her back.  The patient was prescribed Gabapentin, Antiviral, and prednisone as treatment for the diagnosis of Shingles. The reporter consent to follow up.
At 11pm I started feeling chills and was having cold sweats. Around 1 am I went to  the next room to check my temperature and almost fainted. I sat on the floor and started vomiting. I kept gagging nonstop for several minutes. During that time I urinated on myself, I felt strong stomach aches, headache, and my body felt extremely fatigued.  I was dizzy and sweating. All these symptoms came back again a few minutes later. I do not remember how long everything lasted. I woke up the next day with a slightly upset stomach and headache.
Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down twice. Cannot stand or walk for longer than a couple of minutes unassisted (holding onto something) without breathing becoming shallow and dizziness setting in. Intermittent dizziness and inability to focus eyesight occurred throughout the day even if sitting down. Issues have been consistent throughout entire day. Not sure if this is adverse but also started having circulation issues in toes/fingers turning white & numb when either standing, walking or lying down. Experienced chills but only until ceiling fan was turned off. Circulation slightly improved except in feet.
Severe pain, including chest pain. I could feel it moving through my body from the injection site toward my chest. Then dizziness and severe vertigo for 4 days, including nausea, vomiting, fever and eye jerking.
About 18 hours after second shot, legs would not hold me so I had a very hard time walking and standing.; About 18 hours after second shot, legs would not hold me so I had a very hard time walking and standing; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 05Feb2021 10:15 as single dose for covid-19 immunisation at Doctor's office. Medical history included multiple sclerosis from 1995 to an unknown date (Multiple Sclerosis diagnosed 1995). Patient historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in Arm Left on 15Jan2021 10:30 AM as single dose for covid-19 immunisation at Doctor's office. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN] and gabapentin. On 06Feb2021 05:00, The patient reported about 18 hours after second shot, legs would not hold me so i had a very hard time walking and standing. Overall weakness in entire body. It took 12 hours to feel stronger and be able to walk correctly. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovered.
Patient's daughter called on 10/3/19@3:30PM reporting that her mother is having the red rash on the right hand and inside of right wrist. Patient was asking if that is the reaction to one of the vaccine that the patient was received on 10/2/19 (shingrix given on LA and fluzone HD on RA). Daughter was advised to contact PCP.   10/3/19 @ 3:37PM - (pharmacy intern) contacted Dr. and left a message.  10/3/19 @349PM - pharmacist talked to the caregiver about the rash on the right knuckle no rash at the injection site.
I had a sore throat and body aches over night that went away the next morning. My symptoms were mild. I also had an irritating cough. I took PAXLOVID and NYQUIL. My wife had tested positive so I tested and was negative at first, then a day later became positive. Then tested negative some days after.
Around 12 hours after my injection I began experiencing fever, chills, and heart palpitations. These symptoms lasted about 24 hours.
SYNCOPE; HYPOTENSION; This spontaneous report received from an other health care professional (nurse) concerned a 45 year old white not Hispanic male. This report was received from news/social media. 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, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The patient was administered vaccine from an outdoor vaccination site with outdoor temperature around 70-80 degrees. No concomitant medications were reported.  On an unspecified date APR-2021, the patient experienced syncope and hypotension, and was hospitalized (date unspecified). The patient was treated with unspecified fluid. The patient was discharged on an unknown date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, and hypotension on APR-2021. This report was serious (Hospitalization Caused/Prolonged). This case, from the same reporter is linked to 20210415566 (master case); Sender's Comments: V0: 20210441626-covid-19 vaccine ad26.cov2.s-syncope, hypotension. 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).
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 the 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 24-Aug-18, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot # R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The sterile diluent (MERCK) (lot # and expiration date were unknown) was properly stored. 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-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
This spontaneous report was received from a licensed practical nurse and refers to a 4-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-AUG-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Pt felt anxious, had whole body aches; also had swelling and discomfort on Right arm at injection site of Pneumovax.
worse headache; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and HEADACHE (worse headache) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (headache). On 20-Feb-2021, the patient experienced HEADACHE (worse headache). On 16-Feb-2021, HEADACHE (headache) had resolved. On 22-Feb-2021, HEADACHE (worse headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Client called Health center on 6/3/09 2:20 PM to report flushing, palpitations. Had 2-3 episodes of palpitations and flushing. Vaccination for Typhoid given a day before. Pt told to follow up with Hospital ER. If it continued. Pt has no physician. Pt called again at 6pm. No report she wasn't feeling any better. Told to call an ambulance.
increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes; This is a spontaneous report from a contactable consumer (patient sister). A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration, on 30Dec2020 13:00 at single dose in right arm for covid-19 immunization. The patient medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. It was reported that the patient had reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine. Lastly, she had reported that other coworkers have reported the same increase in temperature sensitivity in their extremities. No treatment was received.  The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her third dose of GARDASIL (lot# 654272/0073X). Subsequently the patient experienced excruciating pain in the right arm and turned all white. Patient had no problems after the first and second dose of GARDASIL. The patient's outcome was not reported and she sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
24-48 hours after vaccine, patient develops redness, swelling at site, moderate induration, slightly tenter.  4 x 6 cm.  Ibuprofen and warm compress.
Extreme Nausea  Headache Chills Joint pain Lethargy  Flu like symptoms
15hr p/vax pt had 20min sz activity;diff breathing, ?fever (felt warm), adm to ICU-all test negative;
T103 p/MN fever on 14APR & 15APR92; red arms, vomited x 1 on 14APR; voited x 2 15APR92; diarrhea x 2;
lightheaded; dizzy when standing; falls down; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), DIZZINESS POSTURAL (dizzy when standing) and FALL (falls down) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheaded), DIZZINESS POSTURAL (dizzy when standing) and FALL (falls down). At the time of the report, DIZZINESS (lightheaded), DIZZINESS POSTURAL (dizzy when standing) and FALL (falls down) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received, contains reporters contact details and outcome for events as recovered.
Headache, Diarrhea, backache, headache, diarrhea,dizzy Narrative:
HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Cellulitis in left buttock; Abscess on buttock; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4247306-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for colitis ulcerative. Relevant medical history included: "Lump on left buttock" (unspecified if ongoing). The patient took concomitant medications with antibiotics. The following information was reported: CELLULITIS (medically significant), outcome "not recovered", described as "Cellulitis in left buttock"; ABSCESS LIMB (non-serious), outcome "not recovered", described as "Abscess on buttock". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Abscess and cellulitis in left buttock/patient on antibiotics unknown onset and Abscess and cellulitis in left buttock/patient on antibiotics unknown onset was not provided. Causality for Pfizer BioNTech Covid-19 vaccine: The reporter's causality for the event Abscess on buttock (Abscess limb) and cellulitis was reported as possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Cellulitis and Abscess limb. 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
Chief Complaint  co illness x 5-6 days with shortness of breath and increasing weakness. negative home covid test 3 days ago. arrives tachypneic, in RD, with O2 54% on RA. history per pt son. History of Present Illness Patient is a 74-year-old male presents to the ER complaining of shortness of breath which started 5-6 days ago.  He took an in-home COVID test 3 days ago was negative.  He tells me had 2 doses of earlier this year  and had the pfizer booster 9-30-21.  In the ED tested positive for COVID.  In triage, patient's room air O2 sat was 54% on room.  He denies any fever chills or any known lung disease.  He says he is a nonsmoker takes no medications and has no cough past medical problems that he is awa
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates during the past year, unspecified patients were administered unspecified doses of various vaccines which might have been exposed to unsupportable warm temperature excursions. The vaccines were as follow: GARDASIL (lot number H012643, expiry date ??-MAR-2015 ; lot number 670050/1229AA, expiry date 12-NOV-2013; lot number 672652/0022AE, expiry date 28-SEP-2014 ;lot number 0459AE, expiry date 13-DEC-2014; lot number H009746, expiry date 11-JAN-2015; lot number H010649, expiry date ??-FEB-2015; lot number H013977, expiry date 19-MAR-2015), RECOMBIVAX HB (lot number H014132, expiry date 08-FEB-2015; lot number 670232/1259AA, expiry date 19-DEC-2013; lot number 670943/1260AA, expiry date 27-MAR-2014; lot number 1740AA, expiry date 07-JUN-2014; lot number reported as 1294AE, expiry date 07-SEP-2014; lot number reported as 0384AA, expiry date 02-NOV-2014; lot number 0385AE, expiry date 08-NOV-2014; lot number H01432, expiry date ??-FEB-2014), VAQTA (lot number H010145, expiry date ??-FEB-2015; lot number 671931/1168AA, expiry date 15-JUN-2014 ; lot number 672274/1442AA, expiry date 06-AUG-2014; lot number reported as 0109AE, expiry date 21-OCT-2014; lot number reported as 05358AE, expiry date 24-JAN-2015; lot number 0273AE, expiry date 06-DEC-2014; lot number H010437, expiry date ??-FEB-2015), ROTATEQ (lot number H012981, expiry date ??-FEB-2014; lot number 671575/1350AAm expiry date 27-MAY-2013; lot number 671982/1693AA, expiry date 29-JUN-2013; lot number 1807AA, expiry date 29-AUG-2013; lot number 0208AE, expiry date 27-SEP-2013; lot number 0576AE, expiry date 25-OCT-2013; lot number H011443, expiry date 15-NOV-2015; lot number H015680, expiry date ??-FEB-2014), M-M-R II (lot number H012572, expiry date ??-JUN-2014; lot number 671320/1121AA, expiry date 12-JUL-2013; lot number 1449AA, expiry date 13-SEP-2013; lot number 1769AA, expiry date 10-NOV-2013; lot number 0233AE, expiry date 26-JAN-2014, lot number 0683AE, expiry date 02-APR-2014; lot number reported as H009781, expiry date 15-MAY-2014; lot number H01032, expiry date 20-MAY-2014) and (merck) VARIVAX (lot number H018449, expiry date ??-OCT-2014; lot number 1059AA, expiry date 05-JUL-2013; lot number reported as 1059AA, expiry date 05-JUL-2013; lot number 1274AA, expiry date 05-AUG-2013; lot number H007702, expiry date 30-MAR-2014; lot number H017705, expiry date 25-SEP-2014). It was unknown at this point if any patient received more than one dose of any of these vaccines. No adverse effect reported. it was unspecified if the patients had sought medical attention. Additional information has been requested.
Two vaccines IPV and DTaP given on the left thigh on 7/30/07. 8/1/07 Pt returned to clinic swelling from upper thigh to effusion through knee and below knee. Treatment Benadryl, Ibuprofen, Ice.
Pt. states that after receiving the 1st dose of Phizer 03/04/2021, started experiencing symptoms of left arm pain. MRI recommendation  02/28/2022 for follow-up.
I encountered patient casually 4 days post vaccination, and he recounted how he had fever and the "shakes" that evening after receiving the flu shot. He was ok the next day. He said, he had had a previous reaction such as this 2 years before, last year was ok. His consent had a "no" answer to the previous rx question. He did not call MD.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-OCT-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration date 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 56, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
There was no adverse event immediately following the injection. Instead, there was a general decline in health and well being beginning 3-4 months after vaccination. I suspect the vaccine contributed to a generalized Autoimmune response.
Temperature of 104.8 degrees for 8 full hours. Unable to get temperature to lower.