chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient (36-year-old male, , first dose in left arm, Pfizer Lot # EW0162, expiration date 04/18/2021) was vaccinated by RN at 1453. Patient arrived alert and oriented x3, answered "no" to all screening questions, and revealed to nurse that he had a fear of needles. Nurse then offered to vaccinate patient in the zero gravity chair, patient refused stating that it would be embarassing. Patient also stated if he looked away from the needle, he would be fine. Patient received the vaccine in his left arm, nurse directed patient to sit in the front of the observation area by the EMT table, patient agreed. Patient was alert and oriented when leaving vaccine station #3. When patient made his way to the front of the EMT station to have a seat, he ended up falling at 1459. It is unclear if he loss consciousness and then fell or fell then loss consciousness. Lead RN was then alerted at 1500 by the lead ancillary, , who I ) instructed to call EMS. The recorded time of the EMS phone call is 1501. While waiting for EMS, I  attempted to rouse patient by calling his name and rubbing his sternum for several minutes and obtained a set of vitals. Vitals are as followed: BP: 119/76, O2: 100%, P: 59 taken at 1502. Patient exhibited eye movements when name was called repetitively and then patient opened his eyes at 1504 stating "Somebody just hit me", while attempting to gesture to the juncture where his neck met his skull. While patient was alert, he was oriented x1. Patient could not remember where he was, what had happened, or what day it was. Patient only remembered first and last name but could not remember his age. While speaking to patient, patient loss consciouness for a second time at 1505. Another set of vitals were obtained at 1506, BP: 104/80. After getting a reading of the blood pressure, patient suddently roused at 1508 and began erratically moving his arms and legs, attempting to stand while yelling out "Somebody just hit me! Get off me! Who are you?!" Patient insisted on getting up, RN  and I  assisted patient to transfer into the zero-gravity chair. EMS arrived at 1510 and assumed care of patient. Patient was continually yelling during EMS assessment. EMS left with patient at 1515, hospital ER unknown.
6MAR97 pt had febrile sz (grand mal) @ 730AM w/t102.5 that spiked rapidly;called 911 sent to ER;3PM had focal sz in peds office;815PM has been having focal sz since 6PM approx 5-10min;legs would give out & collapse, diarrhea, rash
Body aches, fever, nausea,  dizziness, weakness, tiredness, extreme flu-like symptoms
heart include flashes really bad which is; This is a spontaneous report from a contactable consumer. This consumer (Patient) of unspecified age and gender reported that the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number/Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient called because it said on form to relate any type of possible side effect, so they know that the patient had been kind of waiting in a doubt to see and then also figure out what was going on, it was been crazy busy here for the patient. So the patient had heart include flashes which was really bad. The patient wanted to know if that was a normal side effect or not. The outcome of event was unknown.
does not have tingling in her  tongue but loss of taste; hurting hands; Chills; Feels Weak; Feels the same as when she had Covid in Dec.; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 07Mar2021 as dose 1, single for COVID-19 immunization (age at vaccination: 50-years). Medical history included covid-19 from unspecific date in Dec2020 to Dec2020.There were no concomitant medications. On 08Mar2021 the patient reports" does not have tingling in her tongue but loss of taste, hurting hands, chills, feels weak, and feels the same as when she had covid in December. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report received on 20 April 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; received on 09 February 2009, 05 May 2009, 16 June 2009 and 20 April 2010 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 03 March 2012, approximately one year and ten months after the last dose. On 31 March 2012, the subject developed paroxysmal cough without whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 01 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin/penicillin starting on 12 March 2012 for 10 days. The subject was not hospitalized. At the time of final contact on 04 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 32 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Friday morning 6/3/05 client c/o numbness and tingling left arm. Went to work but numbness in all 4 extremities and neck by noon. Went to hospital. Admitted 6/3/05 and released 6/4/05 afternoon. Client has returned to pre vaccine condition. Information from medical records states viral syndrome, weakness. msv
RASH SPREADING, CRUSTING AND BLISTERING, FUSSY ESP AT NIGHT.
bump at the injection site; rash at the injection site; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed rash at injection site and bump at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed a rash and bump at the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events of rash at injection site and bump at injection site was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of unexpected Vaccination site mass and expected Injection site rash.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
pain on eye movement; high fever; joint/muscle ache; joint/muscle ache; headache; nausea; unable to sleep; shivered most of the night unable to feel warm; shivered most of the night unable to feel warm; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; This is a spontaneous report from a contactable physician (patient himself). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899), via intramuscular on 04Jan2021 11:45 at single dose in left arm for covid-19 immunization.  Medical history included allergies: allergy to certain sunblock. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (lot number EH9899) for covid-19 immunization on 18Dec2020 10:00 AM in left arm via intramuscular. The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 12hrs after second vaccine (05Jan2021), patient had high fever, and accompanying symptoms such as joint/muscle ache, headache, nausea. Fever was severe enough, patient was unable to sleep and shivered most of the night unable to feel warm, patient was also unable to check temperature due to status of severe symptoms. Upon waking in the early morning, fever was better, symptoms of headache/nausea/joint/muscle ache persisted rest of day. Fever was around 101 rest of day time. By second day (05Jan2021 12:00 am), fever subsided, residual mild headache and pain on eye movement remained for another day. Eye pain on movement persisted for 4 days after fever. The patient took ibuprofen 200mg for high fever, joint/muscle ache, headache. Events were assessed as non-serious. Outcome of these events were recovering.
Pt received two vaccine 1/31/17. HIGH DOSE INFLUENZA, right upper deltoid, IM. PCV-13, left upper deltoid, IM. Pt walked into clinic today and reported allergic reaction. Pt evaluated by provider. Pt reports tenderness, swelling, and warmth, RUD. Denies fever, chills, SOB. Pt had cataract surgery 2/1/17 the morning after injections given. Provider treated patient for cellulitis of right upper extremity. DYNAMEN 500 mg PO 4 times daily x 10.
This spontaneous report as received from a pharmacist refers to a 61 year old male patient without drug reactions or allergies. The patient's current conditions or medical history were not reported. On 13-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX (plaque forming units) 0.65 ml, subcutaneously (lot J011337, exp date 13-DEC-2014). Co suspect were not reported. Concomitant therapies included allopurinol and indomethacin. On an unspecified date in February 2014, the patient developed gout, and went to the pharmacy with prescription for prednisone and colchicine for the treatment of gout. At the time of the report the outcome for gout was unknown. The patient visited a physician for medical attention. Additional information has been requested.
About 9 hours after the vaccine, my arm was very sore at the site, I was experiencing  chills and shaking which lasted for about an hour; frequent bowel movements for about six hours with an upset stomach for up to 24 hours after the vaccine. About 24 hours after the vaccine I had an intermittent headache which lasted for about 12 hours, strong muscle aches across the top of my shoulders and neck for about two hours;  faintness which lasted about 1/2 hour and  one concurrent episode of strong sweating where I soaked parts of my shirt that lasted 5 minutes. Exhaustion lasted for about 24 hours after the vaccine.
Day after vaccine a red rash about 4 inches long and 3 inches wide appear around the injection site.  Itchy was warm to touch. Vaccine given on Friday - today is Tuesday rash still present.
a reaction to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction to the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (a reaction to the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Severe muscle pain Severe chills Fever Tiredness  Headache  Nausea  Injection site pain
This spontaneous report as received from a consumer a 31 year old female patient with seasonal allergies. Medical history was not reported and no pertinent medical history. On 19-JUN-2013, the patient was vaccinated with VARIVAX (Merck) injection (dose, frequency, route and lot number were not reported).  There were no concomitant medications. The patient reported that she was pregnant (5 weeks). Estimated LMP 15-MAY-2013 and EDD of 19-FEB-2014. Blood work was performed (results unspecified). The patient sought medical attention, spoke with the physician. No adverse effects reported. The patient did not receive treatment. The pregnancy outcome was unknown. Additional information has been requested.
I was sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I was sick) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick). At the time of the report, ILLNESS (I was sick) outcome was unknown.            Patient reported was sick for nearly week after the injection.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-627434, MOD-2022-611803 (Patient Link).
PATIENTS ARM IS RED, SWOLLEN AND HOT TO THE TOUCH. AREA AROUND INJECTION SITE AFFECTED IS ABOUT 2 INCHES IN DIAMETER.
MODERNA COVID-19 VACCINE EUA Vaccine administered at 3:00 Pm. At about 7:00 PM I started to notice my left arm hurting a bit and my left arm was swollen from the injection site all the way to my wrist.  Swelling stopped right before the wrist.  The skin on my left arm appeared like a veiny red rash, not raised however.  I also started to get flushed with hot, red blotches all over my chest and face.  Symptoms increased in intensity and didn't seem to be resolving so I took two Benadryl at 9:00 PM.  After about 30 minutes the redness and flushing started to improve.  Arm pain increased greatly to the point that I could not sleep.  I took two Tylenol at 3:00 am and that took the edge off the pain.  By the morning , the redness and flushing disappeared from chest and face. Left arm is still swollen and painful as I write this at 12;39 PM on Wednesday 2/10/2021. I had called the doctor on 2/9 but did not get in touch with them until 2/10.  They told me to call 911 or go to ER if breathing issues.
Mild warmth (L) thigh 2-3 days after vaccines. Erythema and cluster tiny vesicles developed 9 days after vaccines given.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: This case reported by the pharmacist via GlaxoSmithKline website. The age at vaccination was not reported. In 2018, before the patient was able to get her 2nd dose of SHINGRIX, the patient had developed shingles. The call center representative, attempted to reach out to the healthcare professional to obtain additional details however, the healthcare professional was not available. The call center representative left message at pharmacy for a healthcare professional with  case number.
Death  9/9/08 Death certificate states COD as idiopathic seizure disorder.  8/5/08 Reviewed ER medical records of 6/12/2008. Records reveal patient found unresponsive, prone on her bed when parent went to awake for school.  Last seen at bedtime.  Pupils fixed & dilated, cyanotic & pale, incontinent of urine, developed pulmonary edema during resuscitation. Unable to resuscitate.
Information has been received from a registered nurse concerning a 6 year old male with no pertinent medical history and who has drug reactions/allergies to amoxicillin, who on 01-AUG-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck), (lot number not reported). There was no concomitant medication. On 30-SEP-2007, the patient presented with a rash and on 02-OCT-2007 was diagnosed with chickenpox. No lab diagnostics studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
PATIENT UPON RECEIVING VACCINE IMMEDIATELY PASSED OUT IN CHAIR; SHE SLID AND BUMPED HEAD SLIGHTLY AGAINST WALL. PATIENT WAS  OUT FOR ABOUT 30 SECONDS. UPON COMING TO, PATIENT WAS FINE. EMTS WERE CALLED TO EVALUATE PATIENT AND PATIENT WAS DEEMED OK AND LEFT WITH HER MOTHER WHO WAS WITH HER AT THE TIME. SHE HAD NO OTHER COMPLAINTS AND MOTHER HAD STATED PRIOR THAT THIS HAD HAPPENED IN PAST WITH OTHER VACCINES. PATIENT IS OTHERWISE OK AT THIS TIME AND WENT HOME WITH HER MOTHER; SHE IS TO CONTACT US AND MD IF ANY OTHER CONCERNS ARISE.
Narrative: Patient reports arm pain 02/10, resolved within 48 hours Other Relevant Hx: Symptoms: & arm pain Treatment:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 23-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Fatigue, chills, injection site pain, lethargic, called in sick at work
Patient came to counter and said she had rxn to vaccine from yesterday, defined swelling in entire upper arm down  to elbow and into shoulder. Hot to the touch, and painful.
Moderate redness at injection site; Slight swelling at injection site; Moderate itching at injection site; A spontaneous report was received from a consumer of unspecified age and gender, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced moderate itching, moderate redness, slight swelling at injection site.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On an unspecified date, approximately 7 day prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (lot number unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, seven days after the first dose of vaccine, the patient developed moderate redness, slight swelling and moderate itching at injection site. Treatment included diphenhydramine 50mg which helped. The patient's symptoms lasted about 48 hours.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events, moderate itching, moderate redness, slight swelling at injection site were considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient, who experienced events of moderate itching, moderate redness, slight swelling at injection site. The events occurred 7 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
clinic administered 65,000 doses of DTP to date; 1 of 21 pts who had adverse event recvd DTP/OPV; same evening had nausea, vomiting, local reaction, fever; tx included Phenergan & APAP suppositories; recovered;
Pt reported redness, soreness at site of injection & swelling from injection site almost to elbow (L) delt - injection site of PNEUMOVAX soreness later that night, swelling next morning.
High grade fever, chills, not eating. ER visit 01/26/2010, was given instrutions on how to mange a high fever that keeps coming back and sent home. Today 01/27/2010 is back to his PCP, no update yet on what doctor has said. Had no previous illness, and no one sick in home.
The next morning after my shot I felt sick. My symptoms included tiredness, headache, body aches, nausea, and I was extremely shakey. This lasted from the time I got up at 6am until about 3PM. I struggled to eat but once I did I started to feel better.
little pieces of steel found in the vials. Also said "flakes of rubber were found in one; three people died in; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (three people died) in a  patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (three people died in) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION (little pieces of steel found in the vials. Also said "flakes of rubber were found in one). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT CONTAMINATION (little pieces of steel found in the vials. Also said "flakes of rubber were found in one) had resolved.            Concomitant product was not provided by the reporter  Patient reported that that 3 people died after second dose of Moderna vaccine and stated it was not due to the vaccine but to the flakes of rubber and little pieces of steel found in the vaccine.  Treatment information was not provided  Action taken was not applicable.  Company comment This case concerns a patient of unknown age and gender who died after the second dose of the vaccine and also experienced non-serious event of product contamination. . Limited information. Dechallenge and rechallenge is unknown. The benefit-risk relationship is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender who died after the second dose of the vaccine and also experienced non-serious event of product contamination. . Limited information. Dechallenge and rechallenge is unknown. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Td was inadvertently given ID instead of PPD matoux; w/in 24 hrs 13NOV92; pt exp an inject site react which included blistering; required MD; 14NOV pt better; during the interval had fever of 99.2 & flu like sx; unk if tx was given;
I gave him the shot in the right arm after giving a Hepatitis A and BEXSERO in the L arm without incident. He said HPV hurt and he passes out immediately. He came to in 5 minutes but was not stable for 17-80 minutes. He recovered.