chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 6 month old male who on 03-MAY-2006 was vaccinated with MMR. Suspect vaccine administered on the same day included a third dose of PEDIARIX in the left arm and concomitant vaccine included Hib conj vaccine. Previous vaccinations included two doses of PEDIARIX administered on 04-JAN-2006 and 03-MAR-2006 respectively. On 03-MAY-2006, 5 hours after vaccination with PEDIARIX, the patient experienced twitching on his left side which the physician described as "drawing up head toward left". The event lasted for 10-15 minutes and then completely resolved. The patient was seen in the physician's office and was advised to take BENADRYL. The healthcare professional considered the events were a congenital anomaly. The following day, on 04-MAY-2007, the physician who didn't think this was seizure activity ordered an electroencephalogram (EEG) to rule out the possibility of seizure activity. The EEG result was normal. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. The reporter noted that when the patient received his MMR vaccine at 16 months old, he started twitching, wouldn't stand, became irritable, glassy eyed and extended his head away from his body 30 hours after receiving the vaccine. The symptoms resolved. The subject did not receive any additional vaccines that day, nor has he received any additional DTaP vaccines outside of the 3rd dose as part of PEDIARIX.
Narrative: The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt received 2nd dose Pfizer on 2/09/2021. Pt tested positive for covid on 3/26/2021. PT has a PMH significant for CHF, AF, smoker's cough, COPD, PVD, HTN. Per note ....."He presented to the ED on 3/26/21 after a mechanical fall. X-rays showed a comminuted right hip fracture. He was also found to be COVID positive on 3/26, although he has received doses of the COVID vaccine 1/20 and 2/9. He initially was oriented but has been acutely encephalopathic and unable to make decisions. He has been diagnosed with bacterial/aspiration PNA. He was receiving antibiotics initially. His daughters decided after multiple discussions about his poor prognosis to pursue comfort care including hospice placement and no surgery. They also asked for comfort feeds and to discontinue antibiotics. "
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 29-SEP-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2013, the patient was treated by a physician at a clinic for a severe vesicular outbreak, which was diagnosed as herpes zoster ophthalmicus. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, herpes zoster ophthalmicus was considered to be medically significant. Additional information has been requested.
Redness to back of arm evening of day given shot. Called Saturday to say site red, swollen, very warm about 4+ inches around injection site - injection dark red and a line from site. No fever. Sent to ER. Admitted on 6/29.
This case was reported by a nurse via sales rep and described the occurrence of injury in a female health care professional wit ROTARIX lyophilized formulation (batch number A41CB558A, expiry date unknown). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced injury, inadvertent exposure to vaccine and pharmaceutical product complaint. On an unknown date, the outcome of the injury, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injury to be related to ROTARIX lyophilized formulation. Additional details were reported as follows: The age at vaccination was not applicable for this report. The vial cap of ROTARIX lyophilized formulation popped off which then broke and lead to cutting self (injury) and was exposed to vaccine which led to inadvertent exposure to vaccine. It was reported that, the pressure related issue occurred more than once as the altitude was 5000 feet (exploding issues). No side effects were reported. The expiry date of vaccine and the date of birth of the patient were not reported. This case was one of the 4 cases reported by the same reporter.
Initial report received from a consumer, the mother of a patient on 15/Oct/2005. The mother reported that her 11 year old daughter developed itchy red raised spots on the front and back of her torso and neck two days after receiving the injection of Fluzone (lot number not reported) in the deltoid on 11/Oct/2005. The spots were not on the patient's face or extremities. She had no fever and no other symptoms. The physician prescribed Benadryl. The patient also had just started on a cream for a patch of eczema on 11/Oct/2005. At the time of this report the patient had not recovered.
black bump on the injection site; his legs are itching (burning); his legs are itching (burning); This is a spontaneous report from a contactable consumer (patient's daughter) received from Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported) on 29Jan2021 for COVID-19 immunisation. The patient experienced black bump on the injection site, his legs were itching (burning) on Feb2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
this is technically not a adverse event per vaccine , my boss wanted me to report this, the patient wanted a flulaval vaccine and i made an error and gave her at first a twinrix vaccine, after realizing the problem, I gave her the flulaval she really wanted.  The incident happened like 2 hours ago, as of right now she does not have any adverse problems from the wrong vaccine given
This spontaneous report as received from a medical assistant refers to 11 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Fever, local reaction - swelling, malaise -> redness at injection site with swelling. Chills with fever. Seen office - 11/1/2010. Clear lungs and no swelling to tongue.
Got sick on 2021-6-12. Sore throat, cough, exhausted after climbing stairs, sneezing blood.  My temperature was normal when i measured it every day 36.5-37 deg. Celsius.   Saw a doctor on 2021-6-21 when my eyes went bloodshot the prior day.  They prescribed antibiotic eye drops.  Saw a different doctor 2021-6-22 who prescribed antibiotic pills. They worked very well and everything seemed fine.  After several days of symptoms returning (sore throat etc?) i went back to the second doctor (2021-7-11) and was prescribed more antibiotics. These ones appear to have cleared the symptoms up entirely (fingers crossed).
12 hours after a FULL 3rd dose (not booster) I became severely ill for approximately 8hrs. Severe sweating, mild fever (100) and just a horrible feeling of being. Came very close to going to the E.R. After about 8hrs sickness subsided and I was tired but fine! Never had any other problems! Again I was severely ill, laid in a chair and moaned and moaned, probably one of the sicker times I?ve ever experienced.
The day after immunization, wife of patient called pharamcy to inquire about swollen, hot, painful tissue area of uppper arm where immunization given.  Recommended call physician to rule out cellulitis.  Patient visited Dr. that day & Dr. recommended Tylenol as treatment.  The following day, arm turned red in color and patient returned to Dr. and received Augmentin prescription for cellulitis.  Patient started today 2-16-04.
2 hrs of unconsolable, high pitch screaming, 3 hrs p/vax given;
Patient began complaining of dizziness after first moderna vaccination and became diaphoretic, warm, and unresponsive for  1 minute. Patient was then laid down in cot, head down and lower extremities held up. Vitals were taken, patient became responsive, stating he was still weak. Patient remained in cot for 5 minutes. Patient slowly sat up taking sips of water stating he felt much better after 10 minutes. Patient stated this is normal occurrence with vaccines and blood draws. Advised patient to inform nurses of occurrence for second dose.   Vitals at 1350- BP 114/50, HR 58, O2: 96%, 1357: 112/63, HR 69, O2 96%, 1400: 114/72, HR 68, O2 99%.
8/17/99 afternoon, swelling, redness & blister first noticed today 6/17/99 given motrin;
28 years patient was given Fluzone HD in error/ no AE; 6 month pregnant patient inadvertently was given the Fluzone High-Dose in error/no AE; 28 years patient was given Fluzone HD/ no AE; Initial information received on 20-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 28 years old female patient who received 0.5 ml of dose INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ242AA expiry date 04-MAY-2020 via intramuscular route in the left deltoid on 20-Dec-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported 6 month pregnant patient inadvertently was given the Fluzone High-Dose in error/no AE occurred at 6 Months of pregnancyThe reported 28 years patient was given Fluzone HD/ no AE occurred at 6 Months of pregnancyThe reported 28 years patient was given Fluzone HD/ no AE occurred at 6 Months of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No past pregnancy was reported.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that vaccine was given to a 28 years old patient.  It was also a case of vaccine exposure during pregnancy. Fluzone High Dose was inadvertently given to a 6 month pregnant patient.  At the time of reporting, it was not reported if patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Itching bilateral forearms, then experienced palpitations. Paramedics called. Advised to take Benadryl by paramedics.
Rash started in afternoon. H1N1 vaccine given 11/3/09 0.5mL IM (L) deltoid patient is pregnant 17 wks 5 days at time of vaccination patient developed hive type rash on arm immunization administered in (L) deltoid. C/o sinus congestion headache rash spread to abdomen. Given Benadryl 50mg po q 6 hours prn.
Day after injection - swollen left hand  8 days after injection - injection site firm and red, about the diameter of a baseball
Lymph nodes was swollen; The whole side of the body hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph nodes was swollen"; PAIN (non-serious), outcome "unknown", described as "The whole side of the body hurt".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I don't really like how my body felt; Migraine headache; I was like tired and drowsy; I was like tired and drowsy; This is a spontaneous report received from a contactable consumer or other non hcp (patient, self-reporting).   A 38-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0173 and expiration date was not reported), via an unspecified route of administration on 05May2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included iron; ergocalciferol (VITAMIN D); amlodipine besilate taken for an unspecified indication, start and stop date were not reported. On 05May2021 the patient stated that, have a quick question patient son was 18 and they both were scheduled to Pfizer 2 vaccine on Wednesday and patient concern was when son got Pfizer vaccine, he was fine. When patient got, for about four days patient had Migraine headache and was like tired and drowsy, patient don't really like how body felt, it took a while for headache to go away, like it was like light migraine and patient was taking Tylenol and have to get the second vaccine, but patient thinking may be going to have same type of side effect and little bit worried about it, patient son was fine. Outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested
felt dizzy; seemed like a night sweat/whole body broke out into a sweat; abdominal pain/stomach hurts a little bit; about 50% of the time she will have to go to the bathroom and have diarrhea; Hot flashes; mild headache; feels weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 16Mar2021 09:30 (Lot number: EN6205) at the age of 47 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "anxiety" (ongoing); "contraception" (ongoing); "Allergic to all kinds of Penicillins" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE HCL taken for anxiety, start date: Nov2019 (ongoing); JUNEL FE taken for contraception, start date: Mar2020 (ongoing). Past drug history included: Amoxicillin, start date: Jan2021, reaction(s): "rash", notes: had a reaction in early Jan2021; treated with a steroid, Prednisone; Amoxicillin, start date: Jan2021, reaction(s): "hives"; Prednisone, start date: Jan2021, for Rash; Prednisone, start date: Jan2021, for Hives. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovering", described as "felt dizzy"; NIGHT SWEATS (non-serious) with onset 16Mar2021, outcome "recovering", described as "seemed like a night sweat/whole body broke out into a sweat"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Mar2021, outcome "not recovered", described as "abdominal pain/stomach hurts a little bit"; DIARRHOEA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "about 50% of the time she will have to go to the bathroom and have diarrhea"; HOT FLUSH (non-serious) with onset 16Mar2021, outcome "recovering", described as "Hot flashes"; HEADACHE (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "mild headache"; FEELING ABNORMAL (non-serious) with onset 16Mar2021, outcome "unknown", described as "feels weird". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening after vaccination, past 5pm of 16Mar2021, the patient felt dizzy, had hot flashes and her whole body broke out into a sweat. Hot flash would come on and then she would get dizzy. She stated that it happened through the night about every 2 hours. The events last for about a minute and she just feels weird afterward. The last time this happened was about 17Mar2021 09:30, stated that it was not as strong and confirmed she had diarrhea. The patient went to bed with a mild headache and she did not have it when she woke up in the middle of the night. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Patient reported red, swollen, sore arm by day 2. Day 3, the swelling and redness was better, still sore to the touch. Getting better with OTC treatment- ibuprofen, ice.
Vaccine was given to the patient expired. Vaccine expiration date was 07/20/23 patient received vaccine on 07/26/23 So far patient feeling ok, just pain in left arm.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patients were vaccinated with PROQUAD (Merck) that was improperly stored. Concomitant medications were not reported. The nurse stated that PROQUAD (Merck) was exposed to a temperature as high as 14 Fahrenheit (F) for an unspecified amount of hours. No adverse effects were reported. The outcome of improperly stored PROQUAD (Merck) have been administered and no adverse effect was unknown. This case is linked to 1406USA009396, 1406USA009397, 1406USA009398 and 1406USA009282. Additional information has been requested.
Sore arm 3/26; Very sore arm; runny/stuffy nose on Saturday, 3/27 morning. Sore Throat and fatigue on Sunday 3/28; diarrhea and fatigue on Monday, 3/29; continued fatigue on Tuesday 3/30. Sore arm through 4/5.
NOTICEABLE RED DOTS LIKE A RASH ON UPPER CHEST AREA MORE ON LEFT SIDE UNDER CLAVICLE. LEFT FOREARM BUMPS, RAISED AND WHITE BLOTCHES. RIGHT FOREARM SAME THING WITH BUMPS BUT LESS OF THEM.
BODY ACHES; MILD FATIGUE; This spontaneous report received from a patient via a company representative 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, batch number: Unknown) dose was not reported, administered on APR-2021 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 APR-2021, the subject experienced body aches. On APR-2021, the subject experienced mild fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and mild fatigue on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210432815.
complete state of confusion and disillusion; Dose 1 on 05Feb2021, doe 2 on 25Mar2021; shingles; acute reaction to the vaccine and it killed her/ the shot killed her; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Mar2021 (at the age of 88 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Myeloid leukaemia from early 2020. Concomitant medication included ruxolitinib phosphate (JAKAFI) taken for myeloid leukaemia. The patient previously received the first dose of BNT162B2 on 05Feb2021 (at the age of 88 years old) for Covid-19 Immunization and experienced confused state; panicked; Urinary tract infection (UTI); shingles; within 2 days it looked like somebody had punched her in her face, her face was purple on one side; shooting pain, across left cheek from her nose, her cheeks, down to her mouth. On 25Mar2021, somebody at that recovery center thought that it was a good idea for her to go get another vaccine. And the patient also had acute myeloid leukemia (Later clarified as history) and this was known by all parties. And when she got that vaccine on 25Mar2021, she didn't even make it back to the recovery center, they took her straight to the hospital because she went in to a complete state of confusion and disillusion then. And she really never recovered and she died on 07May2021 and the reporter just want to let you all know because reporter just listened to NPR and listened to doctors try to prove some relationship between the shingles and the vaccine, and reporter was not saying shingles caused it or vice versa but she had an acute reaction to the vaccine and it killed her. For the patient's Height and Weight, Reporter stated She was 4 foot 11, she was a little bit taller but as she got older her spinal cord begin to kind of shrink up on her, so 4 foot 11 works, she was barely 100 pounds when she died. For the Reason of Death, Reporter stated Somebody decided that it was a good idea to give her second COVID vaccine, that's what killed her. If she hadn't got the second COVID vaccine, she was recovering, she was doing much better, and the reporter spoke to her on 24Mar2021, just before she got that shot and she was never the same after that, the shot killed her, reporter was not saying you all killed her, she was saying the person who said it was a good idea to give her the shot, killed the patient. The reporter was not a doctor, resisted it somebody not do that but they went ahead and did it anyway and it killed her. She suffered for 90 days after she got her shot and suffered like hell after she got her second shot. It was unknown if Autopsy was performed. The outcome of event "acute reaction to the vaccine and it killed her/ the shot killed her" was fatal, of the other events was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: acute reaction to the vaccine and it killed her/ the shot killed her