chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post Gardasil Vaccine Syncopal Event Syncope x ~3 seconds, seized, and regained consciousness after Gardasil shot was given. Patient states she passed out from shots when she was in 6th grade. Patient states she has a hx of fainting from blood draws. Last time she fainted from blood draw was this year.  Insists to take her exam, "I cant get out of it."  Last meal more than six hours prior. Given croissant to eat and stayed in office until felt better.   5:15 PM BP: 101/52, Pulse: 52 - laying 5:24 PM: BP:107/64, Pulse: 58 - laying  5:30 PM: BP: 108/72, Pulse 66 - sitting  5:38 PM: BP: 111/71 , Pulse 60 - sitting 5:47 PM: BP 114/81, Pulse 66 - sitting  5:52 PM: BP 111/66, Pulse 66  - standing 6:01 PM: BP 118/75 Pulse 78 - standing  Patient is going to get her 2nd HPV at home
Two episodes of delirium, vomited twice/two times now woke up delirious not knowing where he was; Two episodes of delirium, vomited twice; Got sick; Couldn't get up; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on the right arm on 19Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included liver cancer and chemo. There were no concomitant medications. It was reported that for two times, the patient woke up in the morning delirious, did not know where he was, hollering for his wife, couldn't get up, got sick and vomited, after he got up he felt pretty good. States he fell asleep on couch that night, toward morning he rolled onto floor, flopping around on floor like a wet seal, flopping arms around tried to roll over, pulled muscle in rib cage, after he got back up, got sick and had to vomit. Once he got up and went to the bathroom and all of that went away, wanted to know if this is this related to the Covid vaccine. This morning (unspecified date) he laid on the couch and he was about half scared to lay down because he was afraid something would happen again. The patient confirmed that he experienced this twice the day after or a couple days after the vaccine (unknown date). The patient stated that it has not happened again. The outcome of the events was unknown.
The purpose of this VAERS report is to document that a 3rd dose of Pfizer COVID-19 vaccine was administered to a 17 year old that is unlikely immunocompromised. Mother of patient stated that she checked with the patient's doctor about patient recieving and 3rd dose, and the patient's doctor recommended/approved the 3rd dose. Patient recieved the 2nd Pfizer dose on 03/24/2021, without complications.  Patient has a history of Tetralogy of Fallot, that was surgically repaired.  Patient was observed for 15 minutes after vaccine administration and no adverse effects were noted. Provider spoke with father of patient and discussed signs and symptoms of myocarditis.
24 hrs after vaccine, disturbance of left peripheral vision x 45 min, numbness left side of mouth, left arm/hand x 4 minutes, mild right frontal HA followed, examination normal. DX: headache, paresthesias. possible migraine with prodome side effect of vaccine can not be ruled out. no previous history of migraine. C/O left arm/hand numbness as well as left side of mouth.
Caller stated that on her 2nd dose in the evening, she had allergic reaction and went to the ER; lips and face swell; lips and face swell; itchy welts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller stated that on her 2nd dose in the evening, she had allergic reaction and went to the ER"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), outcome "unknown" and all described as "lips and face swell"; URTICARIA (non-serious), outcome "unknown", described as "itchy welts". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200462735 similar report from same reporter
12/24/2021 Covid symptoms started with runny nose, mild headache, a bit of a fever but very mild, very bad cough, and congestion. Symptoms lasted 6-7 days. Tested positive on 12/24/21 with a home test and then went to a pharmacy to get tested through PCR which was positive.
Patient reports she did not feel well after immunization, later in the day experienced shortness of breath and had pea size lump on arm.
Info has been received from a NP concerning a 19 year old female who in approx. 1997, when she was 14 years old, was vaccinated with the 3 dose series of Hep-B vaccine. There was no concomitant medication. Following each administration of the vaccine, the pt experienced flu-like symptoms and developed a high fever. It was reported that the symptoms got worse after each vaccination. The pt was recently checked for titers and the titer was found to be negative. Unspecified medical attention was sought. In follow-up, the NP reported that the pt was lost to follow-up and since the vaccine was not given at her clinic, the nurse could not provide the name of the Hep-B vaccine that the pt received. No further information is expected.
Patient received Flucelvax Quad PFS and the day after administration it started to leak from her the arm/ it started to leak from her arm on the place where the vaccine was administered; This spontaneous case was received on 17-Oct-2022 from a pharmacist via Communications (reference number: SEQW22-04566) and concerned a 21-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.   On 12-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml; route of administration: intramuscular (IM); anatomical location and indication not reported). The batch number reported was 942437 and expiration date was 30-Jun-2023.  On 13-Oct-2022, one day after receiving Flucelvax Quadrivalent, it started to leak from patient's arm, on the place where the vaccine was administered.   On the same date, the patient recovered from the event of 'vaccination site extravasation'. As reported, it was just a drop from the patient's arm and then it stopped.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 21-year-old female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, patient reported a drop leaking from her arm. Causal role of the suspect vaccine is assessed as possible related, due to plausible temporal relationship and an absence of confounders.; Sender's Comments: A 21-year-old female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, patient reported a drop leaking from her arm. Causal role of the suspect vaccine is assessed as possible related, due to plausible temporal relationship and an absence of confounders.
pain at injection site; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9241, expiration date not reported) via an unspecified route of administration on the left arm on 24Dec2020 12:15 at a single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pain at injection site with the first dose. No known allergies. 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. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.
Patient given vaccine without dilution of vial, thus receiving six times the normal dose. Patient notified immediately upon realization at the pharmacy (30-60 minutes post injection). Patient monitored with phone calls throughout the weekend. Pt reported feeling a little tired Friday/Saturday, but is otherwise doing well at time of this report.  Polices, procedures, and re-education implemented to prevent for future vaccines.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported
This spontaneous report received from a physician concerned an adult female.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 not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.On 19-NOV-2021, the patient experienced janssen covid 19 vaccine administered after 1 hour past 6 hours expiration, and off label use.The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen covid 19 vaccine administered after 1 hour past 6 hours expiration and off label use was not reported.This report was non-serious.
Severe swelling and edema in both lower legs. Patient went to emergency room and was evaluated for blood clots. Did receive Lovenox injections. Patient is awaiting further results and folllow-up.
the adverse event occurred in the right foot/ ankle: numbness, swelling, tenderness to touch, tingling,  warmness, pain traveled across from right to left to ankle causing inability to stand on the right foot. I am unable to work.  Had an appointment with the neurologist as well besides my primary doctor.
Headache and chills approx 12-14 hrs after dose. Treated with ibuprofen
Unknown after vaccine administered on 10/5/2004. Medical Records received on 12/07/2004 states asystole and bilateral retinal hemorrhages. Autopsy Report received on 1/12/2005 states SIDS.
Information has been received from a nurse concerning a 23 year old female patient who on 20-MAY-2009 was vaccinated with a second dose of GARDASIL (Lot # 0294Y). On 26-MAY-2009 she could hardly move her arm due to pain. On 27-MAY-2009 the patient went to the physician and he stated there was no cellulitis. At the time on the report on 27-MAY-2009 the patient had not recovered. Additional information has been requested.
4days p/vax pt awoke not acting right/lethargic; began persistent vomiting; adm to hosp & dx w/intussusception
Developed fever (101F) one day after MMR vaccination.  Developed rash on most of body four days after vaccination.
Narrative: COVID infection following COVID vaccine series 02/03, Pfizer, dose #1 02/24 Pfizer, dose #2 08/16 COVID swab, result: detected 08/17 pt cc: exposure: unknown
Woke up Sunday evening w/t101.5 continued to wake up during nite; Mon, Tues, Wed, Thurs night w/inc Friday devel rash (red sl raised or chest, back face & hands; rash cleared up; PA felt sx due to MMR vax;
unable to get 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to get 2nd vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to get 2nd vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (unable to get 2nd vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This report refers to a case of Product Dose Omission Issue for mRNA-1273 (Lot number: Unknown) with no associated AEs.
2hours later extreme pressure in sinus dizzy Then progressively got worse been 3 weeks unable to work. Very fatigued / dizzy all day pressure in sinus ears. Need help alone.
Patient fainted at the office soon after vaccine was given. Felt dizzy for the next 3 days. Had pain in left arm and painful lymph node in the axilla, felt achy. Had no vomiting.
Angioedema, CoughWheeze, Tachycardia, second dose:wheezing Narrative:  Other Relevant History:
Patient hospitalized for left hip pain & total hip replacement within 6 weeks of receiving COVID vaccination.
I have gained about 10 pounds since the booster shot. Since mid February, 2022, I have been dealing with bloating, stomach pain, burping and diarrhea on a daily basis. I had extreme bloating and discomfort on Feb 12 and 13.  The bloating continued and then diarrhea started - Feb 22, 23, 24, then Feb 25 I was up with multiple bouts, 7 in less than a 24 hour period. I can't eat bread at all, or milk. I have found that bananas, rice, chicken, chicken broth, some aged cheeses, eggs and a few other things are less likely to provoke a reaction. I have also reorted to pepto-bismol and imodium. I was diagnosed with IBS in the mid 1990s, but have had very little trouble with it since about 2000. This is not what I'm used to.
Patient stated when she removed her bandage later on the day she received the vaccine, the skin was white and felt "rough" to touch. She denied any unusual pain, fever, swelling, or redness. She said the white patch has gotten bigger since Sunday and it appeared to me to be depressed. She has received the flu shot previously and never had a reaction. She received a PNEUMOVAX in her right arm on the same day and had no local reaction. I advised her to seek medical attention from her physician as soon as possible since I was unfamiliar with this kind of skin reaction.
Blood clot on her eye after vaccination; Her HCP told her that she could wait even 3 months to get the 2nd dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot on her eye after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Enucleation of eyeball.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot on her eye after vaccination) (seriousness criterion hospitalization) and OFF LABEL USE (Her HCP told her that she could wait even 3 months to get the 2nd dose). At the time of the report, THROMBOSIS (Blood clot on her eye after vaccination) and OFF LABEL USE (Her HCP told her that she could wait even 3 months to get the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown. Treatment information not provided. Her HCP told her that she could wait even 3 months to get the 2nd dose Patient decided not to give more information as she believed it wouldn´t help her.   Reporter did not allow further contact; Sender's Comments: 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.
Pt developed hives/rash to upper chest and shoulders shortly after injection.  There was no airway involvement, SOB, edema or other symptoms. BP 170/90, HR 80, and SP0297%. She was given 25mg of benadryl. EMS services and ER evaluation was offered but the pt declined.  She elected to continue observation here at the site and then departed at appx. 220pm. She was improved and symptoms were nearly resolved when she departed. She was given instructions to follow up with her PCP to discuss possibly receiving the Jannsen vaccine.
This is a 15 year old male without PMHx  who presents with chest pain for one day after having Pfizer COVID vaccine 2-3 days prior. As per father patient had first dose without any sx except mild soreness on the site of injection. On 6/9/21 he received the second shot of Pfizer vaccine. That day he only fell mild pain on site of infection only. Next day he suffered from chills, HA, and fever. He took Tylenol for it. The day prior admission he had a mild headache and pain on the middle of the chest, dull, not radiating, and on/off. There was one episode of emesis after dinner and after taking TUMS he went to sleep. The parents check on him through the night and upon waking up he complaint still with chest pain, now increased and radiating to left side of the chest. The parents decided to bring him to ED for evaluation where he was found to have elevated troponins and he was admitted for myocarditis likely secondary to the Pfizer vaccine.  His troponins were monitored q8hrs and he was started on Toradol q6hrs. See EKG and Echo results below. Due to increasing troponins 6/13, he was given IVIG with resulting improvement. At this time, we are still monitoring his troponin inpatient with plan for potential cardiac MRI. He will be discharged home on Ibuprofen 600mg TID and follow up with cardiology with exercise restriction likely for a few months, tbd by outpatient cardiology follow up.
This spontaneous report was received from the registered nurse regarding a 11 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 13-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
had to re start the Shingrix series if more than 6 months have elapsed since the first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose a year ago or so).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had to re start the Shingrix series if more than 6 months have elapsed since the first dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2023 A physician mentioned that patient was older than 80 years. The reporter called to ask if a patient had to re start the Shingrix series if more than 6 months have elapsed since the first dose. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Tdap injection 7/8/16. Pt noted redness on left arm at bedtime on 7/14/16. Temp. 97.9 today in office. Redness is 14 cm down arm and 12 cm across. Pt does not c/o pain at site. Arm is warm to touch.
I barely felt the shot and had plenty of energy all day, but by evening there was local pain/tenderness where the shot had been administered. The next day, I experienced severe fatigue and my temperature  was over 99*. My arm was still tender and I also had a lot of nausea. Last night after work, I took two aspirin and slept 10 hours and now I feel much better with some energy.
pt recvd vax & devel aches & h/a; No further details were provided;
returned ambulatory to clinic 1 1/2 hr p/vax yellow-fever vax; c/o rash, itching; medicated w/1mg epi;
Patient noticed swelling in neck (lymphadenopathy)  around 10:30 PM (4-5-21). She said there was no pain or discomfort in left arm, but noticed a "small amount of swelling" at the injection site (left deltoid). She went to bed shortly after. Woke up following morning (4-6-21) at 7:15 AM & had generalized aching at the following body sites: back of head, neck, both legs, & both feet. She compared the aches to a case of "bad flu." Also reports malaise (tiredness, lethargy) and spent the entire day "laying around." On 4-7-21, the aches had resolved but she still felt tired & lethargic. On 4-8-21, all symptoms resolved & patient "felt fine." She did contact her primary care provider, & on 4-8-21 she filled a prescription for celecoxib 100 mg: 1 cap once a day, #30 capsules, which she began later that day.
3RD DOSE MODERNA COVID VACCINE GIVE 11/19/21, LOT #066F21A pt had a positive COVID test 7/23/22; admitted on 7/28/22 to hospital for PT (swing bed services); remains weak with AMS; despite attempts at rehabilitation with PT, pt's status worsened; no oral intake x 3 days; less responsive; admitted into hospice care 8/7/22 with comfort care; pt passed away in the hospital