chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer who saw a video on the internet referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced reactions after the vaccination and subsequently died due to an unspecified reason; it was unknown whether an autopsy was performed. The reporter did not provided causality assessment between the adverse reaction and vaccination with GARDASIL 9. Upon internal review the patient's death was determined to be medically significant. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1809USA001815: Reported Cause(s) of Death: Unknown cause of death.
LOST/PASSED AWAY; This spontaneous report received from a consumer via a company representative via social media concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient lost/passed away from unknown cause of death. It was unspecified if an autopsy was performed. It was reported by consumer that, "I lost my 23 old granddaughter after getting the Johnson and Johnson vaccine. She had an existing heart condition. She passed away 3 months after getting the shot. Needs lots more testing and the real truth about the risk of the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221135528-lost/passed away. 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. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient called today (2/8/19) and complained of shoulder pain, limited range of motion, and arm weakness. Said the shot hurt worse than it usually does.
Pt reports having swelling, pain, skin redness and aches on L arm. Pt states pain is approx. 4-5 inches down from where vaccine was placed. Pt also reports a bump below where the vaccine was placed. It is not hard or warm to touch. Pt denies N/V/D and fever.
I received my Moderna COVID Booster and about 12-18 hours after my shot, I had a large red "rash" around the injections site on my arm. The spot was itchy, hot to touch, and had a hard bump inside my arm where the injection was given. This lasted from Tuesday - Friday, having significantly decreased on Friday. Saturday, 11/13 the redness was no longer visible.
Varicella vaccine failure-twin sisters.  Developed a light case of chickenpox on Monday 01/13/04.  Approximately 50 lesions, going away 01/15/04.  Exposed to 8 year old brother, who did not have vaccine. Brother developed illness 12/31/03.
no additional adverse event; Expired vaccine used; This spontaneous report was received from a pharmacy technician concerning a patient of unknown age. No information about the patient's concurrent condition, medical history or concomitant therapy was reported.   The pharmacy technician reported that the first dose of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 1 dosage form, lot # R005341, expiration date 06-DEC-2020; route was not reported) was administered to the patient on 08-JAN-2021 as prophylaxis (expired product administered). This dose was properly stored. The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose and route were not reported) was administered to the patient on 08-MAR-2021 as prophylaxis. The pharmacy technician did not have lot/expiration of second dose. No additional adverse events were reported.
Child went from a typically developing boy, to full regression in to Autism within one week of his MMR shots. He also recieved the Varicella vaccine on the same day. He has never received the 2nd dose of the MMR.
Narrative: COVID infection following COVID vaccine series 02/02, Pfizer dose #1 02/23, Pfizer, dose #2 09/10 Pt admit to medicine cc: "Nausea and vomiting after covid" dx: COVID-19 complicated with pneumonia and hypoxemia LOS: 3 days 09/10 COVID swab, result: detected 09/10 pt cc: exposure: unknown 09/10 CXR impression: 1. Asymmetric right lung consolidation concerning for pneumonia in the appropriate clinical setting. No significant left lung consolidation. 2. Known right upper lobe nodule reidentified. 09/10 BNP: 153.5 09/10 CRP: 7.551 09/10 DDIMER: 0.36 09/10 SARS-COV-2 Variant Sequencing result: pending 09/11 Eval: negative 09/11 DDMINER: <0.22 09/12 FIBRINOGEN: 459 09/12 DDIMER: 0.37 09/12 ESR: 58 09/13 FIBRINOGEN: 469 09/13 DDIMER: 0.25 09/13 ESR: 43 09/27 Troponin I result: 0.020 09/27 CXR impression: Interval decrease in right mid/lower lung zone airspace disease, but increase in right upper lung zone and new left midlung zone airspace disease, suggestive of multifocal pneumonia.
Patient came in with 1/2 inch red stripe around the inside of her deltoid on the injection arm. She also complained of swelling under her armpit with tenderness to touch. She did have a fever as well.
On the 8th day after receiving the COVID vaccine the injection site developed a red circle around it, with a hard area In the middle and it was itchy.
I tested positive for COVID after receiving my first dose of the vaccine. My son was sick prior to me feeling bad and he also tested positive for COVID. I was tired and my blood pressure was high. I had no fever, but I had chest pain.
Patient was incorrectly given a booster dose despite it not being approved for the patient's age group. No adverse events were observed during the observation period and no additional treatment was required.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 59 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Chills; Diarrhea; fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIARRHOEA (Diarrhea), PYREXIA (fever) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills), DIARRHOEA (Diarrhea), PYREXIA (fever) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), DIARRHOEA (Diarrhea), PYREXIA (fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment details were not provided.
My underarm became sore. This time it lasted longer (8 days) & was more pronounced. At times it felt  like a knife stabbing into the upper right (toward torso) quadrant of my left armpit. Moving my arm was not a factor.
Apprx 5 hours post vaccine, my left hand began to burn. Within an hour after that the burning became worse. My right hand is beginning to burn, and that sensation is spreading as well, however not quickly. I also feel a bit on an area of my neck/chest, but it doesn't seem to be spreading so far. There is no redness or swelling present, just pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Genital herpes" (unspecified if ongoing), notes: Other medical history: Genital herpes. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], stop date: 19Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
On Saturday 1/27/22 I first went for a gentle walk/run and afterwards went to the gym to work out. I do this routine every Sautday and up to three times a week. After about 20 minutes, while I did bench presses, when I came up, I became extremly dizzy. I immediataly left the gym and sat in my car for about one hour until I could drive home. The dizzyness lasted about 4 days, being the worst in the morning. It felt like being drunk and walking on a sailing boat. I've experienced vertigo before that was related to my ear. This felt different, as I could move my head without getting dizzy. It seemed my blood sugar was also fluctuating extremly during that time (anywhere from 50 to 170). After the four days of dizzyness I got better, but still felt out of breath when walking and experienced heart palpitations.
AT THE TIME RIGHT AFTER VACCINE, PATIENT STATES HER ARM FELT WARM AND TENDER TO THE TOUCH.  ON 10/21/15 SHE REPORTED TO THE PHARMACY AND THE PHARMACIST NOTICED HER ARM BRUISED AND PURPLE, PATIENT DID NOT COMPLAIN OF PAIN.  SHE DID NOT SELF TREAT, PHARMACIST RECOMMENDED ACETAMINOPHEN IF SHE HAD PAIN AND FOR HER TO NOTIFY HER DR.
Patient received 6 mo - 4 year Pfizer monovalent for shot 2, instead of Moderna shot 2 for the 6 month to 5 year age group.
Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who in April 2007, was vaccinated with the first dose of GARDASIL. Since the injection in April 2007, the patient has had a small lump at the injection site. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007.  Initial and follow-up information has been received from a physician, concerning a 13 year old female patient, who in April 2007, was vaccinated with the first dose of GARDASIL.  Since the injection in April 2007, the patient has had a small lump at the injection site.  Follow up information from the physician confirmed there had been no further contact with the patient, however, she added that the patient had "moved or flinched and tightened her muscle during the vaccination."  The area was described as a slight induration, about 1 inch in diameter.  At the time to this report, it was unknown if the patient had recovered from the event.  The patient sougth unspecified medical attention.  Additional information has been requested.
site sore to touch/Left arm injection site hot, red and starting to itch and hard.; site sore to touch/Left arm injection site hot, red and starting to itch and hard; site sore to touch/Left arm injection site hot, red and starting to itch and hard; This is a spontaneous report from a contactable consumer (Patient). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an intramuscular route of administration, administered in Arm Left on 12Feb2021 11:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history cholesterol and When she was 3 years old, she had whooping cough. Concomitant medication(s) included Livalo 4 mg once a day for cholesterol, Clopidogrel 75 mg daily for blood thinner for stents in heart both taking for 2 year. On 14Feb2021 the patient experienced vaccination site sore to touch/left arm injection site hot, red and starting to itch and hard. She measured it 3 inches by 1.5 inches wide. They have her scheduled to receive second dose on 05Mar2021. She would like to know if she should receive it on the same arm, or was that too soon to get it on the same arm.  She was on a walker and don't know if using walker had agitated her arm.  She needed to use walker for 4 1/2 years prior. They pinched it up and she did not feel it when she gave her the injection. Because of her age and she has always gotten a flu shot, everybody was asking her if she wanted to get this vaccine. She was on a blood thinner, and she did tell them she was when she got the vaccine. She had stents put in her heart prior to the vaccine. She had Historical Vaccine Flu shot for immunization in Oct2020, but none after that except the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included investigation: she measured it 3 inches by 1.5 inches wide on 14Feb2021. The outcome of event was not recovered.
Next day Tiredness/ lethargic; This is a spontaneous report from a contactable Other HCP. A 27-year-old male patient receive second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247), via unknown route of administration on Left arm on 11Feb2021 11:15 (the day of vaccination), at single dose for covid-19 immunisation. The patient's medical history includes historical vaccine the first dose of bnt162b2 (BNT162B2, Lot number: EL3247), via unknown route of administration on Left arm on 21Jan2021 11:15 AM (the day of vaccination). Concomitant medications were not reported. It was reported that patient experienced next day Tiredness/ lethargic on 12Feb2021 08:00 AM and did not received any treatment. Patient did not received any medications within 2 weeks of vaccination. 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 not been tested for COVID-19. The outcome of events was "Recovering".
Left thigh 7 cm redness/swelling induration, mild pain from gait N.
minimal sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minimal sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included CELECOXIB (CELEBREX), HYDROCHLOROTHIAZIDE, METOPROLOL and LEVOTHYROXINE for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (minimal sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN (minimal sore arm) outcome was unknown.
received first dose and tested positive for SARs-COV-2 a couple of days later; received first dose and tested positive for SARs-COV-2 a couple of days later; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported, the husband received first dose and tested positive for SARs-COV-2 a couple of days later and states "wife never had it". She had not received first dose of product. She was asking for the recommendation of waiting fourteen days between infection and dose, she does not know if previously reported, but "probably not". The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events was reported as unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Drug ineffective and COVID-19 and suspect drug BNT162B2 cannot be excluded.
Irritability, fussiness, pallor x 36 hrs large black stool (guaiac neg) (no currant jelly").
Narrative: Veteran reported diarrhea the day after his first pfizer vaccination  x2-3 days. Symptoms self-resolved. Pt reported this ADR when he came back for his second dose on 3/17/2021. Both doses were administered without complications.
Severe abdominal pain beginning 2 hours after ingestion, vomiting began 4 hours after ingestion.  Vomiting for several hours, stomach pain gradually subsiding over 5 days. Patient (self) on bedrest for two days following with stomach pain and weakness. I am reporting this as I don't want anyone else to go through this if it happens to be a bad lot.
Medium-strength Muscle Ache at injection site. Muscle Tightness and Hindered mobility at injection site. Started a few hours after injection, continued for 6 hours, until now.
This spontaneous report as received from a healthcare worker refers to a currently (at the time of the report) 31 years old male patient. The patient's medical history and current conditions were not provided. On an unknown date (reported as "childhood"), the patient was vaccinated with a dose of M-M-R II (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient underwent a laboratory test which showed positive titers for mumps and measles but negative titers for rubella. The outcome of rubella titers negative was unknown. The relatedness between adverse event and M-M-R II was not reported. Additional information has been requested.
Patient insisted that the Covid booster she will be getting is her third dose when RN and another clerk asked her. The RN also asked her if she's okay with getting Moderna instead of Pfizer for her 3rd dose and she said that it was OK.  After a few minutes when the RN administered the Moderna Booster on the patient, another clerk said that the system showed it was her 4th dose and that she already received her 3rd dose 3 months ago. The Lead RN asked her why she said it was her 3rd dose when the system showed she already had it 3 months ago and the patient responded with "ohhh i thought it was a FLU Booster" and shrugged off what happened. Patient counseled for possible side effects, sent for observation. No reactions noted.
Day 1 - Extreme tiredness 3 hr later. Dizziness 4 hrs later.  Face swelling and head inflammation. By evening extreme dizziness and overall weakness, joint and muscle pain all increased overnight.  Arm soreness and swelling all day and worse at night. No redness or rash. Couldn?t  sleep well.  Day 2 - All the above but worse except arm soreness not as bad. Couldn?t work either day. Difficult to do daily activities. Worse symptom both days is dizziness, weakness, face swelling, joint and muscle pain.
Patient in observation are refers to feeling dizzy patient was evaluated 39 dxt. Patient was move to unit for continuous evaluation. He was given 2 glucose tablets of 15 grams. we finished evaluating patient he was cold to the touch. It was evaluated by staff and patient was reevaluated 9:58 patient refers to feeling well and wishes to go home to eat. Patient reevaluated dext 93 patient refers to want to go home and eat.
This case was reported by a pharmacist and described the occurrence of arm pain in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). In 2011 in the same year after vaccination with FLULAVAL, the subject experienced left arm pain and arm rash. The pharmacist stated there was nothing present around the injection site. The exact location of the rash on the arm was unknown. The patient stated to the pharmacist that "I still have pain in my arm and now have a rash". At the time of reporting the events were unresolved. Follow up information received from the pharmacist on 13 December 2011. At the time of the follow up report the events were resolved. The pharmacist considered the events as unrelated to the vaccination with FLULAVAL. The rash was on the opposite arm of the vaccination and the subject was seen by her provider who felt that the rash was due to a bug bite and unrelated to the vaccine. The pharmacist selected that the events were not serious.
Myalgia, Arthralgia, Fever, TENDERNESS AT INJECTION SITE, FATIGUE,  CHILLS Narrative:
This case was reported by a nurse and described the occurrence of an injection site reaction in a 27 month old male patient who received hepatitis A vaccine inactivated (Havrix).  The patient's medical history was notable for upper respiratory infection on an unspecified date.  On 07/27/2004, the patient received the first dose of Havrix in the left thigh.  During the administration of Havrix, on 07/27/2004, the patient moved which resulted in the needle coming out of the patient's thigh.  The nurse stated that some of the vaccine was administered subcutaneously.  The recommended route of administration for Havrix is intramuscular.  One day following the administration of Havrix, on 07/28/2004, the patient experienced injection site reaction characterized as redness and swelling.  The nurse stated that the injection site reaction was nickel sized.  The patient was seen at a physician's office.  The injection site reaction resolved on 08/01/2004.  The nurse considered the events to no be related to vaccination with Havrix.
Patient fell on the floor few minutes after administration of 2nd doe of HPV (gardisil). Patient hit her face on the floor. Burst her lips and  swollen forehead.
" Per Agency and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and Agency instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes."
Client reported face rash and increased heart rate 15 min. post vaccination.  Client observed by EMS, vital signs taken, and within normal limits.  Pox 97 %. No resp. distress.Client stayed in observation additional  30 mins, symptoms resolved, client advised to contact primary physician ASAP.   Client denied h/o allergies prior to vaccine, reported allergies to shellfish post vaccination.
Fever and vomiting about 12 hours, post vax. Vomiting persistent and was hospitalized on 6/15/01. Antibiotics were started.