chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Gardasil. Three minutes after the vaccine was given she said: "I don't feel good" Then she went pale, stiff, fainted. She didn't recall what happened. She came back after 5 minutes. Her BP was low, 60/40 and received epi 0.3 mg.
Patient reported on 7-17-21 that she began experiencing lower back pain about a week after the injection. It has since increased in severity to a rash that begins at her left lower abdomen and wraps around her waist to her back.
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old daughter with no drug reactions/allergies and no pertinent medical history, who on 10-MAY-2012 was vaccinated with the first dose GARDASIL (dose, route and lot number not reported) and with a dose of an unspecified meningitis vaccine during an annual physical exam. The reporter stated that pregnancy test drawn during that visit returned a positive result for pregnancy on an unspecified date. No adverse effect reported. It has been reported that the patient was 7 weeks pregnant. The patient's last menstrual period was approximately 29-MAR-2012 and estimated delivery date would be on 03-JAN-2013 (day approximated). The patient sought unspecified medical attention. No treatment was given for an AE. At the time of the report the patient's outcome was unknown. Follow-up information has been received from a physician via Pregnancy Questionnaire for GARDASIL, a Pregnancy Registry product, concerning 16 year old female patient, adopted from another country, with history of mood disorder, who on 10-MAY-2012 was vaccinated with the first dose of GARDASIL (dose and route were not reported) (lot number 672653/1860AA). Concomitant medications included: WELLBUTRIN 150mg daily, lithium 300mg twice daily and LO-OVRAL. The physician reported that the patient's current pregnancy was registered to OB/GYN and that estimated conception date and date of last menstrual period were unknown. At the time of the report the patient's outcome was unknown. Follow-up information has been received from a nurse for GARDASIL, a Pregnancy Registry product, concerning 16 year old female patient. The reporting nurse stated that the patient went to OBGYN but the patient was not seen in their office recently and could not find any baby information. The pregnancy outcome was lost to follow up. Additional information is not expected.
C/O mild Headache, Slight Intermittent dizziness, abdominal cramping
15 hours after the second shot- I had intense body shaking/chills, headache, diarrhea and sharp body pain in my low back and neck. Even my  toes are sore! and my arm is very sore.
poss infantile spasms; had some stiffing; poss sz & cried a lot on the day of the inject; mother only brought pt in 2 days later p/several sz episodes; hospitalized now; hx of epilepsy in maternal uncle; was well baby visit;
1st two weeks: palpitation, then went away 3rd week: shortness of breath, then went away in about a month started to have chest discomfort or mild chest pain on the left side. Has persisted since then for three months.
she doesn't want to have second shot because afraid to pass through this again; Really sick; Arm is sore; Chills; Running high fever; Throwing up every hours; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (she doesn't want to have second shot because afraid to pass through this again), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills) and PYREXIA (Running high fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03BB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills), PYREXIA (Running high fever), VOMITING (Throwing up every hours) and HEADACHE (Bad headache). On an unknown date, the patient experienced ANXIETY (she doesn't want to have second shot because afraid to pass through this again). At the time of the report, ANXIETY (she doesn't want to have second shot because afraid to pass through this again), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills), PYREXIA (Running high fever), VOMITING (Throwing up every hours) and HEADACHE (Bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitants - blood pressure medication. Treatment information as not reported.
pt felt chest tightness after receiving vaccine, benadryl administered and pt returned to normal within 15 minutes. Vitals remained stable. ? anxiety
1 year and 2 months after vaccination of dose 2 Moderna, May 18th, 2022, I noticed swelling in right ankle and discomfort going up my right lower leg. I immediately went to the doctor on May 19th due to the last vaccine giving the same symptoms (found a blood clot), and he had bloodwork done as well as sent me to the Hospital. They done leg scan/ultrasound that day. They found 2 areas of DVT/blood clots (1 in right ankle and 1 behind right knee). They called the doctor and he prescribed 5mg Eliquis. I have a follow up with my doctor in 3 months.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 23-JUL-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
6/22 around dinner time started feeling left side chest pains and 6/23 felt about the same. It eased up a little on 6/24 where it was more tolerable. It has persisted even through today. Doesn't hurt all the time, but I definitely feel it's still there. Especially if I sneeze, cough, or hiccup and when I turn over while sleeping. No fever.  I did not go to the doctor. I recently moved to MS and do not have a doctor here yet and I do not have health insurance.
Case number PHEH2015US021218, is an initial spontaneous report received from a health care professional on 19 Oct 2015. This report refers to an 8 year old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX, (batch number: 173991) intramuscularly at a dose of 0.5 ml on 15 Oct 2015. The case was reported as non-serious. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Local reaction to flu vaccine site red and hot with circumference approximately 2 inches around inj site. No airway problems. Pt instructed mom to use BENADRYL by mouth and ibuprofen for discomfort & go to ER with any throat swelling/respiratory problems.
headach,fever,chills,weakness, muscle weakness,upset stomach, sweating(night)
reactive arthritis; 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 49-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient reported she received Pfizer vaccine last September (year not reported, pending clarification). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: ARTHRITIS REACTIVE (medically significant), outcome "unknown", described as "reactive arthritis". After the 1st shot, she was fine, just a sore arm. But then 4 days after her 2nd dose she developed reactive arthritis. She stated it was debilitating she had to wear double knee and ankle braces and could barely walk. She has had blood work and markers (unknown results), xray confirming she did not have arthritis and it was reactive arthritis. The patient stated this ruined her life for 6 months and spread through her entire body. She also stated she lost work and can't function. She reported being healthy 49-year-old woman. She stated there have been 4 known cases for reactive arthritis from CDC. She also reported that in her social workplace that every single person either has had an adverse rection or someone in their family has had an adverse reaction, mentioned stroke and heart attack. She also reported that her best friend who is younger than her had side effect of leaky heart. Therapeutic measures were taken as a result of arthritis reactive.   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-202201222423 same patient and product, different dose and events;US-PFIZER INC-202201224968 same patient and product, different dose and events;
UTI; bedridden; Product dose omission issue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (UTI), BEDRIDDEN (bedridden) and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 040A21A,) for COVID-19 vaccination.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Cancer.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-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 started PALBOCICLIB (IBRANCE) (Oral) 100 milligram once a day. In April 2021, the patient experienced BEDRIDDEN (bedridden) and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) and BEDRIDDEN (bedridden) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue) had resolved.            Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-121339, MOD-2021-121339 (Patient Link).   Reporter did not allow further contact
About 30 minutes after my injection, I noticed my left hand went numb.  I have had numbness/tingling in left hand since.
I got 1st dose of vaccine on 02/25/21 and I had so much pain in my arm so I took two Tyenol. After two days  no pain or patch at all . Again stared lots of bruise pain red patch at vaccine spot from Saturday 03/06/21.
Next day after vaccination, Mom noted redness, warmth, swelling of right arm where PPD was given. Saw Pt on 04/21/2005 area of redness was 9x10cm no swelling, minimal tenderness.
Day 6, 7, and 8 after second dose, I had infrequent sharp, electrifying chest pains with radiating pain to my left arm. My heart was fluttering and irregular compared to normal. The pain and fluttering resolved, so I did not seek immediate medical attention.   This occurred the same amount of time after my first dose of the vaccine for only one day.
This spontaneous prospective pregnancy report was received from a nurse practitioner refers to a 38 year old female patient without pertinent medical history and allergies. On an unknown date in 1983, the patient was vaccinated with one dose of M-M-R II, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported) when the patient was 7 years old. No concomitant therapy. The reporter stated that the patient was "about 12 weeks" pregnant (Maternal exposure before pregnancy). The patient became pregnant with and estimated last menstrual period (LMP) of 29-OCT-2014 and estimated date of delivery (EDD) of 05-AUG-2015. On 15-JAN-2015, the patient had a titer drawn an d the result of it was mumps antibody test negative described as the patient was negative for mumps. The reporter stated that the patient who is also a physician had a titer drawn because she was going to start a new job at a hospital. It was reported that the patient did not seek medical attention and treatment was not given for the event. The pregnancy outcome was outcome pending. Th outcome of mumps antibody test negative was unknown. The relatedness between mumps antibody test negative and therpay with M-M-R II was not reported. Additional information has been requested.
Fever of 101 for 18 hours, extreme fatigue, body aches, headache that is still lingering today
Patient reports feeling dizzy, double/blurry vision and cotton mouth. Not felling ill earlier today. BP 130/90 HR 92 School counselor called her mother.
Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date; Vaccine was stored in refrigerator and administered beyond 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially stored in the refrigerator on 27-May-2022. Date of administration of vaccine on 29th or 30th of Jun 2022. The vial did not undergo any temperature excursions.  It was reported that Route and Body site was deltoid.  No treatment medication was reporter.
Information has been received from a physician concerning a 16 weeks old female patient who in December 2009, was vaccinated with a dose of ROTATEQ (route and lot # unknown) at 16 weeks of age. The physician stated the she was a "micro preemie" and she was not release from the hospital until 16 weeks. No adverse effects reported. The patient sought medical attention at the physician's office. This is one of several reports from the same source. Additional information has been requested. This is an amended report. The ONUM of multiple=2 was deleted. The reporter's reportability was changed from do not send to periodic.
Pt awoke the morning after vaccination with hives all over body.  Pt does have new onset history of chronic hives and had a case that just recently cleared up.  Pt seeing primary care for antihistamine medication and further followup.
12 hours after the shot I had flu ;like symptoms, fever of 100, sore joints, headache, nausea, chills, and ended about 18 hours later they subsided and then noticed yesterday I had mouth ulcers, red dots on the tongue, deep sore throat , swollen neck glands, have had no treatment as of yet. it is getting worse everyday. I have never had this before
sore arm in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (sore arm in the site of injection) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Stroke (ended up disabled) in 2019. Previously administered products included for Product used for unknown indication: flu shot on 20-Sep-2023. Past adverse reactions to the above products included No adverse event with flu shot. Concomitant products included METOPROLOL for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL and POTASSIUM for an unknown indication.    On 28-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE PAIN (sore arm in the site of injection). At the time of the report, INJECTION SITE PAIN (sore arm in the site of injection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   On 21-Feb-2021, the patient received first dose of moderna covid-19 vaccine (batch/lot number: 006M20A), on 25-Mar-2021, second dose (batch/lot number: 040A21A) and on third dose was 2022 (batch/lot number: unknown). It was reported that with the last dose patient got sore arm in the site of injection and it is still a bit sore.  The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027802 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027802:Dose 1, same reporter, different product
Stiffness in the injection arm (left); Swelling in the injection arm (left); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in the injection arm (left)) and VACCINATION SITE SWELLING (Swelling in the injection arm (left)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in the injection arm (left)) and VACCINATION SITE SWELLING (Swelling in the injection arm (left)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiffness in the injection arm (left)) and VACCINATION SITE SWELLING (Swelling in the injection arm (left)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or other non hcp.   A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration on 19Jan2021 dose 1, single and received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection Lot Number: EN5318) via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing thyroid disorder. Concomitant medications were not reported. The patient tested positive for COVID virus, after being fully vaccinated on 06Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Aug2021. The outcome of the events was unknown.  Product Quality Complaint: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Severe chills, 100.9 temp, elevated heartrate (88 bpm) began around 9 PM, lasted 2 1/2 hours.  Used heated blankets to help convulsive chills .  Took one Extra Strength Tylenol.  Fever gradually lessened, returning to normal 48 hours after the injection.
Burning sensation at injection site just after injection.  Radiated to elbow.  30 min later took jacket off and saw that the skin was red from injection site to elbow.  50mg benadryl given.  Sensation resolved and arm redness decreased by 4:20PM
Large circular red welt tender, hard and hot to touch. Lasted for 4 days.