chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after getting the flu shot I was so sick with the flu; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a female patient of an unknown age who after getting the flu shot was so sick with the flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date in 2014 (6 years ago) (unknown latency), after starting the suspect vaccine therapy, the patient got the flu shot just one time. She was in home health and they had the medical personnel in the office giving it out for free to whoever wanted it. The very next day after getting the flu shot the patient was so sick with the flu (influenza). That was the sickest she ever had been in her life. She would never get the flu shot again. Never been sick like that before or since.  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Case previously recorded as MA2009-4373. Initial case report received from a health care professional via agency, on 16 NOV 2009. A 19 month-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102045P1) i.m. on 10 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008119.
Patient received the COVID 19 Pfizer age 12+  vaccine for her second dose instead of the pediatric COVID19 pfizer (age 5-11).  Patient was contacted after administration and no symptoms were reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 25th May 2018 and experienced injection site pain, refer case US2018185589). On 9th August 2018, the patient received the 2nd dose of Shingrix. On 9th August 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On 11th August 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were reported as follows: This case was reported by the patient's wife. The patient experienced injection site pain after receiving 2nd dose of Shingrix. The event was lasted for 2 days.
24 hours after vaccination, patient developed temperature of 103 degrees F, listlessners, and swelling/redness/endoration.  Left upper left arm extending to elbow and past shoulder.  Sofe of DTAP on left upper arm.  Symptoms lasted ~48 hrs.  Tylenol and Benadryl given.
rash-waist, back, legs, arms 11FEB; joint pain knees-bilaterally 13FEB; pt exposed to rubella disease wk of 23JAN-27JAN95;
Unknown adverse event at this time.  Report is being made d/t the patient receiving a complete Moderna series prior to getting the Janssen vaccine according to Immunization Registry Information System. Patient also received the two dose series of Moderna less than 28 days apart outside of the 4 day grace period. The Moderna series was not administered at this facility. Patient confirmed to the LPH nurse receiving both doses of Moderna after receiving the single dose of Janssen.
I was 14 weeks pregnant when I got the shot. This was a booster (half dose)  I had chills, arm soreness, covid arm (red patch), headache that was moderate/severe and only occurred momentarily when changing positions. The headache was the worst part. It has lasted until today (11/8) but is much better today and yesterday.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 at 15:00 as dose 1, single (Lot number: FW0171) at the age of 60 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "COPD(Emphysema)" (unspecified if ongoing); "Pre-Diabetic" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Sinusitis" (unspecified if ongoing); "Hayfever" (unspecified if ongoing); "HFpEF" (unspecified if ongoing); "Known allergies: sulfites" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA; PROAIR HFA; IPRATROPIUM. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: SLEEP PARALYSIS (non-serious) with onset 22Apr2021 at 02:00, outcome "unknown", described as "About 2 am my eyes popped open out of a dead- sleep and I couldn't move my entire right side. It lasted less than a minute". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sleep paralysis. Additional information: Patient believe the rush of adrenal from the shock of not being able to move stopped the paralysis.
No adverse reaction patient tolerated well, dose given out of vial that was in the fridge after 30 days.
Required return to physician.  Upper arm red, warm to touch, and moderately swollen.  Treated with Z-pak for URI.  Changed to cephalexin.  Temp of 101 day following immunization, with chills and aches and pains.
Family members report that patient had multiple seizures in the evening approximately 3 hours after receiving his vaccination.
Father reports that after he had received his 1 year old vaccinations, he developed high fever and seizure-like activity several hours later consisting of eyes rolled back, shaking of bilateral upper and lower extremities, and being unresponsive. He was evaluated in the Emergency Department on 7/13/22 and thought to have had a febrile seizure. Father denied that he had rash, difficulty breathing, cough, congestion, vomiting, diarrhea, or other symptoms after receiving those vaccines.
HEMATOMA  ALL OVER THE BODY/RIGHT LEG AND RIGHT ARM/LEFT LEG/NECK; NOT FEELING WELL; BURNING SENSATION INSIDE BODY; FEELING HOT; PAIN IN LEFT LEG AND FROM THE KNEE DOWN TO FOOT; FEELING TIRED; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stenosis of back, and hypothyroidism.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid. On APR-2021, the subject experienced pain in left leg and from the knee down to foot. On APR-2021, the subject experienced feeling tired. On 10-APR-2021, the subject experienced burning sensation inside body. On 10-APR-2021, the subject experienced feeling hot. On 11-APR-2021, the subject experienced not feeling well. On 19-APR-2021, the subject experienced hematoma all over the body/right leg and right arm/left leg/neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation inside body, and feeling hot on 11-APR-2021, had not recovered from hematoma all over the body/right leg and right arm/left leg/neck, pain in left leg and from the knee down to foot, and not feeling well, and the outcome of feeling tired was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
presents w/ 3 inches of erythema, swelling & warmth to rt deltoid region;states has been getting worse;no treatment;disrupting sleep;
Diffuse hives developed within 45 minutes of flu shot vaccination; no anaphylaxis.
Information has been received from a consumer with no medical history or concurrent condition concerning herself (a 9 year old female) who on 26-DEC-2008 was vaccinated with the first 0.5 mL dose of GARDASIL. She received the second and third dose of GARDASIL on 26-FEB-2009 and 26-JUN-2009 respectively. Lot# was not provided. There was no concomitant medication. The patient reported that she experienced severe headache and change in attitude after receiving first, second and third dose of GARDASIL. The patient sought medical attention. Allergy test and eye exam were performed. At the time of report the patient had not recovered. The patient also mentioned that when she was child she broke out in hives after taking AUGMENTIN (manufacturer unknown) and liquid Prednisone (manufacturer unknown). Additional information has been requested.
The site of injection was red and a bump was present.  The patient complains of pain at the injection site.
This spontaneous report as received from a registered nurse refers to an approximately 359 days (reported as 6 days before 1 year old) male patient. The patient pertinent medical history was not reported. On 02-FEB-1999 the patient was vaccinated with M-M-R II and VARIVAX (Merck), which was 6 days before the patient turned 1 year old. No adverse effect was reported. No product quality complaint (PQC) was reported for M-M-R II and VARIVAX (Merck). This is one of the two reports received from the same reporter. Additional information has been requested.
Patient was supposed to get second dose of Pfizer but was accidentally given a Moderna dose. He did not develop any symptoms while on site and hasn't at time of this report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient came back to the pharmacy on July 11, 2018 with a large red rash by the vaccination site. She said her arm still hurt a week after the shot.
Administered on Saturday January 2, 2021.  On Tuesday started with some ear pain and lymph node swelling.  Wednesday much worse lymph node swelling and right side of face with some swelling.  Tingling  began  and bumps with red line formed on forehead.  Thursday-same except swelling I'm lymph nodes was so painful it woke me  up. Today, Friday January 8th I went to a doctor's care.  Diagnosed with shingles.
Muscle aches- generalized; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN) and unspecified multi-vitamins; all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 04Feb2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021 at 11:00, the patient experienced muscle aches- generalized. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle aches- generalized was resolved on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported  It was reported that the vial was removed from the fridge on 17Aug2021 in the morning, punctured at 3:00 PM and put back in the fridge around 5:00PM.  On 18Aug2021, the punctured vial was taken out of the fridge at 8:00 AM, administered to 7 patients between 8:00AM - 12:00 PM. 2  patients received their first dose, and 5 received their second dose. Duration of excursion - 15 hrs between 3:00 AM and 12:00 PM
Immediately follow injection patient's heartrate went to 119 and patient felt panic/possible short of breath, patient was allowed to go outside to remove mask. Heart rate increased to 163. Patient was allowed to leave as she felt fine other than the high heart rate. Rate went down to 84-91 while driving home from 4:41 to 4:59 and then it increased again to 166 and came down to 102 by 5:01. No other issues that night. The following 3 days patient had periodic increases in heartrate while at rest to 161 on Thursday, 158 on Friday along with chest tightness and "feeling off", and Saturday 172. Patient also had lower back pain on Thursday and mild fatigue on the 3 days.
Patient's arm hurt (pain at injection site); This is a spontaneous report from a Pfizer sponsored program "from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient's arm hurt (pain at injection site). Clinical outcome of the adverse event was unknown at time of this report.   Information about lot/batch number has been requested.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This case was reported by a healthcare professional and described the occurrence of hepatitis b surface positive in an infant subject of unspecified gender who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. On an unspecified date in 2007 the subject received 1st dose (birth dose) of Engerix B. The infant was tested for hepatitis B surface antigen 5 days later and tested positive. The circumstances for why the infant was tested were not known by the reporter. The infant believed to have been tested while hospitalized for an unknown reason. No other information was known at the time of reporting. The outcome of the event was unspecified.
Rash - Near Injection site; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash - Near Injection site) and PAIN IN EXTREMITY (Arm Pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 207M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash - Near Injection site) and PAIN IN EXTREMITY (Arm Pain). On 03-Mar-2021, VACCINATION SITE RASH (Rash - Near Injection site) and PAIN IN EXTREMITY (Arm Pain) had 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.   No relevant concomitant medications were reported. No treatment medication were reported.
Patient came into the pharmacy requesting Tdap vaccination accompanied with a friend. Within 1 minute after adminstering vaccination patient face was flushed, threw his head back and went into a seizure, both his hands were clenched and twisted, his right foot was twisted.cradled patient head to prevent injury, he groaned and had another episode by then with his friend's help i had the patient lay on the floor on his back. within 30 seconds patient was awake and questioned what just happened. The entire episode may have lasted less than 3 mins. After this patient was alert, had him drink some gatorade , which he threw up after 5 mins. after about 30 mins patient was well enough to be on his feet and left the pharmacy
On 3/1/00, received call from mom stating child was seen at an Urgent Care last evening for severe swelling of her right leg at the injection site. The redness was the size of a large orange and has increased some more today and has begun bruising. The swelling stayed the size of a large orange. All symptoms began 24 hours, post vax. Seen at Urgent Care with a follow-up visit with PMD on 3/1/00. Child was placed on Augmentin.
Very fatigued, didn't happen after 2nd shot. HUGE headache 2/28 and 3/1, with a migraine on 3/1. Pain on top right of head quite strong. I don't generally get migraines. Took 3 Advil
Seven days after the booster I started having an elevated heart rate and I couldn't breathe. I had my husband stop the car because I thought I was having a pulmonary embolism. Finally, my heart slowed down. After that, every time I got up, my heart would race, and I couldn't breathe. I went to see Dr. , and they did a test, and they said my breathing was normal. He suggested I go see a Cardiologist. I went to the Cardiologist and he had me wear a monitor for 30 days. When I went back to see him a month later, he told me I had AFIB. He had me go see a specialist that does heart ablations, and he thought that would fix it. I went to have the surgery, but they couldn?t go through the vein. Now, I am just stuck in a wheelchair. I was put on four medications: Amiodarone, Diltiazem, Digoxin, and Duloxetine. They have not worked.
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR (Merck) and VARIVAX (Merck) both given on 2 April 2010. There were no concurrent medications. On 2 April 2010, between 09:30 and 10:00, the subject received 1st dose of KINRIX at 0.5 ml in the left thigh. On 5 April 2010, 3 days after vaccination with KINRIX, the subject experienced an allergic reaction on his thigh that was tight, red and spreading. The subject was treated with BENADRYL. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported two other cases, see case A0855336A and A0855505A.
This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided. On 09-FEB-2019, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB intramuscularly from lot # R005114 with expiration date 26-NOV-2020 for prophylaxis (Product storage error). The vaccine was exposed to a temperature of 73 degrees Fahrenheit for a time frame of 74 hours and 45 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger. The physician also stated that she was advised that it was ok to use the vaccine which was exposed to the temperature excursion. This is one of the two reports received from the same reporter.
dizziness, body aches, severe fatigue, headache, chills, diarrhea x 5 days (onset started 3 days post vaccine)