chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received the vaccine, she said she was fine and stood up immediately to move to another chair. Her mom asked her again how she was and she said actually I don't feel good. She put her head between her legs and after that she went unconscious and fell to the ground.  911 was called immediately. She came to in about 30 seconds. MS arrived in less than 5 minutes. They took her temperature, BP, pulse and BS. All normal. They think she had a vasovagal response. She did not go with MS. She is going to her pediatrician today to get looked at further
Information has been received from a nurse concerning an 18 month old female who on an unspecified date was vaccinated with the first dose of VARIVAX (Lot#, dose and route not reported). On an unspecified date the patient experienced injection site reaction. The reaction was red, warm to the touch, injection scabbed and had a lump. The patient was given BACTRIM for the reaction. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the outcome was unknown. Follow-up information has been received from the physician on 28-AUG-2012 via a vaccine adverse experience report concerning the same patient with a weight of 30.4 lbs and a height of 33 inch. The patient had a birth weight of 7 lbs 10 ozs. The patient had none pre-existing allergies, birth defects or medical conditions. It was reported that the patient was vaccinated in left leg with VARIVAX (Merck) (lot # reported as 0047AE, expiration date 20-FEZB-2013) in a private doctor's office/hospital at 10:00 AM on 01-JUN-2012. And injection site became erythematous 11 days post vaccination on 12-JUN-2012. No fever. The patient was slightly tender. Medical/surgical intervention was required. No relevant diagnostic tests and laboratory were reported. The patient had none illness at time of vaccination. There was none adverse event following prior vaccination. The patient was recovered on 30-JUN-2012. Additional information is not expected.
Sudden weakness and tingling in hands , feet, arms, legs.  Stiffness in back of neck, pressure in the back of the head and temples.  No pain, no fever.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L030865, expiration date 07-JUN-2018 (dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit and 32 degrees Fahrenheit to 35 degrees. The Medical assistant also reported, that other vaccines, that were not PEDVAXHIB, were also improperly stored (case # 1703USA010647). There was no product quality complaint (PQC) involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA010647.
Patient had febrile seizure 16 hours after receiving flu shot - went to ER- Given antipyretic.
NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609) dose was not reported, administered on 22-MAR-2021 at 10:40 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious.
Pt received influenza vaccine in left deltoid on 10/05/2010. The next morning mom noticed a low grade fever and the left upper arm was swollen, red, warm and pruritic. Pt was brought to ED after sx did not resolve with Motrin. Pt was given IV cefazolin and PO Benadryl but area of inflammation continued to spread. Pt switched to IV clinda.
Day of injection arm swollen and sore by 7 pm. Next morning woke  up with headache, body ache, chills and extremely tired.  These symptoms last all day and night.  Slept most of day and laid around.  Next morning still felt tired but aches and chills gone.   5 days later, midday headache and body ache started again with chills and tired feeling.  Lasted 4 hours and then stopped.  Never ran a fever or had any other symptoms.  Never saw a doctor just road it out.  Seem to be fine now, 8 days later but still feel tired off and on.  Might just be because I'm old.
Left arm pain from 1st day of shot.  Only able to do minimal movement of my arm. Pain continues to present. Unable to get a doctor visit  till 12/03/2021.
erythema multiforme (minor) <48 hrs p/vax; rash still developing
Dose was given over 12 hours after the 12 hour period of room temperature storage.
10/06/2022  Started with Sore throat along with  Cough. On 10/07/2022 my cough and sore throat started getting worse. On 10/10/2022 I wanted get an antibiotics because I thought I had a normal cold. I tested myself to see the doctor but I tested positive for COVID-19  So, I couldn't see my doctor instead  I did tele health  yesterday at 10:00AM he prescribed  me Hydro -met and IV antibody.
EXPIRED VACCINE USED; MEDICATION ERROR; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-JUN-2021, the subject experienced expired vaccine used. On 04-JUN-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and medication error was not reported. This report was non-serious The Product Quality complaint number: 90000181971
Initially I had a left sore arm and pain went into my shoulder and then to my neck left side and it felt like pins and needles on my head.
Rash on injection site that spread to be about palm size; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash on injection site that spread to be about palm size) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20D) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching). On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on injection site that spread to be about palm size). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash on injection site that spread to be about palm size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received the vaccine on 20JAN2021 and on 6FEB2021 she experienced itching. On 7FEB2021 the patient reported rash on injection site that spread to be about palm size. Symptoms are ongoing
Severe vertigo experienced for four days and counting. Early morning symptoms are the worst, but symptoms continue throughout the day and evening.  As a professional helicopter pilot,  I cannot perform my job with these symptoms.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-OCT-2017, the patient was vaccinated with 1 expired dose of M-M-R II subcutaneously, lot# L039551 and expiration date 07-OCT-2017, reconstituted with sterile diluent, lot#  L044727 and expiration date 01-JUN-2018. There were no adverse effects reported.
430PM elevated temp despite APAP & cool tub baths;fast & shallow breathing w/full body twitching, t106 was reported by mom;transported to hosp ER via amb about 830PM treated & discharged
Pt. presented with nausea and dizziness at 1310 taken to exam rm. Vital signs obtained. Doctor called to evaluate pt. Pt. was treated with O2, Epi, and BENADRYL. Pt. released to ambulance services, transported to hospital.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1  single (Lot number: EP2553), in left arm and on 06May2021 as dose 2 single (Lot number: EW0167) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 029H21B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Vacinnated 26 Aug, 08.  That evening, cramps in legs, nauseated, vomiting and diarhea.  Please Note:  My wife also had the same vacines the same day, same lots # etc.  She became ill 27 August in the p.m.  She also fainted on 28 August.  We are still struggling with feeling sick.
The whole even lasted 12 days. My highest fever was 101.8, body aches, chill, lethargic, slept a lot, no appetite, 2 days of metal in my mouth taste, post nasal drip.
1st dose April2022, 2nd July 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old male patient who received HAB (Twinrix) (batch number j477y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in April 2022).   On 12th July 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th July 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The pharmacist reported that the patient was late for the second dose of Twinrix. No adverse event was reported. No data provided for the first dose of Twinrix. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
I experienced a breakthrough case of COVID-19 with fever, body aches and coughing.
got a minor nose bleed.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (COMIRNATY), in Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "stroke" (unspecified if ongoing), notes: she has a history of having 3 strokes and had been taking Eloquis and a baby aspirin which were both last taken on 23Jan2022. Concomitant medication(s) included: ELIQUIS taken for cerebrovascular accident, stop date: 23Jan2022; BABY ASPIRIN taken for cerebrovascular accident, stop date: 23Jan2022. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "got a minor nose bleed.". Additional information: Caller states she has a history of having 3 strokes and had been taking Eloquis and a baby aspirin which were both last taken on 23Jan2022. Caller states that she received the Pfizer Covid19 vaccine 1st dose in Dec2020 and got a minor nose bleed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02350. Initial report was received from a health care professional on 24 February 2012. A 10-year-old female patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of DTaP (manufacturers, lot numbers, routes and sites not reported) on 28 August 2001, 25 November 2001, 13 December 2001 and 26 December 2002. The patient had received a 0.5ml dose 5 injection of DTaP (manufacturer, lot number, route and site not reported) on 15 May 2006. On the same date, the patient also received a 0.5ml dose 4 injection of IPV and a 0.5ml dose 2 injection of MMR (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 24 January 2012 with complaints of coughing fits for over a week, congestion only at nose, bringing up mucus with cough, feels nauseous after cough, shortness of breath (SOB), sore throat, achy, dizzy, ear pain, headache, poor appetite, diarrhea, croup and asthma. Upon examination, the patient had nasal congestion and lungs were clear to auscultation bilaterally with no wheeze or crackles. The physician's assessment was bronchitis, cough, reactive airways disease (RAD) and diarrhea. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, FLOVENT and albuterol. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of MRSA, refractive error, infantile asthma, influenza, allergic rhinitis, strep, otitis media (OM), vomiting, breast milk allergy and soy allergy. The patient was up-to-date with HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father had a medical history of environmental allergies, asthma and sinus infections. The patient's mother had a medical history of sinus infections, environmental allergies and eczema. The patient's brother had a medical history of asthma. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Patient developed diarrhea, aches and chills after receiving the second dose of flu vaccine for the season.  Vaccine was administered by an intern under the supervision of RPh.
Patient became very hot and flushed during her 30 minute observation time following vaccine administration. Patient became tearful. She stated it felt like her throat was beginning to swell. Rapid response was called and patient was wheeled to Emergency Department with Rapid Response Team.
child received Havrix Im in left deltoid, and then was given Gardasil .5ml IM.  Immediately after Gardasil, pt experienced arm tingling, followed by flushing, diaphoresis, "Couldn't see", nausea and emesis x1.  Symptoms resolved within < 5 minutes and left office feeling "perfectly fine"  No treatment necessary.  Felt tired the following day but otherwise no residual symptoms, nor any vaccine site localized rash/swelling.
I went on June 14 2022 and recieved my first dose of the Covid19 vaccine and after approx 4 days I started to feel the top shoulder bone in my left shoulder on the same arm as I recieved the vaccine.  On my next visit on July 12 2022 to get the second dose, I told the technician that was administering the shots that my shoulder bone felt bruised like I was hit on top of the shoulder with a metal bar or something  hard like that and I asked if I should report my symptoms and he advised me not to.      Sometime late in the month of July or early August, I had an appointment with my primary care physician and mentioned my symptoms to him and he said the pain should go away in a few weeks and that the vaccine may have entered my bone marrow.  I also asked if I should report my symptoms to the FDA or other officials and he also advised not to report and said that if my pain did not improve he will send me to a specialist to get steroid injections. So as of today's date I decided to report my side effects to you. I don't know if the vaccine has given me irreversable side effects, but I would like to get an answer from someone on my next course of action.
Staring in late April, 2021 I started to have incidents of falling.  I have fallen once in April and five times in June, 2021.  For the majority of the falls, I could not pinpoint a cause for the fall (no tripping etc.) and it happens without warning and so suddenly that I can't prepare for the fall.  I didn't even realize I was falling until I was on the ground in one instance.  In addition, I experienced vision loss for about 20 minutes on or about June 12, 2021.  Based on my description, my ophthalmologist believed I had a visual migraine.  I have never had anything like this previously.
Pt fainted in waiting area chair - was on floor - had her lie down and elevate feet, once she felt better we moved to IMZ booth for privacy and she fainted again and did not fall out of chair - called 911
Initial report received from a health care professional on 10 November 2014. A 41-year-old female patient, had received an intramuscular dose of FLUZONE vaccine (lot number: UI200AB, expiry date- 30 June 2015) in left deltoid on 10 October 2014. The patient illness at the time of vaccination was unknown. The patient pre-existing physician diagnosed allergies, birth defects and medical conditions was unknown. It was reported that patient had received flu shot yearly. On 10 October 20014 i.e. same day after vaccination patient had experienced Pain and swelling with soreness in left arm since vaccination and now hard to move arm without pain which increased from 2/3 at rest to 8/10 when moving. Has weakness in the left arm. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was not recovered. Documents held by sender: None. Followup information received from a healthcare professional on 23 January 2015. It was reported that patient was seen once on 8 September 2013.
I experienced a very sore arm approximately 5 hours after injection. Later that evening I had shivering, muscle and joint pain, light-headedness and headache. These effects continued until the morning of Feb. 10, 2022.
Generalized tonic-clonic seizure lasting 10-12 minutes, fever to 103.0.
1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - severe x 2  days 3. Muscle/joint pain entire body and injection site - moderate x 2 days; mild continuous; 4. Fever, chills x 1.5 day 5. Fatigue - mild ongoing; 6. Swollen lymph node in neck on the left side (same side received injection).
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue and sickness. On an unknown date, the outcome of the fatigue and sickness were recovered/resolved. It was unknown if the reporter considered the fatigue and sickness to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter stated that the day after his/her second shingrix shot he/she woke feeling very fatigued and had to call out sick from work. The reporter wanted to know how long, on average, these side effects last. Consent to follow-up was requested.
Stroke (blood in the brain); heavy legs; not feeling himself; difficulty walking secondary to stroke; Bad Headache; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who experienced bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, and not feeling himself.    The patient's medical history included atrial fibrillation (A-Fib) four years ago. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included blood thinners.   On 10 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient experienced a headache.   On 28 Jan 2021, he reported having a bad headache, heavy legs and was not feeling himself. On 29 Jan 2021, the patient was admitted to the hospital and was told he had a stroke (blood in the brain). Patient was discharged on 02 Feb 2021. He now has difficulty walking and is trying to walk with a walker and has to go to rehab. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The events bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, not feeling himself and headache were resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's medical history of atrial fibrillation and concomitant use of blood thinners may have been contributory for hemorrhagic stroke.