chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started experiencing  some light-headedness the Saturday after vaccine.  Mainly when bending over and exerting any type of energy.  On Sunday, this worsened and the most extreme/sudden headache came on while at grocery store to the point I started spinning and almost fainted.  These symptoms only became more intense on Monday 9/20, so I went to Urgent Care.  They were a bit concerned because I had just had the vaccine, so they drew some blood and did an EKG.  Everything appeared normal for the most part, so they advised me if things don't get better to go to ER and get a CT scan.    Things did not improve, and I also started experiencing some chest pain, so I went to ER on Tuesday 9/22.  They were also concerned  by symptoms due to the fact that I had just received the Janssen vaccine, so they decide to take a bunch of bloodwork, a CT, and an EKG.  The CT came back okay, but the EKG came back abnormal.  The doctor indicated that he would be very concerned if I was an overweight 60 year old man who smoked.  Not the case, but this was still a bit concerning.  He did release me and informed me to follow up within the next month with a primary doctor to have another EKG done.
STOMACH ACHE; BODY ACHES; HARD TO BREATH; NASAL CONGESTION; SHAKES; LIGHT HEADED; LOST TASTE FOR A LITTLE BIT; BODY CHILLS; FEVER; This spontaneous report received from a patient concerned a 21 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinach allergy, alcohol consumer, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 17-DEC-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, the patient experienced stomach ache, body aches, hard to breath, nasal congestion, shakes, light headed, lost taste for a little bit, body chills, and fever. Laboratory data included: Body temperature (NR: not provided) 100.5 degrees F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from stomach ache, body aches, hard to breath, nasal congestion, light headed, body chills, lost taste for a little bit, and shakes. This report was non-serious.
Herpes zoster reaction 2 days post exposure to vaccine on same arm as vaccine afebrile treated with valcyclovir, vaccine given 1/29/16.
Pt recvd vax & w/in 1-5 mins pt exp burning, wrist to hand & pain which lasted 40 mins; pt took 2 Advil;
Resident was found on the floor by housekeeping.  He was not breathing and had no pulse.  He had a laceration to his nose and blood was coming out of his nose and mouth.  Nurses did CPR on him and sent him to Regional Health Center ER.  He was pronounced dead at the ER.  He was last seen sitting up on the side of his bed by the CMA when she took him his medications.  He was stable with normal vital signs.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient experienced Covid on an unspecified date. The patient received PAXLOVID as treatment of COVID-19 from 07Jul2022 to 11Jul2022. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect drug BNT162B2 cannot be excluded.
This spontaneous report was received from a healthcare worker (immunization administrator) concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of GARDASIL (Lot # not provided) which were exposed a supported temperature excursion, continued to be administered to unspecified patients on unspecified dates since 07-AUG-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for Atrial fibrillation with RVR within 6 weeks of receiving covid vaccination.
11 days after receiving the booster shot, I started with hives on my hands, neck, chest and scalp. The hives have continued every day since. They come and go on different areas of the body throughout the day.
I had pains on my right shoulder for more than two weeks, I had to see my primary Doctor after I had vaccination done at parking site.
mild stenosis/ burning sensation and numbness in legs and hands/still in pain; Heart palpitations; muscle spasms in the hands; This spontaneous case was reported by a non-health professional and describes the occurrence of STENOSIS (mild stenosis/ burning sensation and numbness in legs and hands/still in pain), PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (muscle spasms in the hands) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced STENOSIS (mild stenosis/ burning sensation and numbness in legs and hands/still in pain), PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (muscle spasms in the hands). The patient was treated with Physical therapy (Physiotherapy) for Stenosis. At the time of the report, STENOSIS (mild stenosis/ burning sensation and numbness in legs and hands/still in pain) had not resolved and PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (muscle spasms in the hands) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: No specific issue showed up in lab reports. On an unknown date, Magnetic resonance imaging: MRI was normal with diagnosis of mild stenosis.         No concomitant medication information was reported.  The patient received second booster dose of Moderna vaccine in Oct-2022, and after 4 days of administration, he got burning sensation and numbness in legs and hands, heart palpitations and muscle spasms in the hands.  The patient consulted with the physicians.  The patient was still in pain and being treated with heavy pain medications and was also on physiotherapy.
arm became hurt; swollen like a size of her palm under the area where she got the shot; redness and feeling hot; redness and feeling hot; sometimes irritable when sleeping; This is a spontaneous report from a contactable consumer (patient herself). An 89-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 09Jun2021 as 2nd dose, single dose (at the age of 89-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 19May2021 as 1st dose, single dose for COVID-19 immunization. Patient had no reaction on previous exposure to vaccine (first dose). Patient took the 2nd dose of the PFIZER COVID 19 vaccine on 09Jun2021. On the night, when she had the 2nd shot her arm became hurt, felt it was swollen like a size of her palm under the area where she got the shot, redness and feeling hot, sometimes irritable when sleeping. She wanted to know if these were the reported side effects of the vaccine.  The outcome of the events was unknown.   Follow-up attempts are possible. Further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and current condition was not reported. On 17-NOV-2014 the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
4/24/14 Morning began w/ rash in groin area and down upper legs. One larger red spot on abd. (+) itching (-) fever.
Sweats, chills, body aches, joint pain, headache, fatigue, severe site injection pain, 24 hour duration
patient fainted in the observation room after vaccine was given, brought to EMS room via Wheelchair. States this happens every time he gets a shot. Allowed to rest and given water discharged in stable condition @ 930am
nauseous; Diarrhoea.; Tired; Feel sick; This is a spontaneous report received from a contactable consumer, the patient. A 50-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in right arm on 20Mar2021 at 09:30 hours (at the age of 50-years-old) as single dose, for COVID-19 immunisation. Medical history included breast cancer stage IV. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 20Mar2021 at 10:30 hours, the patient experienced nauseous, diarrhoea, tiredness and feeling sick. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events nauseous, diarrhoea, tiredness and feeling sick were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from nurse practitioner referring to multiple unspecified patients of unknown age. No pertinent medical history and concurrent conditions reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. Additional information has been requested.
Itching rash hive covering body, back, legs arms stomach breasts, still experiencing symptoms of hives for 8 plus days Treatment calamine lotion, and Zertec  Also experienced two TIAs after both shots
Local swelling at injection site that continued to increase to severe redness, swelling and hot to touch.  Given cephalexin and triamcinolone cream to inject site.
On day 1 post vaccination, patient presented nausea, vomiting times 3, fever, muscle aches and pains, weakness and moderate pain on both vaccination sites. No erythema or swelling. On day 2 post vaccination, developed headache (migraine type) and vomiting times 1. IV fluid administered and bed rest.
Elevated temp (102) 15 min p/receiving vax; lethargic but no convulsions; highest temp 104.5; hosp 12 hrs p/rec. vax; dismissed 24 hrs later;
Patient states that since she received her COVID vaccine on 1/7/2021 she has been experiencing migraine headaches causing her to miss several days of work.  Patient indicates that her first headache was the evening , a few hours after receiving her vaccine.  Patient indicates that she has missed several days of work due to migraine headaches.
patient had headache immediately after receiving vaccine as she was in her post vaccine waiting period.  Over the next couple of days, she has developed numbness and tingling in the same side of her face as the side she received the vaccine
This spontaneous report was received from a 58 year old female patient, regarding herself. Concomitant medication was reported as "blood-pressure". Pertinent medical history and drug reactions/allergies were none. On 02-MAY-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot #, expiry date, route of administration were unspecified). On 04-MAY-2016 (two days after being administered vaccine), the patient developed a headache and was currently experiencing injection site reactions which included: redness, swelling and "heat" around the injection site. Lab diagnostics studies performed were none. Therapy with ZOSTAVAX was continued. The outcome of headache was recovered (dissipated) after taking TYLENOL. The outcome of injection site reactions was not recovered. Causality assessment was not provided. The patient did not seek medical attention. No product quality complaint (PQC) was involved. No further adverse event information was provided. Additional information has been requested.
Information has been received from a registered nurse concerning a 7 year old male who on 20-JUN-2003 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot#, site of administration unknown) and a dose of PREVNAR. On 31-JUL-2007 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck)  (lot# 657449/0597U) into the left arm. On 29-JUL-2009 the patient developed rash on body for a day. The physician examined and found approximately 25 lesions, afebrile. And the patient was diagnosed "probable varicella". No relevant diagnostic tests were performed. At the time of reporting the patient's rash on body persisted. Additional information has been requested.
My husband is fully vaccinated and sick with covid-19; My husband is fully vaccinated and sick with covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My husband is fully vaccinated and sick with covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient had small bump around the injection site after patient received the vaccination. She iced it and was observed in the waiting area. Swelling went down and patient went home. She had no other symptoms and was not under any distress.
I'VE BROKEN OUT IN HIVES ALL OTHER LEGS, UPPER ARMS, STOMACH AND CHEST.  I'VE BEEN USING ANTIHISTAMINE CREAM AND TAKING BENADRYL.  THERE'S BEEN NO RELIEF.
It started with swelling, redness, and heat at injection site pretty soon after the injection on Friday 5/21. By Sunday, 5/23, patient had instability when standing and walking; her dementia had gotten worse; there was edema in her whole right arm; and she started having tremors.  She was brought to Hospital by ambulance that afternoon and has since had decreased appetite and thirst; continuing swelling at injection site and in her whole right arm; terrible tremors; very low oxygen levels; and is almost comatose. The doctors there have said her kidney function has dropped to unacceptable levels and they are also monitoring her heart. She has been put on hospice care as of this time, 5/26.
Feeling anxious with elevated heart rate; vitals obtained/ stable, rest, po hydration, monitor x 30 minutes symptoms improve/ subside, "feels better" released from facility to home
Patient was vaccinated beyond use date of 5/6/2022. No symptoms reported by patient.
tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch; She can't sleep; Her quality of life is not good since then; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache) and CHILLS (chills) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had not resolved and INSOMNIA (She can't sleep) and IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Negative. On an unknown date, Magnetic resonance imaging: Negative.         No concomitant product reported by the reporter. It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the doctors kept saying they don't know enough about the COVID vaccines. They had other patients who had tinnitus. They say to wait it out and let it go away. She did wait it out and do what they were saying. Her quality of life was not good since then. that the ringing turned into a piercing sound and it's pulsating in her left ear only. It was a high pitch. It  was repetitive like a ceiling fan. It was all day. It was a high-pitched pierce. It was hard to turn it off and not think about it. No treatment medication reported by the reporter.   This case was linked to MOD-2022-685668 (Patient Link).
Dizziness, Feeling Faint, Hearing problems at time of shot. Heart palpitations, Short of breath, Cough, fatigue, arm soreness, dizziness, chills after shot.
At 14 hours post injection I experienced a fever of 103.9. Some chills, significant head ache and body aches Temperature fluctuated over the next 10-14 hours My auto check in expired before I felt well enough to respond
Gave infant PEDIARIX, Hib, PCV 13 at approx 10:15 on 8/2/12. Rec'd phone call from mother approx 3pm stating infant inconsolable since receiving shots this a.m.
Aside from sore arm, fatigue, headache which lasted a few days, the pt was taken to the ER with chest pain and was diagnosed with a new pulmonary emboli
This spontaneous report was received from a nurse who was referring to 6 unspecified patients of unknown age and gender. The patients had no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On unknown dates, 6 patients were vaccinated with PNEUMOVAX 23 lot number M042324, expiration date 10-JUN-2018, intramuscularly (dose was not reported) for prophylaxis. On unknown dates, the patients experienced swelling at the injection site to the size of an apple and pain at the injection site to the point where they were unable to sleep for one week. It was not reported if the patients received any treatment for adverse events or sought medical attention. The outcome of the events was reported as unknown. The nurse requested lot check for PNEUMOVAX 23 lot number M042324. The relatedness between adverse events and suspect therapy was not reported. Additional information has been requested.
SWELLING AT SITE WARM TO TOUCH. CONTINUE TO OBSERVE, REPORT IF NOT GETTING BETTER.
bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination.  On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
Pt had immediate pain on injection which progressively worsened over the next few days to the point she could not lift her arm.
Temperature excursion with Covid vaccine that lasted 45 minutes.; Temperature excursion with Covid vaccine that lasted 45 minutes.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "Temperature excursion with Covid vaccine that lasted 45 minutes.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.