chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 07/11/06 at 10:30AM received 12 mo vaccines, Hib, Pneumococcal (PCV 7) and MMR. On 07/15/06 in the evening child started a fever. Temp reached 102 and alternating with Tylenol and Motrin temp was 99.8. Stopped Motrin and Tylenol evening of 7/18/06 and temp 99.3. Mottled rash noted across nose and neck. 7/20/06 Rash over entire body.
Severe headaches for 3 nights prior to vaccine (same as headaches periodically following COVID-19 illness), "hauled butt" for 90 minutes after vaccine moving furniture, then fatigue, back pain, jaw pain, light chest pain, given 3 - 81 mg ASA, taken to ED, transferred to care center, eventually 3 stents placed 2/19, discharged 2/20.
Stopped making eye contact, no longer cooing or smiling, not responding to parents.  Slept a lot.  No fevers. Poor eating.  Also with jerky movements during sleep and occ during day.  His voice also seemed "hoarse" with an occ cough and some congestion.  Whimpering while sleeping.
I got a small red dot on my face that in 20 minutes tuned into a rash on my whole face and some on my chest . I went to the hospital and they gave me a benadryl and had me sit their for 30 minutes and send me home.
Cried on and off for four days, did not sleep for 13 hours day after vaccines were administered, and when he did sleep, he woke up screaming.
Might have cancer; Inability to walk; Inability to walk or stand without a cane and great difficulty; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (after the vaccination), the patient experienced inability to walk or stand without a cane and great difficulty, might have cancer, and needs physical therapy. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Increase in resting heart rate from the 60?s per minute to 100+. First aware of this 2/1/2021. Persisted until May, 2021.  Extra heart beats began in January and persisted until new RX, Metoprolol, started  June 9, 2021
immed following vax pt felt pins & needles on anterior forearm & hand;also felt pins & needles in lt anterior thigh, calf, foot & lt side of jaw;8hr later arm swelled & was hot to touch;224hr p/vax had a 15cm x 10cm raised welt about
Chest cold; Flu; Hard welt that burned at the injection site; Sore arm; Diarrhea; Exhausted; welt at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Chest cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Sjogren's.   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, 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 experienced LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), INFLUENZA (Flu), VACCINATION SITE PAIN (Hard welt that burned at the injection site), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and INJECTION SITE URTICARIA (welt at the injection site). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown and INFLUENZA (Flu), VACCINATION SITE PAIN (Hard welt that burned at the injection site), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and INJECTION SITE URTICARIA (welt at the injection site) had not resolved.            Treatment included Gluten free diet. Concomitant medications were not provided.   This case was linked to MOD-2021-099463 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional info-2 On 03-May-2021: Initial additional - NNI; Sender's Comments: Limited information regarding the events has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 included: "T1 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: HUMALOG; LEVEMIR; NP THYROID; ROSUVASTATIN; OMEPRAZOLE. Past drug history included: Urushiol, reaction(s): "Known allergies: anything containing Urushiol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti viral from 17Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concomitant condition, medical history or allergy/drug reactions were reported. On 26-AUG-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
After patient took the first shot for 2 weeks,  he suddenly could not breathe and hold his hist very tight in the morning while he was sleeping. My mom tried to wake him up, and he woke up and thought he was dreaming. He was fine during that time and we did not realize it might be caused by the vaccine. However, after patient  took the second shot of the vaccine for 2 days, he suddenly could not breathe again and hold his fist very tight and bite his teeth very tight while he was sleeping. We try to do the CRP for him right away and called the ambulance at the same time. We try to wake him up, but he had no consciousness. And we realized that it might be the vaccine's problem.
I experienced a 10/10 migraine, which I have never had before. This began at 6AM, the day following my 2nd dose. I had 3 occurrences of emesis around 8:30AM. I was extremely tired to the point where it was difficult to stay awake for more than 10 minutes. I slept until around 4PM. I finally was able to eat some dinner and went back to sleep around 8PM. I am finally feeling myself again as of today, Wednesday, 4 days following my shot.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer via other manufacturer Novavax concerned a male of unspecified age, race and ethnic origin. Initial information was processed with the additional information received on 18-AUG-2022. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose was not reported, administered on 01-MAY-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose was not reported, administered on 01-NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2022, the patient had blood tests that showed no antibodies (confirmed immunological vaccine failure) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246992.; Sender's Comments: V0: 20220834612-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
within 3 mins of vax, alerted that patient passed by store staff. EMS contacted and arrived within 5 mins. paramedic reported heart rate=80bpm and BP=80/40. Patient sent to hospital by ambulance
The evening I received the vaccine my blood pressure dropped way down.   The next day it started climbing back to normal.  The problem was it kept climbing for the next 3 weeks.  When I checked into the hospital my blood pressure was 220/105 and enzyme levels were elevated but EKG showed no blockage.  The doctor said I was having a heart attack and was transported to the hospital .
Possible neck swelling; Possible difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Possible neck swelling) and DYSPNOEA (Possible difficulty breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Possible neck swelling) and DYSPNOEA (Possible difficulty breathing). At the time of the report, SWELLING (Possible neck swelling) and DYSPNOEA (Possible difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   Reporter did not allow further contact
Shoulder pain since time of injection never went away. Pain continues at external rotation and flexion up to 8/10. Referral to ortho and PT.
About 24hours after the vaccine I had 3 nights of fever with severe sweats causing me to have to change my bedsheets each morning d/t all the excessive sweating.  I had injection site pain in the arm that lasted about a week and all symptoms subsided on their own.
Cried continuously for 3-4 hrs p/DTP/OPV/HIB on 18JUN91; could not be comforted;
First I got a sore throat and felt really tired. Next, I woke up with a headache and a low-grade fever that lasted most of the day.
Systemic: menstural bleeding-Medium, Additional Details: patient noted menstural bleeding, and she hasn't had her period in a few years
Systemic: fainted-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with VARIVAX (dose, lot# were not reported) which were exposed to temperature excursion of 21F for 15 hours. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Large area of induration and erythema at innoculation site that has persisted for 9 days.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 58-year-old, adult, male patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, batch number: 252235, expiry date: 30-Jun-2019, route of administration and anatomical location: not reported]. At the time of this report, no adverse events were reported. This case: 201804683 was cross-linked to the source case: 201804657 reported by the same reporter.
muscle spasm; local soreness but I could move, it is like a muscle strain; could not swim, could not play tennis, do usual activities could not open the refrigerator door; sick; Received first dose 2 weeks before instead of the recommended 3 weeks period; Tension and soreness in the back of the shoulder; This is a spontaneous report received from a contactable female consumer reported for herself via Medical Information Team. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on 12Feb2021 at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose 2 weeks before that, on 29Jan2021. Instead of the recommended 3-week period. The soreness in the back of the shoulder next day felt pretty sick, on Saturday. By Sunday felt better. A couple weeks went by and she had inflammation on the top of her left shoulder felt like it moved to her neck, ended up having shooting pains at night, it kind of went away she said she got this soreness went down to her side; had muscles spams, could not swim, could not play tennis, do usual activities could not open the refrigerator door. The patient stated that she experienced after second dose of the vaccine tension and soreness in the back of my shoulder one and a half days felt really sick, was fine for a couple weeks and then all of a sudden, it started; first the left side then right side and the neck, kind of a muscle spasm in the back-behind of the right armpit, down there is local soreness but I could move, it is like a muscle strain. The outcome of event pretty sick was recovered, for other events the outcome was unknown.  Information on the lot/batch number has been requested.
patient was given PNEUMOVAX23 that was recalled; Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 08-OCT-2020, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036495, expiration date 13-SEP-2021, 0.5 milliliter; route was not reported) that was recalled for prophylaxis (recalled product administered and product storage error). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
a dose of GARDASIL 9 was administered during a temperature excursion; No additional adverse events reported; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. No information regarding the patients' pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies was provided.  On 11-NOV-2020, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 mL (lot #S008153 was considered valid, expiration date reported and validated as 20-NOV-2021; dose number, route of administration and anatomical injection site were not reported) for prophylaxis. It was reported that on that date, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was exposed to a temperature excursion of 48.8 Fahrenheit (F) degrees and 32.7 F degrees for 47 hours and 15 minutes. No Digital Data logger was reported. No additionally adverse events (AE)/ product quality complains (PQC) reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
SOB with & without exertion, rhonchi, increased fatigue, wheezing; tx: Albuterol, antibiotic, Prednisone (low dose). Others with similar symptoms (employees) with a few hospitalized & others with continuous treatment currently. No cont. meds needed for me.
Patient received Pfizer 5 to 11 vaccine instead of adult vaccine.  Vaccine was mixed as if it were adult vaccine and 0.3mL administered
PT had moderna covid 19 vaccination first dose at 6:27 PM and was sent to observation area for 30 minutes due to multiple reported allegies by the patient At 6:42 PM pt started having hives and itching symptoms. At 6:53 PM code cart opened and Benadryl 25 mg po x 1 dose given at this time BP: 138/86 mmHg and HR 74 Bpm At 7:00 PM. Pt started feeling better and stated she has similar symptoms when she takes certain antibiotics At this time BP:136/86 mmHg HR: 72 Bpm As pt was feeling much better, she was sent home with her husband whom will be driving
A patient under 50 years old presented to the pharmacy for a fourth booster dose. A fourth dose of the Pfizer COVID vaccine was administered 7/26/2022. However, it appears she was not strictly eligible for the 4th dose based on her age and comorbidities. Spoke to patient and there are no reported adverse effects or other concerns at this time.
Per Dr.'s note on 3/12 "Dad relates that he was holding fussy patient during this time when she had what he thought was a seizure and he ended up calling 911 and they brought her via ambulance to regional Hospital emergency room. There she had an additional seizure that lasted about 3-1/2 minutes. They started an evaluation with blood and urine, Medical Center pediatrics was consulted and the initial plan was her to be admitted for overnight observation. She then had an additional seizure lasting 2 minutes and a decision at that point was made to transfer her to Medical Center." Prior to transfer she had an LP which was reassuring, she was loaded on KEPPRA and transported to location. In route she received an IM dose of ceftriaxone. For additional history see Medical Center discharge note. Patient ended up having a full evaluation at Medical Center which included an EEG and an MRI of her brain. There had been some prior question about abnormalities of the spinal cord and as a result the MRI also included her spine. These were read as being completely normal. On the MRI however, patient had some evidence of cysts on her right lobe of her liver. Pediatric surgery was consulted with recommendation for follow-up ultrasound on her liver in 3 months. There had been some concerns about her ovaries and urinary tract and pediatric urology (who would been involved previously as patient has had bilateral hydronephrosis and ureters and bilateral ureteroceles that have been drained) but on review it was felt as though this was considered normal. The patient has been on prophylactic MACRODANTIN on a daily basis since soon after birth. She had a recent dose adjustment for her weight last week. She has pediatric urology follow-up with Dr. in location in August 2019. Dad reports that since discharge she has done well. She got back to location about 3 nights ago. The first night she had some increased fussiness but after that there have been no concerns. She has had normal P.O. intake, urine output and stooling. She has had normal activity without runny nose, cough nor fever."
When I got the shot approximately within a week I thought I was getting a cold and I noticed I was short of breath I let it go longer than I should but husband was sick, anyways I made an appointment with my primary doctor, my blood pressure was taken and it was 180 over 102 with a pulse rate of 122, they told my husband to take me to the hospital my blood pressure 190 over 129 and pulse was 138. I was put on heart medicine and a drip unsure what it was but I was admitted to the hospital on 12/14/2022 and released on 12/17/2022 a Heart catheter showed no blockage. Diagnosis was Arterial Fibrillation in addition chronic heart failure chronic systolic non ischemic cardio myopathy injection flow of twenty five percent. Was also fitted for a fibrillatory and heart vest. I was told I am a candidate for sudden cardiac death.
Soreness tightness in arm, shoulder, neck, hands and chest, fever, flushed skin.
Left sided facial numbness (ear, oracle, earlobe, cheek, jaw).Timeframe going on 25 hours and not yet resolved.
A spontaneous report was received from a consumer concerning a female patient. On an unknown date, the patient received nasal FLUMIST(intranasal). It was reported that the patient had FLUMIST a few years ago and had allergies (preferred term: hypersensitivity) ever since. The outcome of allergies was unknown. The reporter considered allergies to be non-serious.
Pt report night sweat. Gown and bed sheet was wet with seat. Temperature taken, 36.8C, no fever noted. Only 1 occurence occurred, pt denies further occurrence.
Experienced loss of function on right side of body including arm from shoulder down the right side of body to calf area of leg. Experienced numbness and tingling. Blood pressure rapidly rose to 232/128 when checked at hospital ER.  (Patient had Covid-19 in July of 2020)
09Dtap given on 09/17/07.  Mother called on 9/19/07 to report excessive swelling from hip to knee, slightly warm to the touch and "firm".  Fever x 2days-highest was 100.8 degrees.  Swelling has decreased slightly.  Tried to apply cool compress but baby wouldn't allow it to stay on area.  Denies any changes in behavior, eating or sleeping habits.  Has been taking Tylenol prn.
Pt received first dose of ROTATEQ at age 7 mos. - No adverse reactions anticipated/occurred.