chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health professional refers to a patient of unknown demographics. On an unspecified date the patient was administered with expired PROQUAD (Merck), .5 ml, once, subcutaneous. No adverse events were reported. Outcome of the event was unknown. No product quality complaint (PQC) was involved. The reporter considered event to be not related to PROQUAD (Merck). Additional information has been requested. This is one of several reports received from the same reporter.
On 11/1/14 and 11/14/14 patient received PPSV23. On 10/7/21 patient received another dose of PPSV23. Series administered incorrectly.
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's past medical history was not reported. No concurrent medication was reported. On 25 June 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 28 November 2013 and estimated date of delivery was on 4 September 2014. The subject was exposed to the vaccine at 29 weeks and 4 days gestation. No adverse event was reported. At the time of reporting, the pregnancy was still ongoing. The nurse reported another case of vaccination with BOOSTRIX during pregnancy. See case A1078833A. Follow-up information received on 20 October 2014 from the health professional: The patient gave birth to female live infant at 40 weeks gestation by vaginal delivery. Birth weight was 8 lbs and APGAR scores at 1 minute and 5 minutes were 09 and 09. VAERS details were provided.
DEATH; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight, height, and medical history were not reported. As per reporter patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported.  The reported stated that presence of antibodies should be tested before taking the vaccine and taking the vaccine with covid antibodies present can kill. The patient died on an unspecified date with unknown cause of death after vaccination. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210428954 -covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
(1st dose) Pfizer on 3/1/2021 Made Peripheral Neuropathy worse  then (2nd dose) Pfizer on 3/22/21 led to Severe pain for at least 4 months. Pt. was advised from CDC to only receive J&J COVID-19 vaccine due to severe reactions from previous doses CDC approval also to give 2nd booster J&J
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was hospitalized for a twisted intestine on an unspecified date. The outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: The information is limited. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
The patient underwent lab tests and procedures which included SARs-cov-2 test results positive for PCR test on unspecified date.; had a positive PCR COVID test; This is a spontaneous report received from a contactable consumer or other non-health care professional via a Pfizer sales representative. A 74-years-old female patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and first dose on unspecified date and unspecified route of administration both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced positive for PCR covid test after the second dose administration of Pfizer covid vaccine. The patient underwent lab tests and procedures which included SARs-cov-2 test results positive for PCR test on unspecified date. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
The morning after getting the shot, I woke up feeling very weak. A few hours later I began to show fever symptoms (sensitive skin, shaking, 99.5 temp).
Bell's palsey/ facial droop; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 15th May 2021) and (batch number 3393R, expiry date 15th May 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was recovering/resolving.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. Three months before, the patient received a dose of Shingrix on her left arm and 3 days later she developed transient bell's palsey on her right side. The patient has minimal residual till the time of reporting. The health care professionals texted to MIS for discussion of potential other related reports. There is a discrepancy with respect to the outcome of the events Bell's palsy. In Argus core the outcome is reported as recovering/resolving, however in provided source document it is fatal. The outcome of these events retains as per the Argus structural field. As per global ales data sheet, the batch number was updated from L273BZ to 273BZ
Pt given vaccine on 11/4/08, returned to clinic on 11/7/08 with papular, vesicular rash on left side of neck and both hands.
Hives developed and were noticed at about 6:00 pm. BENADRYL was administered. Itching subsided but splotches still there and still remain in the morning 11/10/2016 more meds given for itching.
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 06-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature exucrsion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
nonhemorrhagic cva pt improving after hospitalization, then rehab stay, then home therapies (pt/ot/speech). still dysarthric. r sided weakness improving
On 8/17/2016 had first reaction swelling redness hot to touch doc said apply ice give day or two by 08/19/2016 gone. On 8/20/2016 was hospitalized after suffering a small seizure and calling 911 at hospital had a grand mal seizure.
had hives on her face that lasted a day and a half; It was itchy and annoying but they weren't severe; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.  A 50-unit-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose1, single for covid-19 immunisation. Medical history included allergic to morphine and got itchy, got hives, allergic to penicillin and got itchy, got hives, and ended up in urgent care and allergic to adhesive tape. The patient concomitant medications were not reported. The patient previously took morphine and (benzylpenicillin sodium) PENICILLIN and experienced itchy and hives. On an unspecified date, the patient experienced had hives on her face that lasted a day and a half and it was itchy and annoying but they were not severe. The caller stated she received the first dose of the vaccine and was due for her second dose tomorrow at 13.21. She stated 3 days after the first vaccine she had hives on her face that lasted a day and a half. It was itchy and annoying but they were not severe. She stated she was getting conflicting information on if she should get her second dose. She stated that her primary care was saying yes to get the second dose, another physician (a psychiatrist) said she should not get it, and the pharmacist said it was a gray area since she had a delayed reaction. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 101, aches, headache, sore throat, and extreme fatigue.
Moderna COVID 19 Vaccine EUA Patient stated "my red spot was about 4 inches at it's largest. It was red, warm and painful. Redness lasted about 72 hours. Slight fever of 100.6 on 12-31-20, with next day having fatigue, body aches and diarrhea. Starting 1-1-21 no fever or diarrhea, but fatigued and body aches. 1-2-21 - bodyaches
Involuntary movement of left arm (in same arm) as immunization given for less than 5 mins.
Moderna COVID-19 Vaccine EUA Fever, shivering, sweating, nausea, headache, extreme fatigue, loss of appetite, and general malaise beginning approximately 12 hours after injection, and persisting for the next 24 hours.  Swelling , soreness, and redness near injection site are still present at 40+ hours after injection.  OTC cold medicine (Alka-Seltzer Plus Day and Night), and PLENTY of rest (I must have slept 24 out of the last 48 hours) were the only treatments used. Note: Adverse reactions to the first dose, on 3/25/2021, were limited to the symptoms at the injection site, as noted above.
Swollen glands , chills, muscle and joint ache, fatigue, pain at injection site.  No appetite; couldn't tolerate morning coffee.  This started the morning after the second vaccine.  There were no symptoms at the first vaccine.    Note:  NO fever joint ache seemed to travel throughout the day; started at elbow and wrist on right side, then moved to ribs. Stayed in bed most of the day, drank lots of water (> 64 oz.), ate some soup, and slept more than 12 hours. Felt better the next day, no chills or joint aches.  glands were less swollen, but still fatigued.  Still drinking water and soup.   By about 40 hours after the vaccine, felt normal.   No symptoms  Life returned to normal
she asymptomatically tested positive; she asymptomatically tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 44 years 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), ASYMPTOMATIC COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "she asymptomatically tested positive". The patient underwent the following laboratory tests and procedures: Home AG: (09May2022) Positive, notes: COID test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of asymptomatic covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
4 Month old female returned to the office at 1:30 reporting an unusual episode: @ 1:00 pm today mom reported that pt was in car seat and started screaming mom got her out of the car seat and pt became lethargic and pale. Unable to keep her awake. Episode lasted 5 mins or so. Checked Pulse and O2 in office. HR of 146 and O2% of 97 temp 98.8r
Left sided headache, sharp pain behind left eye 1 day after vaccine.  5 days post vaccine, lightheaded, heart palpitations, dizzy, with headache. Saw MD the next day was treated with ketorolac and sumatriptan with no relief, covid tested negative. Returned to doctors multiple times due to the same symptoms that were intensifying in severity. Treated with antibiotics, steroids, gabapentin etc. saw a neurologist after MRI and was ordered a CT brain scan, showed no abnormalities. Saw an ENT with no significant findings. Received 2nd dose on advice from multiple healthcare providers. Symptoms started to decrease in intensity in April but never fully lost the feeling of brain fog. July symptoms returned very significantly and has effected my ability to focus. Currently being evaluated by a cardiologist.
Information has been received from a physician concerning a patient (age, gender, medical history and concomitant medication use not specified). The physician reported that on 13-JAN-2015 the patient was vaccinated with PEDVAXHIB (lot # J000564, expiration date 02NOV2015), .5 ml, intramuscularly, that had been improperly stored. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
SYMPTOMS: RIGHT SHOULDER joint continued pain, LOSS of full range of motion of RIGHT SHOULDER, ongoing.  TREATMENT: Topical rubs, Advil, Aleve, IBU, Tylenol, Heat, Cold compresses TIME COURSE: 2 DAY after first dose, ongoing and continues to hurt daily around the clock
went to ER after experiencing heart palpitations; shortness of breath; heart racing; irregular heartbeat; blood pressure drop; increased blood pressure
initial event: 7am morning after injection- fever, heaviness of limbs, sleeping, eyes sensitive to light.  2nd morning after, these symptoms subsided, but swelling and sensitivity in axillary lymph nodes, especially on right side. This has continued for 18 days.  At 14 days, severe outbreak of herpes simplex. First such outbreak after 30 years of no recurrence, and no concurrent triggers such as menstruation, alcohol consumption, sexual intercourse, etc
Swelling and itching of the lymph glands of both armpits; under the lower jaw area by the ears, too. That lasted about a week and then faded. Emailed the doctor and there was no treatment. I was about ready to start taking Claritin because of seasonal allergies so I started taking Claritin for the seasonal allergies.
Headache, Myalgia, Arthralgia, Diarrhea,  fatigue
Patient had Guillain-Barre syndrome requiring hospitalization and IVIG. Followed up by rehabilitation.  Symptoms started approximately 3 days after immunization with bilateral lower extremity weakness was started on steroids as an outpatient. With one-week patient was noted to have progressive bilateral weakness, numbness and progressed to ascending paralysis with bowel and bladder incontinence.
Headache; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received second dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer), batch/lot no. and expiration date not provided, via an unspecified route of administration (vaccination location: left arm) on 21Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included sinus tachycardia and Pvc (premature ventricular contractions). He had no allergies to medications, food, or other products. Concomitant medication included atenolol. Historical vaccine included first dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer) for covid-19 immunization on 31Dec2020 09:15 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered at a hospital. The patient experienced headache 24-36 hours, fever at 36 hours, fatigue, and nausea on 21Jan2021 05:00 PM. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Generalized feeling of being ill.  Greater sensitivity to pain in right index finger which is arthritic; Stomach upset.  Oral body temp 97.3. Chills
Left thigh 4 x 5 inch redness, with induration 3 x 4, skin mottled. Right thigh redness 2 in below injection site 2 x 2 area, no induration.  No fever.  appeared after night bath.
HPV9 #1 was given. 6 hrs after administration, pt. developed hives all over her body, worse on torso. BENADRYL was given with some relief. Significantly better after 24 hrs, resolved after 48 hrs.
Pt recvd Engerix-B 9NOV91 & 11NOV91 pt came to ER w/hives, lip swelling, dry mouth & intense itching; tx w/DPH & Pred; pt spent some time in ER but was not hospitalized; 18NOV91 pt returned to ER again w/hives- told poss vax rxn;
She is nursing her baby states her breast milk dried up after she received her flu vaccine baby is 2 months old.
This spontaneous report as received from a physician refers to a 65 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 18-DEC-2009. No other co-suspects were reported. There were no concomitant medications. On 23-JUL-2012 the patient was having joint and muscle pain from knees to groin area. No treatment was given for the events. The patient sought unspecified medical attention. The outcome of joint and muscle pain from knees to groin area was unknown. The relatedness for the reported events was unknown for ZOSTAVAX. Additional information is not expected.
Fever 102.9 for 8 hours, nothing would bring it down! Felt like I got hot by a speeding train for 5 days... had huge (softball size) hard, very painful mass in left armpit to side boob
fever; chills; feeling tired; muscle soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (muscle soreness at the injection site), PYREXIA (fever), CHILLS (chills) and FATIGUE (feeling tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Blood pressure.    On 21-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021 at 12:00 PM, the patient experienced VACCINATION SITE PAIN (muscle soreness at the injection site). On 22-Jan-2021 at 2:00 AM, the patient experienced PYREXIA (fever), CHILLS (chills) and FATIGUE (feeling tired). On 22-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE PAIN (muscle soreness at the injection site), CHILLS (chills) and FATIGUE (feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided. Treatment included For the symptoms he took 2 sets of Tylenol on 21Jan2021 at noon, 2 sets of Tylenol that same day on the evening, and 2 sets of Tylenol on 22Jan2021 at 2am. General medications: for his allergies and for his blood pressure. FM 22Jan2021
Vaccine administered,pt. states "I feel dizzy"  Had near syncopal episode.  Mom and patient helped him to lie down.  I came in and he was pale and diaphoretic but awake and lucid.  After 5 min we sat him up, bp was 108/72, pulse 78.  He took water and stated I want McDonalds.  Normal color, no longer diaphoretic.  Stood and walked without dizziness.  Mom relates , "this is the third time this has happened", and it happens to his sister too.
It was noted that the pharmacy had an extra adjuvant in stock and so we gathered that a diluent was used in combination with the antigen.  It was incorrectly reconstituted
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent.  Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
A nurse reported the occurrence of irritability in a 18-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manufacturer unknown) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  The subject experienced no adverse events following previous immunizations.  On an unspecified date, the subject received her fourth injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manufacturer unknown).  At an unspecified time on the day of immunization, the subject experienced "extreme" irritability.  The mother described the subject as being "really loving and hugging her one minute and then the next minute the child turned evil.  She would start hitting and fussing."  The event continued for two days and then resolved.  The reporting nurse considered the event to be possibly related to vaccine administration.
at 8:45 patient reported that the "site itches" and reported it was "hard to breath". Patient insturected to "take a deep breath". She had her own benadryl and took it. Given epinephrine at 8:50 AM. BP was 140/84 and pulse was 64. At 8:55 patient reported relief from hard to breathe. Ambulance arrived at 9:00 AM.
Inadvertently gave the 3rd dose 2 days after the 2nd dose (of Gardasil).
redness, swelling, and pruritus at injection site, both vaccines were given in same arm
Within about 5 minutes of patient receiving the vaccine, she began to feel dizzy and nausea.  She proceeded to have several episodes of vomiting afterward.  She was treated with oral Benadryl 25mg PO x1, but vomited afterward.  She was later administered Benadryl 25mg IM x1 and Zofran 4mg ODT x1 with improvement in her symptoms.  Vital signs remained stable throughout 2 hours of observation and she was discharged home.  Subsequent telephone follow-up indicated patient's initial symptoms continued to improve by the evening and the following day.  Patient never developed syncope, rash/hives/SOB/lip, tongue or throat swelling.