chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am the epidemiologist reporting on behalf of 69 year-old male patient.  Patient received two doses of the Pfizer vaccine, according to immunization records. The first dose was on 1/11/21 and the second was on 02/01/2021.  The patient died on 02/02/21 (one day post dose 2) in nursing home. The death certificate lists ?acute myocardial infarction? as the immediate cause of death secondary to ?hypertensive heart disease? (unknown onset). Other significant conditions contributing to death but not resulting in underlying cause include Parkinson?s disease, hypothyroidism, and hyperlipidemia.
Migraines 5 days after 1st dose Head Pressure  Tinnitus Headaches Brain Fog Eye Floaters
Break thru covid, symptoms were cough, congestion, fever for 12 hours, loss of taste and smell for 3 weeks.
Information has been received from a physician concerning a female patient (age not reported) who on 06-AUG-202 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#639488/0572L). On 20-FEB-2007 the patient developed a break through chickenpox 5 years after getting the vaccine administered to her. Patient had less than 30 lesions. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
A few hours after vaccination, I experienced noticeable sinus/nasal congestion.  The following morning, 12 hours post vaccination, I experienced sore arm,  headache and GI upset.  Those symptoms resolved completely  within 72 hours. On the morning of February 18, 2021 (8 days post vaccination), my arm become sore again at area of injection.  A  painful raised welt, about the size of half a tennis ball, developed.  About 12 hours later, the raised site became red and itchy.  The rash continued to spread over the next 24 hours to approximately 3.5? x 2.0?.  The site continued to improve daily and swelling, pain and itchiness  resolved in 5 days on February 23, 2021.  A very slight, flat, painless discoloration  was still detectable in a small area (approximately 0.5? x  1.0? until  February 26, 2021.  During this time, I used cold compress and topical Benedryl cream on the site 2x on February 19th and February 20th.
A legal complaint was received from an attorney alleging that a male child received a fourth dose of Hib-TITER on 9/3/99. He also received a series of Tripedia, Recombivax-HB, Engerix-B, Hepatitis B vaccine (manufacturer unknown) from August 1998 through November 2000. According tot he legal complaint, the child experienced mercury poisoning and toxic neurological effects due to the cumulative exposure to thimerosal in the vaccines. This case was serious since these events were considered medically important.
Severe Diarrhea with cramping lasting 2 days (so far) & chills (no fever) - took pepto bismol , hydration, brat diet, rest
This spontaneous report was received from a physician concerning to a female patient of unknown age. In July-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that a patient after received ZOSTAVAX months later in October 2012 developed a dry, itchy, red rash on her back. The outcomes of the event were unknown. The relatedness for the events were unknown for ZOSTAVAX. Additional information is not expected.
Burning sensation on rash; Face swollen; Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash; Fever; Rash became itchier; This spontaneous case was reported by a non-health professional and describes the occurrence of BURNING SENSATION (Burning sensation on rash), RASH PRURITIC (Rash became itchier), SWELLING FACE (Face swollen), RASH (Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash) and PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced RASH PRURITIC (Rash became itchier), RASH (Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash) and PYREXIA (Fever). On 01-May-2021, the patient experienced BURNING SENSATION (Burning sensation on rash) and SWELLING FACE (Face swollen). At the time of the report, BURNING SENSATION (Burning sensation on rash), RASH PRURITIC (Rash became itchier) and SWELLING FACE (Face swollen) outcome was unknown, RASH (Rash on arm/ Rash started spreading/ Rash spreaded throughout body/ Painful rash) had not resolved and PYREXIA (Fever) had resolved.            The patient was not taking any concomitant medications. The patient has not sought medical attention and no treatment information was provided.   This case was linked to MOD-2021-100584 (Patient Link).
Couldn't breath; went to the restroom and peed 4 times, too much the first night; something happened to her heart; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:50 (age at vaccination 54 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing high blood pressure. Concomitant medication(s) included amlodipine (AMLODIPINE) 5mg by mouth one time daily taken for hypertension and ongoing (started at 39 years old, increased to 10mg, then back to 5 mg; unspecified water pill (started one year ago) and ongoing taken for blood pressure was too high, fluoxetine (FLUOXETINE) 40mg, one tablet by mouth one time per day (started 3-4 years ago. Maybe 2016. Patient cannot remember). The patient previously took amoxicillin and experienced allergy (She has severe allergy to amoxicillin). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced couldn't breathe, went to the restroom and peed 4 times, too much the first night on 20Apr2021, something happened to her heart on 17Apr2021. Patient stated, she experienced a strange thing. Last night and the night before. she is overweight. 2 nights ago, she was sleeping and woke up and couldn't breathe. Her nose and mouth were stuck, and she drank water, and she was ok. It happened 2 times where she felt she couldn't breathe. It was horrible, she had to drink a little bit of water to get better. Her mouth and nose were closed and she doesn't know how it happened. It happened 2 nights ago, 4 times total. It occurred 3 times the first night and last night she didn't drink water, but the first times she needed water. Reporter added the breathing is improving but doesn't know if it will occur tonight. She traveled too long to receive her vaccination. She did not take her water pill yesterday, because she finished the medicine. she have to wait now for like 1 week. The name of the medicine starts with Tr and she cannot remember. She is a engineer, a designer. She was abused at work. They didn't expect a broken English speaking and a woman in their department. She was good at her job. After surviving 6 months, she started taking Fluoxetine. The outcome of event Couldn't breath was resolving, Frequency urination was resolved on 20Apr2021, something happened to her heart was resolved on 17Apr2021.  No follow-up attempts are possible. No further information is expected.
Protracted, inconsolable crying x 2 1/2 hrs despite APAP @ time of vax;
next day infection was warm to the touch, hard, and swelling followed by a fever.06/15/2021 patient was diagnosed with cellulitis. prescribed cesadroxil.
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Fever for 5 days, the highest over 103 degrees the 1st 3 days. Fever treated with infant TYLENOL.
Urticaria (hives) and edema (skin swelling), starting in head and neck (day 1), progressing to whole rib cage, chest, back, and groin (days 2, 3), arms, legs, and feet. Extreme itching, producing insomnia. TREATMENT: (1) Antihistamine tablets - Cetirizine, and (2) Steroidal cream.
product was stored under refrigeration and reached its allowable 31-days in the fridge on 31Aug2021 and remained in the vial under refrigeration until being diluted and given on 07Sep2021; product was stored under refrigeration and reached its allowable 31-days in the fridge on 31Aug2021 and remained in the vial under refrigeration until being diluted and given on 07Sep2021; This is a spontaneous report from a contactable Nurse reported for a patient. A 13-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Dose: 0.3 mL, Lot number: EW0178, Expiration date: 30Nov2021) intramuscular, administered in left deltoid on 07Sep2021 (age at vaccination was 13 years) as dose 1, 0.3 ml single for COVID-19 immunization. The patient's medical history was unknown. The patient's concomitant medications were not reported. The product was given in one of the satellite offices. The patient did not receive any prior vaccinations within 4 weeks and last vaccines were in 2012. The additional vaccines administered on same date of the Pfizer Suspect included first dose of HPV Vaccine (Lot number: T027789, Expiration date: 27Feb2023, administered in right deltoid), first dose Meningococcal Vaccine (Lot number: AMVA568A, Expiration date: 31May2022, administered in right deltoid) and first dose of Tdap (Lot number: E55XZ, Expiration date: 24Jun2022, administered in left deltoid). The caller reported a possible invalid dose of Comirnaty (Pfizer-BioNTech COVID-19 vaccine) for a patient. The caller reported that the product was stored under refrigeration and reached its allowable 31-days in the fridge on 31Aug2021. The product reached it's 31 days in the refrigerator on 31Aug2021 and the dose was given that day, 07Sep2021. The product was stored in the vial in the fridge before being diluted and remained in the vial under refrigeration until being diluted and given on 07Sep2021. A dose of Comirnaty given after the beyond use date to a patient. This was the first dose for the patient, he was the only patient involved. The caller asked if the dose should be readministered. The patient did not require a visit to Emergency room or Physician office. It was unknown if any relevant test were done. The case was assessed as non-serious.  Follow-up attempts are completed. No further information is expected.
Shortness of breath and GI pain 15 minutes after receiving vaccine.  Given Loratadine 10mg at office.  Still experiencing GI symptoms. Developed half dollar sized raised and painful red rash and muscle pain at injection site 24 hours post injection.  Still experiencing. Developed diarrhea 24 hours post injection.  Taking Pepto Bismol as package directs to help mitigate.  Still experiencing.
12:34pm shots administered, 12:49 pt reports hot flushing feeling in head, 12:52pm BP=149/84mmHg 73 pulse. Flushing seems to decrease, 12:56pm BP=140/85mmHg pulse is 81bpm, 1:02pm BP=107/73mmHg pulse=85bpm at this time pt feels fine no more flushing no more hot feeling in head pt feels like she did before shot given.
The patient was brought in for his 2 month well child visit which usually includes the first set of immunizations. There was no completed immunization record in the patients chart and the physician ordered the following vaccines to be given: DTAP, IPV, HIB/HEP B, PREVNAR and Rotovirus, The vaccines were given as ordered by this writer causing them to be duplicated.;No adverse reaction
Child received 0.25 mL dose instead of a full 0.5 mL; This case was reported by a nurse via call center representative and described the occurrence of underdose in a child patient who received Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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: 7-Dec-2022 Reporter's comment: The nurse reported that there was a possibility a child might had received 0.25 ml dose of FluLaval QIV instead of a full 0.5 ml dose for their first influenza vaccine.   At the time of reporting, the nurse did not had any verified information including date of administration, lot number of the dose administered, or any patient information. The reporter consented to follow-up. This is 1 of 2 linked case, reported by same reporter. Additional supportive information: The patient received might had received 0.25 ml dose of Flulaval QIV instead of a full 0.5ml  dose, which led to underdose.; Sender's Comments:  US-GSK-US2022183617:Same reporter
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: pt came to pharmacy on 5/19/2021 to show/discuss brusing and slight redness near injection site area. Patient has also experienced bruising/itching/injection site reaction (lump) to flu shot approximately 2 years ago.
"Covid arm" occured eight days after vaccination. My arm has been bruised since receiving the first dose and then starting today it is red, warm, and itchy.
Over a course of two weeks - Headache; muscle/joint pain; lethargy; fever of 100.8; redness and fist-sized swelling at injection site; rash on abdomen; scratch, sore throat; low-grade fever; congestion; cough; diarrhea; extreme dizziness
I had a breakthrough case of Covid-19 with nasal drainage and cough, feeling bad, visited urgent care, thought I had flu.
1/26 /2021 - pt went to ER for chest pain 2/9/2021 - pt received Pfizer COVID vaccine 1st dose 2/17/2021 - cardiac arrest with death
Narrative: COVID infection completion of COVID vaccine series 05/06/21 COVID vaccine dose #1 05/27/21 COVID vaccine dose #2 07/24/21 Pt denies any symptom; preop COVID swab -COVID POSITIVE 07/29/21 Pt remains asymptomatic
Significant tenderness at site of the injection for 3 days, pain when moving arm, underarm swelling
This case was reported by a nurse via call center representative and described the occurrence of pain in a 57-year-old male patient who received BOOSTRIX (batch number 3457Y, expiry date 20th May 2019). On 22nd May 2017, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 23rd May 2017, 1 days after receiving BOOSTRIX, the patient experienced pain and swelling. On 26th May 2017, the patient experienced muscle twitching. On 26th May 2017, the outcome of the pain and swelling were recovered/resolved. On an unknown date, the outcome of the muscle twitching was not recovered/not resolved. The reporter considered the pain and swelling to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the muscle twitching to be related to BOOSTRIX. Additional details were reported as follows: A patient developed bicep twitching 4 days after vaccination with BOOSTRIX. The symptoms were bothersome enough that the patient sought follow-up care from the physician who ordered the vaccine. The batch number of BOOSTRIX was corrected 345Y7 to 3457Y.
Accelerated heart rate over 100 BPM while at rest or laying down.  Heart rate is declining on day 2, but still 25% higher than normal.
Pt came in off for appt. 5-12-2021, stated that he lost his Taste and was chilling on 5-9-2021
Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 mL, injection (Oka/Merck) (lot # and route not provided). Subsequently, the patients developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Further information has been received from a school nurse who reported that a male patient was vaccinated with varicella virus vaccine live, on 15-JUN-1995. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). No further information is available.
2 days after booster dose patient experienced a self reported flare up of her TMJ with headache and earache that started on day 3 as well. She contacted her PCP and was provided with medication for these symptoms. On 12/12 (8 days after booster) she presented to the ED for acute chest/abdomen pain and was found to have acute cholecystitis requiring surgical intervention.
vial expired on 12/31/21 and was given to pt on 1/3/22, per Pfizer RN expired vaccine window is 32 days max pt is not having any s/sx of adverse reactions pt is re-scheduled for booster per Pfizer recommendation to contact cdc to have pt re-vaccinated
Baby 34 days of age and given shots for infant at least 6 weeks of age.  All immunizations were given too soon.
Pt called pharmacy 5/17/16. Reports she is having pain in her arm and shoulder. She felt shot (pain) when she received it. She has been to her doctor but he said there was nothing he could do. She also went to ER on 5/16/16 for shoulder pain. She said ER said they couldn't find anything. Pain, swelling and difficulty moving shoulder.
Since shortly after my first vaccine I have had digestive issues (intense stomach cramping that left me debilitated).  I also experienced consistent adrenal surges each day while working.
When I first woke up I had a scratchy throat and within 12 hours a dry cough and hoarseness. I had some nasal congestion and sneezing. I completed an at Home COVID-19 test on July 23 and it was positive. A Paxlovid prescription was called in by my son who is a doctor. I took the first dose the same day. The symptoms improved about 3 days later. 2 days ago the hoarseness returned so I retested and it was negative. I am still hoarse. My symptoms were very mild throughout this process similar to a common cold. I may still have the dry cough and sneezing occasionally.
Hip pain; Knee pain/Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Hip pain) and ARTHRALGIA (Knee pain/Joint pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Wheelchair user, Broken leg (Recovered) in 2010 and Shingles (Recovered) in 2010. Concurrent medical conditions included Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Hip pain) and ARTHRALGIA (Knee pain/Joint pain). At the time of the report, ARTHRITIS (Hip pain) outcome was unknown and ARTHRALGIA (Knee pain/Joint pain) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of LEG BROKE was not provided. The reporter's causality for the event(s) of KNEE AND HIP PAIN and SHINGLES with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Significant live follow up. Medical history and Moderna vaccine dosage information were updated. Hip pain was added as an event. Knee pain outcome updated. Reporter causality was updated.
Narrative: reporting due to pt recieving covid 19 vaccine within 42 days of death. pt placed on hospice care -pt had for end stage esophageal, gastric, and bladder cancers
sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date:24-MAR-2023 The case was received from the patient via interactive digital media. The patient asked did you got sick with the vaccine. The patient when got his or her second shot he or she thought that was going to have to go to the hospital, better by the next day. The follow-up could not be possible as no contact details were available.
Meningitis B # 2 was inadvertently administered at age 13.  First dose was administered 2 months earlier by another provider 2 months prior.
On 04/15/2013, patient vomited shortly after breastfeeding at 8 pm in the evening. She proceeded to vomit after her 3 feedings during the night and early morning. She was very lethargic and slept constantly, only waking to nurse, which she would then vomit up and go back to sleep again. Her father and I took her in to walk-in clinic. She was seen by Dr. who diagnosed her with a UTI. She could not keep down even a teaspoon of fluid and after no wet diapers and one diaper that contained a small amount of foul smelling, black, tarry stool, we proceeded to the ER. She was diagnosed with an intussusception and was transported via ambulance to another hospital. The night of 04/16/13, she underwent an air and contrast enema to reduce the intussusception. She was then placed on the surgical floor of the hospital for monitoring throughout the night and the next day until she could eat without vomiting and had a bowel movement. She was discharged on 4/17/2013.
inconsolable crying starting 1 to 2 hr p/vax;until AM next day;fussy & crying off & on second day;PMD called avised mom to watch child;
Pt recvd 3 doses of Engerix-B & 19NOV91 it was determined that pt did not respond to the vax series;