chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered on 18 Dec 2019 a Pentacel vaccine that was delayed in transit due to bad weather/no AE; if it is needed re vaccinate someone who received 1 dose of Pentacel that went through a temperature excursion after being in transit too long/ no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  It was reported that 2 months old female patient was vaccinated with pentacel vaccine on 18 Dec 2019  that was delayed in transit due to bad weather/no AE (poor quality product administered) and if it is needed re vaccinate of Pentacel that went through a temperature excursion after being in transit too long/ no AE (product storage error).of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 18-Dec-2019, the patient received a 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ198ABA via unknown route in unknown administration site.  It was a case of actual medication error due poor quality vaccine administered.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a registered nurse (R.N.) concerning a 7-year-old white male with no pre-existing allergies, birth defects or medical conditions, who on 07-JUN-1999 was vaccinated in the left arm with a first dose of Varivax (lot# 630027/0312J). Concomitant vaccination given on the same day included a third dose of ENGERIX-B (lot# 2937A2) given in the left arm. There was no illness at the time of vaccination. On 22-APR-2006 the patient experienced multiple vesicles and papules on his abdomen, back and foot. Unspecified medical attention was sought. No treatment was provided other than comfort measures. No laboratory or diagnostic tests were performed. It was noted that at the time of the report the patient had recovered. Additional information is not expected.
11/01/2022 I had an ultrasound and the doctor did not see a heartbeat and the baby was too small. I had another ultrasound the next day and a week later that confirmed the diagnosis. It was still measuring the same size and no heartbeat. On 11/11/22. I was given misoprostol to induce. The fetus measured .5 centimeter. On 12/18/22, I had two DNC's that did not work so she gave me mifepristone. On 12/19/2022 I was given misoprostol again which worked.
Developed shingles rash, event is ongoing. Taking  Famciclovir For 6 days.
Patient admitted 5/17/21 with new PE. Placed on blood thinner and discharged 5/18/21.
Inject given @ 945AM mom returned to clinic 7 hrs later w/pt c/o persistent inconsolable crying, 1 episode vomiting 6 1/2 hrs post inject; pt referred to MD for eval; t100.2 ax;
Patient given smallpox vaccine on 6 Mar 07.  Patient came to emergency room at Medical Center on 16 Mar 07 complaining of left upper arm redness and swelling. Patient was educated on keeping site clean and covered.
"itchiness" Narrative:  As reported by employee on 6/25/2021: *************************************** "I STARTED HAVING SOME ITCHINESS IN MY RIGHT HAND GOING UP MY RIGHT ARM. IT LAST FOR A FEW MINUTES. THEY CHECKED MY BLOOD PRESSURE, WHICH WENT UP A LITTLE BUT THEY GAVE ME SOME BENADRYL ALSO."
Information has been received from a consumer concerning her 4 year old son who was vaccinated with VARIVAX (Merck) when he was 3 years old.  One year later, the patient developed shingles and had another case of shingles after 6 months and had another two cases of shingles again later on.  Additional information has been requested.
broke out w/rash that consumed entire body given DPH & taken to MD body turned black & blue;dx erythema mult;
Itchy eyes and whole body and vision slightly blurred; Itchy eyes and whole body and vision slightly blurred; Itchy eyes and whole body and vision slightly blurred; This is a spontaneous report from contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173; Expiration date: not provided) via an unspecified route of administration on 05May2021 at 10:00 (age at vaccination 40-year-old) as dose 1, single for covid-19 immunization Doctor Office / Urgent Centre. The patients medical history and concomitant medications were not reported. Patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient took second dose of BNT162B2, Lot number: EW0185 on 26May2021 for Covid-19 immunization. On 05May2021 at 14:00, patient experienced itchy eyes and whole body and vision slightly blurred. The patient did not receive any treatment for adverse events. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
HYPERtension complained of generalized fatigue after administration of vaccine. BP was 159/78; pulse78
I was really tired for about two days after receiving the vaccine. I had a regular scheduled mammogram in 09/2022. In 12/2022, I was notified that I have a small cyst in my left breast. No action required. Also in 12/2022, I developed hives that was all over my body. I had been exposed to COVID-19 but I tested negative. I have seen several doctors and they not believe that it is due to allergies, but they think it's COVID-19 related. I have been on antihistamine which helps but I still have random breakouts. I have noticed that heat will make it flareup.
~24 hours after vaccine administered, the patient became acutely obtunded/lethargic after eating breakfast.  No preceding illness, no fever, no trauma, no ingestion.  Nml behavior before Sx onset.  Lasted ~12 hours.  No response to Narcan. 4/4/08-records received for DOS 1/22-1/27/08- DC DX: Change in mental status secondary to adverse reaction to vaccine administered 1 day prior to symptom onset. Became lethargic, very drowsy. Difficult to arouse.
Client stated, after receiving vaccine her arm started to itch and  she took Benadryl and placed a warm compress towel on the arm. The following morning around 6:30 a.m. she noticed it was red, warm to touch and hard.
Rash arm, swollen inj site, face pruritic rash occurred within 24 hours of vaccination.
5/2/03 mother called to let us know child had reaction to shots given 4/2/03. Child had "transparent rash" on arms and backs of hand and was "acting strange." "When I talked with her she acted like she didn't hear me." She also had a "fear" cry. She spoke with her MD about child. Child was never evaluated by physician.
Patient presented for well child exam.  School advised mom that child needed vaccines.  Per system patient was due for Kinrix, Proquad and influenza.  These vaccinations were administered at visit.  Upon charting of vaccinations, nurse realized patient was given Kinrix and Proquad in August of 2021.  The vaccinations did not cross over into system.  Patient was given extra set of vaccines.  No adverse reactions noted.
After receiving the vaccine, I had a migraine headache, and this happened after each COVID-19 vaccine. On 07/04/2022 I started not feeling well with a sore throat. On 07/06/2022 I tested positive with a home test for COVID-19. I contacted my doctor and was prescribed PAXLOVID. I rebound after taking the full prescription and was sick for a week. I also experienced a racing heart, high blood pressure, heart palpitations and fatigue.
In the evening on 5/29 pt experienced chest pain in the center-left chest, was advised at urgent care where he was found to have elevated troponin levels with normal vitals, exam, EKG, and chest X-ray. He was admitted to the hospital where he continued to have intermittent chest pain and had increase in troponin levels during his admission. He was then transferred to a different hospital where he continues to have elevated troponins and is being worked up for possible myopericarditis.
She had a heart attack and died.  Vaccine received on 5/7/2021, per notes chest pain began 5/8/2021, presented to the ED on 5/11/2021, diagnosed with anterior STEMI, directly to cath lab where she had a PEA and then V fib arrest.  She passed away on 5/12/2021.
Chest Pain : Long lasting throughout day - squeezing pain Chest Palpitations: Throughout whole day Hair loss: Occured more intensely after getting vaccine Headaches: Lasted for a few minutes Muscle Pain: started on 6/29/21, been occuring randomly and has continued up to current date
pt recv vax 7FEB97 following day 8FEB it was reported that pt exp cellulitis, 15cm x 12cm area of erythema which was indurated, tender & warm, in deltoid region;tx w/ATB;pt completely resolved;
Tachycardia Narrative:  Developed tachycardia >100 BPM 3 hours after vaccination, which was sustained for over an hour. Athletic, no known h/o cardiac issues. Was sitting on cough watching TV and felt palpitations, which prompted him to take his pulse. Rechecked pulse after 30 minutes after palpitations started and pulse was still >100 BPM (no pulse oz, was manually counting). He continued to feel palpitations for over an hour since they started, but did not recheck his HR. Thinks that the palpitations did not last much longer than an hour. This is reported to be very atypical for him as his resting HR is ~60-70 BPM. No other s/sx of immediate allergic reaction or anaphylaxis reported. 2nd dose was deferred in favor of an allergy referral due to concerns for immediate allergic reaction of sustained tachycardia w/o other clear source within 3 hour time frame after vaccination.
Within 5 minutes of administration of flu vaccine, patient complained of loss of vision. Patient fainted but was grabbed by mother so he didn't fall. Patient was pale, diaphoretic and sporadically unresponsive. After 45 minutes of laying flat and drinking fluids, patient recovered.
A female reported that she received an injection of tetanus toxoid in 1981. Subsequently, she developed a fever and an injection site reaction characterized by swelling and inflammation extending from elbow to shoulder. The reporter declined to provide additional info and declined to grant permission for follow-up investigation.
Subsequent to receiving one dose of varicella virus vaccine live on 3/5/95, the pt became pregnant.  EDC is 11/20/99. An ultrasound revealed no fetal abnormalities. In October, 1999, the pt experienced a group b streptococcus infection confirmed by a cervical culture. She was treated with intrapartum ampicillin. On 11/24/99at 40 4/7 weeks gestation, the pt gave birth to a normal healthy male. Physical exam of the infant revealed mild icteric skin. On 12/06/99, the report indicated that the baby was "doing fine". No further information is available.
PATIENT GIVEN tDAP AND MENACTRA IN LEFT DELTOID, HPV IN RIGHT DELTOID.  C/O DIZZINESS, PUT HEAD DOWN.  WITHIN MINUTES, PATIENT GREEN IN COLOR AND VERY CLAMMY.  HEAD PUT FURTHER DOWN.  AFTER SEVERAL MINUTES TRIED TO MOVE CLIENT TO NEXT ROOM TO REST WHEN SHE FAINTED IN HALLWAY.  LOWERED TO GROUND AND FEET PUT UP ON CHAIR.  PULSE AND BLOOD PRESSURE TAKEN.  911 CALLED.  PATIENT SLOWLY OPENED EYES.  STILL CLAMMY AND PALE.  RESCUE ARRIVED, DENIED NEED FOR OXYGEN.  COOL, WET COMPRESS PUT ON FOREHEAD.  PULSE OX 98%, PULSE 60 AND BLOOD PRESSURE 100/60.  SLOWLY ABLE TO GET PATIENT TO SITTING POSITION.  BLOOD PRESSURE TAKEN AGAIN AND PATIENT HELPED INTO CHAIR.  GIVEN WATER TO DRINK.  MOM PRESENT THROUGHOUT INCIDENT.  DENIED NEED FOR TRANSPORT TO ER.  PATIENT REMAINED ON PREMISES FOR ANOTHER 15 MINUTES DRINKING WATER.  NURSE ASSISTED OUT TO HER CAR.  MOM DRIVING, AND MOM WILL BE HOME WITH PATIENT ALL DAY TO OBSERVE.
This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, feeling bad, pain and influenza-like symptoms. On an unknown date, the outcome of the fever, feeling bad, pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, feeling bad, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, but it was taken as an adult, as per vaccine indication. The patient experience adverse event after receiving 2 doses of SHINGRIX vaccine. Till the time of reporting, the reporter decline to report and would update safety via correspondence. No additional details were provided. This case was 1 of 3 cases, reported by same reporter.
Client reported L subcostal chest pain. History of 3X MI; B/P 200/100; no acute distress; chest pain occurred around 2 minutes post Pfizer vaccine. EMS called and arrived within 3 minutes. No SOB; lives in truck; n meds; unsure of meds; HTN. EKG normal. At 9AM B/P 200/100, HR 80. EMS took over care of client.  Ambulance called and on site within 3 minutes. Client refused to be taken to the ER. Client expressed to drive himself to the hospital. Client left the building per client request.
I got shingles; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 48-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : ER8729 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:00 as DOSE 2, SINGLE for covid-19 immunization. Medical history included , hypersensitivity from an unknown date and unknown if ongoing Known allergies: Eritromicyn.The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications two weeks of vaccination. The patient previously took bnt162b2 for covid-19 immunization, eritromicin. On 07May2021 18:00 The patient experienced i got shingle.Therapeutic measures were taken as a result of i got shingles. The outcome of event was recovering.  No further information is expected.
Client was administered an expired vaccine expired on 19 May 2018 and it was administered on 21 May 2018. Client tolerated vaccination well at time of administration.
Rash to arms and legs, torso.  Pt came to Emergency Dept and received IV solumedrol, Benadryl, and famotidine.
had an ache in the arm after receiving their Covid 19 vaccines; This is a spontaneous report received from a contactable consumer. A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EK9231) via unspecified route of administration on 13Jan2021 in left arm and second dose of bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EL8982) via unspecified route of administration in left arm on 01Feb2021 09:15 at a SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced ache in the arm on 02Feb2021. Patient tested positive for Sars-Cov-2 IGM after receiving both covid 19 vaccines on 23Mar2021.The patient underwent lab tests and procedures which included blood test was positive, COVID-19 PCR Test and Sars-Cov-2 IGG was negative on 23Mar2021. She had gone to her doctor on 02Mar2021 for a normal blood draw and received her blood work results. The doctor's office called her and told her she had IGM markers. Her doctor told her she needed to get a Covid 19 virus test. She also had the nasal swab test for Covid 19 and that was negative. She's never been symptomatic for Covid 19, she's never had a fever, shortness of breath, or cold like symptoms. The outcome of events Sars Cov 2 IGM positive test after receiving both Covid 19 vaccines (COVID-19) and Sars Cov 2 IGM positive test after receiving both Covid 19 vaccines (vaccination failure) were unknown and pain in arm was recovered on 03Feb2021.  Information on Lot/Batch number was available. Additional information has been requested.
Dizziness, Headache, Myalgia, Arthralgia, c/o fatigue,injection site sore. Told to visit primary care physician if no improvement. Narrative:
Patient got flu shot twice. She had previously received flu shot on 10/17 . Patient made a duplicate appt and got flu shot again on 11/01/2022. Patient was asked to wait around for 15-30 mins and had no rxn or any other symptoms.
Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg; Hard swelling about size of quarter at injection site; Hard swelling about size of quarter at injection site; Sore in the left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg), VACCINATION SITE INDURATION (Hard swelling about size of quarter at injection site), VACCINATION SITE PAIN (Sore in the left upper arm) and VACCINATION SITE SWELLING (Hard swelling about size of quarter at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore in the left upper arm). On 04-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hard swelling about size of quarter at injection site) and VACCINATION SITE SWELLING (Hard swelling about size of quarter at injection site). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg). At the time of the report, PAIN IN EXTREMITY (Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg), VACCINATION SITE INDURATION (Hard swelling about size of quarter at injection site), VACCINATION SITE PAIN (Sore in the left upper arm) and VACCINATION SITE SWELLING (Hard swelling about size of quarter at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information indicated none.
Pt developed seizure activity < 12 hours. S/P Hep A vaccine #2. Admitted and started on Anticonvulsants. 3/3/09 MR received for DOS 1/7-10/2009 with D/C DX:  Status Epilepticus.  Fever. Seizure-epileptic, tonic clonic. Pt presented following suspected generalized convulsive seizure in status epilepticus on arrival.  T=101.8'F.  Tx with Ativan.  Lethargic initially then began seizing again. Tx Cerebyx and phenobarb.  Intubated 2' to lethargy. Stable and seizure free remainder of admission.
Patient seems confused, pale, shaking and aggressively cursing that his "employer is making him get the vaccine" following pfizer vaccine administration. Patient seems to be having a panic attack/anxiety related to receiving the vaccine. Patient did not respond to Pharmacist's questions regarding  his well being and symptoms felt. Patient fell out of chair. Patient claims he did not feel well and needs medical attention, ambulance was called around 11:20am.
Blood clot on his left leg, tibial vein; Entire leg continued to swell; Knee started to swell; This spontaneous case was reported by a nurse and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high, Cholesterol and Depression (antidepressants). Concomitant products included PREDNISONE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced JOINT SWELLING (Knee started to swell). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Entire leg continued to swell). The patient was treated with RIVAROXABAN (XARELTO) at a dose of 15 mg. At the time of the report, DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein), JOINT SWELLING (Knee started to swell) and PERIPHERAL SWELLING (Entire leg continued to swell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included for High blood pressure, cholesterol, antidepressant.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). On 04-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # J008423, exp. date 21-JAN-2016) (route and dose not reported) which was exposed to a low temperature of 29F for a total of 11 hours from 30-OCT-2013 until 07-NOV-2013. These excursions were not supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Wrong immunization given (Patient received 1st dose of Pfizer previously and received 2nd dose of Moderna from our clinic)
The baby was well on the morning of 10/16/01. She was taken to the babysitter's house. Father picked up the baby in the afternoon of 10/16/01 to find the baby in moribund state. He rushed the baby to the ER. All resuscitation efforts failed. Baby referred to medical examiner's office.  Cause of Death as per autopsy report was SIDS