chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his sister in law 68 year old, with no pertinent medical history, who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). Concomitant therapy included vitamins (unspecified). In "last Spring" (in approximately March 2010), the patient experienced rash after receiving ZOSTAVAX (Merck). The rash was not at the injection site. The consumer did not believe his sister in law had itching. The patient did not seek medical attention. On an unspecified date, the patient had recovered from rash. No further information is available. This is one of two reports from the same source.
Information has been received from a physician concerning a 12 year old female with asthma and allergy to pertussis and a history of tension headache who on 23-JUN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL 9lot no. 659437/12660) into the right deltoid. Concomitant therapy included tetanus toxoid and albuterol. The physician's office got a call "last night", on approximately 15-JUL-2008, stating that the patient experienced severe migraine and went to the emergency room. The patient was treated with IV fluids, REGLAN and released. The patient was not hospitalized. The outcome was unknown. Additional information has been requested.
Excess sneezing that started approximately 18 hours after the vaccination and lasted for 12 hours.  The patient sneezed a total of 30 - 40 times.  There were no other symptoms, such as rhinorrhea, rhinitis, or anaphylaxis, therefore this may have been a mild allergic reaction to the vaccine.  The sneezing resolved without intervention.
Muscle weakness on left side, fatigue, tiredness, slurred speech. Stroke like symptoms according to Emergency Room doctors but all test came back negative.
Database order added the incorrect expiration date . Patient received vaccine that was outdated by 4 days.  Patient experienced no side effects.  Patient is monitoring.
Patient presented to the ED with difficulty breathing and was diagnosed with pulmonary embolism prior to this visit. He then presented to the ED on 4/19/21 with similar sx and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "htn" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300182757 same patient, different product and event;US-PFIZER INC-202300183358 same patient, different dose and event (DOSE 2);
Administered Pfizer purple cap vaccine; it was left in the fridge for longer than manuf. recommended. Called Pfizer and advised us to revaccinate patient.
patient started to have burning and redness size of two big quarters around the vaccine site on her left arm the afternoon after getting her pfizer booster shot.  The redness was gone today, as I looked at the patient's arm 5 days after the shot was administered.  I could see a little swealing under her left arm pit.  patient was instructed to report the side effect to her doctor.
Information has been received from a pharmacist via a field representative referring to an adult patient of unknown age and gender. On 14-FEB-2016 the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, lot/exp., dosage and frequency unspecified), followed by her second dose of RECOMBIVAX HB (lot# reported as L030609, exp.26-JUN-2017; strength, dosage and frequency unspecified). No adverse effect was reported. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX QUADRIVALENT (batch number 77R93, expiry date 30th June 2018) and (batch number 34RE5, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On an unknown date, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site swelling and injection site erythema to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by Medical Assistant. The health care professional reported the patient had injection site reactions after receiving FLUARIX. The symptoms reported included pain, swelling, and redness the size of a half dollar. No patient information was available. This was 1 of 4 cases as reported by same reporter for same events.
Patient received .25 mL instead of 0.5 mL for his 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received .25 mL instead of 0.5 mL for his 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069821A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received .25 mL instead of 0.5 mL for his 2nd dose). On 23-Dec-2021, ACCIDENTAL UNDERDOSE (Patient received .25 mL instead of 0.5 mL for his 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Patient got the vaccination for flu and SHINGRIX on 09/24/2018. She was ok that day but woke up in the middle of the night with fever and chills. The next day morning she had shivering, diarrhea, body ache and rash on the right arm. Was feeling very sick and dizzy and was in the same state for 2 days. On 9/27/2018, she called the pharmacy to report and pharmacist advised her to consult md. The md gave her the nausea medication and prednisone  and said he could not do anything else. She called pharmacy on 09/28/2018 and I advised the patient to take mulitsympton Tylenol and an allergy pill as well we keep herself well hydrated. She was also advised to take Imodium for diarrhea. Will check with patient on Monday.
Starting about 11 pm and getting worse by midnight I started throwing up, my body hurts so badly, particularly my lower back and I felt like I was burning up. I did stop vomiting after a few hours but am still in bed right now (11am) feeling like I was hit by a truck. I feel utterly exhausted and can hardly get out of bed. I have never had a reaction like this before, just the usual achey body etc.
rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included POTASSIUM, BUMETANIDE, PRAVASTATIN, AMIODARONE and WARFARIN for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH (rash all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash all over body) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.
Pt stated "I feel funny all over" VS 140/64 76 R, Resp 20 reg., Pt placed in surpine position. Spirit of Ammonia adm; OJ 2 cans given to pt and chocolate. Pt stated "I am feeling better and ready to leave" PT discharged via wheel chair, Upon getting into car, became SOB, To ER Stat.
Death; A spontaneous report was received from a other health care professional concerning a 57-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided.  On 02 Feb 2021, prior to onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 043L20A) in the left arm for prophylaxis of Covid-19 infection.  03 Feb 2021, it was reported that the patient died. The patient was not experiencing any symptoms prior to death. He was on hospice care, not hospitalized. No further information was provided. Treatment information was unknown. The cause of death was not reported. Plans for an autopsy were unknown.  Action taken with the mRNA-1273 in response to the event was not applicable.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown
Sore left arm; Redness around injection site; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PRURITUS (Itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, PAIN IN EXTREMITY (Sore left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Eyes red on fire mattery, nose stuffy and yet runny, chills, aches heart beat slightly increased, next day weak, felt like walking on a boat unstable, felt fine by day 3.
Admission Date: 10/17/2022 Discharge Date: 10/24/2022   DETAILS OF HOSPITAL STAY: Patient is an 85-year-old man with a past medical history of coronary artery disease, atrial fibrillation, hyperlipidemia, CHF, mild dementia, who presented to the emergency department due to generalized weakness and worsening shortness of breath.  Was found to be hypoxic in 80s and was placed on 2 L of oxygen.  His lab workup was consistent with leukocytosis and COVID-19 PCR was positive.  Chest x-ray was consistent with persistent moderate pulmonary fibrosis with superimposed mild airspace disease.   He was admitted to the hospital, started Decadron and remdesivir which he finished in hospital 10/23. Discharged on 4 more days of Decadron 6 mg po daily.  Patient showed some improvement in terms of symptoms and feels better.  By the time of discharge he was on RA. Unfortunately he has generalized wa          He has history of paroxysmal A. Fib, but during this hospitalization his heart rates have been ranging between 20-50 and EKG consistent with Mobitz type 1 AV block.  EP was consulted, and they had no plan for pacemaker as patient was completely asymptomatic. Echocardiogram was within normal limits.  All other lab workup which included TSH was within normal limits.  Patient will benefit with a heart monitor for 14 days at the time of discharge. Chronic diastolic dysfunction, AS s/p bioprosthetic valve, CAD s/p CABG were well controlled.  Net IO Since Admission: -2,450 mL [10/24/22 1440]  Mild anemia and Thrombocytopenia stable. PT/OT recommended SAR, but patient wife did not want him to wait until 10/28 when out of respiratory isolation, so he was discharged home. Family is around to help wife.
After flu shot on 10/23/06, she had sore arm and fever of 100F come and go, coughs and hoarse voice. She was sick up to today 11/9/06. Doctor gave her sick leave and put her on Z-pack.
03/24/2021, I began to notice an extreme increase in insulin resistance and blood sugar. Symptoms of rheumatoid arthritis, severe bone and muscle pain, severe mouth and eye dryness, and a 20 pound weight gain with no changed in diet or exercise.
Patient received his vaccination, within 5 minutes or so, his throat felt "itchy".  Patient has no increased work of breathing and no other complaints.
Pfzier second dose on 5/4/2021 few days later on Thursday night I got rapid heart rate with shortness of breath and cold/shivers and continued to get rapid heart rate every night sometimes around 8-9pm sometimes waking me up at 1am or 4-5am for the next 2 weeks or so
Patient with complaints of lightheadedness 30 minutes after receiving vaccination. Patient stated that she did not eat today, powerade and a lollipop provided. Shortly after, patient with complaints of dizziness and slow heart rate. Vitals at 1546: HR 65 BP 90/62 and RR 20. At 1605, patient with increased drowsiness, dizziness and a brief moment of lapse in consciousness. Evaluated by paramedics on scene and declined transport to ER.
Pt recvd DTP/OPV/MMR/PPD & then devel a swollen red arm, fever 103, & vomited;
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 31-JAN-2019, the patient was vaccinated with an improperly stored dose of VARIVAX one dose, subcutaneous, lot# R020651 and expiration date 18-JUL-2020, for prophylaxis (strength and frequency were not reported) reconstituted with a properly stored sterile diluent. The temperature excursion was of -9 Centigrade degrees (°C) to 8°C (-9°C), during 3 hours. A previous temperature excursion was not reported. A digital data logger was not involved. No adverse effects were reported.
Patient states friday night 07/18, patient complained of decreased imobility of left area due to pain on left deltoid, saturday 07/19 night.  Complained of nausea, generalized weldness, especially to neck shoulder and back, swelling, redness present around injection site to left deltoid.  Patient too Ibuprofen, theraflu and iced left deltoid area and came in monday 07/21.  Status post showed some improvement.  High mobility to left arm, slight down pain.
Bronchitis; Sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immuno-compromised" (unspecified if ongoing), notes: I am immuno-compromised. Concomitant medication(s) included: HUMIRA, start date: Oct2018 (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: SINUSITIS (non-serious) with onset 06Nov2022, outcome "unknown", described as "Sinus infection"; BRONCHITIS (non-serious) with onset 12Nov2022, outcome "not recovered". Therapeutic measures were taken as a result of sinusitis, bronchitis.  Additional information: Patient was diagnosed with a sinus infection on 06Nov2022; took Augmentin for 10 days, Prednisone for 5 days. Used Albuterol via nebulizer as needed. Evolved into bronchitis 12Nov2022; took Prednisone for 10 days. Used Albuterol via nebulizer as needed. Bronchitis persisted.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202300002212 Same patient/vaccine, different event;PFIZER INC-202201402915 Same reporter/patient, different drug/AE;
On January 26, I noted generalized swelling at injection site (left arm).  On the evening of January 27th I developed hives and itchiness. As of January 28th, redness remains, and lymph nodes under left armpit are a little tender.
I contracted COVID-19 with symptoms of fever of 100.0, sore throat, cough, congestion, runny nose, and fatigue. I was prescribed PAXLOVID 12/17/22. I was ill for 3 days before my symptoms began to resolve. I am still experiencing a tickle in my throat and runny nose. I am not fully recovered yet.
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L023232, expiry date: 25-FEB-2017 (Strength, dose and route were not reported), which underwent temperature excursions of 31.3 Fahrenheit degrees for 119 hours 15 minutes, 46.5 Fahrenheit degrees for 30 minutes and 30.8 Fahrenheit degrees for 108 hours on unspecified dates. No previous temperature excursions were reported. Data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician and a consumer's family concerning an 88 year old "healthy" female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (MSD) and a third dose of PNEUMOVAX 23 (MSD). The consumer received ZOSTAVAX (MSD) and PNEUMOVAX 23 together and "almost immediately" experienced swelling, pain and redness at the injection site (unspecified site). The consumer then had difficulty breathing and was hospitalized. The consumer developed a low grade fever. The consumer was then sent home. About 9 hours later the consumer returned to the hospital and had low blood pressure. The consumer arrested but was resuscitated and placed on a ventilator and stabilized. about 6-8 hours later the consumer arrested again but could not be resuscitated. The consumer died and the cause of death as reported by the physician was "probably a reaction from the vaccines". It was reported that the consumer died 2 days after receiving the vaccines. The consumer previously received PNEUMOVAX 23 in 2008 and 2009. Please reference WAES # 1010USA02427 for the patient's experiences on PNEUMOVAX 23. Additional information has been requested.
Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21
Pt recvd 2nd dose of vax on 15MAY92 & on 16MAY92 exp nausea, bloating & diarrhea; pt recovered;
Long term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 17:30 as dose 1, single (Lot number: ER2613) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrodantin, reaction(s): "known allergies: Macrodantin", notes: known allergies: Macrodantin; Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. The following information was reported: AMNESIA (non-serious) with onset 20May2021, outcome "recovered with sequelae", described as "Long term memory loss". The event "long term memory loss" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of amnesia.  Additional information:  Patient was no covid prior to vaccination. Patient had covid tested post vaccination. There is no other vaccine in four weeks. There is Other medications in two weeks
The pt experienced a 4"x3" area of redness and warmth at the injection site. The doctor prescribed cold compress, and Tylenol for discomfort and Allegra (antihistamine) as needed.
7/22/14 - Reporting a med error. On 7/18/14: Without checking patient's record (relying on memory, bad idea) I was certain he was due for HPV #3. HPV #3 was admn. 4/29/14. Patient had a sore arm that resolved 7/20/14. He states he feels well on 7/22/14.
There was no adverse outcome. The patient received an unnecessary dose of polio vaccine along with the intended Dtap. Mother denied that pt had fever, H/A, fussiness or other symptoms when I called her the next day.
Patient called in today, 02/04/2021 to let me know he had some adverse reactions to the COVID vaccination he received on 02/02/2021. Patients states that in the evening after the vaccination he developed at 102 degree f. fever that was accompanied by a headache and body aches.  Patient also stated he did not sleep well that night.  He stated his this symptoms lasted approximately 24 hours.  He denied any symptoms today.  Patient also reported that he was positive for Covid-19 in March of 2020.
This spontaneous report has been received from a Rheumatologist, via Pfizer (Manufacturer Report Number 2018278171), concerning a currently 69 years old female patient. The patient's concurrent conditions included allergy to sulfa and hydroxychloroquine, and rheumatoid arthritis. The patient's historical drugs included ENBREL and other unspecified therapies (Illegible information). The patient's concomitant therapies included XELJANZ and RHEUMATREX. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (concentration, dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX 23. At the time of reporting, the patient's outcome for allergy to vaccine was unknown. The causal relationship between PNEUMOVAX 23 and the event was assessed as related.