chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative refers to a 11 year old male patient. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 31-AUG-2018, the patient was vaccinated with a dose of GARDASIL 9 (lot#, expiry date and strength unspecified) via intramuscular route, for prophylaxis. The reporter stated that shortly after the vaccination, the patient experienced tonic clonic movements and passed out. She sought medical attention and was in the physician's office at the time. The events recovered on an unspecified date in 2018 (also reported as present status unknown). Causality assessment was not provided. Upon internal review, tonic clonic movements and loss of consciousness were determined to be medically significant.
Inner arm red, heat, dry, scaly. Pharmacist told patient to watch area & seek medical attention if not better. Patient said area was better & would see doctor if got worse. Pharmacist told patient to take BENADRYL & ADVIL. Pharmacist called patient on Saturday & Monday & patient improved. Patient did not see doctor.
a little more sore than the first two shots; got the full 0.5 mL dose as booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little more sore than the first two shots) and OVERDOSE (got the full 0.5 mL dose as booster dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06S21A, 012M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Peripheral arterial disease.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (got the full 0.5 mL dose as booster dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (a little more sore than the first two shots). On 07-Oct-2021, OVERDOSE (got the full 0.5 mL dose as booster dose) had resolved. At the time of the report, PAIN IN EXTREMITY (a little more sore than the first two shots) outcome was unknown.            No concomitant and treatment information were reported by the reporter  Booster shot lot number reported as 06S21A or 06521A   This case was linked to MOD-2021-005696 (Patient Link).
have 2 kids that enlarged heart from this vaccine now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "have 2 kids that enlarged heart from this vaccine now".  Additional information:  The reporter had 2 kids that enlarged heart from this vaccine now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200071313 same reporter/drug/AE, different patients;
Arm and shoulder and elbow aches with very strong muscle cramping with weakness in the arm since the shot was given 6-7 weeks ago.
Severe fatigue, muscles aches and weakness, joint pain, swelling of throat, shallow breathing.  Persisted form 6/27/21 to 6/30/21.
Heart racing that wouldn't stop and a nerve feeling and felt hyper. Pulse was 127/78 pulse 86 Small on and off small roaming headaches Chest pains near heart on and off Afternoon felt like I had high blood pressure but was normal 99.8 temp for a few hours in evening, then normal Felt asmatic like allergies on and off for a few days Exhaustion next day with some chest congestion 2 days after on awakening, dizzy. Went away in a bit.  Felt exhausted and achy for days.
This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (painful intestinal cramping ), DIARRHOEA (sort of diarrhoea/loose stool), CHILLS (chills) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (painful intestinal cramping ), DIARRHOEA (sort of diarrhoea/loose stool), CHILLS (chills) and FATIGUE (tiredness). The patient was treated with LOPERAMIDE for Diarrhoea, at a dose of UNK dosage form. On 15-Mar-2021, GASTROINTESTINAL PAIN (painful intestinal cramping ), DIARRHEA (sort of diarrhoea/loose stool), CHILLS (chills) and FATIGUE (tiredness) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported.
Like a couple months after the shot, I started having pain, like very strange pain like nauseous like wanting to throw up. I did not do anything and it went away. It came again in October and in November I threw up while I was driving so I went to the hospital. The hospital CT scan. It showed I had an erupted ovarian cyst. They told me if there was any fever, I would have to have surgery to remove the cyst. I did not need surgery. The hospital told me to follow up with a gynecologist. I found an gynecologist that took my insurance, I was told that it was side effect from the vaccine.
Information has been received from a pharmacist concerning a female patient in her 60's who on 2-JAN-2009 was vaccinated with a dose of ZOSTAVAX. The patient's daughter mentioned to the pharmacist that the patient was "sick" after receiving ZOSTAVAX. As of 13-JAN-2009 the outcome of the patient was unknown. Additional information has been requested.
Patient reported all over hives within 24 hrs of receiving FLUVIRIN shot, took BENADRYL. Resolved approximately 24 later, never any past problems with flu shots.
medication error due to PENTACEL was not reconstituted correctly before administration to a patient with no reported adverse event; Initial information received on 17-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced medication error due to Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was not reconstituted correctly before administration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1 of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection with unknown batch number, strength & expiry date via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a non-serious event "medication error due to pentacel was not reconstituted correctly before administration to a patient with no reported adverse event" (product preparation issue) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  It was reported that "This situation is reported as a medication error due to PENTACEL was not reconstituted correctly before administration to a patient. This is reported as a medication error; they report that a patient received PENTACEL, but they only received the liquid DTaP-IPV portion; it was not reconstituted with the powdered HIB portion. The physician notes that this error with PENTACEL was made 2 months ago, and it was the patient's 1st dose in the PENTACEL series. The physician also reports that the patient was recently in the office again for their well-visit, and the patient received the 2nd dose in the PENTACEL series; the physician confirms that the 2nd dose of the PENTACEL series was reconstituted correctly".  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
bronchospasm that has not quit and it hurts/it started in my back and its right up to the middle of my chest; I was in tears last night because of that; it hurts; I couldn''t even sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: BRONCHOSPASM (non-serious), outcome "not recovered", described as "bronchospasm that has not quit and it hurts/it started in my back and its right up to the middle of my chest"; INSOMNIA (non-serious) with onset 10Sep2021, outcome "unknown", described as "I couldn''t even sleep"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "I was in tears last night because of that"; PAIN (non-serious), outcome "not recovered", described as "it hurts".  Additional information: It was reported that Well 2 hours after I got it, it put me into a bronchospasm that has not quit and it hurts, I couldn't even sleep last night and I got that on 10Sep2021(Further not clarified hence not captured in tab). Why would I have that kind of reaction if it was FDA approved? And it started in my back and its right up to the middle of my chest. I was in tears last night because of that."  Follow-up attempts completed. No further information is expected.
pt recv vax & inconsolable x 4 hrs, twitchy, jumping per mom; given APAP
Redness, swelling at site, pt developed headache several hrs post inj. Seemed to subside as of 7/13/12, itching at site.
was in bed for 2 days; fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (was in bed for 2 days) and PYREXIA (fever) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced MOBILITY DECREASED (was in bed for 2 days) and PYREXIA (fever). On 17-Apr-2021, MOBILITY DECREASED (was in bed for 2 days) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-365654 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow up received and contains The Email address updated.
About a week or two after receiving the vaccine, my period started getting heavier than usual. The next period was even heavier. My most recent period started on June 19th and got extremely heavy (1 pad per hour, heavy clotting) in the past two of three weeks. I had my Mirena IUD removed on June 27th, because I thought it was affecting my period. My period slowed for the 3 days it was out, then started heavy again after starting the mini pill. I was bleeding so heavy that I was dehydrated and hospitalized on July 9th. I was drinking a lot of water that day, but eventually threw up and felt like I was going to pass out. I had tingly and cold fingers and toes.  After stopping the mini pill that night, my period has slowed but not stopped.
Rash, maculo-papular, started on neck then spread from head to trunk, continued.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 4 patients. This is the 2nd of 4 reports. An adult patient (over 60) of unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in the days before report (Dec2016), at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. The patient was treated in an urgent care center. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595828 Same reporter/drug/event, different patient.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L024993 with expiration date 17-OCT-2017, dose and route were not reported). It was reported that the vaccine was improperly stored at 33.6 (unit not provided) for 89.5 hours and then was back in range. There were no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received on 16-NOV-2017 from a 78 year old male patient referring to himself. Medical history included two stents placed in December 2014. Since then, he has taken LIPITOR and AZOR regularly. Until 12-OCT-2017, his blood pressure and heart rate were under control. On that date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) at his physician's office. Just prior to the injection, his blood pressure was 120/70 and his heart rate was 70. By 1:00 pm, he could feel his heart racing. He went to the local Emergency Room (ER) at which time his heart rate was up to 150. The doctors diagnosed him with atrial fibrillation. The patient was treated with metoprolol and after a night's stay, his heart rate returned to 70. His medications now include metoprolol abd "the very expensive" ELIQUIS. He stated he never had an atrial fibrillation problem before. The patient believes he had an allergic reaction to PNEUMOVAX 23. His cardiologist said the reaction was very possible in someone with a preexisting condition. The patient feels the safety information provided on the company's website does not adequately warn patients of the risks. He stated that for those with cardiovascular problems, while the benefit from the vaccine may protect against pneumonia, the risk is death from an out-of-control heart. The patent feels he is entitled to compensation for the life-threatening event. The outcome of the events was recovered. Causality assessment was related. Upon internal review, atrial fibrillation was considered medically significant. The patient considered the atrial fibrillation and allergic reaction to PNEUMOVAX 23 to be life threatening. Additional information has been requested.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who received a dose of PREVNAR exposed to 1 degree Centigrade for a period of nine days on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day.  Concomitant medications were not reported.  In Mar-2006, PREVNAR was exposed to 1 degree Centigrade for a period of nine days (medication error).  On an unspecified date, the patient received a dose of that incorrectly stored PREVNAR.  No adverse event was reported.  The reporter was unable to specify the number of patients who experienced this event.  Additional reports will be generated when identifying information is provided.  No additional information was available at the time of this report.
Patient was administered Pediarix on 8/2/2022, which is not valid.  Her previous dose of Infanrix was received on 5/17/2022.  The correct spacing of dose 3 and dose 4 of DTaP vaccine is at least 6 months.  The IPV component is also not valid, as dose 4 is recommended to be administered after the age of 4 and at least 6 months after the previous dose.  The child also received an extra dose of HepB.  No known adverse issues experienced by child.
a little sore; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer vaccine on 09Feb2021 and noted that it felt just a little sore that's all. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Pt recvd 2 doses of Engerix-B & 13JUL92 exp allergic arthritic reaction & serum sickness; seen by 2 MD's; sx still persisting;
Flare of ulcerative colitis. My flares look like bloating, gassiness, diarrhea (liquid).
Local skin reaction - ongoing redness and tenderness. Chills, somnolence, and disequilibrium - resolved by his clinic visit today (9/20/18) at noon. Weakness - almost resolved today at noon, but slight weakness persists.
0.2ml of undiluted Pfizer COVID  5-11yr vaccine administered  - should have been a 10mcg dose and was given 28mcg patient had no adverse reaction, mom was advised to give tylenol/ibu and apply ice mom also advised to monitor for local and systemic reactions as patient was a higher risk for these with the increased dose in contact with mom 8 days after incident and patient remains free of any ill effect
Case number PHEH2012US024945, is an initial spontaneous report received from a nurse on 17 Dec 2912 with a follow-up received on 08 Jan 2013. This report refers to a 12 year old female patient. Her medical history and concomitant medication as not reported. She was vaccinated with MENVEO (batch number: X11047) intramuscularly in to the left deltoid on 17 Dec 2012. The patient received only Men CYW only. The CDC confirmed that the child received partial dose of MENVEO; however no harm would come to the patient by receiving only the liquid component of the vaccine. No adverse event was reported. Follow-up received from the nurse on 08 Jan 2013: Updated site of vaccination and comment from CDC.
Local reaction, swelling, redness, warmth of injection site R greater than L treated for cellulitis.
28hr p/vax pt devel rxn @ shot site;67x 77mm raised, flat lesion of nl skin color;lesion began to itch 3 days p/onset & cont to itch x 3 days;probable allerg rxn to varicella;
Pt inadvertently received Pediarix instead of a DTaP. The result is that she received an extra dose of the polio vaccine and a double dose of Hep B. Pt experienced no adverse reaction and pt's mother was notified. The occurrence was 12-29-03, there was no adverse reaction to the patient. The time of the occurence was approximately 3:45 pm.
Joint pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration at Left arm on 22Jan2021 11:45 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported.  Concomitant medication included duloxetine. The patient was not pregnant. No known allergies. The patient experienced joint pain and nausea on 24Jan2021 10:00. No treatment received for the events. No COVID prior vaccination. Nasal Swab performed on 25Jan2021, but result was pending. The outcome of the events was not recovered.
Immune level checked on 2/2/21 and was immune.( 1.38) Immunity rechecked on 8 / 20  and was found to be non-immune (.06)
Within 4 to 5 hours, she had a fever of 103.8 degrees. The next morning, her arm at the injection site was very red, swollen, and red. She also started throwing up that next morning and continued for about 48 hours. The fever remained high for about 48 hours, as well.
On May 26, 1999 the pt developed varicella sx with less than 50 lesions and low-grade fever. It was indicated that treatment with diphenhydramine hydrochloride, was recommended.
Two side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Two side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Two side effects). At the time of the report, VACCINATION COMPLICATION (Two side effects) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-310988 (Patient Link).
Severe injection site pain the first day and itchy skin; followed by severe armpit pain the 2nd and 3rd day after the shot.  Feels like someone hit me in the armpit with a baseball bat.
Avery sore - red arm - tiredness - muscle pain - shivering - nausea
Rheumatoid arthiritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthiritis flare up) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthiritis flare up) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPOMEDROL) for Rheumatoid arthritis flare up, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthiritis flare up) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Very limited information regarding this event has been provided at this time. No further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Concomitant drug was changed as the treatment drug.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
Lightheaded  BP 93/52, 118/68 rechecked  HR 65 Sp02: 99%  Seen and cleared by EMS