chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA255147 and 2018SA254040 (same reporter). This case involves a 42 years old patient (gender not reported) who received a 0.5 mL expired dose of FLUZONE QUADRIVALENT, lot UI826AC via intramuscular route in the left deltoid on 06-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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 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. List of documents held by sender: none.
Swelling on her hands with reddish thing.; Swelling on her hands with reddish thing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). This consumer (Patient's Husband) reported for a 40-year-old female patient (Reporter's wife).  A 40-year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Lot number: FC3180) at the age of 40 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "Swelling on her hands with reddish thing.". Therapeutic measures were not taken as a result of peripheral swelling, erythema.  Additional information: Is the patient also the reporter was reported as no. Reporter stated his wife did a vaccine like on Aug24 with (Withheld) so, it is almost like 9 days, what reporter was seeing here is Like, she is still having you know, swelling on her hand with reddish thing so, it is like, truly like, when he took a vaccine. It was there for 1 or day then, it went away, Everything fine. But (incomplete sentence) and Weight is somewhere around, probably like 125 lbs. Yeah. Weight, he was not sure about it, but it will be around 125 lbs. Yes 125 pounds. No. I am pretty sure about it, Around that area, 1 or 2 up and down. Reporter stated, 24-August we have taken the vaccine in the evening, Like, we only took the vaccine around nighttime, Like, there was some swell up there, Like, we were giving some little bit ice pad and things like that. It was there for like a day or two. We didn't have much, it was quite normal, then we left it. Now it was there, Like continuously. The problem is from the day of vaccine. LOT NO: Reporter stated It is FC3180. It looks like, it is written on the vaccine report card (Confirmed later and captured in tab). Reporter stated he did not see any expiration date on it. No other medical conditions. Lab test was Reporter stated as no. No treatment was taken. Reporter stated, So, what is the next step? I mean so, We should (incomplete sentence), Right. Reporter was informed about Pfizer Medical Information and telephone number was shared.  Follow-up attempts are completed. No further information is expected.
Pt heart rate increased to 103-105 before normalizing (over the course of a few hours)
After receiving the HPV vaccine by Dr. at 11:00am she informed my daughter and I that we could leave. As we were waiting to get picked up at 11:09am patient stated she felt "nauseous" and immediately passed out and went into convulsions (fingers, toes and back became stiff). I tried for a minute and a half to wake my daughter up but she was unresponsive. After lightly smacking her face a couple of times at 11:11am she came back and was very sluggish and unaware. A stranger carried her to the nearest entrance back into clinic where they placed patient in a wheelchair and checked vitals and blood pressure. No further treatment was given and Dr. advised my daughter and I to leave. I am now going to take her to the hospital for a blood test.
Sudden numbness in entire right side of body from underneath breast through to my toes. I have been diagnosed with partial transverse myelitis and my symptoms have never gotten better.
Sore arm; raised knob/Knot and redness at the injection site; bruised; This is a spontaneous report from a contactable consumer (patient, self-reported). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date: Jun2021), via Intramuscular, in Arm Left, on 13Feb2021 at 11:30 AM (age at vaccination: 71 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date: May2021), via Intramuscular, in Arm Right, on 27Jan2021 (age at vaccination: 71 years), as a single dose for COVID-19 immunization. The patient did not receive any prior vaccinations within 4 weeks. The patient reported that she received the second shot of the Pfizer covid vaccine last Saturday 13Feb, and she still has a raised knob on an unspecified date in Feb2021, not as red as it was before, was seemingly going the direction of her elbow, and looks bruised. She was looking for information related to these symptoms. The patient stated she hasn't really had any problems with it or side effects. However, at the injection site, she still has a knot. It's starting to look like its bruised going down on her arm. She clarified further she still has a knot there where the shot was injected and it's still red and raised, however it looks like it starting to go down her arm. The patient wanted to know if that was part of the vaccine. She knew it has to come from the shot but was that okay. The patient explained about the second day after receiving the second vaccine, she started to feel her arm get sore on 15Feb2021 and it was kind of red. By the third day, it got a little bigger but she knew that's where they put the medicine into the arm/muscle and everything. The injection site has a knot. When probed for the outcome, the caller explained it's kind of been like this. She started out with nothing, then she developed the knot at the injection site and had some redness and its real sore. She was just thinking by this time, the knot should be going away by now. It looks like it's bruised around the knot and was going down her arm. The events did not require a visit to emergency room or physician office. Outcome of the event raised knob/Knot and redness at the injection site was recovering and for all other events, it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
breast tenderness bilateral mammogram, CBC, SMAC, Thyroid, Prolactin testing;
Patient was seated completing the15 minute observation period and at 1349 was witnessed by clinic staff dropping his phone, leaning over to pick it up and falling down onto the floor.    As nurse approached, patient laying on his right side below the chair with full body convulsions lasting approximately 15 seconds. Patient's head supported and protected, eyes rolled back, skin appeared pale, incontinent of urine. Patient appeared to regain consciousness for a few seconds and then began to convulse again for 5 seconds. Patient then regained full consciousness with no postictal confusion.
Patient states< "I received three shots on 10/10/12 about 11:00 a.m.  The student put all three shots in my right arm.  Later that day about 2:00 p.m. I could not use my arm.  Went to doctor and was told to use warm compresses on my arm and that I should not have had three shots in one arm."
Severe body aches, joints pain, slight increase in body temperature, mood changes, nervousness, severe headache, toothache and nausea, it has been almost 4 weeks since I received the vaccine and I am still suffering from these symptoms.
Epstein barr virus; Swollen liver; Pain in upper right quadrant; This spontaneous case was reported by a pharmacist and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION (Epstein barr virus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced EPSTEIN-BARR VIRUS INFECTION (Epstein barr virus) (seriousness criterion medically significant), HEPATOMEGALY (Swollen liver) and ABDOMINAL PAIN UPPER (Pain in upper right quadrant). At the time of the report, EPSTEIN-BARR VIRUS INFECTION (Epstein barr virus), HEPATOMEGALY (Swollen liver) and ABDOMINAL PAIN UPPER (Pain in upper right quadrant) outcome was unknown.        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 taken, and no treatment was given. Company comment: 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. However, Very limited information regarding these events has been provided. Further information has been requested.; 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. However, Very limited information regarding these events has been provided. Further information has been requested.
Arm hurt for 2 weeks at site on injection inflammation on underside of arm 2 weeks. Tendons underarm felt tight when lifting arm then experience nausea, malaise, fever and every side effect on list for 2 days.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: Reporter was a patient. The age at vaccination was not reported. The patient denied permission to contact their physician.
had an emergency; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had an emergency) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced IMMUNISATION REACTION (had an emergency). At the time of the report, IMMUNISATION REACTION (had an emergency) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant and treatment medications were not reported.   Reporter did not allow further contact
Subject in pneumococcal vaccine trial, with severe COPD, was admitted to the hospital fro severe colitis on 11/8/2008. Vaccination took place on 9/10/2007. According to the physician, the relationship to treatment is 'Unlikely'. We would be happy to forward the Study's SAE Reporting Form upon request.  5/14/09 Received SAE for 11/8-11/18/2008. FINAL DX: severe colitis Records reveal patient experienced abdominal pain, vomiting & diarrhea. Had left hemicolectomy, appendectomy & colostomy for impending perforation.  Developed colostomy necrosis & returned to OR POD 3 for revision.  Readmitted to hospital for CHF.
2nd instance of Anthrax vaccination causing an adverse reaction at the site of injection.  4th series was given and injection site swelled and burst seeping blood and puss.  This one has started to do the same thing even though it was administered in the opposite arm.
Like a cellulitis or poison ivy rash; Discomfort today on the left hip; Broken capillaries 4 inches long; Soreness at the point of injection; Rash at the waist; A spontaneous report was received from a physician concerning a 66-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced soreness at the point of injection, discomfort today on the left hip, broken capillaries four inches long, rash at waist and cellulitis or poison ivy rash.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Tylenol.  On 14 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 041I20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient had soreness at the injection site.   On 15 Jan 2021, he noticed a rash on his waist, no blood on the skin and broken capillaries under the surface four inches long under the rash poison ivy or cellulitis, and discomfort on left hip. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.   The event soreness at the point of injection was considered recovered/resolved on 15 Jan 2021. The outcome of the events discomfort on left hip, broken capillary four inches long, rash at the waist without blood on skin and like a cellulitis or poison ivy rash was not reported.; Reporter's Comments: This case concerns a 66-year old, male patient, who experienced non-serious unexpected events of musculoskeletal discomfort (left hip), capillary disorder, and rash, a non-serious expected event of injection site pain. The event of injection site pain occurred 1 day after first dose of mRNA-1273, lot # 041l20a. The event of musculoskeletal discomfort (left hip), capillary disorder occurred 2 days after first dose of mRNA-1273, lot # 041l20a. The event of rash occurred on an unspecified date after first dose of mRNA-1273, lot # 041l20a. Treatment included Tylenol. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
This initial spontaneous case, received on 30-Oct-2017, reported by other non-health professional and concerns a female patient of unspecified age. On an unspecified date in mid-October (reported as third week after), the patient was administered with FLUCELVAX QIV(dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: F95225A (as reported), expiry date: not reported). Immediately, after administration of FLUCELVAX QIV, the patient experienced the pain (initial injection was very painful). It was reported that, pain eased up after a couple of days. Reporter stated that, the patient's arm hurt for just over a week and got cured. The outcome of the event was reported as recovered. The reporter assessed the case as non-serious.
Had A Seizure while driving...had not had a seizure during the day for 8 years Hit a light post with my car and damaged vehicle driving at approx. 25 MPH 11/2/09:  Hospital records received for dates of stay 10/29/09 to 10/30/09. Dx:  Breakthrough Seizure Disorder, History of Seizure, Motor Vehicle Accident.  Assessment: Epileptic patient maintained seizure free on Tegretol x 8 years, received H1N1 vaccine and had a seizure while driving his car the following day.  Accident was at low speed and pt. was unhurt.  Monitored in the hospital overnight and discharged to home.  Keppra started BID.
Pt recvd 3 doses of Engerix-B 29NOV90, 27DEC90 & 28MAY91 & it was determined that pt was a non-converter; No treatment given;
Dizziness, Myalgia, UrticariaPruritus, Fatigue Narrative:
No adverse reaction; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Pediatric Pfizer (orange cap) administered to 12 year old patient. Guardian was notified of administration error and patient received correct Pfizer formulation (purple cap) for second dose on 12/4/2021. Immunization program also notified of administration error.
This case was reported a pharmacist and described the occurrence of tendon pain in hand in a 35-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to DEMEROL and possible anxiety disorder. On 31 May 2011 at 13:00 the subject received unspecified dose of ENGERIX B at 1.0 ml in the left arm. Within a month after vaccination with ENGERIX B, the subject experienced tendon pain in hand (tendons in the left hand were sore). The subject remarked that when he makes a fist, it feels like they are going to snap. At the time of reporting the outcome of the event was unspecified. The pharmacist considered the event was possibly related to vaccination with ENGERIX B. The pharmacist referred the subject to his physician.
got tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got tested positive for covid) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (got tested positive for covid). The patient was treated with VITAMIN D NOS ongoing since an unknown date for COVID-19, at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) ongoing since an unknown date for COVID-19, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date for COVID-19, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (got tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, SARS-CoV-2 test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
JOINT PAIN; NOT FEELING WELL; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetic, high cholesterol, and migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch no. was not reported and has been requested.  No concomitant medications were reported.  On MAR-2021, the subject experienced joint pain. On MAR-2021, the subject experienced not feeling well. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, joint pain, and not feeling well. This report was non-serious.
The patient woke up in the middle of the night with severe pain in her left arm and nausea which kept her up for three hours. She later noticed swelling in her left arm.
received booster of 0.5 ml/received a full dose as their booster instead of the half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received booster of 0.5 ml/received a full dose as their booster instead of the half dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (received booster of 0.5 ml/received a full dose as their booster instead of the half dose). On 23-Oct-2021, ACCIDENTAL OVERDOSE (received booster of 0.5 ml/received a full dose as their booster instead of the half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
pt recv vax 9SEP98 & learned that she was pregnant (LMP 5AUG98);23SEP98 pregnancy was confirmed by n ultrasound & pregnancy test (hCG);f/u info indicated that pt pregnancy ended in a spontaneous abortion 5-6wk from LMP;
HIVES ON LEFT LEG AND RIGHT ARM  AND THE RIGHT SIDE OF THE NECK; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced hives on left leg and right arm and the right side of the neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on left leg and right arm and the right side of the neck. This report was non-serious.