chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not able to eat; belly hurts/abdominal pain/pain in stomach; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jun-2021 and was forwarded to Moderna on 24-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of FEEDING DISORDER (not able to eat) and ABDOMINAL PAIN (belly hurts/abdominal pain/pain in stomach) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for Chronic pancreatitis.    The patient's past medical history included Pancreas disorder (Hospitalized because of problems with pancreas). Previously administered products included for an unreported indication: AMOXICILLIN and macrodantin. Concurrent medical conditions included Allergy to antibiotic (Macrodantin  manifested by rash) and Allergy (Amoxicillin manifested by bad rash).   In October 2020, the patient started PANCREATIN (CREON) (unknown route) 3 capsules with meals 1 capsule with snacks. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced FEEDING DISORDER (not able to eat) and ABDOMINAL PAIN (belly hurts/abdominal pain/pain in stomach). At the time of the report, FEEDING DISORDER (not able to eat) and ABDOMINAL PAIN (belly hurts/abdominal pain/pain in stomach) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had been out of CREON for one and half days and could not find the CREON because of the shipment from her pharmacy was late. Patient was unable to eat  since june 10 as she needs CREON tablets to digest the food. No treatment information was provided by the reporter. No concomitant medication was provided by the reporter.
Syncope occurred 5 minutes after immunizations.  C/O nausea, dizziness. B/P 138/60. Pulse 88. Oxygen saturation 96% room air.
Reported severe left upper/outer arm pain since second dose of Pfizer vaccine, swelling, leg cramping, weakness.  Nose bleed on 5/12/2021, facial pain and headache. Finger pain and frozen joints. Symptoms worsen.
Approx one week after vaccination, pt developed shingles on left upper quadrant of abdomen.
26 YO patient did not get 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 26-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date at 22 years of age).   On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: 26 YO patient did not get 2nd dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-APR-2023 The second dose had not yet been given.  The vaccine administration facility was the same as primary reporter. The health care professional (HCP) declined to provide any adverse event details at this time, but did consent to safety team follow up. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination.
face red w/burning, then next day face peeled, dry & flakey, inject site red & raised;
My friends doctor blacked out with the first Pfizer vaccine injection; This is a spontaneous report from a contactable consumer. A 5-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced blacked out with the first pfizer vaccine injection on an unspecified date.  The outcome was unknown.   Information on lot/batch number has been requested.
Pain in the left arm/pain was persistent and dull; Arm with limited mobility; Pain was sharp at the point of administration if pressed; This spontaneous case was received on 20-Sep-2020 from a consumer via Agency (reference number: SEQW20-03976) and concerned a 59-year-old, male patient.  The patient had no relevant medical history. The patient's concomitant medications included Avastin (bevacizumab), synthroid (levothyroxine sodium) and pantoprazol, all used for an unreported indication.  On an unspecified date in 2020, three weeks prior the initial reporting, the patient was vaccinated with influenza virus vaccine polyvalent [brand not specified, route of administration: intramuscular, anatomical location: left arm and dose: not reported] for influenza prophylaxis. The batch number was not reported. It was reported that the vaccine was not for over 65-year-old patients.  On an unspecified date in 2020, after receiving influenza virus vaccine polyvalent, the patient experienced severe pain in the left arm, with limited mobility. The pain was persistent and dull, and it was sharp at the point of administration if pressed. It was also reported that the pain was getting worse. No corrective treatment was given for the events.  At the time of initial reporting on 20-Oct-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Case updated on 27-Nov-2020: Correction made to information received on 20-Oct-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No changes in narrative.   Company comment: A 59-year-old, male patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient developed pain in extremity, injected limb mobility decreased and vaccination site pain. With information available, causality is assessed as possibly related.; Sender's Comments: A 59-year-old, male patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient developed pain in extremity, injected limb mobility decreased and vaccination site pain. With information available, causality is assessed as possibl
There was a needle malfunction.  The patient received less than half of a dose, then the needle retracted without administering the full dose.  The patient was given a full dose after this incident.
Hives for 2 weeks followed by dermotographia for 7 weeks with positive bloodwork (never previously positive).
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
I was not pregnant yet when I received first dose on 12/22/20 but became pregnant within the 3 weeks that my 2nd covid vaccine was due on 1/11/21. I chose to get the vaccine since CDC was then recommending pregnant patients to receive it stating it was safe. I had my first ultrasound on 2/1/21 in which they found the embryo had no heartbeat and estimated that it stopped growing at around 8 weeks. At the time I should have been 10 weeks gestation.
Started out with a large ring like rash  around injection site about a week after first dose. Now has developed into hives on chest, neck, and face. Chest congestion also developed about a week after. Took covid test and received a negative result.
Received shot in the AM Friday morning (04/01/2022), by 8:00 that evening I started having extreme body aches. Saturday morning woke up and from the site of my shot to the side of my right breast, I started having sharp pains, still today (04/04/2022) the side of my right breast is still very tender and sharp pains. I also had three large red welts around the site of my vaccine.
Day after dose 2 pt developed generalized rash on body. Reported rash (red, raised bumps) on 19May21. Denies any breathing difficulties or swelling.  Pt took Benadryl with relief.  Currently rash only appears if he scratches his skin.
was napping and heard static in my right ear. Then my hearing stopped working. I am left with very loud tinnitus in my right ear. My aunt lost her hearing a year prior, almost to the date, after a sinus infection.
Vaccinated on 7/23/10 at 10AM. C/o rash and itching beginning 7/23/10 pm. Seen in ED 7/25/10 for generalized rash and itching. Employee was treated and released. Continued with itching, generalized rash and lip edema. No resp. issues. Continues f/u with OH/MD as of 7-29-10.
Hemorrhaging from her Fibroids; Diagnosed with DIC; This spontaneous case was reported by an other health care professional and describes the occurrence of UTERINE HAEMORRHAGE (Hemorrhaging from her Fibroids) and DISSEMINATED INTRAVASCULAR COAGULATION (Diagnosed with DIC) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced UTERINE HAEMORRHAGE (Hemorrhaging from her Fibroids) (seriousness criteria hospitalization and medically significant) and DISSEMINATED INTRAVASCULAR COAGULATION (Diagnosed with DIC) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 days due to DISSEMINATED INTRAVASCULAR COAGULATION and UTERINE HAEMORRHAGE. On 08-Feb-2021, UTERINE HAEMORRHAGE (Hemorrhaging from her Fibroids) and DISSEMINATED INTRAVASCULAR COAGULATION (Diagnosed with DIC) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received plasma and blood as a treatment.  This case concerns a 47-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of uterine haemorrhage and disseminated intravascular coagulation. The events occurred 16 days after the first dose of mRNA-1273. The rechallenge was positive. he benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-346425 (Patient Link).; Sender's Comments: This case concerns a 47-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of uterine haemorrhage and disseminated intravascular coagulation. The events occurred 16 days after the first dose of mRNA-1273. The rechallenge was positive. he benefit-risk relationship of mRNA-1273 is not affected by this report.
Fever, redness to arm, site hot, red blotches on inner aspect of arm.
No energy; Felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of loss of energy in a male patient who received Herpes zoster (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 loss of energy and feeling bad. On an unknown date, the outcome of the loss of energy and feeling bad were unknown.   It was unknown if the reporter considered the loss of energy and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that he experienced no energy and felt bad after second shingrix dose. Did not consent to follow-up. This case was 1 of 8 cases, reported by same reporter.
Patient comes in the pharmacy with injection site redness, soreness, and pain  in her left arm starting late Friday night 10/11/19 after receiving a Shingrix injection on 10/09/2019, Patient states that she took Tylenol for the pain but it did not help
Large red swollen, warm area 1 1/2-2 in diam at inj site, increased to 3" over next day.
had surgery on my ear 01Sep2022; Not too long after the shot I had a metallic taste that lasted 7 days.; right ear ruptured a week later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CRPS" (unspecified if ongoing), notes: Other medical history: CRPS. The patient took concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 02Nov2021, outcome "recovered" (Nov2021), described as "Not too long after the shot I had a metallic taste that lasted 7 days."; TYMPANIC MEMBRANE PERFORATION (medically significant) with onset 02Nov2021, outcome "not recovered", described as "right ear ruptured a week later"; SURGERY (medically significant) with onset 01Sep2022, outcome "unknown", described as "had surgery on my ear 01Sep2022". The event "right ear ruptured a week later" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tympanic membrane perforation.  Clinical Course: Not too long after the shot patient had a metallic taste that lasted 7 days. Patient was told that was rare but would go away. On, 08Nov2021, patient went to the ENT because her right ear ruptured a week later. Patient just had surgery on her ear 01Sep2022 so hopefully the surgery was a success. The patient was in perfectly good health was forced by employer (Name withheld). No other vaccine in four weeks. Patient had Thyroid medication in two weeks of vaccination. Patient had no COVID prior to vaccination. Patient tested COVID post vaccination. There were no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
localized rxn w/cellulitis-redness, swelling;tx w/ATB;
Syncopal episode 3 min. after administration. Lasted 15 sec. ? Twitching. No sz, no post ictal. Full recovery in 10 min. Emesis x 1. Neg previous history.
3 days after COVID vaccine administration, I developed COVID-19 from family exposure.  Son/daughter tested positive on 12/28/2020.  I started symptoms of HA, ST, myalgias on 12/26/2020 and tested positive for COVID-19 on 12/29/2020
Loss of taste; Loss of smell; Difficulty Breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DYSPNOEA (Difficulty Breathing). On 10-Jan-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, DYSPNOEA (Difficulty Breathing), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Information has been received from a certified medical assistant concerning a male who on 09-JUL-2007 was vaccinated with the first dose of Rotateq.  On 24-SEP-2007 the patient was in the office to get the second dose of Rotateq.  Additional information has been requested.
NauseaVomiting weakness, lethargy, glandular swelling, odynophagia Narrative:
2 weeks post-vaccination acute onset of headache, body aches, abdominal pain, and severe chills
Headache/neck/ear pain 10/10, body aches all over except for bottom of feet and hands, chills/fever,  upset stomach, nausea, no vomiting,  I suspect this was adverse effect of Shingrix vaccine
Stiff/swollen injection site( 5-6 days), loss of appetite(1 .5 days), fever(100 degrees for 1.5 days), rapid heart rate and elevated blood pressure(somewhere around 174/93.
mom reports nonstop crying by pt for >3-3 1/2 hrs that coult not be consoled; no fever, no vomiting, no diarrhea; pt seen by MD the following AM; nl exam; pt was no longer irritable;
Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: DEATH (death, medically significant), outcome "fatal", CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown" and all described as "Caller stated that she knows 2 patients who have died and 2 patients who had stroke.". The patient date of death was unknown. Reported cause of death: "Caller stated that she knows 2 patients who have died and 2 patients who had stroke". It was not reported if an autopsy was performed. Reporter who was a nurse for 30 years wanted to know if and when the COMIRNATY-labeled vaccine will be available and stated that she did not want to get the EUA-approved Pfizer COVID-19 vaccines due to liability and that she is not an "experimental rat". Reporter stated that she knows 2 patients who have died and 2 patients who had stroke. Unable to gather more information on patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the serious events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Caller stated that she knows 2 patients who have died and 2 patients who had stroke
The patient was administered his 2nd dose of Modera Covid-19 vaccine 6 days too early.  He showed up for his 2nd dose on 06/26/2021 and presented a vaccine record card with a wrong appointment date written on it.  The Pharmacist who gave him is 1st dose of Moderana made his appointment for 06/25/21 (21 days).  His correct appointment date should have been written as 07/02/2021 (28days).   The Pharmacy Manager admitted to making a mistake when she wrote the wrong date on his record card.  She said that she later tried calling him to have it corrected but she was unable to reach him at the phone number he gave that Pharmacy.
Patient began screaming and you could tell his stomach was very uncomfortable. He then had a bloody stool and began spitting up frequently. He was not able to sleep longer than a few minutes at a time for several days. The bleeding subsided 2 weeks later, but he is still not his normal self.
Breakthrough case admission after 2 vaccines Pfizer 9/15/21 Lot# FF2588;  Pfizer 11/30/21 Lot# 320308D
Patient reports: swelling, redness, warm to touch at injection site; itching with no rash on back of head and starting in arms and legs, loss of appetite/nausea, fever and chills
This spontaneous report has been received from a pharmacist refers to a patient of unknown age. Pharmacist reported that an unspecified patient received the 1st dose of the GARDASIL (lot# was not reported) series on an unspecified date in 2007, then the 2nd dose of GARDASIL (lot# was not reported) on an unspecified date in 2013. Pharmacist reported that the patient was presently at an unspecified physician's office to receive the 3rd dose of GARDASIL (lot# was not reported) on 15-JAN-2015. No adverse effect reported. Additional information has been requested.
Pt recvd 3 doses of Hep B vax inject date & vax date of first 2 doses if unk; 3rd dose was Recomb given 13MAR91; pt did not respond, was not protected; 5SEP91 recvd booster dose of Engerix-B; 17DEC91 titer tested result-neg;