chrisvoncsefalvay/vaers-outcomes huggingface dataset:
part of a dose leaked out of the syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 42YY3, expiry date 28-MAY-2024) for prophylaxis.   On 24-MAR-2023, the patient received the 1st dose of Shingrix. On 24-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: part of a dose leaked out of the syringe). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 A pharmacist called to inform that earlier that day part of a dose of Shingrix leaked out of the syringe while administering it to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ043AB, expiration date: 22-May-2019, route: intramuscular and site of administration was right deltoid) on 26-Nov-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. Nurse states that she accidentally gave a FLUZONE HIGH DOSE injection to a patient after a temperature excursion/no AE. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Mom reports "a few red bumps" appeared on child approx. 2 wks. after imms. states that the bumps cleared up, then approx 1wk later the child developed a "red rash across her abdomen" also with a temp of 103 degrees which came down with Tylenol. Instructed client to contact physician.
suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The patient had shingles twice once before Shingles vaccine and once after. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Redness and swelling (4 fingers long by 3 fingers wide) at site of injection; presented with a white speck at center of the shot. Pt saw an MD and was given oral cephalexin and a topical antibiotic ointment.
irregular heart rate; my heart rate was 127/rapid heart beat; felt burning in my stomach/left side, under my breast.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 62-years-old, administered in Arm Left on 15Mar2021 (Lot Number: ENG204) as single dose for COVID-19 immunization. Medical history included artificial aortic and mitral valves and rapid heartbeat. Concomitant medication included metoprolol taken for heart rate increased, start and stop date were not reported (as needed). The patient stated that she got the shot on Monday, 15Mar2021. She was calling about having a burning in her stomach, underneath her left breast and having a rapid heart beat on Monday and last night. She got the shot in the morning and that evening (15Mar2021) was when the burning and rapid heart beat started. She did have artificial valves, aorta valve and mitral valve. She was wondering why she has the burning on the left side. It was mainly when she laid down at night. When she gets that [burning] she gets the rapid heart beat, her heart rate goes up to 120 or something. Patient reported, "laid down that night, felt burning in my stomach/left side, under my breast. Guess it was acid. My heart rate was 127- stayed for an hour or so, then I relaxed. Two (2) hours later, it all subsided." It skipped Tuesday but it did happen again last night. It was also like an irregular heart beat. Her heart beat went up to like 111. She states that she didn't notice the irregular heart beat until the fourth day [Wednesday], 17Mar2021. It is like beat skip beat skip. The irregular heart rate ended this morning 18Mar2021 and she confirmed she does not have that now. Treatment: states that she took metoprolol and Tylenol but not at the same time. Clarifies that she only takes Metoprolol if she is having a rapid heartbeat, takes only when needed. It is 25mg. BHC/SW, states this was also listed on the Covid Vaccine card. Patient asked if this is related to the vaccine and if it'll happen after getting the 2nd dose. The patient underwent lab tests and procedures which included heart rate: 127 on 15Mar2021 (my heart rate was 127- stayed for an hour or so), heart rate: 120 on 15Mar2021 (her heart rate goes up to 120 or something), heart rate: 111 on 17Mar2021 (Her heart beat went up to like 111). Therapeutic measures were taken as a result of events which included Tylenol and metoprolol. The outcome of the event irregular heart rate was recovered on 18Mar2021 while for the other events was recovering.
This spontaneous report was received from an approximately 83 year old female patient regarding herself with chronic lymphocytic leukemia. The patient had no drug reactions or allergies to prescription medication. On 25-JUL-2013, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was not reported). On an unknown date in JUL-2013, the patient stated that she had a very sore arm where she received the shot which seemed to get worse to the point where she had trouble raising her arm and she could not sleep on that arm. She stated that she does put heat on her arm at night. She already had prosthesis in her right shoulder and could not raise that arm fully. She stated that if she had known this could be a problem she would have had the injection in her right arm. No treatment was given and lab diagnostic studies were performed. The outcome of the reported events were not recovered. Additional information is not expected.
Lt thigh red, swollen returned call to pt 3/26/06 and redness and swelling going away.
anaphylactic reactions; Initial information received on 02-Aug-2021 regarding an unsolicited valid serious case received from other health professional.  This case was linked with SAD20210802001552 (Suspects PENTACEL, QUADRACEL, MENACTRA, DAPTACEL, ACTHIB, and ADACEL).  This case involves a patient of unknown age who had anaphylactic reactions (anaphylactic shock), while patient received IPV (VERO) [IPOL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (lot number: T1D482M and expiration date: 25-Jul-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious, anaphylactic reactions (anaphylactic shock), (unknown latency) following the administration of IPV (VERO).  Seriousness criteria was assessed as medically significant as per important medical event (IME) list for the event.  No laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown.; Sender's Comments: This case concerns a patient of unknown age who had anaphylactic shock following vaccination with IPOL. The time to onset is unknown. However, patient's medical condition at the time of vaccination and other lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Hives; Itching; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2020, the patient received the 1st dose of Bexsero. In July 2020, 30 min after receiving Bexsero, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to Bexsero.  Additional case details were reported as follows: A last week before from the reporting date, the patient received the 1st dose of Bexsero and 30 minutes later developed itching and hives. The reporter consent to follow up. Clinical supervisor did not provide lot number or expiration of the vaccine because he said that it happened in another facility. He did not provide initials of the patient either.
HEART ATTACK; 3 STROKES; This spontaneous legal received from a lawyer concerned a male of unspecified age. 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 was not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient suffered from a heart attack after received the Janssen covid-19 vaccine. The patient was also suffered 3 strokes as well. The patient was alleged injury 05-MAR-2021, but the law clerk was not sure if that was when the patient received the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and 3 strokes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Medical Assessment comment not required as per standard operating procedure for legal case.
Fever began a few hours after vaccine. Had a seizure about 36 hrs after vaccine.
Chills, headache, body aches, all around not feeling well. I took Aleve for aches. Got a good night sleep and feel 100% better this morning
PATIENT'S ARM WAS EXTREMELY SORE AND COULD BARELY LIFT HER ARM. SHE ALSO STATED SHE WAS NAUSEATED. SHE HAD TO MISS WORK THE NEXT DAY.
Yellow fever vaccine given on 8/12/2012 about 2pm. Patient called 8/16/12 and reported hives all over body, slight fever, soreness on sides of neck. Patient took BENADRYL. Patient told to seek medical attention.
Moderna Covid-19 vaccine administered 5/25/21   5/26/21:  Experienced the following in injection arm: - Large red spot around the injection site - Itchy - Arm very sore and hurts to move - From pain scale of 1-10 (10 being the worst) reported it at a 7 - Upper arm is swollen - Took Tylenol and applied ice to the injection site; Called off of work.  5/28/21:  Swelling in left arm started to subside, the itching stopped and patient could move arm around. Spot was still "warm to the touch" and the redness around the injection site has spread. No leg swelling or calf pain.  Picture was emailed in via MyChart.  6/22/21:  HIVES - Started on left leg 6/12 and progressed since then; now spreading to upper/inner thigh and showing on right leg. Hives red, itchy. Similar to previous allergic reactions. Picture sent via MyChart.  LEG SPASMS - Started in the left leg on 6/7 and have continued; now altering legs. Describes as "charlie horses" in calves typically at night.  PERIOD - was late but did have it and now bleeding stopped.    Patient has also had intermittent tension headaches since getting the vaccine. Takes Tylenol, rests and these resolve. There is no shortness of breath, chest pain. No facial lip or tongue swelling.
Male patient 40 years of age reporting vision loss.  After making contact with the patient he went unconscious.  Medical crew contacted command.  shortly after patient regained consciousness and was able to speak in full sentences and answered questions.  Pt was moved into the back of Aid 46 for further evaluation.  Pt states that this has happened before with previous vaccinations.  Pt states he feels much better.  Medical crew obtained continuous vital to include postural vital signs.  patient states he does not want any further treatment or transport and will stay in care of his girls friend.
This spontaneous report as received from a consumer refers to her male husband of unknown age. She and her husband (the patient) were vaccinated with ZOSTAVAX (dose, route and lot number not provided) on 28-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. After the vaccination her husband caught a cold. It was unspecified if the patient had sought medical attention. The outcome of caught a cold was unknown. She refused to answer any other question except for when they gotten the ZOSTAVAX shot. She had experienced no adverse events from receiving the ZOSTAVAX shot. She refused to provide information about the patient and the physician. Additional information is not expected.
Gave ZOSTAVAX at 11:30AM 7-19-11 -> patient developed fever at around 1:30-2pm on 7-19-11. Used TYLENOL to control it. Back to normal by today approximately 2PM. "Chills" & "fever".
Patient received her Fluzone HD and pneumovax 23 both in her left arm on 9/25/2021.  On Saturday 9/25/2021 she reports getting stuffed up.  Then Sunday morning patient had a headache, congestion, temp of 103, she felt hot, dizzy, and reports her blood pressure was low 103/57 pulse 111.  Sometime Sunday evening she noticed the redness on her arm and her arm was warm.  She called her doctor at the advice of a visiting nurse. She had a zoom visit with her doctor.  The doctor said it was cellulitis and prescribed cephalexin and prednisone for her to take care of it.
On 8/5/23, Patient experienced pain 10/10 in right side of neck up through behind her ear. Unable to lift or turn her head. Pain is same through Monday, 8/7/23.
Two weeks after vaccination, started fever,101 F and Fatigue continue 2 weeks finally recovered.
Large area of broken blood vessels in right eye; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12May2021 09:45 (at age of 65 years old) as single dose for COVID-19 immunization. Medical history included Diabetes 2, high Blood Pressure, High cholesterol. Concomitant medications included: BP meds. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. The patient experienced Large area of broken blood vessels in right eye on 13May2021 08:00 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event was recovered in 2021.  information on the lot/batch number has been requested.
Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 9/30/2022 Discharge Date: 10/12/2022  PRESENTING PROBLEM: Intra-abdominal fluid collection Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type   Patient is a 89 yo Female with PMH of hypertension, hyperlipidemia, Afib on Eliquis, Overactive bladder on oxybutinin and debility using a wheelchair to go to office appointments with daughter who presented to the hospital for hematochezia noted by daughter.  Pt lives with daughter who is her primary caregiver.  It was also reported that pt had been having some intermittent abdominal pain.  In the ER, pt found to be hypertensive, WBC 11, hgb 12.3, Creatinine 1.13.  She had CT A/P performed which showed multiple fluid collections (6.3 x 2.3 x 2.9, 2.9 x 2.2 cm, 5.1 x 3.8 cm). General surgery was consulted who recommended non-operative mgt and IR consult for drainage. She was started on IV Zosyn and admitted to Medicine with Eliquis held in prep for procedure.  Surgery recommended she remain NPO.  Also, of note pt found to be COVID-19 positive, but no respiratory symptoms and satting > 90% on RA.  CXR did show streaky b/l airspace disease.    After admission, it was noted she had rectal bleeding felt could be secondary to hemorrhoid though internal colon mass not excluded and Surgery recommended GI consult for C-scope.  GI evaluated and did not recommend immediate scope given concern for diverticulitis causing fluid collections and would set this up in 6-8 weeks post discharge. GI did recommend pt MRCP/MRI given biliary dilatation seen on CT A/P. Infectious disease was consulted given concern for infectious fluid in abdominal and recommend conditioning IV antibiotics to ceftriaxone/metronidazole.  Pt did develop AKI, suspect due to volume depletion/dehydration and IVF increased.  She was noted to have limited UOP, UA with large blood and Urology consulted with Urine cx ordered and medical cytology of urine.  Urine cx ultimately showed no bacteria.  Urine cytology showed no malignancy.     In terms of COVID 19 diagnosis, was felt she would be probably benefit from remdesivir but held off given AKI with low GRF.    Patient had abdominal drain placed by IR on 10/03.  Culture result from fluid collected finalized as enterococcus, streptococcus and e.coli.  ID recommends 3-4 weeks of IV antibiotics with repeat CT imaging at end of therapy.   For patient's urinary retention/hematuria urology was consulted.  Urology recommends cystoscopy in 6-8 weeks.   MRCP came back showing possible hepatic mass. MRI abdomen with contrast was done, which showed multiple liver masses.     Nephrology was consulted and recommended Foley placement for accurate assessment of I/Os.  Kidney function improved and normalized.   She continued to have poor oral intake. Discussed prognosis with patient and family and daughter who is DPOA. Hospice was consulted. Code status was changed to comfort care.  Patient was discharged with hospice care.
Stroke; This is a spontaneous report from a contactable consumer reporting on behalf of the mother.  An approximately 81-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 23Jan2021 (Batch/lot number: EL3302). Medical history was not reported. Concomitant medications included two unspecified prescriptions. On 13Feb2021 the patient experienced stroke which required hospitalization on the same day. The reporter was not sure of the name but they did a 'CAT' where they went up and pull the clot out of the brain. Event outcome was unknown. The patient was still in the hospital at the time of report. No investigation was performed before the event.
4yo boy who developed large local reaction/Arthus reaction consisting of >10cm patch of erythema with some associated vesicles within 24 hours of receiving MMRV vaccine to right thigh. Systemic symptoms included low grade temp and sore throat. No associated hives, angioedema, arthralgias or myalgias. No problems with ambulation. The following day temperature back to normal and sore throat resolved. Vesicles burst and erythema somewhat darker but resolving. Treated symptomatically with topical steroids.
8 out of 10 muscle soreness and weakness at sight of injection lasting 14 days.
1ST PFIZER VACCINE GIVEN ON 3/19/21 TETANUS GIVEN ON 3/23/21 2ND PFIZER VACCINE GIVEN ON 4/8/21
Swelling in this throat; Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later; ER diagnosed him with COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling in this throat), PERIPHERAL SWELLING (Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later) and VACCINATION SITE REACTION (ER diagnosed him with COVID arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 022M20A and 011M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMOXICILLIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced PHARYNGEAL SWELLING (Swelling in this throat), PERIPHERAL SWELLING (Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later) and VACCINATION SITE REACTION (ER diagnosed him with COVID arm). The patient was treated with APAP for Hand swelling and Vaccination site reaction, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swelling in this throat) outcome was unknown and PERIPHERAL SWELLING (Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later) and VACCINATION SITE REACTION (ER diagnosed him with COVID arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The pharmacy told him to go to the emergency room. ER diagnosed him with COVID arm. They gave him a strong shot of APAP, iced his hand, and kept it elevated. They stated that if it did not get better, then go to the doctors. He went to the urgent care for swelling in this throat and the doctor gave him steroids to help with the swelling of throat and hand. Hand was still swollen a month later.
Initial and follow up information has been received from a medical assistant concerning a patient who on 29-AUG-2007 was vaccinated with a first dose of Gardasil (lot # unknown).  On 29-AUG-2007 the patient's arm was sore from the vaccination.  On 02-NOV-2007 the patient was vaccinated at the physician's office with a second dose of Gardasil.  The patient did not receive the full second dose of Gardasil.  As the vaccine was being administered some of the dose leaked from the syringe where the needle was attached.  The syringe was not a pre-filled Gardasil syringe; the dose was drawn up with a syringe from a single dose vial.  The patient is not experiencing any known symptoms.  Follow-up information was received and the patient's arm was sore from the second vaccination.  At the time of reporting it was unknown if the patient had recovered.  No further information was available.  Additional information has been requested.