chrisvoncsefalvay/vaers-outcomes huggingface dataset:
use expired Ipol yesterday that was dated for August 2; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old patient who was vaccinated with a fourth dose of expired vaccine IPV (VERO) [IPOL] (lot N1G511M and Exp. Date 02-Aug-2019) via intramuscular route in the left deltoid on 05-Aug-2019.  The patient's medical history not reported and concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  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 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.
An 80-year-old female patient had received a Tetanus vaccination and had difficulty breathing. The manufacturer and date of vaccination were unknown at the time of the report. No further information was provided.
shakes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 TREMOR (shakes). At the time of the report, TREMOR (shakes) outcome was unknown. Not Provided          Treatment for the event include paracetamol.   Reporter did not allow further contact
never sicker; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included shingles (had shingles in his/her mid 20 years). Previously administered products included Chickenpox vaccine.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received Flu shot and was sick after getting the shot.
Pt. was in for an OV on 6/28/22, health maintenance flagged due for pfizer booster, MA discussed and verified he's truly due. Patient wasn't sure he had his card along, wasn't planned or known he was going to need it. After Pfizer booster was administered, before leaving the office the patient found his vaccine card, MA noticed he had one written on his card in bright blue ink dated 4/26/22, only then did pt. remember he had one recently with a BP check. The 4/26/22 one wasn't ordered or documented in system hence why it showed due. I looked back through our dose card for the covid vaccine and the story does match up. The doses given match what was on the schedule. We did go back into system on 4/26 and added the dose he received that day. As a result the patient was not due for another booster.
Client received additional dose of Flu Vaccine on 11/19/2022, client had received previous dose of flu vaccine on 10/18/22 .
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown dates, the patients received improperly stored doses of PEDVAXHIB  (lot number M020102, expiration date 08-MAR-2019) (dose and route not reported). The temperature excursion was 34.02 Fahrenheit for 8 hours. There were no previous temperature excursions. This was reported because of a data logger. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008780.
Temp mesaured to be 100.0F; local rxn; joint pain; paresthesias; as of 9OCT91 pt is partly recovered; when pressure applied to inject site, pt reports soreness;
When shots were administered, patient had an episode of decreased level of consciousness that lasted about 5 seconds. He was stimulated by his mother and normalized.
This spontaneous report as received from a 70 year female patient, who was reporting on herself. None pertinent medical history, drug reaction/allergies and concomitant medications was reported. On an unspecified day in April 2015, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). On 23-MAY-2016, the patient developed shingles. The first symptom was a clear bump with a hole in it on her left eyelid. More of the same bumps developed in the left eyebrow area. She also had shooting pains in the left eye area. She took TYLENOL but sent a photo of the bumps to her unspecified physician, who diagnosed her from the photo as having shingles. No labs performed. He prescribed an antiviral and and antifungal that she was taking along with an over the counter probiotic. It was reported that the patient was treated with doxycycline and valacyclovir. She also was using Res-Q by the itchy areas. the bumps were almost gone. One had some redness around it and fluid. The patient was recovering from the event. There was no product quality complaint. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Suspected vaccination failure; Had it once after vaccine; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a 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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
tingling sensation on the sides of patient face and on different parts of the body; feeling illness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling illness) and PARAESTHESIA (tingling sensation on the sides of patient face and on different parts of the body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   Concomitant medications were not reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling sensation on the sides of patient face and on different parts of the body). On an unknown date, the patient experienced MALAISE (feeling illness).   At the time of the report, PARAESTHESIA (tingling sensation on the sides of patient face and on different parts of the body) outcome was unknown.      No treatment medications are included.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Scattered macules and weals with smaller pink papules over trunk on legs and arms. started on 03/15/2005.
Information has been received from a certified medical assistant concerning a 12 year old female patient with cerebral palsy and no drug reactions/allergies who on 23-NOV-2011, was vaccinated with the first dose of GARDASIL, 0.5 ml, IM (Lot # not reported) and on 23-DEC-2011 with the second dose of GARDASIL (Lot# 668261/1397AA, expiration date: 09-APR-2013), 0.5 ml, IM. There was no concomitant medication. On 23-DEC-2011, the patient developed a seizure. The medical assistant noted that the patient had no problems after receiving the first dose. The patient sought medical attention by contacting a physician. At the time of the report, the patient's outcome was unknown. Upon internal review, the seizure was determined to be an other important medical event. Additional information has been requested.
It began with coughing and I thought it could be a head cold. Within a couple of days, I felt extremely fatigued and was still coughing. I took my temperature the day I was going to urgent care and it was 102. I needed to get myself to urgent care because this was not normal and I was fatigued and coughing. I went in and talked to the PA. He did a COVID-19 test and a flu test. I was positive for COVID-19 and I did not have the flu. He asked if I had breathing problems. I had no issues, but I basically had the cough and fever. The PA said my oxygen level was fine, but my blood pressure was up a little bit. He said he would prescribe PAXLOVID for me and that was the extent of it. The PAXLOVID helped me feel better within 24 hours. I did experience the metallic taste which was startling. That went away as soon as I was done taking the PAXLOVID. I felt so much better and I haven't had any rebound.
Red spot on that arm getting bigger; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red spot on that arm getting bigger) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red spot on that arm getting bigger). At the time of the report, ERYTHEMA (Red spot on that arm getting bigger) outcome was unknown. Not Provided          NO Concomitant products used by the patient included. Treatment information was not provided Post vaccination patient experienced ret spot on the arm getting bigger.
Pt  was concerned because after the vaccine, he developed flu like symptoms (bodyaches, fever, etc).   He felt like this for 3 days or so.  He was relieved with tylenol and rest.  No medical attention was needed.
Received MMR, Hep A and varicella on 03/10/17. Was also started on AUGMENTIN for an ear infection on 03/10/17. Hives began on 03/19/17 with hives and angioedema. Patient was administered DECADRON and BENADRYL and was given an EPIPEN and ATARAX.
Discovered after vaccination that Mother lied about age on requisition form.  Actual DOB is different which makes patient under 12 years old and not eligible for vaccine.
This spontaneous report was received from the patient's mother (medical assistant) via a company representative; referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in 2018 (also reported as "a few weeks ago"), the patient was vaccinated with her first dose of GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2018, the patient had one episode of vomiting after received her first dose of GARDASIL 9. At the reporting time, the outcome of vomiting was unknown. The causality assessment between the vomiting and vaccination with GARDASIL 9 was not provided.
Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications were not provided.   This case was linked to MOD-2021-391038 (Patient Link).
Sore arm at site of injection.  Not improving after 24 hours. Disturbing sleep.  Not happy.
On the afternoon after receiving my first vaccine dose (March 25) I began to notice abdominal cramping and a pain on my right lower abdomine...this pain and cramping increased and 5 days later (march29) I sought medical atten at Urgent care.  They referred me for ct scan and blood work at hospital where it was determined that I need to have my appendix removed.  Which is what they did.
Information has been received from a registered nurse, concerning her 24 year old daughter with no known allergies and a history of an papilloma viral infection (HPV) and a loop electrosurgical excision procedure (LEEP) (July 2006), who on 21-MAY-2007 was vaccinated with the first dose and on 31-JUL-2007 with the second dose of Gardasil (lot # not reported).  There was no concomitant medication.  Following the second vaccination (date and duration not specified), her daughter had an abnormal papanicolaou (PAP) smear (details not provided), and sought unspecified medical attention.  At the time of this report, her daughter had not recovered.  Additional information has been requested.
After receiving shot (2nd Moderna COVID-19), almost immediately patient complained of dizziness. Patient then lost all bodily control, almost felt off vaccination chair. Patient appears pale and lost consciousness. Patient was then slowly helped to the ground then all of a sudden patient started to have involuntary muscular twitching almost like she was having a seizure. Immediately I asked to call for paramedic. A waiting patient, who is a law enforcement officer assisted to help patient the floor. Then unpredictably patient sat quickly up and regained consciousness and appeared confused like she had no memory what had just happen. Paramedics did not come as patient had quickly felt better and was able to communicate proficiently. Her breathing was normal. No dizziness reported after. Patient was moved to waiting area and sat down in chair and I took her blood pressure. Blood pressure was normal 112/72. Requested patient to wait for a total of 30 minutes for monitoring. Blood pressure retaken after 10 minutes normal again . Patient was able to walk away by herself without assistance.  I gave patient a call for a well being check at 3pm today and patient insisted she feels normal. Encourage patient to be evaluated by her primary care provider.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) and experienced pain during an injection and then fainted in the office. Subsequently, the patient recovered. The patient sought medical attention at the physician's office. Additional information has been requested.
Mom call to report her son was having squeezing type of chest pain approximately 10-15 minutes post injections on his way back to school where she dropped him off. School nurse was asked to evaluate him. Mom had not notified the school of his chest pain when she dropped him off. 11/4/03 Phone call to mom recommending she take him to family doctor.
For about 24 hours I had a bizarre & scary reaction to the second shot: I lost my ability to SPELL. Even the simplest words. It was just gone.  BUT ON THE SECOND MORNING IT WAS BACK.
died; GBS as a side effect, and died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comment: This case was reported by a patient's son/daughter via interactive digital media. The patient got the Shingles vaccine and got Guillain Barre syndrome (GBS) as a side effect. The patient was died. Additional Supportive Information: The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Screaming, crying for prolonged period post-immunization (6-8 hrs) duration.
This spontaneous report was received from an unspecified reporter via an online article published and refers to a 8051 patients of unknown age and gender who reported the events via Vaccine Adverse Event Reporting System. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced unspecified adverse events. The outcome of adverse events was reported as not recovered/not resolved. The relatedness between the events and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Fever and red itchy rash around injection site started 36 hours after vaccination. Fever resolved in 2 days rash continued. Lump under injection site and heat at site started 1/26/15. Seen today with continued rash. Itching and lump at injection site. Prescribed ZYRTEC and BENADRYL.
A non-serious spontaneous report of vaccine administration into the right eye with resulting itching and redness has been received from a consumer concerning a 31-year-old male, subsequent to FLUMIST. No medical history was provided but he indicated that he wears contact lenses; no concomitant medication information was provided. The patient stated that he has received FLUMIST for the last two years without any adverse reactions. The consumer received a single dose of FLUMIST nasally on 07-Sep-2009 for influenza vaccination. The consumer stated that at the time of the administration of the FLUMIST, he received some in his right eye. Three days later his eye was very itchy and red. He did not seek medical attention or receive any treatment. The right eye redness and itching resolved on 12-Sep-2009. Additional information received on 30-Sep-2009 and incorporated into the narrative included: event and vaccination details and the outcome of the events.
Fever of 101-103 starting day 1 after injection; extreme headache; pain scale of 7-10/10; vomiting; lethargy; malaise; muscle weakness; fatigue; dyspnea; loss of appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0181) , administered in arm left, administration date 04Aug2021 12:00 at the age of 48 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Penicilin" (unspecified if ongoing), notes: Known allergies: penicilin. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Fever of 101-103 starting day 1 after injection"; HEADACHE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "extreme headache"; PAIN (non-serious) with onset 05Aug2021, outcome "not recovered", described as "pain scale of 7-10/10"; VOMITING (non-serious) with onset 05Aug2021, outcome "not recovered", described as "vomiting"; LETHARGY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "lethargy"; MALAISE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "malaise"; MUSCULAR WEAKNESS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "muscle weakness"; FATIGUE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "fatigue"; DYSPNOEA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "dyspnea"; DECREASED APPETITE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "loss of appetite". The events "fever of 101-103 starting day 1 after injection", "extreme headache", "pain scale of 7-10/10", "vomiting", "lethargy", "malaise", "muscle weakness", "fatigue", "dyspnea" and "loss of appetite" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, pain, vomiting, lethargy, malaise, muscular weakness, fatigue, dyspnoea, decreased appetite.  No follow-up attempts are possible. No further information is expected.