chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 29-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated with unspecified number of improperly stored doses of oral, ROTATEQ (lot # L000571; expiration date 26-JUL-2016) route default as oral (doe and strength were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was no concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Very cold, shaking, shivering, could not get warm, headache, slight upset stomach, aches all over. Lasted about 24 hours.
Chronic mild cough.  Treated with Breo inhaler so technically have adult-onset asthma.  Not sure if this is due to vaccine as such because last bout with something like this was in 2009.
Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Dizzy; This is a spontaneous report from a contactable consumer (patient).   A 47-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0198) administered in left arm via an unknown route of administration (at the age of 47 years old) on 14Jul2021 at 16:00 pm as dose 2, single for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. There was no covid prior vaccination and covid tested post vaccination. There was no other vaccine in four weeks and other medication in two weeks. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: EW0180) administered in left arm via an unknown route of administration on 17Jun2021 at 04:30 am as dose 1, single for covid-19 immunisation and experienced no adverse event. The patient had no known allergies to meds or foods. The patient was very healthy otherwise. On 15Jul2021 at 07:00, the patient experienced very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. i was always very regular on time and releasing this much blood and dizzy. It was reported that the patient had very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. The patient was always very regular / on time and releasing this much blood was very abnormal to me. The patient was also crapping more between periods. During previous cycle which came immediately after the second shot, the patient was bleeding so much that she was dizzy. The patient was making an appointment with my OBGYN to discuss. No treatment was received for the event. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Pharmacist.  A healthcare worker of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 on an unspecified date with outcome of unknown.  Information about Lot/Batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt after first shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), SULFASALAZINE, PREDNISONE, GABAPENTIN, CELECOXIB, CARVEDILOL, LISINOPRIL, SIMVASTATIN, TORASEMIDE SODIUM (DEMADEX [TORASEMIDE SODIUM]), TRAMADOL, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt after first shot). At the time of the report, PAIN IN EXTREMITY (Arm hurt after first shot) had not resolved. Concomitant product also include Trelogy inhaler as directed. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Lab test also included antibody tests however results were unknown.
pt recv vax & 31JUL96 or 1AUG(5 pt devel a raised red/condensed erythematous rash all over trunk, head & body x/legs;pt recovered 2AUG95;
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 60-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
2/5/2021, Lip swelling on the inside, called a lye bump. Vertigo was also experienced. 2/18/2021 Allergies seemed to really increase. 6/10/2021 Allergist did not find anything different. Possibly Angio edema. Swelling on lip lasted 14 months. Some time in February 2022 lip swelling began decreasing.
During the 15 minute monitoring window, I began to experience heart palpitations/fluttering. After the 15 minutes I was allowed to leave, where I continued on with heart palpitations for a duration of 30 minutes. Altogether the palpitations lasted about 45 minutes with no other symptoms.
This spontaneous report as received from a nurse via Poison and Drug Center refers to a patient of unknown gender, between the age of 19 years and 29 years old. The patient's medical history and concurrent conditions were unknown. ON 28-JUL-2015, the patient was vaccinated with an unknown dose of (Oka/Merck) VARIVAX (route was not reported, lot # K026386, expiry date 15-DEC-2016) which underwent temperature excursions as follows: 8.9 degrees celsius for 1 hour and 28 minutes on 07-JUL-2015 and 0.4 degrees Celsius for 1 hour and 25 minutes on 28-JUL-2015. Concomitant medications were unknown. The patient did not experience any adverse events. This is one of several reports received from the same reporter. Additional information has been requested.
An adult patient received a pediatric dose of VAQTA; An adult patient received a pediatric dose of VAQTA; No known adverse effects; This spontaneous report was received from a nurse, concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose and route of administration were not reported, lot number R030115 and expiration date reported as 29-DEC-2019, and upon internal validation stablished as the same), indicated for prophylaxis (incorrect dose administered and underdose). No adverse effects were known.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA005301:
then tested positive for Covid-19 the next day, 21SEP2021.; then tested positive for Covid-19 the next day, 21SEP2021.; She says her COVID symptoms are getting a little worse but they are not bad; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 20Sep2021 (Lot Number: FC3182) as dose 2, single (at the age of 18 years) for COVID-19 immunisation and dose 1 via an unspecified route of administration, administered on 30Aug2021 (Lot Number: FC3181) as dose 1, single (at the age of 18 years) for COVID-19 immunisation. The patient medical history and concomitant medications were reported as none. She says that her COVID symptoms began right after she got her second dose of the vaccine. The patient had tested positive for Covid-19 the next day on 21Sep2021 and her COVID symptoms are getting a little worse, but they are not bad on Sep2021. She says that she has been taking Tylenol to treat her COVID symptoms, she doesn't have the Tylenol with her. The patient underwent lab tests and procedures which included covid-19: Positive on 21Sep2021 and body weight was: 120-130lbs on 21Sep2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced; abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced; This is a spontaneous report from a contactable physician. A 74-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. her hepatologist believes that these levels are drug induced on unspecified date. The physician states that a 74 year old female has received both doses of the Pfizer COVID-19 vaccine and her liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced. The patient has had extensive testing and a liver biopsy as well. The patient has not reported this AE yet to Drug Safety at Pfizer. The patient underwent lab tests and procedures which included ALT (alanine aminotransferase) and AST (aspartate aminotransferase): are in the 600's range on an unspecified date and Liver Biopsy (biopsy liver): unknown results on an unspecified date and extensive testing (investigation): unknown results on an unspecified date. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained; Sender's Comments: based on the available information the causal relation ship between the suspect vaccine BNT162B2 and thnte adverse event ALT (alanine aminotransferase) and AST (aspartate aminotransferase) increased cannot be totally ruled out  The impact of this report on the benefit/risk profile of the Pfizer product 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
Parent reports seizure on 4/8 at 4:15 an child transported to Hospital. Sent home with ibuprofen.  4/9 at 10:30 PM seizure taken to Hospital. Sent home at 2:00AM with script of Kefir.  4/10  3 seizures back to back went back to Hospital. EEG  done and told the are not epileptic seizures may be stress induced .  Sent home on 4/11  with  appt set up to see neurologist  June 28.  4/12 had more seizure went to Med Cent then transferred to Hospital. Stay there and was released on the 13th told seizure could be cause by Migrain and IUD or homones Sent home on reglin  and ibuprofen.
It was painful going through my arm; never went back for part 2; This case was reported by a consumer via and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported for 1st suspect vaccine. The age group was not reported but was captured as an adult as per vaccine indication.  The age at vaccination was not applicable for the 2nd suspect vaccine. The patient received 1st Shingrix shot about two years ago from the reporting date and he/she was hated it. The reporter mentioned that, it was painful going through his/her arm therefore he/she never went back for part 2. The reporter was considering getting the shot again and asked if he/she would need two shots since it had been so long in between them or just one. Till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not possible, as no contact details were available.
arm became an infection; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (arm became an infection) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOCALISED INFECTION (arm became an infection). At the time of the report, LOCALISED INFECTION (arm became an infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details included antibiotics for the infected arm.   This case was linked to MOD-2022-445073 (Patient Link).
I contracted Covid 10 days after being vaccinated; This is a spontaneous report received from a contactable 57-year-old male consumer (patient) and contactable other health professional. This patient reported for himself that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 30Jan2021 at 14:15 (age at vaccination 57 years) at single dose in left arm for covid-19 immunization. The patient administered vaccine at hospital. The patient's medical history included graves disease and myasthenia gravis. Concomitant medications included levothyroxine and eszopiclone (LUNESTA). On 09Feb2021 at 10:00, the patient had contracted with Covid-19. The patient experienced the event at Doctor or other healthcare professional office/clinic visit. The patient did not take any treatment for the event. The patient laboratory details included PCR and nasal swab both on 09Feb2021 with positive results. Upon follow up on 22Mar2021, it was reported that the patient contracted COVID after first shot. The outcome of the event was not recovered. The Other health professional considered (reporter) that the Pfizer product had a no causal effect to the adverse event.  Follow-up (22Mar2021): New information received from a contactable other HCP. This other HCP reported in response to HCP letter sent which included: Clinical information added   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   In SEP-2023, the patient received RSV vaccine, FLU VACCINE (NAME UNKNOWN) and COVID 19 VACCINE. On an unknown date, less than 2 weeks after receiving RSV vaccine and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced pain in arm (Verbatim: Sore arms). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 27-SEP-2023 The case was received from the patient interactive digital media. The patient got RSV, Covid and Flu shots last week and had no symptoms except slight sore arm. In SEP-2023, less than 2 weeks after receiving Covid 19 and Flu vaccines, the patient experienced pain in arm. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR135367, reported by same reporter (Husband's case).; Sender's Comments:  US-GSK-US2023AMR135367:Patient husband/same reporter
pt recvd vax & exp 2 inch diameter red patch w/blisters on the rt upper side of chest; 23JUN93 seen by dermatologist who confirmed dx of herpes simplex;