chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child received attached immunizations at 3 months at 15:30. Mothers reports she thinks child is having reaction. Child is pale, sleepy and "knees buckled" when placed in standing position. Temperature 99.6F (ear); able to walk when observed by RN. At 16:00, temperature was 101.6F (ear); sleeping and lethargic. Has no Tylenol and no local MD. Instructed to go to ER. On 5/5/01, pt spiked fever of 105F. Mother took child to Urgent Care Center. Fever was reduced to 102F. Mother states that personnel there, reported he had no other signs of infection. As of 5/7/01, at 09:45, pt still has a fever about 102F with being treated with Motrin/Tylenol alternately.
Information has been received from a licensed visiting nurse, via a company representative, concerning a female student in twelfth grade, who on 14-MAY-2007 was vaccinated at a high school health fair, with the first dose, 0.5ml of Gardasil. Concomitant therapy included MENACTRA. The nurse reported that after receiving the vaccination, the student fainted, and was then taken to her private physician by her parents. The nurse confirmed that the student recovered on the same day, 14-MAY-2007. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were unknown). On 07-JUL-2014 the patient was vaccinated an additional 0.65 ml dose of ZOSTAVAX subcutaneously. No adverse effects were reported. Additional information has been requested.
Approximately 24 hrs. after receiving vaccines, mother stated that child developed fine red rash on both legs, back, abdomen and arms.  No fever.  Child taking Amoxicillin for ear infection x 1 week and this is first time on Amoxicillin
Initial report received from a healthcare professional on 10 OCTOBER 2014. A female patient, whose age and concomitant medication was not reported and medical history was reported as No per reporter, had received a dose of FLUZONE QIV (batch number-UI196AE, expire date - 30 JUNE 2015) dose, dose in series was not reported intramuscularly in left deltoid on 05 OCTOBER 2014. On 05 OCTOBER 2014, after vaccination, the patient presented episode of diarrhea. Laboratory investigation was not reported. Patient had not received any corrective treatment. On an unspecified date the patient was recovered from event. Documents held by sender: none.
Shortly after waking the day after the shot I fell into unconsciousness for a period of about five hours with the exception  of 3 brief return to consciousness. Also, I had Covid-19 the end of December 2020. I am fearful of getting the second shot.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  After vaccination with Flulaval, the subject experienced injection site reaction and burning sensation injection site.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the injection site reaction possibly related to vaccination with Flulaval.  The reporter believed that there may have been a problem with the particular lot of vaccine used.
10 days before I was diagnosed with COVID I had the new bivalent booster dose and I still got COVID; 10 days before I was diagnosed with COVID I had the new bivalent booster dose and I still got COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "10 days before I was diagnosed with COVID I had the new bivalent booster dose and I still got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Went to hospital due to rapid heart rate of 132 bpm. Hospital admitted me, gave me drugs to reduce heart rate. Went to  a Cardiology Specialist and he diagnosed AFib. Medications didn't work ver well. I was then admitted to the ICU to do a 06/14/2021 for a Electrical Cardioversion. The procedure helped, but AFib attacks happen 2 to 3 times a week that I know of.
Pregnancy; Initial Report Received on 08-Sep-2021 (received by Safety on 02-Nov-2021)  A nurse reported to the pregnancy registry that that a female pregnant patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), route and site not specified. The nurse with a vaccinating provider had called the registry asking for options to enroll a patient. During the call, the nurse chose to provide the Registry Toll Free number to the participant. Several follow-up attempts were made over 2 months by the Registry to the nurse to confirm if the participant was interested.  No additional information was reported. Permission to follow-up with the healthcare provider's office was not obtained.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
light sensitivity after the vaccine .   Vitals within normal limits, care transferred to the paramedics.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media a company representative concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 30-JUN-2022 The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s(Unspecified manufacturer) (dose number in series 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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 experienced suspected covid-19 infection and suspected clinical vaccination failure. It was reported "My household- 1 vaxxed and boosted, 3 unvaxed. The vaxed got Covid, passed it on to the others and had it the worst", (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000239078. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220663278 -Covid-19 vaccine ad26.cov2.s -Suspected Clinical Vaccination Failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Vaccine was expired at time of administration.  It was past bud of 10 weeks in the fridge.  It expired on 3/30/22.  Called patient to discuss cdc recommendation for re-vaccination.  Patient is considering re-vax, will call us back.
Diagnosed with non-Hodgkin's lymphoma; Night sweats; Unexplained weight loss; Excruciating pain in left arm from lymph node; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced NIGHT SWEATS (Night sweats), WEIGHT DECREASED (Unexplained weight loss), LYMPH NODE PAIN (Excruciating pain in left arm from lymph node) and FATIGUE (Fatigue). On 07-Sep-2021, the patient experienced NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma) (seriousness criterion medically significant). At the time of the report, NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma), NIGHT SWEATS (Night sweats), WEIGHT DECREASED (Unexplained weight loss), LYMPH NODE PAIN (Excruciating pain in left arm from lymph node) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, White blood cell count: 32000 (abnormal) White blood cells: 32000.         No concomitant medication were reported.  No treatment information was reported.  Company comment- This case concerns a  61-year-old, male patient with no relevant medical history, who experienced the unexpected events of Non Hodgkin's lymphoma, night sweats, weight decreased and lymph node pain and expected event of Fatigue. The events of night sweats, weight decreased, fatigue and lymph node pain occurred approximately three days after the second dose of Moderna COVID-19 Vaccine, while diagnosis of Non Hodgkin's lymphoma was made three months after second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.   This case was linked to MOD-2021-245684 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Followed up received on 7-SEP-2021 that contains updated event as Non-Hodgkin's lymphoma. Case upgraded to serious.; Sender's Comments: This case concerns a  61-year-old, male patient with no relevant medical history, who experienced the unexpected events of Non Hodgkin's lymphoma, night sweats, weight decreased and lymph node pain and expected event of Fatigue. The events of night sweats, weight decreased, fatigue and lymph node pain occurred approximately three days after the second dose of Moderna COVID-19 Vaccine, while diagnosis of Non Hodgkin's lymphoma was made three months after second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.
Around 11pm I had fever and body aches that lasted 2 days and ever since then I have had major fatigue to the point that I cannot be on my feet for more than an hour. The lymph nodes under my right arm are severely swollen.
Extreme fatigue same result after second dose  12/15/18  I have heard others say that they had the  same reaction.
altered taste; diarrhea; bad smelling farts; extremely tired; chills; joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhea), FLATULENCE (bad smelling farts), TASTE DISORDER (altered taste), FATIGUE (extremely tired) and CHILLS (chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 13-Jan-2021, the patient experienced ARTHRALGIA (joint pain). On 14-Jan-2021, the patient experienced FATIGUE (extremely tired) and CHILLS (chills). On 15-Jan-2021, the patient experienced DIARRHOEA (diarrhea) and FLATULENCE (bad smelling farts). On 17-Jan-2021, the patient experienced TASTE DISORDER (altered taste). At the time of the report, DIARRHOEA (diarrhea), FLATULENCE (bad smelling farts) and TASTE DISORDER (altered taste) outcome was unknown and FATIGUE (extremely tired), CHILLS (chills) and ARTHRALGIA (joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Moderna COVID-19 vaccine was drawn up and administered to client during home visit 5 days after the use by date.
Back pain fever headache 05Mar2021-08Mar2021 still experiencing; Back pain fever headache 05Mar2021-08Mar2021 still experiencing; Back pain fever headache 05Mar2021-08Mar2021 still experiencing; This is a spontaneous report from a Contactable Consumer (patient) reported for herself. A 20-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Unknown), via an unspecified route in the left arm on 04Mar2021 at 19:00 (age at vaccination: 20-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has not been tested for COVID-19 post vaccination. On 05Mar2021 at 13:00, patient experienced back pain, fever and headache. It was unknown if patient received any treatment for the adverse events. The clinical outcome of the events was not recovered/still experiencing as of 08Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
A cluster of 2 adult patients who received MENACTRA, lot number U2846AA, instead of TUBERSOL and developed injection site reactions.  Initial report received on 14 August 2009 from a healthcare professional.  A 22 year old male patient, with no known allergies and no illness at the time of vaccination, received a 0.1 ml intradermal injection of MENACTRA (lot number U2846AA) and a dose of ADACEL (lot number UFA86DA) on 12 August 2009.  The patient was to receive TUBERSOL for a TB skin test, but inadvertently received MENACTRA instead.  Concomitant medication was ALLEGRA-D.  On 14 August 2009, the patient returned for the reading of the TB skin test, which was when it was discovered that the patient received MENACTRA instead of TUBERSOL.  At that time, the patient had a raised red papule at the injection site which looked like a positive TB skin test.  The patient's recovery status was unknown.  Follow-up information received on 23 October 2009 from a health care professional.  The ADACEL vaccine (lot number UF486DA, Sanofi Pasteur SA number C3099) administered on 12 August 2009 was a third, 0.5 mL dose that was administered intramuscularly in the left arm.  The MENACTRA vaccine administered on 12 August 2009 was administered intradermally in the right forearm.  The patient had received prior vaccination with MENACTRA on 15 June 2005 without any adverse events.  On 14 August 2009, the patient received a 0.1 mL intradermal PPD (trade name and manufacturer name not reported, lot number 111056) in the left forearm (result of that test was not provided).  The patient recovered from the raised red papule at the injection site on 14 August 2009.  Case 2009-03500 with the same reporter and same MENACTRA lot number was created for the other patient.
Left arm itching  with rash; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), dose number 1, via an unspecified route of administration in the left arm on 13Mar2021 at 12:30 PM (at the age of 68-years-old), as a single dose for COVID-19 vaccination. The patient's medical history included diabetes, arthritis and high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Abd Novolin insulin injections (MANUFACTURER UNKNOWN) and Ozempic (MANUFACTURER UNKNOWN), all for unknown indications on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to vaccination. On 14Mar2021 (day after vaccination), the patient experienced left arm itching with rash; as a corrective treatment for the adverse event patient used anti itch cream (unspecified). The clinical outcome of left arm itching with rash was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
FLU-LIKE SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
Information has been received from a registered nurse who told another nurse about a patient who on an unspecified date was vaccinated with a 0.5ml dose of PNEUMOVAX 23. After getting the vaccination, the patient's arm was "sore at the injection site". At the time of the report, the patient's status was unknown. Additional information has been requested.
Pt was administered HPV9 vaccine in office. Pt noticed he had redness and hives around injection area around 7pm that night. Area was itchy/raised and responded well to Benadryl.
Patient came in for Tdap 4/17/2012 and said that he could still feel areas in arm where he had received his Hep B injections in 2010.  Says it is not painful but he is aware that it is there.
Patient reports itchy rash on trunk and arms. The severity is constant at this time, not increasing in severity.
20 minutes after receiving the vaccine 1/11/21 I had a skin reaction on the left side of my face also felt a little dizzy. I took Benadryl for my skin and was fine after about a hour. Exactly a week later the injection site was red/hot and itchy. The next day which is 1/19/21 same thing the injection site was hot red and itchy. I also felt chest tightness, headache, nausea and dizziness. I spoke with my doctor over the phone and she prescribed me Albuterol which helped with the chest tightness. I also took Benadryl for my arm which helped. The very next night 1/20/21 the same thing happened to my arm again. It got red and itchy and I felt nauseous.
HISTORY -  Had major vein stripping surgery on both legs at age 28 and again at age 57.  In between surgeries had sclerotherapy on both legs.  Have experienced phlebitis before and know how to manage it.  ADVERSE EVENT -  The first day after vaccination sore arm and general malaise.  The next day inflammation on both legs in multiple locations.  (One outbreak is from ankle to knee.) Pain is worse when walking or standing.  Legs are hot and sore to touch.  Never experienced anything to that extreme degree before. Concern about blood clots.  After 10 days it is finally starting to subside.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unspecified dates, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #L022795 and expiry date 05-NOV-2016) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature of 30 Fahrenheit for 12 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was hospitalized on 4/27/21 with pneumonia due to COVID-19 after receiving the first dose of Pfizer on 4/15/21. Per guidelines, all hospitalizations are to be reported.
Patient presented to the hospital for planned outpatient PRBC transfusion. Her blood pressure noted to be very elevated, with systolic 200-220s. Because of that, the hospitalist service got involved. Additional doses of hydralazine and furosemide during the transfusion failed to bring blood pressure down significantly, so she was ultimately admitted for further care. She was provided a 30-day supply of metoprolol, and a new dose of hydralazine at the time of discharge. Hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Vaccinated after tested positive for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Vaccinated after tested positive for COVID 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Vaccinated after tested positive for COVID 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Vaccinated after tested positive for COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication including  diabetic medication and blood pressure medication werereported  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 doesn't contain any new information
flushing, sweating, dizzy, racing heartbeat, pins and needles in both hands, painful/burning armpits