chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child was supposed to receive Daptacel and Acthib but received Daptacel and Pentacel instead with no AE; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 months old male patient who was supposed to receive daptacel and acthib but received daptacel and pentacel instead (wrong product administered), while he received vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel) for prophylactic vaccination.  On 29-Oct-2020, the patient received suspect diphtheria-15/tetanus/5 ac pertussis vaccine at a dose of 0.5 ML once daily via intramascular route and in the anatomical location thigh (lot number: C5624AA and expiration date: 06-Jun-2021) for prophylactic vaccination  On an unknown date, (latency unknown) it was reported that the child was supposed to receive daptacel and acthib but received daptacel and pentacel instead (wrong product administered). Nurse would like to know if there are any side effects that they should be aware of for this vaccination There were no adverse reactions to report at the time of the call. No further information was provided.  No laboratory tests were reported.  At the time of report, no adverse event was reported.  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.
Redness, soreness, swelling, bruising  itching, hot to touch. Headache.
severe cold; Initial information received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involved adult male patient who developed severe cold (nasopharyngitis) after receiving vaccine INFLUENZA VACCINE.  The patient medical treatment, vaccination, concomitant medication and family history were not provided.  Patient use to never get a flu shot and was never sick, hardly ever even had a mild cold.  It was unknown if the patient concomitant disease or risk factor.  Then patient's wife had to start dialysis and her doctor told him he could kill her if he got the flu, so he began taking the flu shot ever year and every year.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious severe cold (nasopharyngitis) 14-days following the administration of INFLUENZA VACCINE.  It was reported ''patient wife passed away four years ago, patient quit taking the flu shot now patient hadn't got sever colds any more again.''  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the severe cold.  At time of reporting, the outcome was unknown for the severe cold.  There will be no information available on the batch number for this case for influenza vaccine.
Fever, tyneol lowered it. Cant break 99.0°. Cough. Fatigue. Joint pain in legs. Migraine. Tightness in right leg, very painful. Possible blood clot? Testing in process.
Patient received the Pfizer vaccination at vaccination unit. This vaccination was administered to left deltoid at approximately 4:12pm. Approximately 10 minutes after vaccine administration this patient displayed reddened hives to face and forehead, hives to bilateral arms, c/o nausea, and reported "my tongue feels heavy." EMS was contacted by vaccine clinic staff. EMS arrived and assessed patient. Patient was transported to ED via EMS.
I became very sick within 6 hours of getting the shot.  I had a high fever,  chills, body aches, difficulty breathing, cough, stuffy nose and head, no appetite,  no desire to drink fluids.  My shot was on a Friday,  I dont remember the next 1.5 days which were Saturday 9/4  and most of Sunday 9/5.  It was 2 days before I could go back to work.  Since the shot I have lost about 50% of my physical strength and endurance.  I now suffer from depression and anxiety. I have lost  weight and I'm struggling to gain it back.  Worst of all is the significant increases in my pain and fatigue levels.  Im now unemployed.  Its been 3 months and I still don't feel like I am back to normal.   I wish I had never gotten the shot at all.
A report was received from a health care professional on 2/4/04 concerning an 8 year old female vaccinee who inadvertently received half of the correct dose of Fluvirin on an unspecified date. On an unspecified date, the vaccinee received 0.25ml Fluvirin. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information received from a health care professional indicated that the vaccinee received half of the correct dose of Fluvirin on 12/3/03. The outcome was unknown at the time of the report. The vaccinee received a second dose of Fluvirin at the correct dose on 1/8/04. Follow up pending.
DOSE ONE OF THE VACCINE ADMINISTERED WAS 6 DAYS OUT OF DATE, NO ADVERSE EVENT
Patient received Bexsero on 6/12/19 5:30 pm in L. deltoid. On 5/12/19 around 10 pm patient started having arm pain and a knot at injection site. Also experienced redness and warmth over injection site. Patient states pain was waking her up out of her sleep. Patient took Tylenol at home which helped some w/ pain. She was seen in the office on 6/13/19 at 1140 AM and was given Prednisone and Benadryl
101°F Fever (20 hrs); Upset Stomach; Vomiting; Tiredness; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 68-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: 6203), via an unspecified route of administration, administered in Arm Right on 27Feb2021 (at the age of 68-Years-old) as dose 2, single for COVID-19 immunisation. Medical history included asthma from an unknown start and stop dates. Concomitant medication(s) included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EM9809), via an unspecified route of administration, administered in right arm on 06Feb2021 04:30 (at the age of 68-years-old) as dose 1, single for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). 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 were reported. The patient experienced 101°f fever (20 hrs), upset stomach, vomiting, tiredness and headache on 27Feb2021 03:00. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 27Feb2021. Treatment was reported as unknown for the reported events. The outcome of the events were reported as recovering.  No follow up attempts are possible. No further information is expected.
4 month old was given a 0.25ml flu injection due to not looking up the DOB during a trial change to the immunization clinic.  Parent claimed child was receiving flu shot and immunization was given before computer information was looked up.
After getting the vaccine had some injection site pain and fatigue for a few days. About 1 week after receiving the vaccine he developed an itchy, dry, flaky, red rash on his arms, chest, back, legs, and waist. No face or genital involvement. No mucosal involvement. Starting using topical Benadryl, hydrocortisone, and topical lotion which helped with itching. Seen by PCP 1 week ago who started him on medrol dose pack. In clinic today (4 weeks post vaccine) he continues to have areas of superficial skin peeling on upper/lower extremities and trunk.
This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates starting on or after 23-FEB-2016") the patients were vaccinated with improperly stored ROTATEQ (dosing regimen unspecified)(lot L029934, expiry 01-MAY-2017; lot L035276, expiry 09-JUN-2017; lot L039297, expiry 19-JUN-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 1C, Time frame: 25 hours, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported, GARDASIL 9 and M-M-R II appear in the product list as these products were involved in the excursion, however, no improperly stored doses of GARDASIL 9 or M-M-R II were administered. No additional information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Patient presented for 1st Covid Vaccine with mother. Patient said he was 12. Vaccine was given. When charting it was discovered that vaccine was given 6/18/21, days prior to 12th birthday. Discussed with mother who said she had "contacted the state and was told it was fine". Explained to mother that 12 yrs is minimum age for vaccine. Untoward effects of vaccine days prior to 12th birthday are not expected. Educated to symptoms and care following vaccine. Reminded mother to schedule and keep appointment for second dose.
Very high fever for 3 consecutive days, chills, pain at injection site, nausea, vomiting, diarrhea for two days following injection, fatigue for about 15 days
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old white Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 08-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient had an antibody test with the SARS-COV-2 IgM and IgG  which showed no antibodies. On 08-MAY-2021, the patient had an antibody test with the SARS-COV-2 IgM and IgG which showed no antibodies (confirmed immunological vaccine failure). It was reported that, the bars for IgG and IgM did not appear and only the control bar lit up and the patient discovered that the test kit expired on 29-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516298-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 13-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Fever, chills, headache, dizziness, swelling, pruritis, and heat at the injection site.
This spontaneous case, initially received from other non-health professional (consumer) on 22-Oct-2018, concerns a 32-year-old adult female pregnant patient. The patient's historical condition included infertility which was resolved. The patient's historical drugs (taken prior to pregnancy) included fertility medication, ZYRTEC(dose: 10 mg, oral ) and vitamin D (dose: 2000 IU, oral) for unknown indications. The patient had used birth control pills (contraceptive) for unknown indication. The patient's concomitant medication included Calcium (dose: 500 mg), Prenatal vitamins , DHA (dose: 300 mg), Probiotics and Cromolyn nasal spray for unknown indications. The patient's last menstrual period (LMP) date was 31-Mar-2018. On 04-Oct-2018, the pregnant patient at gestation age of 28 weeks (third trimester) was administered with FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy). The patient did not experience any adverse effect after the vaccination. The patient's estimated date of delivery (EDD) was 26-Dec-2018. The reporter assessed the case as non-serious.
This case was reported by a physician via a sales representative and described the occurrence of swelling of the injection site in a female subject of unspecified age who was vaccinated with Infanrix, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of Infanrix in an unknown thigh. At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site. At the time of reporting the outcome of the event was unspecified.
pt admitted to hosp with acute encephalopathy and generalized weakness; positive for COVID; given steroids, remdesivir, O2 supplementation; DNR; pt suffered a bradycardic arrest and passed away in the hospital
This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2016 (reported as after a temperature excursion on 09-AUG-2016 and prior to excursion on 09-SEP-2016), the patient was vaccinated with an improperly stored dose of PROQUAD lot # M011661 with expiration date: 08-SEP-2017 (dose and route of administration were not reported). Administered dose of PROQUAD underwent temperature excursions at 58 Fahrenheit degrees for 5 hours. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Red rash; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Headache; vision was unclear; blood pressure was 190/104; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunisation. Medical history included History of High blood pressure. The patient's concomitant medications were not reported. The patient reported that she had the vaccine last Thursday, and Friday she woke up with a horrendous headache she also reported that her vision was unclear when she was trying to read. She said that she has a history of high blood pressure, it was well controlled and has been fine and said that her headache lasted all day and she took Motrin and nothing touched it. She took her blood pressure at 15:00 and it was 190/104, which is really high for her. It scared her. Being a cardiac nurse, she knew to take her blood pressure medication early, and she took additional amounts that she knew was safe. She said that within 1.5 hours her headache was gone. That night her blood pressure was back down. She is really concerned about getting the second vaccine. She said that her blood pressure is fine and has been fine since. The seriousness was reported as non-serious. The outcome of the events was resolved.  Information on the lot/batch number has been requested.
Pt recvd flu vax on 21JAN92 well pt @ time of inject; devel fever, cold, & congestion (general flu type sx) & poor appetite p/recvd flu vax;
Presented self to EMS w/ c/o feeling weak to include rt. arm.  Able to move lt. arm without difficulty.  BP 163/87, HR 108, O2 Sat 99%.  C/O H/A.   Stated H/A existed upon coming to work.  Skin W/D.  Allowed to rest on EMS vehicle.  Stated would prefer to go home.  Daughter called and transported home.  3:50pm B/P 146/86.
Swelling of L shoulder and fever (tactile) started evening after shots and gradually worsened. She developed vesicles at area 48 hrs later.
At 9PM on 4/7, started to experience chills, extreme /migraine level headache, extremely fast heartbeat, extreme shortness of breath, body aches, nausea (vomit and dirrhea),  weakness, and extreme tiredness.
Diagnosed with JME. Seizures well controlled for over a decade with medication. Repeated nocturnal myoclonic seizures for multiple days. Has gotten better,  but not resolved fully. Neurologist had no answer.
My arm went numb; my toes went numb; my eye lids fluttering/ my eye lids are twitching; felt like someone hit your arm; was about to black out; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 (52-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Aug2021, the patient had arm and toes went numb, her eye lids fluttering/ eye lids are twitching, felt like someone hit arm and was about to black out. It was reported that, after the first dose, the patient had some side effects. The patient stated that she had no idea she was supposed to wait after the shot because people were getting up and leaving and the patient was fine until she got 3-4 minutes down the road. The patient's arm went numb, her toes went numb and her eye lids were fluttering. The patient was balling up in a ball. The patient had to kick her shoes off and was about to black out. The patient had to call her mom to sit with her on the side of the road for an hour and a half. It was terrible. The patient really does not care to have any other dose of it put in her body. The patient mentioned that her eye lids were twitching as she spoke. The patient worked for the postal service 5-6 days per week. The patient reported that she still felt that thing in her arm. The patient heard it felt like someone hit her arm. It didn't even feel as bad as a bee sting at first but then both arms went numb, toes went numb and her eyes started fluttering. The patient's eye lids were fluttering constantly. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received bivalent booster without receiving initial series. No significant adverse effects noted after contacting patient.
Pain in arm/shoulder/chest caused fear of heart attack. EKG test run, results negative
Asthma reaction (coughing, shortness of breath), fever, body aches, sensitive skin
Patient reports via phone, redness, pain at injection site, itchiness, and swelling. Denies other affected areas or symptoms. She self applied Benadryl cream for itchiness, seems to be improving at this point.
No Adverse Event.  Booster dose med error.  Full 0.5ml Moderna dose given as booster (instead of 0.25ml)  1 week follow-up with patient determined no adverse effects other than that which was experienced during initial series (body aches and injection site swelling).
For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022; Expired doses administered beyond the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient took booster of Moderna and took total 3 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion.  No treatment information was reported .
Following administration of FLUZONE HD influenza vaccine patient experienced fever, malaise, and severe pain at site of injection. In past year, patient has received the standard influenza vaccine formulation and does not experience any adverse events.