chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of Guillain Barre syndrome in a 49-year-old male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, several  days after receiving Influenza vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant), difficulty breathing and weakness. On an unknown date, the outcome of the Guillain Barre syndrome, difficulty breathing and weakness were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, difficulty breathing and weakness to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2002, the patient received influenza vaccine (unknown brand). A few days after receiving the Influenza vaccine, the patient experienced Guillain-Barre syndrome. The Guillain-Barre syndrome was described as weakness occurring and breathing problems. The patient went to the hospital (details unknown). The patient stated that, since 2002 he had various other immunizations but not the Flu shot, and no adverse symptoms were occurred. However, there was no documentation of any vaccinations received for this patient since 2002. The healthcare professional called to ask about the incidence of Guillain-Barre syndrome occurring with administration of the BOOSTRIX vaccine, as the healthcare professional was considering possibly giving the BOOSTRIX vaccine to the patient.
EXTREME bursitis flare up in my left hip where I have hardware. EXTREME pain leading to nearly passing out. Could barely move without extreme pain for days. 2 weeks later, still soreness in the area and cannot walk more than 10 minutes or so without feeling discomfort. My orthopedic surgeon put me on a 6 day steroid treatment,  and started me on Meloxicam on the 4th day of that treatment and I am still taking it. Both my internist and an infectious disease doctor that she referred me to both feel it was from the vaccine as it is know to inflame the joints. I would like to talk to someone before taking the second of possible.
gen sz approx 6hr post vax & again approx 12hr post vax;
Delay of reaction approximately 4-5 days "COVID" arm, redness, heat, swelling, rash, itching to are of the injection site.  Now two weeks post-injection still some redness, heat, axillary area swelling, and trapezius stiffness, and sore
Mom reported to clinic approx. 10 min after leaving with child in car. Mom stated she thought child was having seizure. Assessed child in car - had feet elevated & head reclined - was alert & oriented. P-92. 911 called by clinic staff to evaluate child after assessed mom declined transport to ER - signed release. 7/7 - called mom for F/U - mom stated child ok at hm. last pm - rested. Had fluids & food - up without problems today.
The patient did not receive the second dose, as it was unavailable; This case was reported by a consumer via call center representative and described the occurrence of product availability issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (4 or 5 years ago, the patient got the first dose of the Shingrix vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.   Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: The patient did not receive the second dose, as it was unavailable.  The patient asked do he/she need to get the 2nd dose or start over with the 1st dose. The reporter advised that the patients consulted with their healthcare provider about this guidance and their individual situation.The permission for consent to follow-up was denied. Additional supportive information: The patient did not receive the second dose, as it was unavailable, which led to product supply issue.
Resident had lunch on 01/14/21 and after lunch around 2:00pm, he vomited and stopped breathing. We coded the resident and 911 paramedics came. They pronounced him dead at 2:18pm.
Post vax, on Saturday, the injection site was itching. On Monday it was the size of 1/2 dollar, hard and red. On Wednesday, she had a rash. No fever.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had not resolved.            No treatment of event was reported. No concomitant medications were reported.   This case was linked to MOD-2021-089113 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Documents added
ELEVATED BLOOD PRESSURE 200 PLUS; FLUTTERING HEART; DIFFICULTY BREATHING; DIZZINES AND LIGHTHEADED; AFTER STANDING GOT A RUSH AND STARTED TO STUMBLE; FLUSHED; FELT VERY THIRSTY; NAUSEA; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, frequency once total, administered on 31-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 31-MAR-2021, within 15 minutes, the patient experienced lightheaded, difficulty breathing, after standing up got a rush and started to stumble, fluttering heart, nauseous, dizziness, flushed and elevated blood pressure 200 plus. It was stated that all symptoms went away that evening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, elevated blood pressure 200 plus, after standing up got a rush and started to stumble, flushed, fluttering heart, light headed and dizziness, nausea on 31-MAR-2021, and the outcome of felt very thirsty was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210415219-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 200 plus And Fluttering Heart. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt recvd a series of 3 Engerix-B vax given 25JUN90, 26JUL90, 03DEC90; On 10JAN91 pt tested negative for HBAB; Hep B vax booster was planned;
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-OCT-2012 11:53, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient plans to repeat dose on 4/20/2021.
I now have myocardial issues; fatigued; while exercising started having rapid heartbeat; This is a spontaneous report from a non-contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 16Sep2021 (Batch/Lot Number: FC3181) (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no medical history and no past drug history. Concomitant medication included methylphenidate taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient reported that a few days after her first shot she was fatigued, then while exercising started having rapid heartbeat. She went to the cardiologist where they did tests (on an unspecified date in 2021) that showed she now has myocardial issues. The onset of events was on 19Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
1 of 5 pts (out of 40 pts) vaxed from same lot who devel a local rxn consisting of rash surrounding site;rash appeared w/in 3 days of vax (varying in size in all 5 pts; largest from shoulder to elbow;area sore & tender;no fever;
Pt presented to the ED with complaints of worsening oxygenation. Pt was found to be COVID positive post vaccination.
CARDIAC PROBLEMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cardiac problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiac problems was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920683.
Patient was asked all screening questions and verified appropriate for receiving vaccine. A few minutes after vaccine administered, patient complains of chest pain and difficulty breathing. Initially administered Benadryl and water. Patient still complained of difficulty breathing, and thought he would lose consciousness. Admistered Epipen and called 911.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M034856, expiration date 27-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014982: US-009507513-1704USA015044: US-009507513-1704USA015042:
Patient completed 30 min post vaccine observation and complained of light-headedness. VS were taken and she was observed for an additional 15 minutes to which she felt better
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash after second dose), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site itch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (injection site rash after second dose), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site itch). At the time of the report, VACCINATION SITE RASH (injection site rash after second dose), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.    Reporter did not allow further contact
Low blood pressure about 7-10 minutes after injection, resulting in faded vision, loss of balance, and muscle weakness. Avoided passing out. Sat down for about 10 minutes and symptoms cleared up, with some visual spotting and muscle weakness remaining for an additional 20 minutes.
24 hrs later pt noticed arm swelling & had red area 3-4" in deltoid area where vax had been administered; swollen area itched & felt tight but did not hurt; no assoc sx;
Same as my wife, but no arm pain. Tired, headache, dizzy, fever of 101, body aches.
Caller states that the woman in the study had brain hemorrhaging and a cancerous growth, after the vaccine.; Caller states that the woman in the study had brain hemorrhaging and a cancerous growth, after the vaccine.; This is a spontaneous report from a Pfizer-sponsored program Support reported by a contactable consumer or other non-health care professional. A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that cardiologist gave him a study which reported a woman, who had the vaccine, died on the operating table, after her brain was haemorrhaging and they found a cancerous growth. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/ Batch number have been requested.; Reported Cause(s) of Death: after her brain was hemorrhaging; and they found a cancerous growth
3 weeks after vaccine, developed rash on neck up to jaw line that kept getting worse, Dr prescribed a steroid cream; also got a large boil on back of head that took 4 to 6 weeks to heal; also developed hives different than the rash- still have them currently everyday.
patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Colonic lymphoma (Malt a type of colon Lymphoma Mucosa Associated Lymphoid tissue) and Chronic lymphocytic leukemia. Previously administered products included for COVID-19 immunisation: Pfizer vaccine (First vaccine EW0162, given in the left arm deltoid muscle) on 22-Apr-2021, Pfizer vaccine (second EW0170 and was given on 11MAY2021) on 11-May-2021. Concurrent medical conditions included Immunocompromised. Concomitant products included RAMIPRIL (ALTACE) and ACALABRUTINIB (CALQUENCE) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error). On 12-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: less than 0.04 (Negative) SARS-COV-2Spike AB,Quant, S, results were less than .04U/ml per ml..         Concomitant medication also include Gayza infusion last given on 21MAR2021 Completed the series. No treatment information were provided.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE mobile vaccine site ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
12 year old patient was given pentacel instead of meningococcal vaccine with no reported adverse event; 12 year old patient was given pentacel instead of meningococcal vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via global medical information (GMI) (Reference number- 00718276) and transmitted to Sanofi on 10-Aug-2021.  This case involves a 12-year-old female patient was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of MENINGOCOCCAL VACCINE (product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On 05-Aug-2021, the patient received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) as a concomitant medication.  On 05-Aug-2021, the patient received a 48 ug dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ436AAA, expiry date: 17-May-2022, vaccine presentation/ national drug code (NDC): 49281-051005] via an intramuscular route at the left deltoid for prophylactic vaccination instead of MENINGOCOCCAL VACCINE (not produced by Sanofi Pasteur) [lot number, expiry date and other dosing details not applicable] (product administered to patient of inappropriate age wrong product administered).  It was a case of actual medication error due inappropriate age at vaccine administration and wrong vaccine administered. (Latency: on the same day).  It was reported that, "caller asks how to proceed, caller states she also received Tdap and HPV vaccines on the same day and received meningococcal vaccine a day later".  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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.
Found unresponsive in a cell at prison. Brought to emergency room with temperature of 107F, metabolic acidosis, sepsis and required ventilation. No signs of illness on the evening of 11/26/2009.
per report from patient: about 15 min after shot, pt immediately experienced mild nausea. after a few hours, pt reports feeling better. after a couple hours later, eye vision when in and out of focus randomly accompanied with short small dizzy spells and fatigue. the next day on 8/4/21, pt reports muscle weakness in both legs still accompanied with eye out of focus and dizzy spells. on 8/4/21, pt reports new onset of tenseness in muscle and shoulders as well as extreme fatigueness. on 8/5/21, pt reports continued extreme fatigue and dizzy spells. around 3-4pm on 8/5/21 , pt reports new onset of shortness of breath and heart fluttering and pounding heartbeat and a headache and hot flashes as well as low-grade fever. reports fell asleep at 4:30pm and woke up at 11:13pm on 8/5/21. on 8/6/21, reports previous symptoms continuing except  for eye going in out of focus has stopped.
Phone call received 8-31-10. Mo stated client complained of pain & refused to walk on (R) leg. Scattered "spots" on both legs, buttocks and up back. Called 9-1-10 client increased running around - spots clearing. 9-9-10 skin is clear.
Localized swelling, mild face tightness, HA, nausea, Naprosyn didn't relief HA. Hydroxyzine
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
On 1/20/00 at 4:30pm the pt returned to the health department with hives over entire body including face. Pt received immunizations approximately one hour before reaction began.
My condition rapidly went down the hill right before bed time. I woke up because of me screaming my wife's name. I tried to get to my phone but my hands were out control for roughly 10 seconds - i never experienced such thing in my life (i will try to describe it - i could move them around shoulder but the rest looked like tentacles - no control over fingers too) . Around 5 seconds into trying to grab my phone i was completely awoken and realized that i covered in cold sweat, my heart rate is extremely high (when i returned control over my limbs i checked and it was >120, when i sleep i usually have around 45). Based on my smart watches my heart rate went all the way up to 160 at the moment when i woke up.   Heart rate went down to ~80 and after 20-30 minutes or measuring everything possible (blood pressure, heart rate, oxygen level, etc) we decided not to call 911. The rest of the night was ok'ish - in AM i checked smartwatch data and my average heart rate was 60 which is 10-15 above normal. Next morning welcomed me with moderate fever (37.5C), joints pain (also never experienced at such scale - literally entire body), headache and bunch of other annoying things (including one impacting vision - until lunch time everything had higher contrast).  Two days after i completely recovered.
Pediatrics staff called to say that infant may have had a reaction to Rotateq. She was seen by Dr yesterday (unknown time) for vomiting and weakness. She did not have fever or diarrhea. He ordered an abdominal X ray (normal), blood culture (result pending) and blood work (mostly normal).