chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with refrigerated improperly stored doses of GARDASIL 9 lot number M031557, expiration date 07-APR-2019 (dose and route not reported) for prophylaxis. The vaccines were exposed to a total time in the range 47°F to 77°F (9° C to 25 °C) (15.8°C actual temperature) for 1 hour 34 minutes. The vaccine doses had previous temperature excursions for a total time in the range 47°F to 77°F (9°C to 25°C ) (17.5° C actual temperature) for 6 hours, 20 minutes. he call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA011935: US-009507513-1703USA006822: US-009507513-1703USA011932: US-009507513-1703USA011933.
Information has been rec'd from a NP concerning a 33 year old male with diabetes Mellitus who on 10/20/00 was vaccinated with rubella virus vaccine live (second generation). On 11/01/00, the pt experienced lymphadenopathy and a rash on his entire body. Medical attention was sought. Additional information has been requested.
Patient recieved vaccine greater than 12 hours drawn up. MD notified pt. no c/o adverse event. declines revaccination.
Immediately after vaccination developed shooting pain down left arm with tingling and numbness in hand. Aching in arm; 1 on a scale of 10.
This spontaneous report was received from a healthcare student refers to a 37 year old patient of unspecified gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event was unknown. Additional information is not expected. The reporter did not wish to be contacted.
BLURRED VISION - I've perfect mid-range and long-distance vision and everything is now blurry.  All the other side effects have subsided except the blurred vision. Other Symptoms that have since subsided:  headache, chills, upset stomach, muscle aches
Sudden nasal infection which I started to take Sudafed for. I also had weakness, fatigue, heavy diarrhea for two days and of course heavy nasal infection. It did not go to my chest however. After 4 days of sickness i now feel much better. I did not have a fever or nausea during my sickness.
Case previously recorded as MA2009-5668. Case received on 20 NOV 2009 via MedCom, from a healthcare professional the following information: Male patient under 4 years was vaccinated i.m. with one dose of FLUVIRIN, batch no. 100813P, on 16 NOV 2009. No adverse events were reported. MedCom no:NA09-008579.
Information has been received from an office manager, physician, and medical assistant concerning a female over 50 years old who on 31-JAN-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U) intramuscularly in the deltoid of the left arm. Subsequently, the patient developed redness and swelling at the injection site. The patient recovered from the redness and swelling on an unspecified date. The physician stated that these reactions had not occurred at the office before and would like a lot check for pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). This is one of three reports from the same source. One of the patients also received the flu vaccine in the other arm. A standard lot investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and research and was released. No additional information is expected.
Developed chills, rigors, and fever of max 103.8 9 hours after vaccine.  Later progressed to nausea, vomiting, diarrhea, abdominal pain, intense headache,  neck pain, and dizziness.  Above symptoms lasted for 36 hours after injection.
the patient passed out and felt dizzy upon waking soon after receiving his first dose of GARDASIL; the patient passed out and felt dizzy upon waking soon after receiving his first dose of GARDASIL; This spontaneous report was received from a consumer via company representative and refers to a 13-year-old male patient. He was the company representative's nephew. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-DEC-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On the same day, soon after receiving the vaccination, he passed out and felt dizzy after waking up. The events occurred in the doctor's office, but a nurse or doctor were not present and the events were not reported to any health care professional. The consumer was instructed to call the physician to report the events and ask whether a second dose of the vaccine should be administered. No treatment was given for the adverse events. The outcome of the events was reported as unknown.   The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.  Upon internal review, the event of loss of consciousness was considered to be medically significant.
The excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees Celsius with no reported adverse event; The vaccines were given post excursion with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an unknown age/gender patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] and tuberculin test [Tubersol] vaccine were given post excursion and the excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees celsius with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, it was reported that the excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees celsius with no reported adverse event (product storage error) for diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and tuberculin test.   On an unknown date, tuberculin test vaccine (lot number - C5994AA, expiry date: 26-Sep-2024) (route, dose, strength, formulation, administration site: unknown) for Immunization and  diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (with lot number: UJ678AAA, expiration date: 09-Sep-2023) (route, dose, strength, formulation, administration site: unknown) for prophylactic vaccination (Immunisation) were given post excursion with no reported adverse event (poor quality product administered)  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  Outcome: Unknown for both the events.  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 the 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.
small spots of hives on the back of his head, arm and legs; rash is all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (small spots of hives on the back of his head, arm and legs) and RASH (rash is all over the body) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (small spots of hives on the back of his head, arm and legs) and RASH (rash is all over the body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (small spots of hives on the back of his head, arm and legs) and RASH (rash is all over the body) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. Treatment included unspecified topical steroid cream. No concomitant medications were reported.
Initial report received on 21 September 2009 from a health care professional. This case is one of a cluster of two cases from the same reporter. The other patient is reported in case 2009-03999. An 86-year-old male patient, who denied any concurrent illnesses, who is allergic to ace inhibitors and has medical conditions of diabetes, increased blood pressure and increased cholesterol, had received a dose of FLUZONE SV 2009-2010 (lot number U3198AA) on 14 September 2009. The route and site of administration and number of previous doses were not reported. The patient denied having received any other vaccines that day. Concomitant medications included Amlodipine, PLAVIX, Metformin, ZOCOR and ASA. Four days post-vaccination, the patient complained of dizziness that caused him to be bedridden. His physician made a house call and treated the patient with Compazine and meclizine. The dizziness lasted at least 24 hours; however the reporter was unsure if the dizziness had resolved completely. Documents held by sender: None.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5 mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 24 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Redness more than 1-2 inches around the injection site on the arm; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. This physician reported similar event for 4 patients. This is the first of 4 reports.  A patient of an unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date on the patient's arm at single dose for routine vaccination.  The patient's medical history and concomitant medications were not reported.  It was reported on an unspecified date that the patient experienced redness more than 1-2 inches around the injection site on the arm. The outcome of the event was recovered on an unspecified date.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019291991 same reporter/drug/event, different patient.;US-PFIZER INC-2019291989 same reporter/drug/event, different patient;US-PFIZER INC-2019292015 same reporter/drug/event, different patient
She is still in they ICU. She started seizing when she was put to bed on Friday, 9/17. 911 called. She was taken to Medical Center where they just stabilized her and transferred her to Hospital at 1 AM. She is heavily sedated and so far they can't find a reason for the seizures. Her heart rate drops down to the 50's and 60's. She's on a ventilator and they have her on blood pressure meds because it has gone low a few times.  We are not allowed in because of covid so we are going off what we are being told.
Sharp chest pain on left side, shortness of breath when lying down,  pain would not go away with OTC medications.
pain in the left eye; swollen eyes like puffy; excruciating migraine above eyes; fever; difficulty seeing; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain in the left eye), VISUAL IMPAIRMENT (difficulty seeing), EYE SWELLING (swollen eyes like puffy), MIGRAINE (excruciating migraine above eyes) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Drug allergy (Codeine allergy), Sulfonamide allergy (Sulfa drugs), Drug allergy (Prednisone), Penicillin allergy, Allergy to antibiotic (Erythromycin), Fruit allergy (Tomato allergy) and Fruit allergy (Banana allergy).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced VISUAL IMPAIRMENT (difficulty seeing), MIGRAINE (excruciating migraine above eyes) and PYREXIA (fever). On an unknown date, the patient experienced EYE PAIN (pain in the left eye) and EYE SWELLING (swollen eyes like puffy). On 31-Jul-2021, MIGRAINE (excruciating migraine above eyes) and PYREXIA (fever) had resolved. At the time of the report, EYE PAIN (pain in the left eye), VISUAL IMPAIRMENT (difficulty seeing) and EYE SWELLING (swollen eyes like puffy) 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 was received by the patient Concomitant medications include cholesterol medications, vitamin supple.ments.
Information has been received from a physician concerning a male who was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) at a pharmacy.  Subsequently the "patient's whole arm swelled up".  The patient sought unspecified medical attention. Follow-up information was received from the physician.  It was reported the patient was not administerd vaccine in the office.  The patient got the vaccine by a pharmacy and the patient's arm swelled up.  No further information is available.
(1) Skin lesions won't heal.  (2) Blood won't clot.  (3) Minor symptoms similar to a head cold.  Vaccination dates: 1/28/2021, 3/2/2021.  During February, I was experiencing high work stress (writing software).  When I am stressed, I scratch spots of keratosis on my arms.  During February, this behavior remarkably resulted in small lesions blossoming into circular lesions the size of a quarter.  These lesions were many (about 6 on left arm alone), large, wet and open sores, painful, and would not heal.  At one point, I had 6 sores on my left arm, several on my right, a painful sore on my right buttocks, two painful sores behind my ear, a sore at the base of my neck in back, and a very painful sore on my scrotum, plus a huge blood blister on my lower lips.  As I was enduring all of this, I also had severe sores within my nose that bled profusely.  All of this was very painful and very unusual.  Nothing like this had ever happened before to me.  I treated the worst of these sores with Neosporin and bandages.  They have improved, but not healed entirely yet.   All of this was initiated by my stress and scratching behavior.  But I am convinced that the extreme results must be due to the vaccines, which seem to have interfered with the healing, made the sores get very large and infected, and kept my blood from clotting.  There has been significant improvement, but I have not yet recovered from this.
Mother noted fresh blood in three different stools 2 days (1/31/07)after administration of vaccine.  Pt. had low grade fever, was irritable, but eating well and slept well. Spontaneously resolved with no treatment. No anal fissures noted on evaluation.
Swelling of the tongue, red mouth that was raw, inflamed gums. Local site reaction-swollen and red spot. Patient did not treat or seek treatment.
This is a spontaneous report from a contactable consumer via Medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 10Mar2021 as first dose single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he had been around daughter and son in law, tested positive this morning on 11Mar2021. Patient wanted to know can they still receive their next dose on 31Mar2021. The patient underwent lab tests and procedures which included covid-19 test positive on 11Mar2021. The outcome of event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268905 same drug/reporter/ event, different patient
Pt developed fever 2 hrs post vax. Mom noticed a rash on face and chest that she thought was from bottle spilling. The next morning rash was very red with hives all over pt's body. Pt had fever and was irritable all day. She was treated with Benadryl and Tylenol. On 7/15/01, hives were gone and rash was less red, and pt had no fever. On 7/16/01, pt back to normal with only slight rash still noted.
This case was reported by a other health professional via call center representative and described the occurrence of general body pain in a 38-year-old female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced general body pain, fever and chills. On an unknown date, the outcome of the general body pain, fever and chills were recovered/resolved. It was unknown if the reporter considered the general body pain, fever and chills to be related to Influenza vaccine. Additional details were provided as follows: In 2006, the patient experienced severe adverse reaction to a flu vaccine. The reporter did not know whether it was a GSK product or not. The reporter did not have lot number or expiration dates.
pt was given vax & devel rash below inj site to middle of area IM;
I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 3/16/2023 ASHD NATIVE COR ART W/UNSTABLE ANGINA PECTORIS I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 3/16/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION
Hives, Itching, Redness, Tight chest, Difficulty breathing/slight wheezing, tachycardia, elevated blood pressure. Received 1 epipen to the thigh, Solumedrol, Benadryl, Hydroxyzine, Albuterol. Monitored for 2.5 hours, transferred to hospital and monitored for another 2 hours. Discharged with RX for Prednisone x 4 days
approximately 3-4 days after administration patient experienced rash on both sides of upper stomach which in her words looked like chicken pox.  It was itchy and she had a low grade fever for a few days.  She also had rash aroundthe injection site approximately 3-4 " diameter that appeared the next day after injection.   She also had increase in eyebrow hair that week.
32wk premie seen for 2mo well check;hx includes apnea & bradycardia;on AB monitor @ home;mom report lead notations (dec HR) pt given shots;seen in ER 2 times over next 24hr w/significant apnea per monitor nurse ? immun related;
Experiencing an achy feeling in the arm of the injection site/soreness of her arm; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a patient (retired nurse).  This case involved a 68 years old female patient who experienced an achy feeling in the arm of the injection site/ soreness of her arm (Pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history included surgery of totally ripped the rotator cuff on the right arm. It was reported that she had surgery last year but still was getting physical therapy.  Past medical treatments and family history were not provided. No other vaccines were given.  Concomitant medications were not reported.   On 17-Sep-2020, the patient received a 0.7 mL once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ488AA, expiration date: 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination.  On 17-Sep-2020, the patient developed a non-serious achy feeling in the arm of the injection site/ soreness of her arm  (Pain in extremity), on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Detailed laboratory test was not reported.  It was not reported if the patient received any corrective treatment.  The patient was not recovered from the reported event at the time of reporting.
I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills on 12/21/20. Mild body aches and soreness at site of injection and just feeling weird. This continued off and on 12/22, 12, 23 and etc. I thought it wasn?t a big deal as I had no respiratory symptoms and no fever. However,  I just haven?t been well since then. I have ongoing nausea, head fog, severe weakness, very tired and just feeling unwell
EXPERIENCED A PANIC ATTACK FOLLOWING HER VACCINE; HEART RATE 110; BP 130/87 WE MOVED HER TO A COOLER QUIET PLACE AND OFFERED HER A COOL DRINK AND SNACK; SAID SHE HAD BEEN STREESED RECENTLY AND HAD FREQUENT PANIC ATTACKS OVER THE MONTH OF JANUARY.  VITAL SIGNS RETURNED TO NORMAL WITHIN 30 MINUTES; PATIENT STILL SHAKING BUT WAS ABLE TO FOLLOW PATTERENED BREATHING AND HR 95; BP 128/82 Driver WOULD BE DRIVING HER HOME ---- FOLLOWED UP 01/23/2021 AT 10AM; SHE SAID SHE WAS BACK TO "NORMAL" BY THE TIME SHE GOT HOME AND THANKED US FOR FOLLOWING UP.  MENTIONED SHE MIGHT START BACK ON HER ANTIANXIETY MEDS THAT SHE STOPPED IN DECEMBER.  GAVE A PEP TALK FOR MEDICATION ADHERENCE