chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in on Thursday 5PM 12/2/2021 to report a post vaccination reaction after administration of his Moderna Series. He received first dose of Moderna 05/03/2021 and second dose 05/31/2021. Patient states he's experiencing weakness and nerve pain in his right arm. He followed up with his primary care physician who said that the weakness and pain should've resolve by now. Patient was given
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during his 1st year of life from 7/93 through 1994 and every time he received a multi-dose vaccine. The alleged results of these vaccinations are that the pt sustained severe and permanent injuries, including being dx'd with severe autism and other neurological disorders. In addition, it is alleged that the pt has sustained further neurological insult from other vaccines, including MMRII, which does not contain thimerosal, but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, permanent personal injuries, severe autism, neurological disorders and the exacerbation of the neurological disorders were considered to be "Other Important Medical Events". No further information is available.
very emotional; became exhausted after a day or two of this/still tired; very dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 12:00 (Lot number: ER8737) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 07Apr2021 12:00, outcome "not recovered", described as "very dizzy"; EMOTIONAL DISORDER (non-serious), outcome "not recovered", described as "very emotional"; FATIGUE (non-serious), outcome "not recovered", described as "became exhausted after a day or two of this/still tired". Therapeutic measures were not taken as a result of dizziness, emotional disorder, fatigue.  Additional information: The reporter thought that might be they were just a little excited, but it didn't went away for days. The patient did not receive any other vaccine in four weeks nor other medications in two weeks. The patient did not had Covid prior vaccination nor tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Had a massive stoke; Convulsions; Gasping for breath; Lost function of left side of bod; Couldn't take tongue out of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a massive stoke), SEIZURE (Convulsions), DYSPNOEA (Gasping for breath), HEMIPARESIS (Lost function of left side of bod) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00C21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Consumer previously had a stoke in his 30's.) and Cardiopulmonary resuscitation. Concurrent medical conditions included Emphysema (little) and Smoker.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a massive stoke) (seriousness criteria death and medically significant), SEIZURE (Convulsions) (seriousness criteria death and medically significant), DYSPNOEA (Gasping for breath) (seriousness criterion death), HEMIPARESIS (Lost function of left side of bod) (seriousness criteria death and medically significant) and TONGUE MOVEMENT DISTURBANCE (Couldn't take tongue out of mouth) (seriousness criterion death). The patient died on 13-May-2021. The cause of death was not reported. An autopsy was not performed.            No Concomitant medication was reported.  No treatment medications were reported.  Patient had a massive stoke, convulsions, gasping for breath, lost function of left side of body, and couldn't take tongue out of mouth on 13May2021. Wife noticed the symptoms of stoke and called 911 immediately. While on the phone with dispatcher, wife performed CPR and used mouth to mouth technique on her husband for up to 20 minutes.  Wife stated they shocked the patient to bring back but it was unsuccessful and patient passed away on 13May2021 in wife's arms.  Patient was on heavy blood thinners.   Company Comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Unknown cause of death
Unknown if attributed to vaccine.  Patient had vaccination on 11/19/2014 symptoms of fever, dizziness, headache began next day.  Patient demise time unclear may not be related however per process noting that vaccination had occurred in the previous 36 hours.
2 days after the 1st vaccine, my left cheek began twitching; 2 weeks after 1st vaccine I began experiencing vertigo that is now intermittent; This is a spontaneous report received from a contactable consumer or other non hcp. A 43-years-old non pregnancy female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number EL3249), via an unspecified route of ad-ministration, in Arm Right on 19Jan2021 12:45pm (age at vaccination 43years old) as single dose for covid-19 immunisation. Medical history included hypertension, asthma from an unknown date and unknown if ongoing. The patient previously took promethazine dm and experienced drug hyper-sensitivity. No covid prior vaccination. Concomitant medications were not reported. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9269,), via an unspecified route of administration in arm right on 12Feb2021 04:30pm as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received other medications in two weeks. Patient inquired that while administer her 1st dose, On 20Jan2021 the patient experienced 2 days after the 1st vaccine, her left cheek began twitching. This intensified after the 2nd vaccine and she is now experiencing pain, numbness, tingling in the area. The left half of her lips also has numbness. 2 weeks after 1st vaccine I began experiencing vertigo that is now intermit-tent. Treatment was received for the events with steroids and Dramamine. No covid tested post vaccination. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
DIZZINESS; CHILLS; JOINT PAIN; MUSCLE PAIN; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, chills, joint pain, muscle pain, nausea, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle pain, joint pain, nausea, fatigue, headache and dizziness was not reported. This report was non-serious.
Body aches; Chills; Fatigue; This spontaneous case was received on 07-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-04209) with additional information received on 10-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-04247) (being processed together) and concerned a 31-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 06-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular (IM), anatomical location: not reported) for influenza prophylaxis. The batch number reported was 348368 and expiry date 30-Jun-2023.   On the same day, about eight hours after receiving Flucelvax Quadrivalent, the patient started experiencing chills, fatigue and body aches.  On an unspecified date in Oct-2022, the patient recovered from all events.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 31-year-old patient was vaccinated with Flucelvax Quadrivalent. About eight hours after receiving Flucelvax Quadrivalent, the patient started experiencing chills, fatigue and body aches. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 31-year-old patient was vaccinated with Flucelvax Quadrivalent. About eight hours after receiving Flucelvax Quadrivalent, the patient started experiencing chills, fatigue and body aches. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
Within about 20 minutes of receiving second dose of vaccine, pt began feeling lightheaded, nauseated and having heart palpations. Juice and crackers given. Vital signs monitored. Pt went to ER for further monitoring and evaluation.  Pt was diagnosed with possible vasovagal episode and was discharged home.
Subsequently post vax, the pt developed an injection site reaction characterized by a large area of redness and swelling.
constant jerk, pallor, crying-no unusual quality, febrile 104.5, vomiting, feet turned bluish;pt resisted touching/holding then became despondent & very quiet;no localized rxn reported s/s persisted for 30-45min;
Body aches beginning 12 hours post vaccination. Tenderness and swelling of underarm lymph node on left arm (same arm as the vaccine site) began 36 hours after vaccine. At time of this report, approximately 68 hours post vaccine, tenderness has increased since yesterday.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose, route not reported; lot # K005178 with expiration date 10-APR-2016, lot # K010437 with expiration date 22-JUL-2016. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had the standardside effects however rather embarrassingly with both doses in the first night after jab i had intense sexual desire whixh is completely abnormal   my meds took away all sexual orgasm desire   it was like the point just before orgasm and went on for about 6  hours both times during high fever
Received immunizations 3/20/07, Approx 0930, Febrile that evening. Parent managed with Tylenol and Motrin. Approx 0400 on  3/21/07 parents reported seizure lasting approx 5 minutes & called ambulance. Evaluated in ER - CXR, UA, CBC, BMP - received IV fluids & baby remained postical for prolonged periods & not taking Good PO & admitted to pediatric unit for observation. Discharged 3/22/07 Assessment: Febrile seizure, Dehydration, Otitis Media. 05/15/07-records received for DOS 3/21-3/22/07-DC DX:Febrile seizure, status post immunizations. Otitis media. Viral illness at time of immunization included fever, conjunctivitis, runny nose and cough. On day of admission fever and 5 minute tonic-clonic seizure resolved with some lasting pallor and cyanosis. max temp in hospital 37.2.
The pain from my RA got much worse within weeks of then shots, Joint pain in general got worse from my neck, wrist, knees and feet.   7 of my fingers at the joint closest to the finger nail dropped.
My arm became hot, swollen, and itchy at the injection site. For several days it had a raised red circular mark around the injection site. On the third day it stopped.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 17-SEP-2012 the patient was vaccinated with M-M-R II dose 2, subcutaneous. Other suspect therapies included (merck) VARIVAX dose 2, subcutaneous on 14-SEP-2012. No adverse symptoms were reported. Additional information has been requested.
I received pain; redness and swelling in my right wrist lasting 2 days. I was given antibiotics and felt better.
high fever for 3 days (about 102); The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (05Jul2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), 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: PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "high fever for 3 days (about 102)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient mother reported that her daughter had high fever for 3 days (about 102). The event was occurred over 2 years ago after receiving the Covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a physician via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain and tingling. BEXSERO was discontinued. On an unknown date, the outcome of the pain and tingling were recovered/resolved. It was unknown if the reporter considered the pain and tingling to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient was in her early 20's at the time of reporting. The age at vaccination was not reported. The patient experienced severe pain and tingling for several days. The patient would not get the second dose of BEXSERO because of the side effects she experienced. The reporter thought it had something to do with receiving this BEXSERO vaccine and MENACTRA previously. The reporter agreed to be followed up. It was unknown if the reporter considered the severe pain and tingling to be related to MENACTRA as well. This case has been linked to the US2018GSK135774, reported by the same reporter.
-mild sore throat ~5 hours after second vaccine, lasting 12 hours -fever up to 101.8 for ~30 hours after second vaccine, lasting ~8 hours
Bad headache, tingling in arm/hand, hoarseness, severe tremors, severe body aches and pain, fever 102, extreme fatigue, insomnia,
Spiked a 104 fever, severe headache, extreme fatigue and arm soreness.  Complained his arm felt like it was going to explode.  Has had intermittent flu symptoms for the following 2 days.
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 76-year-old female patient received, on 12Jul2018 at 20:00, PREVNAR 13, via an unspecified route of administration, in the left arm, at single dose, for immunization. The patient received also, on an unspecified date, tetanus vaccine and SHINGRIX; both for immunization. She got another vaccine 10 years before this report, but she was unsure of the name of it. Relevant medical history included pneumonia (she has had full blown pneumonia before, but about 50 years before this report). Concomitant medications were unknown. On an unspecified date, in Jul2018, the patient experienced cough and tiredness. On 24Sep2018 pneumonia was diagnosed. Patient's clinical course was the following: patient received PREVNAR 13. She also was vaccinated with tetanus shot and SHINGRIX after receiving pneumococcal 13-val conj vac (dipht crm197 protein) and after she developed the cough that never went away. She had a bit of a cough all summer and she noticed she was tiring easily. The patient was seen by her health care provider and was diagnosed with pneumonia on 24Sep2018. He listened to her chest and then said she should have a chest X-ray. She was prescribed (ZITHROMAX) for 5 days. Clinical outcome of the adverse events was recovering. The information on the lot number has been requested.
Complaint of the following symptoms: cough, sore/scratchy throat, and runny nose/congestion
Patient vaccinated x4 (Pfizer: 3/8/21, 4/5/21, 12/13/21, 7/12/22)  Patient admitted to hospital and found to be COVID positive on 7/19/22
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer-sponsored program.  A 58 years old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8733), via an unspecified route of administration on 24-MAR-2021 at the 57 years old at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's COVID vaccine on 24Mar2021 and tested positive for COVID on 12Apr2021. She missed her second dose on 14Apr2021 due to her isolation period which was up at 22Apr2021. The patient was wondering when can she take her second dose. The outcome of the events was unknown.
Initial unsolicited report received from a consumer on 06-Feb-2017. Manufacturer control number: 2016US043962. This case involves an 82-years-old male patient, who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, site and route of administration were not reported) on unspecified date and a capsule of XTANDI (160 mg dose (also reported as 40 mg), frequency: once daily (batch number: 1543978PC, expiry date: 15-Dec-2016) orally for prostate cancer on 03-Aug-2016 till 15-Dec-2016. The patient's medical history and concomitant medications were not reported. On 26-Oct-2016, unspecified duration following the vaccination, and 84 days following administration of XTANDI, patient experienced cold and cough after receiving a flu shot. The patient's lab data and corrective treatment were not reported. As of 22-Dec-2016, the patient was recovering from the events. Reporter comment: Action was taken with enzalutamide treatment in response to event cough was unknown. However, treatment with enzalutamide was discontinued on 15 Dec 2016 due to an unspecified reason. Action taken with influenza vaccine was not applicable. Reporter assessed cough and cold as non-serious and causal relationship to XTANDI as possible based on the implied temporal association. List of documents held by sender: none.
pt stated that he got chills the night after receiving the vax.  Early hours in the morning his temp was 98.7 and reached 101.7.  He was nauseated at this time.  Next morning he woke up 99.4 temp but all other symptoms were gone.  He contacted his PCP at the hospital and they instructed him to call us to file report.
Dilated cardiomyopathy- patient with CHF symptoms starting on 3/12 and noted to have dilated cardiomyopathy with EF <20% on TTE on 3/26.
Patient developed rash on hands, feet and trunk that was tender and painful. He developed myalgias and was unable to walk secondary to pain.
Sore arm evening of injection Joint pain starting 2nd day and continuing for 3 days Not severe enough to call Dr.
Suffered a stroke, CVA, was hospitalized at Hospital. Studies done, no identifiable cause of stroke. She has sustained (R) sided weakness/decreased mobility.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.