chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/4/21, I was informed that I was pregnant with my 4th child. On 4/12/21, I was scheduled for my 1st dose of the Moderna as well as having a first trimester NCIT testing being done. At that exam, my provider was able to find a fetal heart rate (177), he was dated to be approximately 12 weeks and 6 days, and there were no concerns at that time regarding physical abnormalities or brain deformities. Additionally, I was sent out for bloodwork to rule out Trisomies and determined gender of the baby. The results of that lab work came back as negative and we were expecting our first son October 19, 2021. However, yesterday, 5/4/21, I attended my monthly prenatal appointment and the provider informed me that she could not find a heartbeat. She used a doppler scanner and then the in office ultrasound machine; neither of which detected a heartbeat. I was sent out to Radiology for a formal scan to refute or affirm the findings. Sadly, the results came back that I had lost my child. There was no heartbeat found and the results showed that my child stopped growing and remained 12 weeks in size. I am scheduled to have my pregnancy evacuated Friday, 5/7/21 at 1040a. While I am aware that miscarriage in 1 in 4 women, I cannot in good faith say that the vaccine may have contributed to my pregnancy loss. The only change in my routine was the addition of the vaccine. I am hopeful that this pain will not be felt by others and can be researched further to ensure fertility loss or future pregnancy loss isnt a norm following this vaccine.   Additionally, I have had 3 full term, healthy pregnancies prior to this miscarriage. None of these pregnancies had complications and the children were birthed without issue.
bleeding from his nose; This is a spontaneous report from a contactable consumer (patient mother). A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the 1st dose in afternoon and in next morning, when he woke up, he had bleeding from his nose. Patient was healthy teenager. The clinical outcome of the event was unknown.
This spontaneous report as received from a consumer refers to his daughter a female patient of unknown age allergic to neomycin. The patient was vaccinated with PEDVAXHIB (manufacturer unknown) on an unspecified date. Other suspect therapies included DTaP (manufacturer unknown). No concomitant medications were reported. The consumer reported that the patient had the vaccine and had a skin rash and blew up on an unknown date. The patient was given BENDARYL as treatment. The reporter was not completely sure if his daughter received PEDVAXHIB (manufacturer unknown). The consumer mentioned that his daughter may have received DTaP (manufacturer unknown) also. The outcome of skin rash and blew up was unknown. The relatedness of skin rash and blew up was not provided for PEDVAXHIB (manufacturer unknown). Additional information is not expected.
Vaccines given at approximately 11:45 am, febrile seizure at 11:50 pm on 12-18-08. Spiked fever 102  and seen at local ER, chest X-ray and blood work WNL. Treated with MOTRIN.
Redness, itching, heat (site is about 1.5° warmer than temple per temporal thermometer) Started 8 days post-vaccine. Worse on day 9.
5 days post second injection began having substernal pain with associated feeling of my heart "fluttering." Symptoms were episodic and would resolve. Symptoms lasted for 3 weeks before resolving.
Pt recvd vax & devel raised,red welts on body. Pt exp pruritus, swollen elbows,joints aching & rash starting on vax arm then spread diffusely as target lesions. Pt reportedly had 5 prior DTP immunizations
9APR96 pt recv & cried then went limp, unresponsive;seen in ER-nl exam by then;10APR96 falling asleep 45' p/eating became limp;
3hrs after had normal arm pain. 1030 am following day woke up with shivers, soo cold my bones of my spine and arms were hurting. Headache, dizziness and heart rate over 130 (normally low 60s)
PANCREATITIS; LAIV GIVEN OUTSIDE OF APPROVED AGE; A spontaneous report has been received from a consumer concerning a female patient of Unknown ethnic origin (age 71 years, weight 155 lb).    The patient's past and current medical history included appendicectomy (dates not reported), drug hypersensitivity (dates not reported), psoriasis (dates not reported), turbinectomy (dates not reported), diabetes mellitus (dates not reported), cardiac pacemaker insertion (dates not reported), back pain (dates not reported), psoriatic arthropathy (dates not reported), hypertension (dates not reported), hyperlipidaemia (dates not reported), peripheral swelling (dates not reported) and osteomyelitis (dates not reported).     Concomitant medication included metformin for diabetes mellitus, glimepiride for diabetes mellitus, losartan for hypertension and gabapentin for hypertension.     On 16-Sep-2022, the patient received Influenza Vaccine (influenza vaccine), via nasal route, for influenza (immunisation).     During 2019, the patient started treatment with Rosuvastatin (rosuvastatin calcium) 5 mg daily, oral, for hyperlipidaemia.     No malfunction has been reported for INFLUENZA VACCINE.    The report described a medication error for Influenza Vaccine. The reported term was laiv given outside of approved age (Preferred term: Product administered to patient of inappropriate age).    On 26-Jan-2023, the patient experienced pancreatitis (preferred term: Pancreatitis).     Treatment with Rosuvastatin was not changed. It was unknown if any action was taken with Influenza Vaccine.     At the time of reporting, the event pancreatitis was improving.    The reporter assessed the event of pancreatitis to be serious due to seriousness criteria hospitalisation.  The company physician assessed the event of laiv given outside of approved age as non-serious.    The reporter considered that there was a reasonable possibility of a causal relationship between Rosuvastatin and the following event(s): pancreatitis.     Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA VACCINE  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Pancreatitis is not listed in the company core data sheet of Q/LAIV. Underlying diabetes mellitus, hyperlipidemia, hypertension, and advanced age of patient could be possible risk factors to the event. Due to limited information on circumstances leading to the event, action taken with Q/LAIV,  final outcome of the event, risk factors (infection, gallstone disease, alcohol use, smoking, obesity), other medical history ( bile duct stenosis, hepatitis), concurrent diseases, other concomitant medications, family history of pancreatitis, clinical course, treatment details, detailed etiological, diagnostic workup as clinical examination, complete blood work (including pancreatic enzymes as amylase/lipase, inflammatory markers),imaging studies, hepatobiliary endoscopy, pancreatic biopsy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the event and Q/LAIV.
The mother states patient had a headache and had been vomiting and collapsed.Mom found her unrepsonsive. Went to ER found blood in head. Went by care flight and 2nd hospital for surgery attempted; didn't wake, worse bleeding from "abnormal plexus of veins" in cerebellum patient expired. Death certificate states cause of death to be cerebral herniation due to rupture of cerebellar arteriovenous malformation.
Injection 4:30pm Nov 18, at 8:00pm throat started to swell with unbearable pain, tongue swelled and neck. ER, oxygen, Solu Medrol IV, Benadryl IV, Pepsin IV, Throat X ray, blood work.
Patient said she came down with pneumonia 1 week after this dose and has been in the hospital since then.
a strong, whole body heat, and flushing; a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported similar event for 6 patients. This is 3rd of 6 reports. A 24-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Pfizer employee reporting on behalf of a friend, reported her friend texted her last night, 30Dec2020, at around midnight. The nurse and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. Caller said she had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. Caller said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. Outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 vaccine cannot be excluded for events flushing, feeling hot, tachycardia and palpitations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
Seventeen days after my second dose, my appendix almost rupture and had to have surgery to remove it; Dose 1:17Feb2021; Dose 2: Feb2021; Dose 1:17Feb2021; Dose 2: Feb2021; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 at 02:30 (Lot Number: EN6200) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right in Feb2021 at 14:30 (Lot Number: EL9262), both (at the age of 68-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history was none. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient reported that: "seventeen days after my second dose, my appendix almost rupture and had to have surgery to remove it" on Mar2021. The event was serious, the patient was admitted to emergency room and was hospitalized for seventeen days after the event, the event was also assessed as life-threatening.  The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 09Mar2021.  Therapeutic measures were taken as a result of the appendix rupture and included surgery to remove it. The patient outcome of the event was recovering.  Follow-up attempts are possible. Further information is expected.
States complained of sore left arm (deltoid area) approximately 18:00 on 11/06/2003.  Awoke at 13:30 on 11/07/2003 with complaints of increased soreness and "itching" in left lower arm and fingers.  States took antihistamine and Estylenol at 13:30.
Had my pfizer booster on 11/22/2021. Perfectly ok until 11/23 when I experienced SOB, fatigue, weight gain and chest pressure bad enough to see PMD who put me on diuretic. Labs showed BNP on 145. Cardiologist increased my ARB. Chest x-ray was ok.
Patient received 6months immunization shot (4 shots) including dTAP at 1030AM 10/9/06. He noted to have clonic-tonic seizure around 1500 10/9/06. He was send to ER and now hospitalized for work up. He had history of 3 days temperature 100.5-100.9 per rectal. Pending for blood/stool/urine and CSF culture. Will also have MRI brain and EEG done. DC DX: post vaccination seizure.  Treated with Recephin No seizures in hospital.
Information has been received from a father concerning his daughter who in 2008 was vaccinated with the third dose of GARDASIL (Lot # not provided) on an unspecified date. The patient experienced nausea and gastrointestinal issues since then. The patient had seen several physicians in regard to her continue nausea, but they had not been able to determine the cause. At the reporting time the outcome was unknown. Additional information is not expected.
No adverse event; Improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to an 18-month-old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant medications included fluoride. Historical vaccines included hepatitis B vaccine (unknown manufacturer), measles mumps rubella vaccine live (unknown manufacturer), diphtheria vaccine toxoid (+) hib (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13), rotavirus vaccine live reassort oral 5v (ROTATEQ) and varicella zoster vaccine (unknown manufacturer).  On 23-JUN-2023, the patient was vaccinated with an improperly stored dose of hepatitis A Vaccine, inactivated (VAQTA) lot# X003791 and expiration date 01-JUN-2024 in the left thigh as prophylaxis (strength, dose, route, and vaccination scheme frequency were not provided). It was reported that vaccine temperature excursion was not viable and occurred from a digital data logger alarm believed to be due to sensory issues. Monitoring temperature with back up logger. Temperature in range, new data logger was in use. It was also reported a storage in clinical practice. There was no adverse effect reported.  The action taken with the vaccine was reported as "returned, waste in progress".   This is one of several cases by the same reporter.; Sender's Comments:  US-009507513-2308USA004788:Same Patient
Post vaccination, patient developed fever up to 102.7 degrees. Also weakness and dehydration (pt is diabetic and forgot to take his medication).
Mild fatigue; mild chills; mild muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 09:45 (Lot number: EL3247) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID-19, brand=Pfizer,, lot_number=EL3247,, lot_unknown=False,, administration_date=10Mar2021,, administration_time=09:45, vaccine_location=Left arm,, dose_number=1), administration date: 10Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 01Apr2021 10:00, outcome "recovered" (2021), described as "Mild fatigue"; CHILLS (non-serious) with onset 01Apr2021 10:00, outcome "recovered" (2021), described as "mild chills"; MYALGIA (non-serious) with onset 01Apr2021 10:00, outcome "recovered" (2021), described as "mild muscle pain". Therapeutic measures were not taken as a result of fatigue, chills, myalgia.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination,  patient had not been tested for COVID-19. No Allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant via field representative refers to a 66 year old female patient. The patient's pertinent medical history included hypertension and drug allergies were not reported. On 10-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (one time injection) (lot # M018766 and expiry date: 15-OCT-2017). Concomitant medications were unknown. On 11-AUG-2016, the patient experienced fever, red, hot, swollen and painful arm. The patient sought medical attention and treatment was provided for the events. The outcome the events was unknown (action taken was also reported as withdrawn). The relatedness of the events with PNEUMOVAX 23 was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Gout.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurts). At the time of the report, PAIN IN EXTREMITY (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified high blood pressure medicines and gout treatment medicines. The patient's dentist had prescribed antibiotic for tooth. Treatment information was not provided.
Unusual headache x4 weeks radiating from the forehead with R facial numbness with dizziness and neck stiffness. These symptoms were severe and intractable for the first week, and then gradually decreased in severity and frequency. At 6 weeks, symptoms have all resolved except R facial numbness. Numbness includes the forehead, cheek, and jaw.
Patient went into anaphylactic shock and began having her throat close as well as severe itching on her left arm around 3-5 minutes after having her 2nd dose of the COVID-19 shot. Patient gave herself epipen within 5 minutes of symptoms showing . After around 5 more minutes patient required more epinephrine however at this point EMS Had arrived prior to a second dose being necessary from the pharmacy.
Bells Palsy after 2nd dose given on Jan 27th. Onset that Friday night with full effects of BP that Saturday
Patient was given the 2nd dose of Moderna vaccine on 28th day after her 1st was given.  She tolerated the 2nd vaccine well and waited her 15 min here in the office.   Vaccine given at 2:39pm and at 4pm she called our office and stated she was having problems with her left side of her body and could not go down her stairs in her house.  The whole left side of her body she had no feeling in.  We advised her to go to ER.  She went immediately to the emergency room and they transported her to another Hospital.  After arriving at the hospital they diagnosed her as having a CVA of her right thalmus.  She came in to the office today for hosp f/u and she is still having numbness, tingling and weakness on her left side.
1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant.   Went to ER that evening due to chest pain.  EKG showed t wave abnormality.  1st Trop was negative went from 0.08 to 2.3   Had 2 Echo's done and they were normal.  Platelets were 85.    Was discharged without chest pain.  Troponin on discharge was 0.67 and platelets 61.   Was admitted due to Chest pain and troponin.  Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.
I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 degree. Then 14 hours later I had chills and aches. Then I woke up with night sweats that drenched my sheets and clothes. Then I had a stabbing pain in my chest on the left side.
feeling bad; tired; achy; not feeling well; getting mucus; headache is so bad that it hurts to chew; This is a spontaneous report received from a contactable consumer who reported for a 51-year old female patient (mother) that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The medical history and concomitant medications were not reported.  Patient started feeling bad a few hours after the vaccine tired or achy, 3-4 days still not feeling well now getting mucus, now on day 7-8, still had a headache and headache was so bad that it hurt to chew all with outcome of unknown. It was reported as Non-Serious.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Had a hard time lifting her arm/felt like a horse kicked her in the arm; Felt like had muscle failure in vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Immunocompromised.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. Treatment information were not provided.   This case was linked to MOD-2021-343782 (Patient Link).
18 hrs after shot site local rash, redness and itching -10am. By 11am upper arm significantly swollen, bright red, tight skin hot to the touch. School called me. Ice was applied, markings made to see if swelling continued. Emailed Dr. photos and timeline regarding reaction and seeking advice. Dr. said ice and Zyrtec were recommended and he would check with Allergist. Swelling continued resulting in limited arm movements. 9/29/2021?7pm; Claritin was given with no result; 9/30/21 8am Zyrtec given as recommendation from pediatrician. Received follow up email from Dr. that Allergist said Zyrtec likely to not effect this kind of allergic reaction.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient did not get shingles until he/she got Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.