chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to an approximately 74 year old female patient. Information regarding medical history and concurrent conditions were not reported. On 11-SEP-2015, the patient was vaccinated with 0.65 ml ZOSTAVAX vial 19400 PFU (lot # L006392 and expiry date 25-MAY-2016) subcutaneously in the left deltoid. On an unknown date in September 2015, the patient experienced little redness but no rash or blisters at the injection site. The reporting pharmacist did not know when the redness developed, but observed the patient's injection site on 16-SEP-2015. The patient stated that the redness not even bothering her. No lab diagnostics test was performed. The patient did not seek any medical attention. No product quality complaint was involved. The outcome of the event was reported as recovering. Causality assessment was not provided by the reporter. Additional information has been requested.
Got the Pfizer shot at 12:00 PM on September 21st. Arm so sore immediately afterwards I could barely move it. The next morning September 22, I woke up around 8:30 with my left nostril semi stopped up. Blew my nose, and it was a combination of dried blood and fresh blood. Nose bled off and on all day. Same day, felt cramping like from menstrual cycle, and noticed brown red discharge from vagina from Sept 22 thru Sept 26, 2021. I have been Postmenopausal for over 2 years. Slight headaches on Sept. 21 and 22.
3-5 minutes after vaccination was given pt began sweating profusely, had tunnel vision, became nauseous and did not feel good. Had patient drink some water and remain seated. Symptoms subsided within 15-20 minutes. Patient refused medical treatment (911)
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Site of shot became sore and swollen, along with a little redness, about a week after my actual shot. Pain lessened over 1-2 days and then swelling and pain went away after about 2 days.
Pt complained of swollen, tender lymph nodes on neck and head. Denies fever, noted macular papular rash on forehead and trunk. Treated with Tylenol and Vistaril.
cough, shortness of breath, headache, sore throat- off and on, ear pain. tested positive for covid19 10/5/21 LOT #1 not available
This case was reported by an attorney and described the occurrence of mercury poisoning in a male child who received hepatitis B vaccine recombinant for prophylaxis. The attorney stated that by the time the child was 12 months old, he had been exposed to toxic mercury exceeding the allowable levels of mercury exposure. The attorney stated that the child had been diagnosed with mild to moderate autism. This report was received via the litigation process and a physician or other heal care professional has not verified the report. Co-administered vaccinations between 1/10/00 and 12/29/01 were as follows: combination diphtheria and tetanus toxoids and pertussis/haemiphilus influenzae type b conjugate vaccine, oral poliomyelitis virus vaccine, inactivated poliomyelitis virus vaccine, hepatitis B vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed, haemophilus influenzae type b conjugate vaccine, and MMR virus vaccine. On 1/10/00 the patient received Engerix B. On 2/4/02, at 25 months of age, the patient was diagnosed as having delayed receptive and expressive language skills, with an auditory comprehension age of 15 months, an expressive communication age of 16 months, and a total language equivalent of 16 months. On 6/3/02, at the age of 29 months, the patient was tested on the Peabody Developmental Motor Scales and was evaluated at a gross motor age of 18 to 25 months and a fine motor age of 20 months. On 8/22/02, the child was diagnosed with Autism Spectrum Disorder. This case was assessed as medically serious (OMIC). The attorney stated that the child sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders, and impairments.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 13th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to anyone. The patient was given SHINGRIX in right arm. The next day after vaccination with SHINGRIX, the patient noticed a 3 inch by 3 inch raised area at the injection site. This area was swollen, red and hot to the touch.
Face red and hot. Lips red and swollen, blisters in mouth. Feet, hands, all over itchy. Cough, runny nose .Shot arm rash, both times. About 8 to 9 days after both shots, had full head to toe blisters. Had to seek out treatment from my DR. Was given 1 round of Methylprednisolone tabs. One week after still had rash. Put on anther cycle of same rx. At time of second shot still had small signs. Given 2nd shot, 8to 9 days same reaction. I am now into my 3rd round of same rx...and it has been one month since my second shot at time of this report.
Felt lightheaded, laid pt back, Vital signs stable, cool compress. Pt  States feels better, snack and drink and patient left.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In May 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in June 2015, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Numbness in left foot then gradually to my left arm and face.  Heart racing and hard to breathe.
Throat was itching and felt very full; Throat was itching and felt very full; hives on arm; hot sweats; Extreme fatigue; lymphadenopathy in armpit and injection site; lymphadenopathy in armpit and injection site; headache; body aches; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 14Jan2021 09:45 at single dose for COVID-19 immunisation. Medical history included seasonal allergies and depression. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the left arm on 24Dec2020 12:00 at single dose for COVID-19 immunisation. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC) and a birth control pill (unspecified). It was reported that 10 minutes after the second dose, on 14Jan2021 09:55, the patient's throat was itching and felt very full, hives on arm, hot sweats, which went away with Benadryl. The patient also experienced extreme fatigue, lymphadenopathy in armpit and injection site, headache, body aches, and nausea. Therapeutice measures were taken as a result of the events. Clinical outcome of the events was recovering.
Student stated felt light headed and was mildly diaphoretic, then felt like "going to black out", placed in reverse Trendelenberg b/p 92/64, felt better in 5 min b/p 102/78 gradually recovered with return to normal within 15 min, near syncope episode.
Twinrix expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 19th October 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired dose of Twinrix, which led to expired vaccine used. No reactions reported. The reporter consented to follow up.
On 4/25 noticed reddness/mild yellow around shot area. On 4/26 area began to blister up. Redness on leg extending. No medications applied. No pain. Fever of 100.3 today and 100.8 yesterday. No other rashes/No previous rashes. Blister measured: 1.5 x 2.5. Redness measured: 14 x 12 cm.
Patient received vaccine roughly 1030am 01SEP. At 1500 on 01SEP patient reported chills, shaking, headache 6/10. Vitals 36.7C oral, 115bpm, 99% SPO2, 26rr, 137/62 BP. Given Tylenol for pain and prophylactic fever reduction. At 1625 patient reported having contractions lasting roughly 40 seconds at 6/10 intensity every 3.5-4min. 500ml bolus given, IV placed, fetal monitoring found fetal HR to be 190-200s. Patient moved to L&D triage for continuous monitoring. Contractions continued and patient delivered via FAVD at roughly 0051 on 01SEP.
After tetanus immunization, pt. complains of left shoulder pain and decrease range of motion. Xrays negative for acute fracture or dislocation. Pt currently using ibuprofen 800mg 3x daily and was given prednisone dose pack on 4/29/19 for continued pain and decreased ROM. As of 4/29/19, pt still complains of pain with left shoulder flexion and adduction.
on 5/25/00, pt had fever, cold symptoms for 2 days, runny nose, red pharynx, a few papules on face, WBC 5,500. 5/27 via phone call, pt was pale, had macular rash on nose and face, fever was 100.8. Pt was taken to ER on 5/28. DOA, (probably several hours). Autopsy states liver congestion, lung atelectasis, lung congestion, respiratory failure due to streptococcal (group B) pneumonia, ceberal edema,
Began to get rash 2 hrs. after vaccine. By the next afternoon, the back of the arm was covered with the rash and it was swollen, hard, lumpy(3x4 inch area). By the third day the area of rash was larger, but had softened and was still hot, red. Now on day 5, just red.
pt recv vax 24SEP96 & 25SEP96 pt exp fever 101 & hypersensitivity, consisting of severe, gen urticaria & edema on hand & feet;
Severe headache, fever, body and joint pain, extreme fatigue.  I tested positive for COVID-19 in February, and those symptoms were less severe than this.  I continue to have good antibody titers (from blood donation), but was forced against my will to be vaccinated despite that fact.
Pt. has worked out in the rain and heat for years before he retired and NEVER had jock itch.  He developed what we thought was a rash and went to the dr who said it was Jock itch.  Never had it until after the vaccine.  He also has a hot burning feeling in his hands and all his joints hurt
pt recv vax 1130 started crying 2hr p/vax wouldn't bear weight on leg;unconsolable crying all afternoon;slept 10min;ate very little;cried again @ 8PM;wouldn't go to bed;started vomiting 10PM;vomited 5-6x;dry heaves, started to shake;t103.7
2 epidoses of screaming for 2 1/2-3 hrs in the 24 hrs p/vax;
Information has been received from a nurse practitioner concerning a male patient in his 60's who a while ago was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed an injection site reaction with a complaint of pain at the site for several months. The condition then resolved. No further information was available concerning this patient. The reporter also mentioned a second patient who had an experienced post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Received Moderna vaccine at work on 1/7/21. Had a sore arm for a few days. However I developed Shingles on 1/16/21. First was pain in scalp and neck and then a rash developed on my neck. Diagnosed on 1/19/21. Was told to report just encase this was a side effect.
Started about 4-6 hours after vaccination:  Dizziness (30 min), shortness of breath (1 hour), sweating (2-4 hours), fatigue (24 hours), weak feeling (24 hours), high fever (lasted all night, 4-6 hours), head ache (2-4 hours) and body aches (2-4 hours).  Treatment: tylenol to break fever and head/body ache and bed rest (24 hours).
chills, muscule pains, night sweats, Headache,foogy mind set, fatigue
After discussing vaccination status with the patient it was my understanding that the patient had received 1 dose at her doctor's and was in need of the second dose.  It was discovered later that she had already received 2 doses after receiving the 3rd dose. 1st dose - 8/21/2020 2nd dose - 12/24/2020 3rd dose - 2/28/2022  Patient experience a red, itchy rash that was hot extending  from injection site to her elbow.  This was a similar response she recalled experiencing after her 2nd dose.  The rash has since started to fade and is no longer hot.
I got my 1st shot Monday evening. I was fine, arm started hurting about 9pm which was to be expected. Tuesday I woke up within 20mins I was nauseous and threw up multiple times. My body was achy and just felt "blah". Was weak and dizzy when I stood up. I felt like my insides were on fire (like the worst temperature you've ever had) but didn't have a fever. Felt like my brain was going to swell out of my head and it was the worst headache. I slept all day. Woke up long enough to call the dr and fell back asleep. Halfway through the day I ended up with a fever of 102 (it went down after a few hrs). Today I woke up still feeling weak and somewhat dizzy, spacey.
Fever, chills, chest pain, shoulder pain, short breath.  Recommended to see cardiologist and GI doctors. Admitted into emergency hospital and found out that my lungs and hearts inflammations. it was pericarditis and treatment given for this and still on medication and still PCR report shows the inflammation high count.
Pt recvd vax & exp burning during inject w/3rd dose; also exp sore throat, feverish; feeling bodyaches, weakness & was itchy @ the inject site; exp flu like sx; 21AUG92 sx subsided;
syncopal episode; tonic/clonic seizure; This spontaneous report was received from a Clinical Medical Assistant, concerning a 12-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 12-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1st dose, administered for prophylaxis. Lot # reported as s021345, was determined to be not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as confirmed by lot verification team.  (dose, expiry date, route of administration, and anatomical location were not provided). It was reported that he also received other two unspecified vaccines (not manufactured by the company)   On the same date after vaccination, the patient experienced syncopal episode (syncope) and tonic/clonic seizure (generalised tonic-clonic seizure). Ambulance was called and patient was taken to emergency department and later discharged. On an unknown date in 2023, the patient recovered from these events. The patient had been seen in clinic after the episode and had no lasting effects.  The causal relationship between the events of syncope, generalised tonic-clonic seizure, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and the other unspecified vaccines was unknown.   Upon internal review, the events the events of syncope and generalised tonic-clonic seizure were determined to be medically significant.
5 minutes after vaccine she stated she felt heaviness throughout entire body, head felt fuzzy and her heart was racing Blood pressure 136/86,  After drinking  water and sitting for 20 minutes starting feeling better walked around and decided was better.
felt sick; muscle ache; fatigue; headache; fast heartbeat; slight confusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; imiquimod (ALDARA), administration date Oct2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for covid 19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset Oct2021, outcome "recovered", described as "felt sick"; MYALGIA (non-serious) with onset Oct2021, outcome "recovered", described as "muscle ache"; FATIGUE (non-serious) with onset Oct2021, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered", described as "headache"; HEART RATE INCREASED (non-serious) with onset Oct2021, outcome "recovered", described as "fast heartbeat"; CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "recovered", described as "slight confusion". The action taken for imiquimod was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
UNKNOWN BRAND of VACCINE. From urgent care: 75-year-old male with essential hypertension presenting today for headache along with uncontrolled hypertension.  Reading here at 187/106 and pulse rate of 113. Reports being compliant with his hypertensive medication without efficacy.  Headache is new. Transferred to ED from urgent care. From ED: This patient is a 75 y.o. male p/w atraumatic headache that he woke up with this morning. Pain is located in the front, described as pressure, and currently rated 7-8/10. The pain was gradual onset and slowly progressing Associated with mild nausea. He states that he attempted to eat breakfast, but was unable to do so because of his lack of appetite and associated nausea. Worsens with nothing. Improves with rotating his head side to side. He reports a h/o similar HA with elevated blood pressure. He states that his systolic pressure was 150 this morning. The patient received his COVID vaccine yesterday which may have given him his headache
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies Sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from unspecified date in Oct2022 to 04Oct2022. Clinical course: Other medication in two weeks includes amlodipine besylate started on 03Oct2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
immunocompromised patient received half a dose for third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient received half a dose for third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced UNDERDOSE (immunocompromised patient received half a dose for third dose). At the time of the report, UNDERDOSE (immunocompromised patient received half a dose for third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.