chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M027345, expiration date: 01-JUN-2018, lot # M020900, expiration date: 27-APR-2018, lot # M033212, expiration date: 13-JUL-2018, lot # M034586, expiration date: 27-JUL-2018 and lot # M027885, expiration date: 03-JUN-2018, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion between 5 and 14 Fahrenheit degrees for 48 hours. No previous temperature excursions were reported. Data logger was not involved. No adverse effects were reported. A phone call was placed on 22-MAR-2017 to the medical assistant, who reported that, she was waiting for the office manager to download the information and then she would fax it in. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US0095075131701USA005974. The WWID US009507513 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US0095075131704USA006958). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957:  US-009507513-1701USA005974:
Pt presented to ER in cardiopulmonary arrest, unresponsive, and cyanotic. Pt was briefly intubated and given epinephrine IV and ACLS protocol. He became responsive, breathing spontaneously and was extubated. Pt had notable angioedema and was given Solu-Medrol IV and neb treatment which helped. Pt became symptomatic again with tongue swelling and stridor was given epinephrine SQ and taken to ICU. Diganosed in hospital with angioedema.
Developed fussiness, stereotypical eye movements the day of immunizations, was admitted to hospital to rule out seizures on 3/21/13; EEG nl, no specific encephalopathy. No evidence of additional neuro symptoms.
Tinnitus developed around 1 am, I did not have ringing in my ears before. Too early to say whether this will be permanent.
ACUTE NON ST ELEVATION MI  12/12/2021 & 12/13/2021 --  RECURRENCE OF SAME SYMPTOMS
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX and the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was resolved with sequelae. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient took the SHINGRIX vaccine, but still had the shingles. This case was considered as suspected vaccination failure cases as the time to event onset and laboratory results were unknown at the time of reporting. The patient consented to follow up.
Received #2 part of shingles vaccine(Thurs) , Woke up Friday feeling achy and Nausea feeling. Slight headache.
Pain full right arm, can't move arm, happened night after shot. Fingers, arms, & neck, shoulder swollen. Pain scale of 1-10 he says 12. Feels like shoulder has been dislocated.
a few minutes after receiving vaccination, had nausea and vomiting (mother stated patient had been and was very nervous)
6" x 4" sl swollen, sl erythematous area; non-tender to palpation; arthus type reaction;
Significant amount of bloody stool.  Went to hospital and was dx with Milk Protein Allergy.  PCP feels it was intussusception.
According to his wife, patient received the Janssen COVID-19 vaccine at the Center on a Friday afternoon in March; she could not recall the exact date and could not locate his vaccination card. Several hours later, patient began stuttering and was unable to put his thoughts together. Later that evening, he began experiencing muscle aches, nasal congestion, nausea, and was unable to get out of bed. He took some Advil and by the next morning he felt fine and was back to normal. It should be noted that he died suddenly and unexpectedly on 05/05/2021, and an autopsy showed his death was caused by hypertensive heart disease and cardiomyopathy.
Large local reaction now 4cm x 3cm - BENADRYL 25mg PRN & cool compress.
Tinnitus (ears ringing)--ongoing to date. Ears popping and fullness--ongoing to date. Arm soreness--4 days, nausea--1 day. Fever 101 degrees lasted for the day. Migraine--3 days.
After the vaccine, I was definitely sore at injection site with swelling. Low grade fever the next day and then chills and body aches for the next 24 hrs. and then was fine after that. And a headache also. For COVID-19 I had a really bad sore throat, head ache, chills that lasted 3-4 days. Symptoms were moderate.
Patient left to have lunch after vaccines, and their supervisor noticed they started turning red.  They returned to clinic, was assessed by Allergist, vitals were taken, and Epi was administered.  Patient was observed for 1 hr and symptoms were resolved.
child broke out with chicken pox on approx. 12/13/2001.  Verified by nurse on 12/14/01
This spontaneous report was received from a nurse and from the patient who reported that in October 2009, he/she was vaccinated with the first dose of GARDASIL; in November 2009, the patient was vaccinated with the second dose of GARDASIL. The nurse reported that the patient was in the facility on 24-APR-2013 for the third dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a 66 years old female patient reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date in June 2011, the patient was vaccinated with the first dose of ZOSTAVAX (strength, route, anatomical location, lot number and expiration date were not reported) for prophylaxis, subsequently on an unspecified date in February 2015, the patient received a second dose of ZOSTAVAX by accident instead of a PREVNAR 13 (manufactured by Pfizer) (Interchange of vaccine products). The reporter did not specify if she had ever received the PREVNAR 13 vaccination. On an unknown date, following the second administration of ZOSTAVAX, the patient developed a case of shingles (herpes zoster). No product quality complaint was involved. The outcome of herpes zoster was reported as recovering. The outcome of product use issue is unknown.  The reporter did not assess the relatedness between the event and ZOSTAVAX. Additional information is not expected, since no consent to contact the reporter was provided.
fever; headache; so sick I missed two days of work; brain fog; loosing my balance; fell twice; body aches/sever pain in my left side; bloating with nausea; bloating with nausea; high blood pressure; swollen Liver; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Aug2021 at 15:30 as dose 2, single (Lot number: FL3181) at the age of 59 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Strawberries" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose number=1, lot number=EY058U,, dose administration time=03:30 PM, vaccine location=Left arm), administration date: 23Jul2021, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: ABDOMINAL DISTENSION (disability), NAUSEA (disability) all with onset 29Oct2021, outcome "not recovered" and all described as "bloating with nausea"; FEELING ABNORMAL (disability) with onset 29Oct2021, outcome "not recovered", described as "brain fog"; FALL (disability) with onset 29Oct2021, outcome "not recovered", described as "fell twice"; HYPERTENSION (disability) with onset 29Oct2021, outcome "not recovered", described as "high blood pressure"; BALANCE DISORDER (disability) with onset 29Oct2021, outcome "not recovered", described as "loosing my balance"; PAIN (disability) with onset 29Oct2021, outcome "not recovered", described as "body aches/sever pain in my left side"; HEPATOMEGALY (disability) with onset 29Oct2021, outcome "not recovered", described as "swollen Liver"; PYREXIA (disability), outcome "not recovered", described as "fever"; HEADACHE (disability), outcome "not recovered"; ILLNESS (disability), outcome "not recovered", described as "so sick I missed two days of work". The events required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2021) Negative. Therapeutic measures were taken as a result of hypertension, Dr prescribed blood pressure medicine.; Sender's Comments: Based on the available information in the case, an association between the reported events and bnt162b2 cannot be ruled out.  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.
Patient started with body aching throughout on 05/21/2003 at 08:00; no fever.  Patient noticed non-raised red/blotchy rash on left deltoid 05/21/2003 @ 09:00.  Patient has no complaints of itching, but rash is tender to touch.  Patient informed our office on 05/23/2003 at 10:00, and stated he is having slight improvement to site.
Around 12 hours later I felt feverish and achy all over. About 48 hours later I developed an irregular heartbeat, and I had upper chest pressure. I went to the ER on 10/2/2021 at Hospital. They ran test and they diagnosed me with atrial fibrillation. They treated me with Cardizem at the ER through IV. They also prescribed a blood thinner medication for Eliquis 5mg 2xday, and they lowered my aspirin from 162 mg to 81 mg a day. Once they had gave me the medicine in the ER, I started to feel better.
Hives full body; Dermatographism full body; Itching full body; Redness full body; Rash full body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included ISOTRETINOIN and EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In 2021, the patient experienced URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body). At the time of the report, URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-437106, MOD-2021-437129 (Patient Link).
Pt said that she had a fast heart rate and flu like symptoms later at night after receiving her first dose of SHINGRIX. Patient said that she went to the ER where she was given medication (she did not recall what med) to slow down her heart rate, she was given a single dose and situation resolved.
R sore, swollen, redness, blisters-last nite, gone today itching, -in area near the shot - extra strength tynenol.
My eyesight has changed. Before when being on the computer I wore 1.75 glasses - now I have to wear 1.5. Also I now have to wear distant glasses again while watching TV.
Blurry vision almost black out when walking.; Blurry vision almost black out when walking.; Muscle ache; fever; Fatigue; This 32- year-old female patient contactable healthcare professional received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6203), via an unspecified route of administration, on 09Mar2021 at 09:00am (at the age of 32-years-old) as a single dose for COVID-19 immunization, in left arm. Patient is not pregnant. She has had no other vaccines on the same day or in the past 4 weeks. The patient did not have COVID-19 prior to the vaccine. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization, on 16Feb2021, (Lot EN6200), in left arm. Relevant medical history included birth control use. Concomitant medications included: Junel birth control. On 09Mar2021 at 10:00 pm, the patient experienced Muscle ache, fever, fatigue, blurry vision - almost black out when walking. The patient received treatment of ibuprofen for the events. The clinical outcome of the events Muscle ache, fever, fatigue, blurry vision - almost black out when walking was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information about lot/ batch number has been requested.
Information has been received from a Nurse Practitioner concerning a 21 year old female who was vaccinated "by injection" with a second dose of Gardasil (lot # not reported).  "Last week", on approximately 07-MAR-2008 the patient developed an itchy rash at the injection site.  The patient sought unspecified medical attention and was given Benadryl to stop the itching.  Subsequently, the patient recovered from the itchy rash at the injection site.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. No further information is expected.
felt sick; high fever; chills; flu like symptoms; trouble breathing; aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), MALAISE (felt sick), PYREXIA (high fever) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), PYREXIA (high fever), CHILLS (chills) and PAIN (aches). On 09-Jan-2021 at 4:00 PM, the patient experienced MALAISE (felt sick). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), MALAISE (felt sick), PYREXIA (high fever), CHILLS (chills) and PAIN (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021244007 (Pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  Additional Information: The patient was asking "if having swollen lymph nodes is part of the reaction to the vaccine". The patient declined to complete the report. No further clarification or details provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About an hour after receiving the vaccine I had a rash (hives?) on my left shoulder and chest. I took a Benadryl and some Ibuprofen and it went way after a couple of hours.
Unremitting itching on scalp, back, abdomen, legs-especially behind knees, lungs - itching on the inside, as well as a hardening of the skin at the injections site on the right arm, and stiffness in the left shoulder followed the next day. Still uncomfortable, but about 70-80% recovered. Physician told me to change antihistamines from Zyrtec to Allegra, and that helped me turn the corner. I also added Benedryl over the counter for overnight if I could not sleep. Ointments did zero to help.
allergic to something in the process and it has made me seriously ill in the past; allergic to something in the process; Initial information received on 08-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who was allergic to something in the process and it has made me seriously ill in the past , it involved vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, with an unknown formulation and strength, ( lot number  and expiry date: not reported ) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date , the patient was allergic to something in the mfg process and it has made me seriously ill in the past (illness) (allergy to vaccine) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken : not applicable.  Corrective treatment: not reported for the events  Outcome: unknown for both the events
This case was reported in a literature article and described the occurrence of Kawasaki's disease in a infant subject who received Rotavirus vaccine for prophylaxis. On an unknown date, less than a month after receiving Rotavirus vaccine and DTPa vaccine, the subject developed Kawasaki's disease. Serious criteria included GSK medically significant. The outcome of Kawasaki's disease was unknown. It was unknown if the investigator considered the Kawasaki's disease to be related to Rotavirus vaccine and DTPa vaccine. Additional information was provided. This case was reported in a literature and described the occurrence of Kawasaki disease in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus (RV) vaccine (either RV1 or RV5) and unspecified diphtheria-tetanus-pertussis (DTaP) vaccine (manufacturer unknown for both) for prophylaxis. The patient was part of study that evaluated the short-term risk of adverse events associated with rotavirus vaccine (RV) in infants, overall and by vaccine formulation (three-dose pentavalent, RV5; two-dose monovalent, RV1). The patient was a newborn between 2006 and 2014. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received 1 dose of unspecified rotavirus vaccine concurrently with 1 dose of DTaP vaccine (administration route and site unspecified for DTaP; batch number not provided for both). [In this study, RV and DTaP follow similar dosing schedules, with recommended doses at 2, 4, and 6 months (except for the two-dose RV1 which does not have a 6-month dose) with doses at least 4 weeks apart]. The age of vaccination was not provided. On an unspecified date, during 30 days post-vaccination, the patient developed Kawasaki disease. The treatment was unknown. The outcome of the event was not provided. The author did not comment on relationship between the event of Kawasaki disease and unspecified DTaP vaccine and unspecified rotavirus vaccine. The author stated "we did not demonstrate an association between RV and serious adverse events, and the safety was comparable between the two RV formulations, though many events were rare. RV may be associated with a small increased risk of otitis media, but further research is necessary to confirm this association.
She had pain at site, in her arm; Tired; This is a spontaneous report from a contactable consumer (patient). A 54 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (arm) on 05Feb2021 07:40 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  There were no concomitant medications.  The patient experienced she had pain at site, in her arm and tired on 07Feb2021. Patient does not see her physician very often. No treatment was given for she had pain at site, in her arm. Outcome of the event she had pain at site, in her arm was recovered on an unspecified date while unknown for tired.  Information on the lot/batch number has been requested.
Abrupt onset of prickly sensation of skin, sense of lump in throat and racing heart followed by dizziness and near syncope and sense of doom-fell to the floor and remained on the floor in the doctor's area on 7A due to severe light headedness for 90 minutes.  Several medical students and interns witnessed event and called rapid response team after 20 minutes.  Rapid response team arrived and asked me if I was afraid of needles and left since I was alert and speaking while on the floor-they did not check vital signs.   Dizziness lessened but increased again at 4:00 PM and was associated with prickly skin sensation without collapse.   All symptoms resolved completely within 12 hours.
This spontaneous report as received from a physician via a company representative refers to a 61 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Information on dose, route and lot number was not provided. No concomitant medications were reported. It was reported that after receiving ZOSTAVAX, the patient had broken out with shingles multiple times. The patient did not seek medical attention. The outcome of the event was reported as recovered/resolved (date unspecified). No reporter causality was provided. No further information was provided. Additional information is not expected.
Information has been received from a registered nurse concerning a 7 year old male with no medical history and no drug allergies who on 04-OCT-2002 was vaccinated intramuscularly with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#637679/0448M). There was no concomitant medication. On 28-MAR-2007, the patient experienced a breakthrough. Subsequently, the patient was brought to the doctor's office and the patient was treated with acyclovir. No lab studies were performed. As of 02-April-2007, the patient was fully recovered. No product quality complaint was involved. Additional information has been requested. This is a consolidation of two reports concerning the same patient.
11x13cm teardrop (upside down) shaped hot, red rt deltoid;not tender to palpitation;no fever, moves arm well, acts completely well
Patient right deltoid became red and swollen day after shot.  Patient then developed hives which lasted a week.