chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Oct 6th PM after vaccination started breaking out in few hives through out body.  This was relieved with over the counter antihistamines.  These symptoms persisted for the next few days.  On the evening of Oct 8th. he started having redness and itching of hands.  Took antihistamines again and applied over the counter steroid cream to hands.  Went to sleep but at 2AM was woken up by severe redness and itching of hands the right slightly worse than the left.  Research done on computer to diagnose self with acute onset angio edema of hands.  Over the course of the next 10 hours the symptoms worsened until both hands were double in size. and unusable.  Prescribed self a course of Prednisone.  Took 20 mg on the  9th at 10 AM and 60 mg on the 9th at 21:00 and another 60 mg on the 10th at 21:00. During this time I also continued taking round po Benadryl  and Claritin D.  By the morning of the 11th the symptoms started to abate.  Hands reduced swelling enough to be usable but continued redness and itching.  From the 11th onwards has been continuing to take over the counter antihistamines. Also have continued to have occasional bouts of hives all over body since that time.  Also starting on the 11th  developed continual hemorrhoidal bleeding which never stopped. Was prescribed steroid suppositories and hemorrhoid cream to reduce the symptoms.
After the first dose: low mood, did not finish school work After the second dose (dose on 6/15/21, again Pfizer, Lot # EW0181, symptoms started 6/16/21): suicidal ideation & behavior (multiple episodes); confused thinking
No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA006234: US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA009323: US-009507513-2001USA009324: US-009507513-2001USA009326:
Immediately after shot, started shaking. 36 hrs later, felt full-body pain. Still feels pain  from the waste down. (back and butt-Burning paid) 10 days later, went to the ER. Vomitting, no appetite, chest pain. Was given morphine, give  oxycotine when left the ER.
lt knee (above the knee) red rash then blisters;now cleared up;dx as shingles @ L-3 nerve;
vaccine was left out of fridge since  10/15/21.   I had not noticed it was left out and thought it was the new one for the day.   I administered it to the patient by accident.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: pt came in for his first covid shot. checked pt health status pt was fine. while pt was at the observation seat his head went back and he started to have minor sshakiness/seizure like/faintness for about 5 sec. paramedic came and pt refused the pramedic he was checkout by paramedic and was responsive. pt then told us he had been fasting for 2 days and had marijuana on his injection day. pt went home and called his primary dr. and is doing well.
Patient had began having symptoms of L arm pain, redness, swelling and chest pain, the night after his vaccines were administered. Member was taken to ER and was Diagnosed with Cellulitis.  Member only had symptoms to L arm.
I received the vaccine on 08Sep. I have asymptomatic but then I tested positive 16Oct; I received the vaccine on 08Sep. I have asymptomatic but then I tested positive 16Oct; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Lot number: GH9694) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension. Vaccination history included: Covid-19 vaccine ("DOSE X; MANUFACTURER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Sep2022, outcome "unknown" and all described as "I received the vaccine on 08Sep. I have asymptomatic but then I tested positive 16Oct". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) short CBC and long CBC; lab work: (unspecified date) Unknown results; SARS-CoV-2 test: (16Oct2022) Positive; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included Patient received the vaccine on 08Sep2022. Patient had asymptomatic but then tested positive 16Oct2022. She became symptomatic on 11Sep2022. Patient had Covid in Sep2022. Patient came down with Covid positive and symptomatic and sick a few days after getting the bivalent vaccine and patient originally called Pfizer just to ask the question about going forward like if they thought whatever the booster available again for immunocompromised people. Patient came down with Covid positive and symptomatic and sick few days after getting the bivalent vaccine. Patient had surgery on Friday so patient had lab work. Patient had a short CBC and long CBC, patient had a lot of labs. Patient had a PCR, COVID PCR. Patient did actually on day 5, the first day that she tested positive was actually day 5 of symptoms. Patient was really sick before testing positive and took the Paxlovid.
recvd Engerix-B 12MAY92, 14MAY92 devel h/a; tx w/Ibuprofen & ASA neither helped; as of 21MAY92 still had h/a; scheduled a MD visit;
On 10/25 dx'd with shingles given oral medication. Pt. said sore started below elbow on left arm, like an infected hair about 4 hrs after flu shot. Got to the size of a penny by bedtime. Next am had bump like that on left shoulder. Over weekend turned to blisters that scabbed over.  Denies pain. 10/29 getting better - no pain.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for hematuria, copd, malignant neoplasm of transverse colon, HTN, malignant neoplasm of lymph nodes, hx of antineoplastic chemotherapy. Pt received care at outside entity. No note on recent illness or cause of death.
Swelling of face where facial fillers are present. I took a Benadryl to hopefully counter the immune response to the fillers. Fillers had been done in summer of last year.
Extreme fatigue, chills and low grade fever (100) within hours. Fever over 102, 30 hours later with extreme chills, muscular pain, confusion.  Symptoms continuing 52 hours later including extreme back pain.
Irritation/discomfort/irritation in back of throat Excessive mucus in back of throat Difficulty swallowing  Rashes on body - arms, legs,thighs, back
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients may have received doses of improperly stored (albumin status: rHA- recombinant human albumin) PROQUAD injection, lot # M033215 with expiration date on 09-JAN-2018, lot # M040142 with expiration date on 27-MAR-2018 and lot # M042501 with expiration date on 17-APR-2018 (doses and route of administration were not reported). The administered doses of vaccines were reconstituted with STERILE DILUENT (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 10 minutes and also an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 4 hours 40 minutes. Administered doses underwent previous temperature excursions: an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours and an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 30 minutes. A digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA011481: US-009507513-1706USA008591.
6 hours post vaccine-- > arm soreness 12 hours post vaccine-- > fever, chills, headache, body aches, sharp hip and thigh pain bilaterally 24 hours post vaccine-- > symptoms continued; taking OTC Advil 30 hours post vaccine-- > fever 102.2 with continued symptoms;taking OTC Advil 36 hours post vaccine-- > symptoms start to resolve with temp of 99.1
This spontaneous report was received from a 51 year old female consumer referring to herself. The patient's concomitant medication, medical history and drug reactions/Allergies were reported as none. In approximately October 2015, the patient was vaccinated with a dose of ZOSTAVAX (vial 19400 PFU) (lot number, expiration date and dose were not provided). The route of administration was reported as injection. On 06-OCT-2016, the patient was diagnosed with shingles. On 07-OCT-2016, the patient started the VALTREX medication prescribed by the physician. No laboratory diagnostic studies were performed. At the time of the report, the patient was not recovered. The causal relationship between the event and ZOSTAVAX (vial 19400 PFU) was unknown. Additional information is not expected because no consent for follow up has been provided.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 17-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 648 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Initial report received on 19 February 2010 from health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. List of Documents held by Sender: lab results.
Pain and swelling at site of injection lasting more than a month. Extreme pain, can't lie on side.
My reaction to the vaccine was: Complete and utter fatigue, going from the bed to the bathroom and back felt like I had run a marathon, I had brain fog, headache and a temperature.  I ached all over and my vision was somewhat affected.  The idea of eating took too much energy.  No one I have talked to had a reaction like mine.  I believe there is a connection between my reaction and the Valley Fever.  I would like to know if other Valley Fever survivors had similar reactions.  After 36 hours like that, I feel much better.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old female subsequent to FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient received FLUMIST on 05-Jan-2009 which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and on the same day, it was discovered that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter; sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 11 customers not discarding product from the previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009; product complaint investigation results.
Pt states she developed fatigue, body aches, and rash 2 weeks after she got vaccinated. She also developed itchy eyes and a runny nose (unknown onset). She has had these symptoms for 3 weeks. No treatment intervention so far. Rash on thighs, buttocks, fever for about one month 100F - 101F.
Patient is < 18 years old and was mistakenly  given his 1st Moderna shot on 4/01/21 when he was age 16.  Patient is now 17 years old and protocol states that patient should still receive his 2nd Moderna dose and that VAERS be notified a 2nd time of this 2nd/final dose.
6 days after vaccines were given patient had a feverile seizure.  Lasted nearly 5 minutes....temp went extremely high.  Was take by Ambulance to Medical Center to the ER.  ER Dr. came to conclusion after MANY test that this was a reaction more than likely due to patients MMR shot.  DR also called the pediatrician on call who agreed.  Patient was released several hours later.  Was taken for a follow up with the pediatricans the following day where she was cleared - Dr agreed with diagnosis (result of MMR). - ----Patient had several shots at the same time...need to contact Dr. to see what they all were.
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 06-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-17 4USA004461:US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
inadvertently given a dose of Boostrix after it was involved in a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 27-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertently given a dose of Boostrix after it was involved in a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient was inadvertently given a dose of Boostrix after it was involved in a temperature excursion that rendered the product unstable, which led to incorrect storage of drug The reporter consented to follow up. The case is linked with US2023132547, by same reporter; Sender's Comments:  US-GSK-US2023132547:Same reporter
Immune Thrombocytopenic purpura Dx on 7/29/04
Pt dev high fever night after FLUMIST administration. Dev febrile seizure and brought to E.D.
ACID REFLUX; CHEST PAINS; SEVERE HEART BURN; This spontaneous report received from a patient concerned a 7 decade old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 1162124 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. Age at time of vaccination 66 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced acid reflux, chest pains, and severe heart burn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the acid reflux, chest pains and severe heart burn was not reported. This report was non-serious.
NONE COVID 19 EXPIRED 11/22/2022 GIVEN 11/28/2022
she experienced severe muscle and joint pain; she experienced severe muscle and joint pain; severe chills; This is a spontaneous report from a contactable healthcare professional (patient) via a sales representative. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiry date unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization with minor symptoms. The second shot was taken and patient experienced severe muscle and joint pain and severe chills on 12Jan2021. Events took place after use of product. After 24 hours of symptoms she took ibuprofen and symptoms lessened. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Patient describes headache, fever, chills, nausea, abdominal pain, back ache, left arm pain, stiffness x 3 days - resolved spontaneously. However on day 5 she developed erythema, pain, swelling and rash on left upper arm, with circumferential erythema at site of inoculation and surrounding large area involving skin on upper arm approximately 15cm x 30cm that was blotchy, erythematous, warm - most likely inflammatory /allergic reaction. However also has evidence of pustule at site of inoculation - we have marked and are watching for cellulitis. However patient thinks the rash is improving.