chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; A spontaneous report was received from a nurse, who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, within three days after vaccine administration, the reporter stated that she went to the doctor because she had problems with the whole left side of her face. The patient reported she has Bell's palsy now, she cannot smile. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, Bell's palsy, was unknown.  The reporter assessed the event, Bell's palsy, as related to mRNA-1273.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of facial paralysis. The event of facial paralysis occurred approximately 3 days after the first dose of mRNA-1273 (Lot# unknown) administration. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
non-stop bloody, mucus filled stools; non-stop bloody, mucus filled stools; severely high inflammatory markers obtained in utero; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The mother was 28 weeks pregnant at the event onset. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), MUCOUS STOOLS (non-serious), outcome "unknown" and all described as "non-stop bloody, mucus filled stools"; INFLAMMATORY MARKER INCREASED (non-serious), outcome "unknown", described as "severely high inflammatory markers obtained in utero". The patient underwent the following laboratory tests and procedures: Inflammatory marker test: High.  Clinical course: Mother had a vaginal delivery and her baby had nonstop bloody mucus filled stools. Infant was strictly breastfed. Baby was diagnosed with severely high inflammatory markers obtained in utero per her physician. Has this vaccine been tested on pregnant women, along with boosters and side effects on the infants post delivery?? I am assuming by the study where is now reconsidering of administration the vaccine to pregnant and lactating women that you as a company have not tested this on human studies. I know this women and this baby is suffering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195695 Mother case;
14 hours after vaccination: Fever, full body aches, headache, full body tremors, increased thirst Next day: low grade fever, sore muscles, headache, increased thirst
feel achy,(right arm) injection site; Morning felt very sick; General body malaise; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General body malaise), VACCINATION SITE PAIN (feel achy,(right arm) injection site) and NAUSEA (Morning felt very sick) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (General body malaise) and NAUSEA (Morning felt very sick). On an unknown date, the patient experienced VACCINATION SITE PAIN (feel achy,(right arm) injection site). At the time of the report, MALAISE (General body malaise), VACCINATION SITE PAIN (feel achy,(right arm) injection site) and NAUSEA (Morning felt very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided no treatment information given
pt recv vax 27MAY98 & began to have inc temp from 99 to 101 x 5 days;given motrin/APAP routinely saw MD that AM to check ears;
63 yo male received 1st dose of Moderna Vaccine on 3/31/21. Admitted to hospital on 4/6/21 then transferred to another Hospital on 4/12/21 for idiopathic pericardial effusion, acute kidney injury then released home on 4/23/21.  He presented to hospital on 4/25/21 with acute respiratory failure, septic shock, cardiogenic shock, acute myocarditis and acute on chronic kidney injury. Transferred to different Hospital on 4/30/21
3 days after injection I left work with a resting heart rate of 136 bpm, arrhythmia, dizziness, lightheadedness, rash
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Info has been received from a health professional concerning a 4 month old male with no past medical history, who on 11/18/05 at 12:00, was inadvertently vaccinated, SC, in the right thigh with a 0.5 ml first dose of varicella virus vaccine live (lot 650221/0431R). The pt was also inadvertently vaccinated, SC, in the left thigh with a first dose of MMRII (lot 647646/0990P). Other concomitant vaccinations included: a 1st dose of Pediarix (lot AC21A013A) given in the right thigh, a 1st dose of Prevnar (lot A56117H) given, IM, in the left thigh and a 1st dose of Hib conj vaccine (lot 649023/0368P) given IM in the left thigh. There was no illness at the time of vaccination. Subsequently, the pt developed bleeding at one of the injection sites. The nurse had to apply pressure and the baby was screaming. There was no product quality complaint involved. Follow-up info was received indicating that the pt had recovered and that no adverse effects were reported as of 1/3/06. Additional info is not expected.
Redness spread couple inches below site and into armpit. Very hot and itchy. Sought medical care and received a shot in buttock, also provided antibiotic - does not recall name of meds.
Got the 2nd and 3rd shots/Suspected Vaccination; Neuropathy; Shingles; painful; Got the 2nd and 3rd shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the 2nd and 3rd shots/Suspected Vaccination) (serious criteria GSK medically significant), neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: painful) and extra dose administered (Verbatim: Got the 2nd and 3rd shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the neuropathy, shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, neuropathy, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient got the first Shingles shot and got Shingles.  The patient got the 2nd and 3rd shots and horrible reactions.  The patient still had painful neuropathy from the Shingles.  The could not say the shot was the answer. The patient received 3rd dose of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Tinnitus, head fullness, dizziness, getting worse starting the third day after vaccine.  Went to 2 urgent cares in the past week unable to control this. Ear ringing and head fullness have gotten unmanageable in the last 3 weeks.  I?ve received a steroid shot, been on steroid pills and antibiotics, recommended and taking more allergy pills, nose sprays.  Nothing is helping.  I found an allergist to go to but new patient visits are 2 months out.
11-4-02 Lili complained of tenderness under the arm by armpit and breast area. I sent her to urgent care to be examined. She came back with a keflex prescription for infection, which she later decided not to take because she had an allergic reaction to the Rocephin. Shot in the E.R. The keflex was swtiched to Augmentin
Ten minutes post  second dose complaints of throat dry and feeling tight, dizziness. BP-135/64, HR104 and regular. Unlabored resp at 18, O2 sat 96% Fifteen minutes post dose BP 136/83, HR - 101, Resp 16 and unlabored, O2 sat 99%. C/O " remains dizzy and throat feeling tighter", rubbing throat. Benedryl 50 mg in 1 ml given per RN, into R deltoid.  0940 states "I'm feeling more relaxed but throat feels same.  0945 "Throat feels much better but both legs to feet feel funny, tingly".  EMS called.  Denies dyspnea or shortness of breath.  siting up on cart and to Emergency Department per EMS.
Arm soreness around 5:00 pm on day of vaccination Lips began tingling at 7:54 pm on day of vaccination Facial numbness and mild muscular weakness by 8:15pm
Severe wheezing which began in his sleep; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Severe wheezing which began in his sleep) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced WHEEZING (Severe wheezing which began in his sleep). At the time of the report, WHEEZING (Severe wheezing which began in his sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.  The patient's wife stated that it sounded as if the patient had an upper respiratory infection.  The patient was wheezing so severely that it resulted in him using his wife's oxygen machine to continue breathing. The patient had an appointment on Thursday 11-MAR-2021 with his healthcare provider.    Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Pain at the injection site". Additional information: The patient had the first dose of vaccine on Tuesday, 16Mar2021, and the person who administered the vaccine mentioned not to take any aspirin after getting the vaccine. The patient experienced pain at the injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 21 May 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of TRIPEDIA; lot number U1813BA received on 24 September 2007, lot number U1985CA received on 26 November 2007, lot number U2290BA received on 29 January 2008 and lot number U2398BA received on 13 April 2009 (routes and sites of administration not reported). The subject developed a cough on 18 April 2012 and cold-like symptoms on 19 April 2012, approximately 3 years after the last dose. On 25 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 26 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 07 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received from a pharmacist via company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX to prevent shingles. Concomitant therapies included unspecified influenza virus vaccine. On an unknown date the patient experienced Bells Palsy. The outcome of Bells Palsy was unknown. Additional information has been requested.
INJECTION SITE BECAME RED, SWOLLEN AND WARM TO TOUCH. TWO DAYS AFTER THE INJECTION, THE RED AREA MEASURED 13CM BY 9CM. THE PATIENT TOOK CLARITIN AND APPLIED ICE TO THE SITE, AND 2 DAYS AFTER THAT, THE REDNESS WAS ALL GONE. THE PATIENT STATES THAT SHE HAS HAD REACTIONS LIKE THIS BEFORE, BUT THIS IS THE WORST. IT SEEMS TO GET BIGGER EVERY YEAR.
morning of 6AUG92 pt recvd DTP/HIB/Hep B vax & 2 hrs p/returning home pt cont crying w/fever of 101; mom notified MD; no office visit; vigorous crying & t101 cont x 2 days;
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unspecified dates, since 18-DEC-2014, the doses of GARDASIL that underwent a temperature excursion, were administered to unspecified patients (dose, route, lot numbers and expiration dates were not provided). No adverse effects have been reported. No additional information was provided. This is one of several reports from the same source. Additional information has been requested.
had Shingrix about 4 years ago, shingles/ 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 (Shingrix) for prophylaxis.  The patient's past medical history included shingles.  On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the Shingrix vaccine about 4 years before the date of reporting and just had shingles again. The patient asked did he/she get another dose of it. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
Just side effects, pain at injection site for 24hrs.  7 days later pain at injection site, red rash 4-5 in. In diameter, hot, very itchy swelling all on injection stem.  For 2 days so far
SEVERE FEVERS, CHILLS & MUSCLE PAIN X 16 HOURS REPORTED RASH PREVIOUS YEAR AFTER TAKING VACCINE
Varicella vaccine administered subqu in R leg on 1-17-08 at 0930.  Reaction noted after 10 min.  Area red around injection site with 0.5cm raised area noted.  Most likely localized infection.  Advised Dr.  Instructed mother it was best pt did not have Varicella vaccine again v.o. Dr./LVN.  Allergy noted in pts chart.  After 2 days area was normal.
Female patient of 26 years of age is oriented x3 while waiting in observation starts to experience at 10 minutes of post vaccination itchy chest and redness. Immediately evaluated in paramedic's area. at 1:37pm she is evaluated by paramedic. At 1:39pm the itchiness gets worse and radiated to face manifesting cutaneous eruption altered redness of face and mouth. At 1:40pm Dr. orders .25mg of BENADRYL was given on left arm (deltoid area) at 1:55pm looks better at 2:25pm she is discharged by Doctor.
Information has been received from a medical assistant concerning a 17 year old male patient who on 06-APR-1993 was vaccinated with the first dose of RECOMBIVAX HB, and on 06-May-1993 and on 06-SEP-1993 with the second and third doses of RECOMBIVAX HB respectively. The medical assistant reported that recently the patient received 2 pediatric booster 0.5 ml doses of RECOMBIVAX HB on 05-MAR-2010 and 13-OCT-2010 in preparation for nursing school. On 19-AUG-2010 the titers were drawn and the patient was still testing negative for titers. No other adverse experiences were reported. The patient sought unspecified medical attention. At the time of reporting, the outcome of the patient was not provided. Additional information has been requested.
On Sunday May 23, 2021 I received the 2nd dose at 3:50 pm. By 7pm. I was experiencing extreme fatigue. Slept until 6am. Mon. May 24, 2021. Felt fine upon arising with just a mild headache, ate normally and was doing light household activities when suddenly I experienced a very intense headache, with nausea and fainted. I don't know how long I was unconscious. When I came out of it, it was very hard to sit up. My hands and feet felt numb, my body felt very heavy, bad headache and nausea. After a period of time I was able to get up. It took about two hours before the headache and nausea subsided enough that I could function.  Tues. May 25, 2021 I am still experiencing a bad headache and mild nausea with allover muscle pain and fatigue.  Motrin is dulling it enough that I can function.
Customer calling to report that an adult patient was administered a pediatric dose of VAQTA.; This spontaneous report has been received from a nurse concerning an adult patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 16-MAY-2022, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (lot number U031911 and expiration date 11-NOV-2022, was verified to be a valid lot number) (strength, dose, frequency, anatomical injection site, were not provided) for prophylaxis (incorrect dose administered). No other issues or concerns were noted.
Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response.  Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring   Outcome- deduced symptoms and eventual absence of symptoms 24 hours later
This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N018273 expiry date: 17-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
death E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified
On day 12 after administration of 3rd Moderna covid19 vaccine I developed hives (at posterior thighs, lower abdomen, bilateral extensor elbows) and dermatographia (diffuse).  No other known new exposures.  Treated with increasing doses of antihistamines (cetirizine 10mg 2-3 times per day, max dose 30mg), added famotidine 20mg BID-TID without significant improvement so this was discontinued.  Optimized seasonal allergy control with intranasal Flonase.  Urticarial lesions have resolved but dermatographia persists.  Wheal reaction seems reduced with cetirizine, but erythematous flare reaction occurs with any skin contact accompanied by mild pruritus.  Symptoms continue to be ongoing 26 days after vaccine administration.
Vaccines were stored after CDC expiry date; Vaccine administered past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  CDC expiry date was reported as 26-Mar-2022 (lot no- 021F21A).   Date Stored in Standard Freezer for the lot 021F21A was 2 degrees F high, -1 degrees F low on 30-Nov-2021.  No treatment medication was reported.  This case contains information for the second of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
Information has been received from a physician concerning a 13 year old male who on 22-SEP-1997, was vaccinated with the first dose of MMR (route, site, dose and lot number not reported). On 22-SEP-1997, was vaccinated with the second dose of MMR (route, site, dose and lot number not reported). On 14-JAN-2010, the patient experienced mumps. The patient had parotitis and vomit. The outcome for mumps was not reported. No further information is available.
Muscle and joint aches, itching where the shot was given headaches, severe diarrhea. Skin bump, aching and muscle wasting pain in upper arms, Fatigue, Fever