chrisvoncsefalvay/vaers-outcomes huggingface dataset:
didn't get the second shot until 8-9 months later; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix 8-9 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and did not receive second dose until 8 to 9 months later. The patient wanted to know if it was still effective or repeat vaccine was suggested. The consent to follow up was granted.
Approximately two weeks after vaccination, skin in upper right thigh became sensitive and painful to the touch. Also dull ache in lower back. Noticed small, insignificant rash on right thigh about 14 days, July 12th. July 14-15, rash began to grow larger and spread, first on thigh, then on right buttocks. No itching, becoming very painful to the touch. July 16th went to an emergency walk-in clinic because we were traveling out of state. Diagnosed as Shingles and given a prescription for Valacyclovir HCL. As of today, July 21, continuing to take medication. Some areas of rash have crusted and are fading. Others not. Still very painful. No itching.
Information has been received from a Doctor of Pharmacy concerning a 50 year old male with no drug allergies and no medical history who "4-5 months ago", in approximately October 2010, was vaccinated with the third dose of RECOMBIVAX HB (therapy route and lot # not provided). There was no concomitant medication. It was reported that the patient received the three dose series of RECOMBIVAX HB within 6 months as indicated. On 23-FEB-2011 a blood test revealed elevated liver enzymes. No pain noted. Doctor would possibly repeat liver enzyme and possibly a CT, computed tomography, scan of liver. No treatment was given for the adverse event. Patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested.
Developed Supraventricular Tachycardia with a Heart Rate into the 200's.  Documented at a local hospital.
VACCINE EXPOSURE DURING PREGNANCY; MISCARRIED; This spontaneous pregnancy report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: clotting. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy. Reporter stated that, the report showed that the fetus stopped developing at five weeks. On an unspecified date in JUL-2021, the patient miscarried at ten weeks and the pregnancy resulted in a spontaneous abortion. The date of the patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy on JUL-2021, and the outcome of miscarried was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210941603-COVID-19 VACCINE AD26.COV2.S-miscarried. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s) 20210941603-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Soreness in upper right arm where vaccine administered; nausea and diarrhea starting around ~2am in the morning on Tuesday 3/16 immediately following the shot at ~6pm on Monday 3/15
ON 2/5 PATIENT COMPLAIN TO PHARMACY ABOUT ARM.  FIRST 2-3 DAYS, COULD NOT LIFT ARM.  PATIENT STAYED UP ALL NIGHTS AND IN PAIN.  IMPROVED SLIGHTLY DAILY.  STILL AS OF 2/5, PAIN IN SHOULDER.  RANGE OF MOTION WAS LIMITED.  HE DISCUSSED WITH MD AND MD STATED THESE THINGS HAPPEN.  HE WAS TOLD BY MYSELF, PHARMACIST TO PUT ICE ON IT AND TAKE IBUPROFEN. PATIENT WILL NOT USE IBUPROFEN.  HE DOESNT WANT STOMACH ISSUE.  i REITERATED, AND HE STILL REFUSED.  ON 2/11/2020, CALLED HIM AT HOME.  HE STATED HE WAS IMPROVING, STARTING WEIGHT BEARING  EXERCISES AND WAS IMPROVING.  STILL NOT FULL RANGE OF MOTION/  CALLED PATIENT AT HOME AGAIN ON 2/17/2020.  STILL IMPROVING,  RANGE OF MOTION IS COMING BACK.  HE STILL NOT 100% ..  HE DID PLAY GOLF.  ICING, AND STILL NOT TAKING IBUPROFEN.
Thrombocytopenia.  Platelets dropped precipitously. First noticed the drop in December, 2020.  Bottomed out at 31 K/Ul in March, 2021 and slowly started coming back up after that on their own, without treatment.   Dr did a complete workup on me in April, including a bone marrow biopsy, and concluded it was most likely Immune- Mediated Thromobcytopenia (ITP).   I have not needed treatment for this condition, but continue to watch platelet levels every 3 months.   We do not know if this is related to the COVID vaccine, but because it happened in conjunction with getting the shots and because this was a new diagnosis for me, I was asked to report it by the CDC after reporting it on my V-Safe check-ins.   I also received a flu shot (as I do every year), in October of 2020.
I had covid sept 12th. 1st Pfizer vaccine oct 22nd. Almost 24 hours after. Higher fever of 103. Severe aches. Bedridden.  Now 2 weeks later. Exact same side effects.  103.4 temp. Aches. It was exactly the same effects of vaccine. However more intense.. Lasted 12 hours. I feel completely fine now.
Nausea within 20 minutes after the shot that dissipated within 45 minutes. No treatment. 5.5 hours after shot injection site soreness.  Muscle pain at injection site. Tylenol to mitigate pain.
This spontaneous report as received from a physician refers to an unspecified number of patient of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On an unspecified dates since 03-JAN-3016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot # L042846, expiration date 15-SEP-2017, dose and anatomical location were not reported) intramuscularly. No adverse events were reported. On an unspecified dates from 03-JAN-2016 to 24-FEB-2016, the doses were exposed to 49 Fahrenheit degree. Additional information has been requested.
Onset of sx start 12/8 and cont. thru noc. of 12/9. High temp, mac-pap rash over body, severe photo sensitivity, pt. complained of eyes hurting from light, squinting/tearing, cough- Motrin to bring down temp severe sx resolved 8 hr.
pt recv vax  & devel 2in x 2 1/2in erythema & swelling @ site of inj;
Fever, chills, body aches and cough. Patient was seen at local urgent care and diagnosed with pneumonia.
Swelling arm immediately Redness arm immediately Pain immediately Within 12 hours felt flu symptoms & headache
"Prickly" feelings on back upper, and chest area; comes and goes (periodic) lasts 5 minutes.  Had occurred 1 time 2 wks prior to shot.  More frequently post shot.  More with doing push-ups.
Arm pain, unable to lift arm, diarrhea, nausea, body aches, headaches.
hives/chronic urticaria; sick; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA CHRONIC (hives/chronic urticaria) and ILLNESS (sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ILLNESS (sick). In December 2021, the patient experienced URTICARIA CHRONIC (hives/chronic urticaria). In November 2021, ILLNESS (sick) had resolved. At the time of the report, URTICARIA CHRONIC (hives/chronic urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: no allergies no allergies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient started getting hives and patches on patients body and woke up in the morning and a couple hour they were gone. Patient mainly got them in areas in which there was pressure like where socks were on or her knees when they were on a table.   No treatment information was reported.   This case was linked to MOD-2021-067651, MOD-2021-067676 (Patient Link).
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SORENESS AT THE VACCINATION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: alcohol use (consumes occasionally), non-smoker, shellfish allergy, attention deficit hyperactivity disorder, and hypothyroidism for which patient takes T3 T4 compounded thyroid medication, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. Patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, 1 total administered on 05-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included Vyvanse (lisdexamfetamine mesilate) for attention deficit hyperactivity disorder. On 05-MAR-2021, the patient experienced soreness at the vaccination site. On 05-AUG-2021, the patient experienced confirmed covid-19 infection and aching all over the body, malaise which worsened on 06-AUG-2021, sinus pressure, runny nose, sneezing, dry cough where she started coughing up something mucous (assumingly), watery eyes, feverish feeling (patient had not measure temperature but felt like she usually does whenever she has a fever) and that feeling worsened on 06-AUG-2021. The patient experienced terrible headache when woke up on 06-AUG-2021 and she felt like someone was stabbing her eyebrows. Whenever patient tried to move around, like petting her dog, she had a pounding headache and cannot do very much. The patient experienced sore throat which worsened on 07-AUG-2021, the patient experienced burning in the lungs, shortness of breath and raspy voice (which was getting worse), on the same day patient underwent SARS-CoV-2 RT-PCR test (NR: not provided) and results came out positive on 08-AUG-2021.The patient confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at the vaccination site on 07-MAR-2021, recovered with sequelae from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188862.; Sender's Comments: V0 - 20210815593-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Twitching in right eye. Twitching began 12/18/2020 and has not stopped to date (12/21/2020). While not constant, the twitching is occurring often (up to 6 hours each day).
Information has been received from a nurse concerning a female (age not reported) who on unspecified dates was vaccinated with Gardasil.  The patient completed the full series of Gardasil with no events to speak of.  The patient called the practice to ask if the vaccine could have affected her menstruation because she is having difficulties in menstruation and abnormal bleeding.  The staff did not believe it was due to Gardasil.  The patient was not pregnant and is not pregnant.  Additional information has been requested.
11/17/2021-Patient passed away. No medical notes. This occurred 6 weeks within receiving the COVID vaccine.
Narrative:  Patient received second dose of Moderna COVID-19 vaccination on 2/20/21. Pt vomitted, soiled himself and fainted post-vaccination.
loss sense of smell; . Patient reported being sick; really bad body aches; experiencing headache; missed dose; test positive for Covid 19 / she eventually found out was Covid; scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose), COVID-19 (test positive for Covid 19 / she eventually found out was Covid), THROAT IRRITATION (scratchy throat), ANOSMIA (loss sense of smell) and ILLNESS (. Patient reported being sick) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included ACYCLOVIR [ACICLOVIR] for Antiviral treatment, DICLOFENAC for Arthritis, LEVOFLOXACIN (LEVAQUIN) for Asthma, MONTELUKAST SODIUM (SINGULAIR) for Pneumonia, CLONAZEPAM for Sleep problem, ZINC SULFATE (LIQUID ZINC), ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) and VITAMIN D NOS for an unknown indication.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced THROAT IRRITATION (scratchy throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose), COVID-19 (test positive for Covid 19 / she eventually found out was Covid), ANOSMIA (loss sense of smell), ILLNESS (. Patient reported being sick), MYALGIA (really bad body aches) and HEADACHE (experiencing headache). The patient was treated with IBUPROFEN for Corona virus infection, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for COVID-19, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) and COVID-19 (test positive for Covid 19 / she eventually found out was Covid) had resolved and THROAT IRRITATION (scratchy throat), ANOSMIA (loss sense of smell), ILLNESS (. Patient reported being sick), MYALGIA (really bad body aches) and HEADACHE (experiencing headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported she was cleared yesterday 31August2021 from Covid.
No adverse events; patient received PROQUAD today after received MMR II at age of 12 months old; This spontaneous report was received from a registered nurse referring to a child patient of unknown age and gender. The patient's historical vaccine included two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Information regarding the patient's pertinent medical history and concomitant medications were not provided. On 10-DEC-2019 (reported as "today"), the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rha (PROQUAD) (extra dose administered) (strength, dose #, schedule and route of administration were not reported) lot # S027464 expiration date not reported, but upon internal validation established as 02-MAR-2021 for prophylaxis. No additional adverse events were reported.
Child developed rash outer right upper arm lower ext. Mostly the thigh as of 10/18/04 like circles of vesicles. Start with lateral swelling of the thigh. Pt received varicella vaccine on the right thigh on 8/30/04. Pt started on acyclovir on 10/20/04.
No additional AEs; GARDASIL 9 was administered following temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On an unknown date, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form, lot #W014513, expiration date: 26-JAN-2025) was underwent a temperature excursion of 52.86 degree Fahrenheit (F) for 96 hours (worst case scenario as reported). No previous temperature excursion.    On 12-MAY-2023, the improperly stored vaccine was administered to the patient for prophylaxis (strength and route of administration were not provided) (product storage error). No additional adverse events (AEs).  This is one of 5 reports received from the same reporter. ; Sender's Comments:  US-009507513-2305USA005519: US-009507513-2305USA005550: US-009507513-2305USA005725: US-009507513-2305USA005554:
A syncopal episode with decerebrate posturing, hypotension and bradycardia. Spontaneous and immediate return of consciousness with approx 30 minutes until complete recovery and the patient was able to ambulate out of the clinic
09/16/19 pain on right side of face and chest, shortness of breath around 11pm 09/17/19 swelling in right arm, pain in right side of chest and torso. Temp 100.8 Tylenol was taken and  ice packs were applied to arm 09/18/19 Tylenol taken for pain and ice packs applied to right arm 09/19/19 No Tylenol take. Arm was red slightly swollen with induration
01/04/22: EAR PAIN/DRAINAGE, COUGH, FEELING TIRED/SICK
This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis a in a 42-year-old female patient who received HAVRIX for prophylaxis. On 9th November 2018, the patient received the 1st dose of HAVRIX. On 4th December 2018, 25 days after receiving HAVRIX, the patient experienced hepatitis A. On an unknown date, the outcome of the hepatitis A was unknown. It was unknown if the reporter considered the hepatitis a to be related to HAVRIX. Additional information received as follows: On 4th December 2018, the patient was informed of a positive blood test for Hepatitis A. The reporter gave consent to follow up. The pharmacist did not have access to product details as the vaccine was administered at a different site.
swelling, redness, warm to the touch - ice helped pain, but the swelling became worse. Patient became concerned and went to ER on 9/22/22 - provider prescribed doxycycline hyclate 100 mg .
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid ( tart date: 21Apr2023, stop date: 26Apr2023). Clinical course: Had positive COVID test 2 weeks after completing Paxlovid Course. Ptient was somewhat symptomatic.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative:  70 yo male with chronic COPD, OSA, T2DM, cognitive impairment,  carcinoma of colon, BPH, depression, and Parkinson's disease reported having increased SOB with the second dose of Moderna (given 4/1/2021). First dose received 3/4/2021. Per medical record, patient reported increased shortness of  breath one day after second Moderna dose. Stated he normally requires 3L continuous O2. The day after second dose, reported he "turned up my concentrator to 4L and suffered through the day." Also states he initiated home action plan, but  only took 1 of the two medications (either prednisone or doxycycline, record did not specify). Patient not sure if it was the steroid or antibiotic. Oxygen requirements went back to normal by third day and shortness of breath returned to  baseline. Patient reported shortness of breath only lasted 1 day.
Large localized reaction in R arm with pain, swelling, erythema and induration that started within a few hours of receiving the shot. Gradually worsened over the next 48 hrs and developed some numbness and tingling in arm that was vaccinated with Tdap.  OTC Ibuprofen and cold compresses were recommended for pain relief.  Discussed with pt s/s of systemic allergic reaction and need to seek emergent care should they develop.
Suddenly developed moderate hives/welts on back. Spread to abdomen and chest, then neck and face withing 30 minutes. Was prescribed decreasing dose of prednisone. This was the morning of the 15th. As the day went on my thighs (both, very high up near groin) started aching. Uncomfortable to walk or sit for long periods. Getting worse as today, the 16th, has gone on. My hips are very achy and sore today. Hives have finally subsided.