chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a female patient in her sixties with breast disorder, diabetes mellitus and asthma. On 08-AUG-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis. Concomitant therapies included prednisone (manufacturer unknown) and metformin. On AUG-2017 the patient experienced injection site urticaria and injection site erythema. The outcome of injection site urticaria and injection site erythema is unknown. Additional information has been requested.
Tinittis load ringing constant still currently happening treated by emergency hospital and mental health given Zanex and sleeping medication and mental health medication, with no relief going on 7 mo. ear constant ringing 24/7
fever 104 ax 10PM 31AUG93; red swollen rt arm pt would not move arm; face & neck swollen during time temp was elevated;
transverse mellitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  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: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse mellitus".  Medical Information: Yes: Customer and/or medical inquiry forwarded or referred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report received from a consumer concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease., and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 in the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chest pain. On 10-MAR-2021, the subject experienced elevated heart rate. On 10-MAR-2021, the subject experienced occasional shortness of breath. On 10-MAR-2021, the subject experienced soreness throughout legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain, soreness throughout legs and arms, and elevated heart rate, and the outcome of occasional shortness of breath. was not reported. This report was non-serious.
ONE OF FIVE PTS WHO EXPER. SWELLING OF INJECTION SITE AND FEVER ( 1-3 DAYS) AFTER IMMUNIZATION.
Woke up Sat itchy. Sun arm became sore w/area 6" x 1" of redness on arm. Not hot to touch. Face felt slightly tingly, and felt like she had a hair tickling her face all day.
First day following vaccine I felt very tired with a slight headache, minor soreness to the vaccine site on my arm. That evening my cheeks started to get very red at the cheek bone. The next day, two days after the vaccine, my left cheek bone began to ache and throb. Both of my cheeks at the cheek bone are red, swollen, but only my left cheek bone hurts. I put ice on it to relieve the swelling in the pain, but it has not done much to help.
This spontaneous report has been received from a medical assistant and the patient's mother and referred to a male patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the first, second, and third doses of GARDASIL (dose, frequency, route of administration, lot numbers and expiration dates were not reported) for prophylaxis and completed the series. Then, on 08-MAY-2017, the patient was vaccinated inadvertently with a fourth dose of GARDASIL (dose and route of administration were not reported; lot number L036301 and expiration date 20-DEC-2017). There were no adverse effects reported. Additional information has been requested.
Very sore arm and significant fatigue starting about 5 hours following injection. Arm remains quite sore and there is a large redness "rash" that I just noticed, which was about 43 hours post vaccination.
Chicken pox type spots started appearing 9/28/08 5pm and fever to 103, tylenol brought it dow but back up to 100. Here at Health Dept. 17th-20th. Spots seen. Follow up 4:30 pm- Got benadryl and tylenol- temp. & rash continue. Temp. controlled with tylenol.
Nausea, hyperventilating, racing heart beat, fever, chills, vomiting
TOOK SECOND DOSE A DAY LATE; This spontaneous case (PVX2019-1096) was received from a consumer on 03-May-2019. It describes a male consumer who "took second dose a day late", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the second dose a day late. The doses were taken on 30-Apr-2019 and 03-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took second dose a day late" was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
she is nervous and fretting; inserted the needle in her arm, she started to bleed and bleed and bleed; This is a spontaneous report from a non-contactable consumer (reporting for herself) via the medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, as soon as the pharmacist inserted the needle in her arm, the patient started to bleed and bleed and bleed. The patient stated the RPh wiped off the blood and she started to bleed again. The patient questioned if the vaccine actually went into her arm and asked if did the vaccine get a chance to penetrate into her muscle or not. The patient stated her first vaccine went OK but her second one had a bad outcome. The patient asked if there was nothing that says when a person bleeds while the vaccine was being administered means that the vaccine did not go in. The patient asked if there was information about anyone bleeding instantly once the needle goes in. On an unspecified date, The patient was nervous and fretting. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented to the pharmacy and received the vaccine. After administration, the pharmacist reviewed the online record and documented that the patient had received the first dose only 2 weeks prior.
patient developed a Rash and hives on her lower extremities, trunk and upper extremities, on 3/2/21, two weeks after first Moderna shot, she also ate crab claws 2 hours prior to onset of rash - she has never had a reaction to shellfish before; presented to MD on 3/3/21 with severe urticaria, used triamcinolone cream prior to MD appointment, prescribed hydroxyzine following the appt, didn't like hydroxyzine was switched to zyrtec, hives have gotten a little better but are still there, follow up MD appointment today 3/8/21
Yesterday morning I started feeling dizzy/lightheaded; decided to take blood pressure (140/70); that's a little higher than usual; sat down with feet up.  Drank water.  Felt a little better.  Began getting  slight headache (never have headaches); arm began itching at injection sight.  Went on with day.  This morning, about 4"30 a.m., before rising, felt lightheaded again and arm hurt.  Slight headache again. Stayed in bed a little longer.  Arm began hurting more especially when trying to raise it.  Injection site felt warm to the touch and felt a knot  at site.  Upon feeling better, got up.  Felt lightheaded again but got up anyway.  No nausea.  Arm still hurts upon trying to raise it but not as much.  I take my high blood pressure medications together at night at bedtime.  I use the Lantnprost at bedtime.
On June 9th, patient noticed a small, itchy rash begin on her right wrist only. Since then, it has spread to her forearm and injection site area on the arm. It is itchy, red, and consists of tiny little bumps. It is only on right arm. No arm swelling. No other symptoms.
after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touching skin), heat causes itching and tingling and well as redness and swelling with hotter temperatures at longer durations.  This has been occurring since after receiving the first vaccine, with increased severity after the second.  The symptoms last from 20-2 hours after exposure and then resolve.
Eyes ache/ eyes hurt to turn; Eyelids are puffy; Itchy; Injection site being the biggest problem; Chills; Headache; Body aches; Temperature of 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem) and CHILLS (Chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 006B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Temperature of 100 degrees F). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in October 2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Temperature of 100 degrees F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: high (High) 100 degree Fahrenheit.         Patient received the booster shot and felt sick. He stated that he used to take a statin before receiving the Moderna Vaccines.
After my shot, I stayed at the facility for 15 minutes. When I started my drive home, I noticed a medicinal taste  coming from the back right side of my mouth. Approximately 10 minutes later I had a numbing/tight feeling in my right jaw. This quickly traveled to the right half of my mouth, the right side of my nose, my right cheek, my right eye (even behind the eye/a lot of pressure), above my right eyebrow, and to my right ear.   I called the health department. They said they could not give me medical advice and I should call my doctor or go to the ER. I called my doctor. In the meantime, the numbing/tightening somewhat subsided. However, it was still quite there and noticeable.   By the time I went to sleep that night, the numbing/tingling had just about all gone away. The next day I still noticed it in the corner of my right, my mouth and right cheek. By that evening it was entirely gone.   My doctor?s nurse called the next day. She said my doctor still suggested that I get the second shot. However, I?m very nervous to do so.   I wrote on a previous page that the time of my shot was 2:20. That was my appointment time. The time of my shot was 2:37 pm.
This spontaneous report as received from a registered nurse refers to the patients of unknown age and gender. It was reported that 13 doses of GARDASIL (doses, units, patient route of administration, lot number were not reported) were improperly stored and administered to unspecified number of patients since 11-SEP-2014. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Necrotizing enterocolitis, symptoms started 24 hrs after Pentacel, Prevnar, Hep B and RotaTec vaccine administration, diagnosis made 3 days after vaccine administartion. Admitted to the hospital on 05-23-09.  6/11/09 Received hospital medical records of 5/23-6/2/2009. FINAL DX: pneumatosis Records reveal patient experienced bloody stools, diarrhea, decreased appetite, decreased activity & fever.  Seen in outlying ER & transferred to higher level of care.  Sugrery, GI consult done.  Tx w/TPN via PICC line, IV antibiotics.  Improved but developed ileus which resolved by d/c to home. 8/21/09 Received ICD9 codes: 58989; 5781; 5131; 75060.
Severe muscle spasms, body aches, sore throat and vomiting for 3 days, low blood pressure 6 hrs later after the injection. Finally feeling better on the 4th day
immed p/ inj pt c/o dizziness, eyes rolled back, became limp, fainted;arms tonic/clonic for 10seconds, facial twitching then opened eyes wide & began to cry;c/o nausea;no color change, no diaphoresis;MD felt rxn a vagal response to pain;
Pt reported in the evening of 11/27 after getting her vaccine her arm "swelled to the size of a baseball." She applied a cold compress and took ibuprofen. The swelling decreased and it then began to itch. The patient is doing fine this AM and reports no reaction just called to let me know it happened.
A nurse reported that a female employee of a long-term care facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed "flu-like symptoms" that resolved approx. 48 hrs after onset. No further info was available at the date of this report.
Vomiting, later presented to outside facility, ultrasound showed intussusception.  Transferred to Med Ctr, barium enema done and negative, assumed intussusception self-resolved.
Left arm sore and feels hard at injection site - began approximately 11 hours after injection - still painful, though less, and feels hard, on 03/18/22 at 11:30am Swelling , redness, and itching at injection site - began approximately 11 hours after injection - symptoms lessened but still obvious on 03/18/22 at 11:30 am  Headache and buzzing in head - began approximately 11 hours after injection - alleviated by acetaminophen first taken when fever started - slight headache and buzzing in head on 03/18/22 at 11.30am Fever of 99.7 - began approximately 12 hours after injection - alleviated by acetaminophen - continued through mid day on 03/17/22 - no fever on 03/18/22 Pain and swelling under left arm - soft, bulbous area below armpit - pain began on 03/16/22 - swelling noted approximately 10:00pm on 03/17/22 - swelling remains
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR, stop date: 16Dec2022; STATIN [NYSTATIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 17Dec2022 to 22Dec2022 (Lot number: GF3597) for treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with VARIVAX injection (subcutaneously; dose, lot# and expiration date were not provided). On an unknown date,the patient developed chickenpox, despite that she was vaccinated with VARIVAX when she was younger. The reporter stated, that a school nurse reported the patient's mother that it is not unusual to see chickenpox in females even if with immunization around puberty. It was unknown if the patient received any treatment or had lab diagnostic studies performed. The outcome of vaccination failure and chickenpox was not provided. The relatedness between adverse events and VARIVAX was not provided. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009251:
patient received Fluad instead of Fluzone High Dose/ NO AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.   This case involves a male patient who received vaccines FLUAD instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number, expiry date site and route of administration not reported) (wrong product administered) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
he was so feeling poorly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received COVID-19 Vaccine - Manufacturer Unknown, (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "he was so feeling poorly".  Additional Information: The reporter did not know which vaccine the patient got. Because of the event, the patient took a couple days off of work.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
second dose scheduled beyond 37 days; accident; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled beyond 37 days) and ACCIDENT (accident) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled beyond 37 days) and ACCIDENT (accident). The patient was treated with TETANUS VACCINE (intramuscular) for Accident, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled beyond 37 days) and ACCIDENT (accident) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator.  Treatment information for accident provided.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with the associated AE of accident.
I started getting symptoms of muscle aches, congestion, fatigue, headache. Then I developed a cough and low grade fever. I took 2 at home COVID-19 test that were positive. The low grade fever broke today, 6/2/2022. I woke up sweating this morning. I contacted my doctor and was advised to take cough medicine for the cough.
At about 30 minutes after injection, pt complained of light dizziness. We had her wait additional minutes.  I checked on her several times. She felt no urgency to call an ambulance. A family member was going to  pick her up.  I checked with her again- She complained of slight chest pain.  We have a walk-in clinic in our store- I walked her over to the clinic. We called the ambulance from the clinic. Her blood pressure was slightly elevated. She was not clammy or short of breath. I left her at the clinic where she was transported to the ER.  I spoke to pt at 9:01 pm.  She had just returned home from the ER- She said They ran and EKG at the hospital and gave her Nitroglycerin Tabs.  They found no problems with her heart and stated they felt it was anxiety.  She told me she felt no anxiety.  Just was glad she was getting her 2nd shot