chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an unknown number of patients who were vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced breakthrough cases of "full blown" chicken pox after receiving varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. There was no product quality complaint involved.
Narrative:  Patient reports developing dizziness on day 2 after the vaccination. This was associated with lightheadedness, but no falls, sycope, confusion, mentation changes, or vision changes. It was exacerbated by changing positions quickly and he noted no relieving factors. After development of the dizziness, he experienced 2 days of nausea that then lead to vomiting and episodes of diarrhea. After the nausea/vomiting and diarrhea resolved, he continued to experience dizziness (although with some minor improvement) for several days until spontaneous resolution.
testicular cancer; My neck is starting to hurt; it's slowly just starting to get my whole head to stop; I feel paralyzed; This spontaneous case was reported by a consumer and describes the occurrence of TESTIS CANCER (testicular cancer) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TESTIS CANCER (testicular cancer) (seriousness criterion medically significant), NECK PAIN (My neck is starting to hurt), HEAD DISCOMFORT (it's slowly just starting to get my whole head to stop) and FEELING ABNORMAL (I feel paralyzed). At the time of the report, TESTIS CANCER (testicular cancer), NECK PAIN (My neck is starting to hurt), HEAD DISCOMFORT (it's slowly just starting to get my whole head to stop) and FEELING ABNORMAL (I feel paralyzed) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was reported that the patient's neck was starting to hurt, felt like Superman. The patient was tazed and it's slowly just starting to get whole head to stop and felt paralyzed. The patient also had testicular cancer. The patient woke up to, out of the surgery and wrist band was saying COVID DIEN.   Company comment: This is a spontaneous case regarding an adult male patient, with no reported medical history, who received  mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/BA.5) and experienced unexpected and medically significant event of testicular cancer. Vaccination date and onset date of the event were not provided,  latency cannot be assessed. Patient mentioned that, on an unknown date, a surgery was performed for an unknown indication.  At the time of the report, the outcome was unknown. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Pt presented to ER on 3/2 w/ complaints of  worsening wheezing, SOB, and cough that started 4 days prior.  Tested positive for Covid-19 in ER.  Tested positive for Covid in December 2021.  Pt was started on solu-medrol, Dr. suspects chemo therapy induced pneumonitis. Pt currently being monitored in hospital.
adacel was administered the day of the excursion on 20-Mar-2022, lowest temperature was 29.2 degrees F with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from health care professional.  This case involves a 51-year-old female patient to whom adacel was administered the day of the excursion on 20-Mar-2022, lowest temperature was 29.2 degrees F with no reported adverse event after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Related case 2022SA098672   On 20-Mar-2022, the patient received a dose of 0.5 ml, Frequency: once, Strength = standard, of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (lot number: U6923JAA, expiry date:21-Jan-2023) via intramuscular route in the right deltoid for immunization.  On 20-Mar-2022, Adacel was administered and lowest temperature was 29.2 degrees F with no reported adverse event (product storage error) (Latency: same day).  Action taken was not applicable.  Outcome was unknown.   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 the 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.
09/22/22  I was at my doctor's office and I felt so nauseous and felt like I was going to throw up. I felt very warm and then I did threw up a lot. I started breaking out in hives and itching like crazy that night. 9/23/22 hives were all over my arms and legs. I went to the pharmacy and showed them and told me to take BENADRYL and if it did not go away in a few days, to call my doctor. It did not seem to help. I went to the urgent care on 9/26/22. They gave me a steroid injection and I almost immediately, within an hour, I started feeling better. In a few hours all the hives were completely gone.
Had an egg size knot come up under vaccinated arm about 3 hours after vaccine; Was painful also painful into breast area; Was painful also painful into breast area; This is a spontaneous report from a contactable pharmacist. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via intramuscular route of administration in the right arm on 20Aug2021 at 19:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as unknown. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any medications within two weeks of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 20Aug2021 at 22:45, about 3 hours after her vaccine, the patient experienced an egg size knot came up under her vaccinated arm and it was painful also painful into her breast area. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Tylenol or pain medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events egg size knot came up under her vaccinated arm and it was painful also painful into her breast area was recovering at the time of this report.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; WRONG PRODUCT ADMINISTERED; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a physician concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was a healthy individual. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 subject experienced inappropriate age at vaccine administration, wrong product administered, and off label use in unapproved age group. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration, wrong product administered and off label use in unapproved age group was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Patient was supposed to get a booster dose of 0.25ml and received a dose of 0.5ml.
Body aches, head aches, chills, nausea, vomiting, 103+ fever ( comes and go)  for 4 days
first Shingrix/12-07-2019/is planning on receiving the second Shingrix; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   Previously administered products included Shingrix (first dose received on 7th December 2019).   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 information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was planning on receiving the second Shingrix vaccine soon.  The reporter did not consent to follow up.
4 of 13 pts tested negative for HBSAB.Pt EBU 910053 recvd 3 vax,3rd of which was Engerix-B on 16NOV90.
Has some injection site pain/ Pain injection site; Body Aches; Pain in the opposite shoulder/the pain in the right Shoulder; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3248) solution for injection intramuscular in the left arm on 18Jan2021 (at the age of 69-years-old) as a single dose for COVID-19 vaccination. Medical history included rotator cuff surgery (1.5 years ago, moving the shoulder around freely time to time and then it flares up time to time) and positive Covid test on 17Mar2020. There were no concomitant medications. On 18Jan2021, the patient experienced has some injection site pain/pain injection site and body aches. In Jan2021, the patient experienced pain in the opposite shoulder/the pain in the right shoulder. The outcome of the events injection site pain and body aches was recovering. The outcome of the event shoulder pain was unknown.
Fatigue; Joint pain; Fever; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever) and MYALGIA (Body aches) 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 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm soreness). On 28-May-2021, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported.   Reporter did not allow further contact
This case was reported by a consumer and described the occurrence of taste loss in a 69-year-old female patient who received BOOSTRIX (batch number STN9R, expiry date 13th December 2016). The patient's past medical history included whooping cough (about two years ago). Concurrent medical conditions included penicillin allergy. Concomitant products included SYNTHROID. On 13th November 2014 09:30, the patient received BOOSTRIX. On 14th November 2014, 1 days after receiving BOOSTRIX, the patient experienced taste loss (serious criteria disability), dysgeusia and taste bitter. On an unknown date, the outcome of the taste loss and taste bitter were not recovered/not resolved and the outcome of the dysgeusia was recovering/resolving. It was unknown if the reporter considered the taste loss, dysgeusia and taste bitter to be related to BOOSTRIX. Additional details provided: In the initial report received from consumer call the AE reported was lost sense of taste after vaccination with BOOSTRIX which was considered by the reporter as disabling. On the same day (05 January 2015) follow-up information was received from the consumer and physician: The consumer said that the bitter taste tasted like metal. Since this occurred on Saturday, she was unable to see her HCP. She went to urgent care to see a doctor there. The doctor recommended seeing a neurologist or an EENT specialist. The patient has an appointment tomorrow with the EENT specialist. The consumer asked for information about the issue and ingredients in the vaccine. She was referred to discuss the information with the specialist but noted to view the prescribing information to answer some of the questions she asked. She did say that there had been a slight change in taste, but it was on 5% to 10% in change. The bitter taste still remains.
11/1/2019 - received Flu vaccine at annual wellness visit at clinic 11/17/2019 - Emergency department 51-year-old male who presents today with complaints of ataxic gait. Patient will be admitted to hospital for evaluation of possible CVA versus TIA versus VP shunt malfunction. 11/18/2019: Problem list: -Miller Fisher variant of Guillain-Barré syndrome, with ataxia, ophthalmo paresis and areflexia. -Medically complicated obesity   We recommend initiating IVIG stat. Baseline forced vital capacity and negative inspiratory force stat, to be repeated every 4 hours. Lumbar puncture, looking for albumin?cytology dissociation Aspiration precautions Watch closely for respiratory distress, indications for elective intubation will include forced vital capacity below 20 mL/kg or decline in negative inspiratory force. GQ 1B antibodies Physical, occupational, speech therapy   11/29 - Hypoxic respiratory failure secondary to GBS.  The patient developed significant respiratory distress and fatigue 1/21   Diagnosed GBS, Miller Fisher variant with opthalmoplegia and BL ptosis.  Received 5 doses of IVIG, neurology following and PLEX X 5 .  Received plasmapheresis (5 of 5) on 11/29, plan for plasmapheresis 11/29.  LP increased proteins 104 and 3 WBC .   3.  History of TBI in 2007, status post VP shunt.  CT scan showed no evidence of hydrocephalus.
It's been over a month and I have a scar that looks like an bruise and a small bump inside my arm still. I also had dizziness the first night, as if I had been drinking (I was sober), and a very very mild fever the next day or so.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Pt recvd vax 20MAR92; onset of maculopapular rash from neck to feet on 6APR92; accompanied by generalized aching, swelling of small joints of fingers; reaction resolved in 1wk w/o tx;
Left upper arm became very hard and very itchy. And was very red it lasted about 4 days. The redness moved from injection site the whole way around my upper arm almost to the elbow. Initial injection prick didn't hurt but just before needle was removed it really hurt. Nurse said I was the first one to say that.
PT REPORTED TO THE PHARMACY STATING SHE WAS FEELING UNWELL AFTER RECEIVING THE COVID VACCINE. SHE REPORTED FEVER, INJECTION SITE REACTION, LYMPHNODE SWELLING, BACK PAIN, SOB. SHE STATED SHE TOOK TYLENOL AND IBUPROFEN WITH NO RELIEF. I COUNSELED HER ON THE COMMON SIDE EFFECTS FROM THE VACCINE AND ADVISED HER TO SEE HER MD AS WHAT SHE WAS REPORTING COULD BE REALTED TO AN UNDERLYING CONDITION.
Anaphylaxis - Vaccine given @ 1:45 pt went home started @ 5:00 pm with hives then 7:00 pm chest tightness, SOB then went to ER. Pt went home from ER symptoms next day returned and is currently admitted to ER.  7/23/09 Received ER medical records of 7/9/09. FINAL DX: anaphylactic reaction Records reveal patient experienced malaise, scattered red hive rash, itching, facial swelling, abdominal pain & nausea, SOB, difficulty swallowing.  Had been seen in ER on 7/8 for same symptoms, tx w/Epi & d/c to home.  Symptoms recurred on 7/9 & epi pen had been given by parent prior to ER.  Tx w/IV antihistamine, steroids.   Stabilized & d/c to home.
swelling towards her elbow.; upper arm swelling at the injection site; Red circle; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling towards her elbow.), VACCINATION SITE SWELLING (upper arm swelling at the injection site) and VACCINATION SITE ERYTHEMA (Red circle) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (upper arm swelling at the injection site) and VACCINATION SITE ERYTHEMA (Red circle). On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling towards her elbow.). On 09-Jan-2021, VACCINATION SITE SWELLING (upper arm swelling at the injection site) and VACCINATION SITE ERYTHEMA (Red circle) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling towards her elbow.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 06 jan 2021, patient experienced upper arm swelling at the injection site and red circle for 72 hours after the vaccine. On 13 jan 2021,afternoon the symptoms came back,a red circle and swelling towards her elbow. No Treatment for the event was given; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Mom states that daughter had a fever on 03/28/04.  On 03/28/04 pt developed a rash.  Mom states the rash has red blotches and several circles with bruising in the center.  Mom stated that pt was taken to ER and told her daughter had chicken pox.  Mom took pt do MD.  She sated that MD did not feel the daughter's rash was Varicella, had a local reaction to vaccines.  Mom stated that MD gave pt a third injection in the office and a prescription of antibiotic "hydroxyz".  MD also gave mother a five day course of steroid pills.  Mom stated that pt had swollen lymph nodes in back of neck at MD office.  Mom stated that no pictures were taken of pt.  Rash in ER or in MD's office.  PT covered in red blotches now but mom stated that pt was improving.  Mom stated that pt had a reaction in past from something she was exposed to, but the source still has not been identified.  History of previous steroid taper 1.5 weeks before immunizations.
Received Attenuvax Booster vaccine. 30-40 minutes after administered complained of nausea, vomiting and pulse rate was elevated to 140. To ER; treated by ER physician epi and Benadryl.
Marked swelling and redness 13 X14 cm around injection site on left deltoid.
Patient received vaccine at 1:45 PM then proceeded to check out in the grocery line at approximately 2:00 PM and fainted and exhibited epileptic-like symptoms (rigid body, uncontrollable movement, involuntary urination). EMS services were utilized and patient was transported to hospital for further evaluation.
Information has been received from a physician assistant concerning a female patient who on 26-NOV-2007, was vaccinated IM with a second dose of Gardasil. That evening, the patient developed a skin rash. On 28-NOV-2007, the patient went back to the physician's office for a follow up visit. At the time of this report, the patient's outcome was unknown. It was reported that the Gardasil was given a week after the flu vaccine. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning a 11 year old female patient with hypothyroidism who on 01-MAY-2008 was vaccinated with a first dose of Gardasil.  Concomitant therapy included SYNTHROID.  On 03-MAY-2008 the patient experienced encephalopathy after receiving the first injection, was seen at the emergency room (ER).  Subsequently she was hospitalized.  Laboratory diagnostic test spinal tap was done.  No further information was provided.  The patient had not recovered.  Additional information has been requested.  06/16/2008 MR received from CDC for DOS 5/6-27/2008 with D/C DX:  Meningoencephalitis.  Hypothyroidism.  Hypocalcemia. Pt presented to local ER with c/o pain in the arms and legs, headache and then episodes of shaking of the arms and legs, stool incontinence and unresponsiveness and progressive changes in mental status. In local ER had witnessed episode of eye rolling and shaking of the arms and legs. Transfered to current facility for further w/u.  CSF showed WBC pleocytosis. PE (+) for brisk DTRs on the L and difficult to elicit on the R. 10/6/2008 Additional records received from initial ER 5/3/08. Pt presented with disorientation and not feeling well since 5/2/08. Had Gardasil 5/1/08. In ER had several episodes of tremors, clenched teeth, rigid, downward going toes and clenched hands drawn to the chest. Transfered to above facility to r/o meningitis.
Patient was 11 years old at the time of vaccination and currently Pfizer COVID-19 vaccine is only approved in ages 12 years old and up.
this is 1 of 2 pt from this site to devel an inj site rxn p/vax;