chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Horrible body odor; Extreme night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SKIN ODOUR ABNORMAL (non-serious), outcome "unknown", described as "Horrible body odor"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Extreme night sweats".  Additional information: The reporter wanted to know whether we had any information on how to get rid of the horrible body odor as a side effect of the booster shots. The reporter so far known 12 women with this issue. They also had extreme night sweats. The reporter had read 12 different articles regarding this side effect. A lot of people were having this trouble and this was becoming a major problem.   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.
Patient given the orange cap dose (0.2mL) in error. Provider advised me per the CDC website to administer the gray cap dose (0.3mL) same day as the error occurred.
no additional AE; Nurse reporting expired MMRII administered to patient.  No temperature excursion.  Read supported disclaimer.  No additional AE.  No PQC.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 02-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (product administered) for prophylaxis (lot # t007231 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and established as 27-FEB-2022) (strength, dose, route of administration and anatomical location were not provided).   No adverse event reported.
Hives type rash all over body. Unsure if related to amoxicillin or other environmental exposure, but family claims no context and has been on amoxicillin in the past with no reaction.
Patient states she has a red spot a little bigger than the size of a quarter on the back of her arm where vaccination was given & it itches at times.  Advised patient to take some Benadryl.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-FEB-2009, the patient was inoculated with ZOSTAVAX at a grocery store pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-FEB-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
extremely ill/sick; aches/pains; flu symptoms; high fever/102 F fever; extreme fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever) and FATIGUE (extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer of lung stage IV (terminal cancer patient).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever), FATIGUE (extreme fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever), FATIGUE (extreme fatigue) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         The patient was on several medications but did not mention them.   The patient received vaccine in unknown arm.   This case was linked to MOD-2021-326237 (Patient Link).
I found out I was positive with covid/tested positive with the Covid-19 virus; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable female consumer (patient, self-reported).   A female patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration on 19Mar2021, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It sated that, the patient received a 1st dose of the vaccine on 19Mar2021 and tested positive with the Covid-19 virus on 30Mar2021. She wants to know if she still needs to take the 2nd dose on the scheduled date on 02Apr2021. Her husband was also scheduled for the 2nd dose on 02Apr2021 and will take the test scheduled on 31Mar2021. Also reported that she received first dose and was supposed to get the 2nd dose today, On Sunday she became ill, Monday she went for test and on Tuesday 30Mar2021, she found out she was positive with covid. Her doctor told to wait for 30 days from the time she was diagnosed. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Initial unsolicited report received from a consumer (Patient's parent) on 27-Jan-2017. This case involves a five-year-old male patient who was vaccinated with a fifth dose of Fluzone Quadrivalent (batch number, expiry date, dose form frequency and site of administration not reported) via intramuscular route on 15-Sep-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were unknown. Illness at time of vaccination was none. Concomitant medications were not reported. Any other vaccines with four weeks of vaccination were not reported. On 03-Oct-2016, 18 days following the vaccination, the patient's mother reported that the patient complained of neck pain and later was sleeping following which he could not walk and vomited. The patient could not hold his  falls before he could walk. The patient was seen by a neurologist and had Magnetic resonance imaging (MRI) done and the subsequent diagnosis was Acute disseminated encephalomyelitis (ADEM). The patient had a seizure there with eyes going back and forth. The patient was hospitalized on an unspecified date for therapy and was in hospital for 40 days. Later the patient could walk with poor balance and core strength and his right arm was not moving fully and here were lesions in his spinal cord. The patient required ER visit. The patient was previously vaccinated with four doses of Fluzone on unspecified dates. On an unspecified date X-ray of collar bone was carried out. Brain scan was done on an unspecified date as well as a test for meningitis which was revealed as negative. The patient received medication (unspecified) for vomiting. The patient was put on Electroencephalography (EEG) and received steroids. The patient had not recovered from the events. List of documents held by the sender: None. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM) with associated symptoms, following FLUZONE VACCINE. Patient was had swelling overhead due fall details regarding it is needed, patient also had lesion in spinal cord. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
A report was received from a healthcare professional on 10/02/2003 concerning a 35 year old female vaccinee who experienced malaise, soreness at the injection site and developed mild to moderate total body ache after inadvertently receiving expired Fluvirin vaccine on 09/30/2003. On 09/30/2003, the vaccinee felt ill, had mild to moderate total body ache on 10/01/2003 and had soreness at the injection site a couple of hours following vaccination.  The body ache had improved at the time of the report, however the soreness was continuing at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/02/2003: Further information was received from a healthcare professional on 01/02/2004 indicating that the vaccinee received Fluvirin on approximately 10/01/2003.  The vaccinee experienced redness on her arm and soreness the following day 10/02/2003.  The redness on the arm and the soreness resolved 2-3 days later.   Follow up pending.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The Hospital called pharmacy asking us to report VAERS. Patient was found unresponsive morning of 3/25 and taken to hospital. Hospital staff stated patient is in ICU and still unresponsive. All tests have been negative. The only thing they know about patient is he received the COVID vaccine yesterday 3/24
This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 18-OCT-2017 and 19-OCT-2017, were administered for prophylaxis improperly stored doses of VARIVAX with lot number N009768 and expiration date on 24-MAR-2019, M-M-R II with lot number M044350 and expiration date on 04-NOV-2018, and PROQUAD with lot number N009774 and expiration date on 20-SEP-2018. The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The reporter also stated that one dose of VARIVAX and M-M-R II were administered concomitantly while one dose of PROQUAD was separately administered. Information regarding dose, dose number and route of administration of the vaccines were not provided. It was reported that on unspecified dates, the vaccines were exposed to a temperature of 16 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1710USA010582:
Patient presented to labor and delivery unit on 12/28/2021 for treatment with COVID-19 monoclonal antibodies due to testing positive for COVID-19 infection on 12/27/2021 and experiencing symptoms. She was 29 weeks pregnant at presentation. During infusion, patient experience an anaphylactic response to the infusion and was kept for observation. Patient's status improved and she was able to be discharged home on 12/29/2021.
One day after vaccination developed large red local reaction below the injection. The local reaction is tennis ball sized, red, hot painful and itchy. Still present 4 days later.
About 4 hours after the flu shot I began shaking as if having chills and felt warm but didn?t register a fever.  I was very tired.  About 5 hours after the shot I began vomiting, grew weaker, and developed a headache  About 12 hours after the shot the shaking stopped as well as the vomiting.  46 hours after the shot most of the symptoms are gone.
Dizziness; nausea; body aches; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: not reported, Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history included seasonal allergy. The patient concomitant medications were not reported. The patient experienced dizziness, nausea, body aches, fever on an unspecified date. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with known seizure d/o and hydrocephalus had breath holding with vaccine and brief Sz. Tx'd with O2 and Obs x 15 mins.
positive covid test in asymptomatic fully vaccinated pt (booster <14days prior to test)
PATIENT EXPLAINS THAT SHE REMAINED "ALMOST CONTINUALLY DIZZY" AFTER RECEIVING VACCINE FOR ABOUT 2 WEEKS AFTER A FOLLOW-UP THE PATIENT STATES THAT DIZZY SPELLS ARE NOW MORE SPORADIC-USUALLY OCCURING AFTER SHE WAKES IN THE MORNING OR WHEN SHE STANDS UP AFTER SITTING FOR A LONG TIME-EFFECT SOUNDS ORTHOSTATIC IN NATURE. OF NOTE: PATIENT EXPLAINS THAT SHE DID HAVE DIZZY SPELLS IN HER 20'S THAT WE DUE TO LOW BLOOD PRESSURE.
the pt has a inflamed, red , hot to the touch  arm and was diagnosis-ed  with cellulitis
Nauseous over the night, passed out over night from dizziness, headache took tylenol 500 mg twice yesterday, slight headache 9/1/21 today, swelling all over arm, has a rash on chest and back (raised bumps), shoulders, and arm (redness)
Patient reported a large local reaction at injection site.  Approx. 5 inches x 2 inches.  Red, raised, achy, itchy.  Lasted 5-7 days duration.
pain in left arm injection site/pretty similar to normal pain after injection which was dull and sore and hurt to lift arm; This is a spontaneous report from a consumer (patient) from a Pfizer sponsored program COVAX US support. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8734), via intramuscularly in left arm on 02Apr2021 at 16:30 (at the age of 20-years-old) as 1st dose single for COVID-19 immunisation. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic, chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Patient had no family medical history. Patient had no concomitant medications. No adverse event following prior vaccination. Patient was not administered with additional vaccines on same date of the pfizer suspect. On 02Apr2021at 22:00-23:00, patient experienced pain in left arm injection site. As reported, patient had a pretty similar to normal pain after injection which was dull and sore and hurt to lift arm. No ER (emergency room) or physician's office required. The outcome of events was resolving.  No follow-up attempts are needed. No further information is expected.
zoster-related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On 06-MAR-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered at the physician's office (dose, route of administration, anatomical location, lot # and expiration date were not specified) for the long-term prevention of herpes zoster or shingles. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated at the physician's office for shingles or zoster-related injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Headache, Myalgia & Fever Narrative:  Had to go home from work
Pfizer vaccine was administered outside of the clinic - reported by patient   DEMAND ISCHEMIA 5/15/2021 BRCA1 GENE MUTATION POSITIVE  DEMAND ISCHEMIA 5/15/2021 ALLERGIC RHINITIS DUE TO POLLEN
A week later both had some blood in nose, fever, and arm hurt; A week later both had some blood in nose, fever, and arm hurt; A week later both had some blood in nose, fever, and arm hurt; Husband felt heart thump thump-took antacid felt better; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (A week later both had some blood in nose, fever, and arm hurt), PAIN IN EXTREMITY (A week later both had some blood in nose, fever, and arm hurt), PYREXIA (A week later both had some blood in nose, fever, and arm hurt) and PALPITATIONS (Husband felt heart thump thump-took antacid felt better) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Pneumonia.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (A week later both had some blood in nose, fever, and arm hurt), PAIN IN EXTREMITY (A week later both had some blood in nose, fever, and arm hurt), PYREXIA (A week later both had some blood in nose, fever, and arm hurt) and PALPITATIONS (Husband felt heart thump thump-took antacid felt better). The patient was treated with CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) at a dose of UNK dosage form. At the time of the report, EPISTAXIS (A week later both had some blood in nose, fever, and arm hurt), PAIN IN EXTREMITY (A week later both had some blood in nose, fever, and arm hurt) and PYREXIA (A week later both had some blood in nose, fever, and arm hurt) outcome was unknown and PALPITATIONS (Husband felt heart thump thump-took antacid felt better) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Had Covid-19 in November-was hospitalized- got pneumonia, had a blood clot.  .
Information has been received from a medical assistant concerning a patient who was vaccinated with two doses of MMR II as a child but still had negative titers to measles. No adverse reactions reported. The medical assistant stated this would be a new patient in their office and she did not have any information on the patient. Additional information has been requested.
He got the vaccine, when she gave him the shot if felt like liquid fire going in, it was then fine.  Two hours later the arm started swelling up and got so swollen he could hardly move the shoulder.  Then it started moving into the shoulder quadrant, as far as your fingers can spread, all the way back onto the back itself.  It then traveled up to the neck, to the spine to the ear in that quadrant and stops at the knot behind the ear.  The pain is so bad that you press on the knot behind the ear the headache will go away.  The headache is so intense  it feels like it's going to blow off and takes migraine headache medicine which does not help it.  It now has caused vision issues, he cannot read/blurry vision with large print things close up.  He can see fine 5' or further with no problems, but nothing up close and he can't drive due to this or use the computer as he can't see the keyboard to type.  The pain has continued even up until today, 4/14/21.   The shot area is fine now.   Originally when the symptoms started he could not turn his head as it hurt so bad, and has taken all this amount of time to actually turn his head some, but cannot turn it to the left much.  He can gently and slowly turn his head but it is painful.  He has gone to his doctor and went to the COVID clinic with the first vaccine who want to see him to a neurologist.