chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 18-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004401: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA00126.
Right arm extensive erythema slight induration warmth, linear streaking w/ cellulitis. IV Ancef x 1 Augmentin 875mg  BID.
At times I would experience a feeling of being flushed, and my heart would race. It would eventually calm down and go away. When I go up the stairs sometimes it would happen as well. Sometimes the left side of chest would have a fluttering feeling, and sometimes there would be sharp pain that would resolve quickly. When I seen a doctor, they had me wear a heart monitor for 30 days. Then I came off of it in mid September 2021. In fall 2021 I seen a cardiologist and was diagnosed with having a-fib. I haven't been in constant a-fib it just comes and goes. I was prescribed a blood thinner Eliquis and  a beta blocker Metoprolol. I am not saying that this is caused by the vaccine but it just occurred around the time I got the vaccine.
The night the patient got the vaccine the administration site was swollen, throbbing, painful and red.  In about 3 days the patient's arm was sore throughout and at 4 days, a bruise developed.  On 10/5/2015, the patient reported the administration site was still sore to touch and that there was pain throughout her arm and fingers.  The patient tried ibuprofen to relieve her pain.
pt had a positive COVID test on 10/4/21 while in the hospital; was treated with ABX, fluids, dexamethasone; was dc'd to SNF where he passed away with one of the causes of death being Pneumonia due to COVID 19
Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old male patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comments: A medical assistant called to report that, a pediatric dose of Engerix-B was administered to a adult patient. The reporter had consent to follow-up. Additional supportive information: The adult patient received the Engerix-B pediatric dose, which had led to adult use of a child product and underdose.
The initial case was missing the following minimum criteria: This case has been considered invalid as unspecified adverse event. Upon receipt of follow-up information on 04Sep2018, this case now contains all required information to be considered valid. This is a spontaneous report obtained from a contactable nurse. A 66-year-old female patient received, 03Sep2018, PREVNAR 13 at single dose and SHINGRIX, both for immunization. Relevant medical history and concomitant medications were unknown. The patient received, on an unspecified date, in May2017, PREVNAR 13 for immunization. On an unspecified date, in Sep2018, the patient experienced sickness and she was feeling quite ill and feverish. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested.
Headache, body aches, joint pain, fever, violent chills, vomiting, fatigue, brain fog
Adacel was given outside of age recommendation to a 4 month old; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 months old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6321AA, expiry date- 07-JUN-2021 via unknown route in the left thigh on 20-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration. Adacel was administered to a 4 month old in error as the first dose of a DTaP series.  It was unknown whether the patient had any adverse event.  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 and Module VI of the 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.  Documents held by sender: none.
On Jan 13th I started developing soreness, redness, and  the area around the  injection site is raised. Today, Jan 14th  it continues to be red, raised, and slightly itchy, and warm to the touch.
This spontaneous report as received from a pharmacist refers to a 101 year old female patient. The patient was vaccinated with PNEUMOVAX23 nine years ago, in approximately March 2006. The last month, in February 2015 the patient experienced pneumonia. The pharmacist asked if the patient should received PREVNAR 13. The outcome of pneumonia was unknown. Additional information has been requested.
fever; chils; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via intramuscular route of administration in the arm left on 06Jun2021 at 09:15(at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included lactose intolerance. Concomitant medications included tilactase (LACTAID) from unknown date for lactose intolerance. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via intramuscular route of administration in the left arm on 16May2021 at 10:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 at 06:30 the patient experienced fever, chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with Ibuprofen. The clinical outcome of the event fever, chills and nausea was recovering.  No follow-up attempts are possible. No further information is expected.
Sore throat, chills, fatigue, runny nose. 7 days into illness-rash on torso, starting on 9/27/21
Child received an influenza shot. She received 0.5mL of FLUZONE instead of the scheduled dose of 0.25 mL.
After receiving 4 vaccinations, patient stood up and started to walk out of exam room.  She suffered syncopal episode which caused her to fall and hit back of her head on the floor.  EMS was activated and she transported to the hospital for evaluation.
brain fog; tired; Cold hands and feet; rapid heart beat; body aches; shaky; anxiety; insomnia; This is a spontaneous report from contactable other healthcare professional as a patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL9267) via an unspecified route of administration on 24Feb2021 at 15:30 pm in the left arm as a first dose for COVID-19 vaccination (age at the vaccination 52-years-old). Medical history and concomitant medications were not provided. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19 (details unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021, the patient experienced cold hands and feet, body aches, tired, shaky, rapid heart beat, insomnia, anxiety and brain fog. The patient did not receive treatment for adverse events. The outcome of the events of cold hands and feet, body aches, tired, shaky, rapid heart beat, insomnia, anxiety and brain fog was reported as recovered. No follow-up attempts are needed. No further information is expected.
tested positive to COVID-19 after getting the first dose of the COVID-19 vaccine; tested positive to COVID-19 after getting the first dose of the COVID-19 vaccine; This is a spontaneous report from a contactable consumer(patient). A 29 year old female patient of unspecified age received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot: unknown), via an unspecified route of administration at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. On unspecified date, the patient tested positive to COVID-19 after getting the first dose of the COVID-19 vaccine and she would be out of quarantine by the time she should receive the second dose of the vaccine. the reporter wanted to know whether it is recommended to receive the vaccine after testing positive to COVID-19. The outcome of events was unknown.  Information on the lot/batch number has been requested.
dull heart ache; palpitations; Pfizer Booster Dose; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 10Jan2022, outcome "unknown", described as "Pfizer Booster Dose"; ANGINA PECTORIS (medically significant) with onset 11Jan2022, outcome "not recovered", described as "dull heart ache"; PALPITATIONS (non-serious) with onset 11Jan2022, outcome "not recovered", described as "palpitations". Clinical details: the patient had been having palpitations with a dull heart ache since 11Jan2022. These episodes came every 5-10 minutes and getting progressively worse.  The lot number for bnt162b2 was not provided and will be requested during follow up.
100mm x 100mm induration, area very warm and erythematous; cellulitis
Left arm started hurting. It hurt for 2 days. Then my right and left arm started hurting. this went on for another 2 days. then both my arms ,across my back and both hands went numb. Went to emergency room. They did test. Said i had blocked heart artery. They removed blockage. I was in serve pain, It felt like my bones was breaking. I end up going to the doctor 2 days in a row. The doctors think that the vaccine may have trigger that reaction.
This spontaneous report as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of GARDASIL 9 (lot number L016429, expiration date 09-AUG-2017) (dose and route not reported) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
has a fever; and cannot move her arm where she received the injection; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, injected limb mobility decreased and feeling unwell. On an unknown date, the outcome of the fever, injected limb mobility decreased and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, injected limb mobility decreased and feeling unwell to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient had a fever and cannot move her arm where she received the vaccination.   The patient did not felt well. The reporter did not consent to follow up.
Adult dose of Pfizer given to 10 year old Pt. Called mom to inform once the problem was discovered and she states he was fine for 3 days then had body aches, fever, was eating less, and had watery eyes. everything resolved after 3 days except still has the watery eyes a little.
pt recvd vax;w/in 4 hrs of vax,exp T 100-101,sore arm,sore joints & was achy;sx lasted 36-48 hrs;pt feels fine now;
E87.1 - Hyponatremia N17.9 - AKI (acute kidney injury)
presented to the hospital on 01/23/2022 in the setting of recent diagnosis of metastatic s quamous cancer and recent back surgery for mets to the spine with recurrent back pain. While inpatient she experienced fever and was tested and found to have COVID.  She was initially on oxygen but weaned down. The patient was felt to have a poor prognosis.  Despite advanced cancer and likely and part thanks to vaccination she tolerated the COVID infection fairly well throughout her stay but her pain remained uncontrolled.  Was communicated to family that her prognosis was poor and that her functional status was poor which would make any interventions in the outpatient setting from Oncology perspective difficult. Palliative Care was consulted and the patient's son in consultation with his brothers elected on the patient's behalf (she was confused for the latter half of her stay) to pursue hospice care for her.  She is discharged today to home with home hospice.
Ocular migraines.  For both second (March12) and third (Sept 25) does, had ocular migraine within 53 and 63 days after the dose. I rarely have ocular migraines.
I was going to die; This serious case was reported by a consumer via market research programs and described the occurrence of near death experience in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified and COVID-19 VACCINE. On an unknown date, less than 2 years after receiving Flu vaccine unspecified, the patient experienced near death experience (Verbatim: I was going to die) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Flu vaccine unspecified.   It was unknown if the company considered the near death experience to be related to Flu vaccine unspecified.   Additional Information: GSK Receipt Date: 18-MAY-2023 The case was reported by a consumer via market research programs. The reporter received flu vaccine and covid vaccine together, after vaccination she experienced terrible and she thought that she was going to die. The reporter reported that she did not receive vaccine last year and she would not ever do it again. The reporter did not consent to follow up.
Information has been received from a physician concerning a female with asthma who was vaccinated with the first dose of Gardasil "a few weeks ago."  Subsequently, while in the office, the patient developed fever, chills, sweating, difficulty breathing and swelling at the injection site.  The patient sought unspecified medical treatment.  On an unspecified date, the patient recovered.  Additional information has been requested.  This is one of two reports received from the same source.
The patient developed severe swelling and redness at the injection site, preceeded by nausea, flushing and faintness. The upper arm was swollen 3x the normal size and erythematous. 24 hours later the patient was still markedly swollen with warmth and redness.
09/01/22 presents to EC ED for "cough". PMHx of "multiple sclerosis , COPD and bronchiectasis"
Ran 101.5-102 temp for about 24 hours; Pounding headache; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6204) via an unspecified route of administration in the left arm on 14Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient had no known allergies to medications, food or other products. Concomitant medications included anastrozole (ARIMIDEX), atorvastatin calcium (LIPITOR), biotin (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and denosumab (PROLIA) injection; all from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient had run 101.5-102 temp for about 24 hours, pounding headache and extreme fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of high temperature, headache and fatigue extreme was recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
He got his vaccine, within 15 minutes he was staring, and was offered something to drink and some graham crackers and his wife said and the nurse came over to see what was going on, and said that he had an absent seizure, he was not responding to anything.  His oxygen was 93, his BP dropped.  The nurse was watching his eyes to see if there was any reaction, but there was not.  They kept talking to him until he responded and he had no idea of what happened.  He has not had any more seizures.  He has never had any seizures in the past.  He came out of it and they did not take him to the ER.  He is fine now.  He currently has cellulitis around his eye.
At 4:15pm, right deltoid used for DTAP injection, severe itching after administration, down to just past elbow.  No rash, no sob, no whelping.  Red/pink quarter-sized area at injection site.  Benadryl 25mg PO liquid given, itching stopped per client.
vaccine given on the 21th vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (vaccine given on the 21th vial puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (vaccine given on the 21th vial puncture). On 08-Nov-2021, PRODUCT ADMINISTRATION ERROR (vaccine given on the 21th vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
I received the second dose on 1/20/2021 at 630 am.  I felt very fatigued on 1/21/2021 and slept most of the day, and at  730 pm I noticed a large, moveable, painful swollen lymph node above my left clavicle .
On 2/16/00, reported swelling in left axilla area. Referred to Occupational medicine. Had adenopathy in epitrochlear, axillary and supraclavicular areas, very tender. Gradually resolved over a week. Returned to full duty on 2/25/2000. Consulted lab and they believe it is an exaggerated T-cell response to TD vax.
Large (approx. 3? x 2?) red firm rash around injection site, slightly itchy but not painful. Noticed firmness day before but a rash hadn?t appeared then.
My menstrual period came after 20 days from the previous period and lasted 10 days. This is not consistent with my normal cycle.
Patient received 2nd  vaccination before the recommended time interval. Patient received 2nd dose 21 days after first vaccination instead of the recommended 28 days.