chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)) (lot and expiry date: not reported) (incorrect product storage). The vaccine was exposed to a temperature of 50F and a minimum temperature of 35F for an unknown time frame. No adverse effects were reported.  There was no prior temperature excursions.  This is one of the four reports received from the same reporter.  Additional information has been requested.
Tinnitus; Dizziness; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy). At the time of the report, TINNITUS (Tinnitus), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer.   A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation.  Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date.  The patient died on 02Apr2021.  An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain
Injection site sore for a couple days.  One week later got red, fevered, raised and sore at a sight below the injection site.  Lasted for about a week; is still a little red but all other symptoms have gone.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in May2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and in Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunization. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "sleep apnea" (unspecified if ongoing); "hypogonadism" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), suspected COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Covid-19 treatment included Paxlovid from 17May2022 of lot number GA6765 for the indication of treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; Pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, case #01528098, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines. The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom. The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was four of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022AMR154683:Same reporter US-GSK-US2022AMR154684:Same reporter US-GSK-US2022AMR154589:Same reporter
AS SOON AS SHE GAVE HIM THE VACCINE, HIS LEG BULDGED UP, TURNED PURPLE, AND HAD A RASH AROUND IT. NURSE SAID IT WAS NORMAL. THEN, HE CRIED FOR 2 DAYS WITH NO RELIEF FROM TYLENOL OR IBUPROFEN. I CALLED THEIR CLINIC AND THEY WANTED ME TO TAKE HIM BACK BUT I WOULD NOT GO BACK TO THEM BECAUSE OF WHAT THEY DID TO MY SON. HE WOULDN'T EAT, HE WOULDN'T DRINK FOR FIRST COUPLE OF DAYS, HE STOPPED CRAWLING AND SITTING UP BY HIMSELF. THE DOCTOR'S AT THE HOSPITAL WANTED ME TO TAKE HIM TO A NEUROLOGIST IN ANOTHER CITY FOR HIS NEW CONDITION. HE ALSO WAS HOSPITALIZED BECAUSE HE HAD LOW BREATHING LEVELS WHICH THEY CLASSIFIED AS RSV AND BRONCHIOLITIS.
PT REPORTED BEING DIZZY AND A HEADACHE. PATIENT REPORTED BEING NERVOUS BP: 140/80 HR:75 02:98
GI symptoms / began shortly after receiving dose; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2021, the patient received the 1st dose of Shingrix. On 15th July 2021, immediately after receiving Shingrix, the patient experienced gastrointestinal disorder. On an unknown date, the outcome of the gastrointestinal disorder was unknown.   It was unknown if the reporter considered the gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and she currently experiencing gastrointestinal symptoms, that began shortly after receiving dose. No demographics were provided. The reporter did not consent to follow up.
Mild hives. About 10-12 visible spots, mostly on left hand (injection on right hand). Only one spot was itchy. Hives went away within a few days, but most spots are still kinda visible if you look at it.
Pt stated she felt fine after the injection (injection site- left upper arm 11/3/2014).  Went to chiropractor on 11/14/14 and her right shoulder blade is hurting on  11/15/14. I did notice patient had soilin her nails and asked if patient did any yard work.  She denied any yard work but stated if may be the result of the tdap shot.
Information below was sourced from the patient record in the hospital EHR system: Patient presented to ED with PMH of HTN and family history of premature CAD who presented with 2 hours duration of substernal chest discomfort. He had been in his usual state of health prior to this evening. He received the COVID Vaccine on 5/12/21. He went out with his wife for dinner and then upon return, started to have some substernal chest discomfort radiating down his arm. This is associated with some SOB and nausea. No vomiting, no diaphoresis. The pain continued for about 2 hours and then he decided to come to the ED. The EKG was consistent with inferolateral wall MI. States that he has been very active without exertional chest pain or dyspnea. He does have a history of HTN and is currently on lisinopril for this. No known history of hypercholesterolemia. Denies any diabetes. No smoking history. No history of PVD. His mother did have a bypass in her early 60s. At age 37, he did have a catherization following an episode of substernal chest discomfort. The patient states this catherization did not show any abnormalities.    Following this, the patient proceeded for PCI stenting with a DES for an occluded OM2 . Patient received Aspirin, Brilinta, Atorvastatin, Metoprolol, and Heparin prior to PCI stenting. Cardiology note confirms acute inferolateral STEMI due to occluded OM@, successfully opened and stented acutely.
Hospitalization  - He notes fever, chills, fatigue, myalgias, cough, and shortness of breath.  CTA demonstrates bilateral viral pneumonitis. No other known aggravating or alleviating factors. No other associated symptoms.
Adverse event of mild skin infection reported by patient. Patient went to Emergency room and was given a prescription for Doxycycline monohydrate 100mg 1 tablet twice daily for 10 days. At this time, patient has not picked up the RX.
Around 1 am I woke up having to sneeze and blow my nose over and over again. It got better for a few hours while I slept and then worse again around 9:30 am. I had to call in from work. I?ve been blowing my nose and having watery eyes all day. I took my usual allergy pill but it did not help. I?m reporting this because runny nose isn?t listed as a common symptom.  I have soreness in my arm but no other symptoms other than maybe a slight headache and fatigue.  I?m worried I might actually be sick but I?ve hardly left my house for months so that seems unlikely.
This spontaneous report as received from an individual who worked at a pharmacy but was not a pharmacy technician or a health care professional refers to a female patient of unknown age with no medical history On 12-FEB-2013 the patient was vaccinated with live ZOSTAVAX (lot# was not reported). There was no concomitant medications. The reporter reported that the patient had" white bumps on the back part of tongue that appeared between the time the vaccine was administered and now." The patient called the pharmacy for medical attention. The outcome of the adverse event was reported as not recovered/not resolved. Additional information has been requested.
Ache - joints and muscles - blood - pressure: high and high cholesterol - blood pressure varies - depression - headache: uncontrollable - problem with skin
Patient was a 3 year old and the provider ordered for them to receive the Influenza Vaccine but the nurse administered a Tdap vaccine instead.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the date of vaccination 05-07-2021
I developed a high fever and chills the night after my second Pfizer Covid-19 shot. By the following day, 8/24/21, the fever persisted all day and I had a terrible headache, joint pain, neck pain, swollen lymph nodes on th right side of my neck, and shoulder pain. By the late evening of 8/24/21, I was very ill. I could not sleep because of a persistantly high fever (102.2 degrees) and a terrible sensation of "heartburn," though I have never had heartburn in my life. It felt like I had swallowed a pill that got stuck in my throat and burned throughout the night. I had chest pain, shoulder pain, pain when breathing, etc. I also vomitted twice in the night and felt dizzy. By 8/25, the fever has continued.
temperature excursion; This is a spontaneous report received from a contactable reporter other HCP, Program ID is (004756).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), (Batch/Lot number: unknown); meningococcal group b Rlp2086 (TRUMENBA), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "temperature excursion".   Additional information:-called in asking if the Prevnar 13 and Trumenba vaccine she has in the office are still viable after it's exposed on a temperature excursion. Gathered caller's information. Caller did not provide any address. walk through the caller how to check stability calculator. about to ask if the vaccine is administered/given to patient but caller hang up.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein), meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
experienced arm pain following dose one of Shingrix; administer Shingrix in a location other than the deltoid; administer Shingrix in a location other than the deltoid; This case was reported by a pharmacist via call center representative and described the occurrence of pain in extremity in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) and (batch number YA724, expiry date 29th January 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) and (batch number YA724, expiry date 29th January 2022) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On 7th August 2019, the 1st dose was an unknown dose. On 7th August 2019, the patient received the 2nd dose of Shingrix. On 7th August 2019, the 2nd dose was an unknown dose. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in extremity, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the vaccine administered at inappropriate site and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix and Shingrix.  Additional details were provided as follows: The physician may administered Shingrix in a location other than the deltoid because the patient experienced arm pain following dose one of Shingrix. The vaccine administration facility is the same as primary reporter. The physician reports the patient noted arm pain after receiving dose one.  HCP could not specify which arm.  The follow up consent was granted. The case US2019219218 was found to be duplicate of case US2019AMR220254. Hence case US2019219218 would be deleted and all the information of this case will be added in case US2019AMR220254 which is case of record for this patient.
Pt arrived to facility for 1st dose of Pfizer Pediatric COVID vaccine (LOT# FL8094). At approximately 1445, vaccinator inserted needle into patient's arm and pushed on plunger. Patient immediately moved away from needle. Vaccinator observed more than half of the vaccine leaked out of needle. Vaccinator reported incident to Lead Nurse. Lead Nurse consulted the CDC Interim Clinical Considerations. According to CDC Interim Clinical Considerations, patient was able to receive a repeat dose immediately. At 1448, vaccinator administered the 1st dose of Pfizer Pediatric COVID vaccine (LOT# FL8094). At approximately 1515 patient left facility with unlabored respirations and steady gait.
Information has been received from a physician concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 19-Oct-2005 the patient developed an abscess and was hospitalized. The patient's outcome was unknown. Additional information has been requested.
pt given vax on 29JUL92; mom called that evening reporting pt screaming x 4 hrs (4-8PM) w/no relief-sometimes turning blue in face & vomiting; finally quiet when called-OK following day;
Seizures and mental retardation following DPT injection in 1991. Was evaluated and treated medical center. Problems permanent. 11/22/05 Review of 3-page medical record (add Hib vaccine for 4/1/92, no other info avail.), 4-page d/c summary (myoclonic seizure disorder, best date for onset of AE probably 5/10/92 as it was stated that by 8/92 there had been a 2-3 month history of symptoms), and 14-page medical record (dx infantile spasms, delayed language).
broke out in rash on back & front of trunk & apparant hive on lt arm & rt arm; fever on 22JUN94 temp not checked by thermometer was given APAP; rash gone by 1JUL94; lt a scaly patch; did not see MD
No other issues or concerns noted.; Varivax had a temperature excursion nad had been administered; This spontaneous report was received from an office manager, referring to a patient of 4 year old of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 14-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U022320, expiration date 15-JUL-2023, for prophylaxis (strength, dose, route and frequency were not reported) (product storage error). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 44.5 hours. On 01-AUG-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to -12C for an estimated total time out of range of 14 hours. On 20-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
I had sinus issues with an occasional upper respiratory like cough. That lasted for 4 days. I had no fever. I took allergy sinus medicine.
(1) Pain in (L) upper arm - (2) Pain in (R) upper arm - Pharmtist aware in pain continuing in (L) arm when shingle shot given in (R) arm - Nurse doesn't take pain serious - neither did pharmistis. Is this the normal? Pain level 5.
5/6  - 2nd dose of Pfizer COVID mRNA vaccine 5/7 - fatigue, malaise, muscle aches, fever 5/8 - near resolution of symptoms 5/8 - dinner with family and 6-7 beers; chest pressure sensation at bedtime with fatigue, malaise, some dyspnea 5/9 early AM - woke with acute L chest pain, stabbing, radiation through chest, worse with exertion, 7/10 in severity, pleuritic, also with dyspnea 5/9 - presented to ED. Afebrile, hemodynamically stable, CBC and CMP overall wnl other than mild hyperglycemia. CPK 500s. ESR 4, troponin 3.77, EKG with t wave inversion in III, chest xray normal, d-dimer negative. COVID/resp viral panel negative. Initially admitted to the ICU and treated as NSTEMI/ACS with heparin drip, aspirin,  beta blocker, and statin. left heart cath with normal coronaries and TTE was normal.  Troponin peaked at 7 and downtrended to 5. a1c is pending. 5/10 early AM - symptoms had resolved. Cardiology recommending cardiac MRI to further evaluate but working diagnosis is  myocarditis.   He has no precedent viral illness, and no history of tick bite but does live in a wooded area and goes for hikes, states he always checks for ticks after being outside.