chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got really really cold had to put hat and gloves; couldn't quit shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "got really really cold had to put hat and gloves"; TREMOR (non-serious), outcome "unknown", described as "couldn't quit shaking".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216477 Same reporter, drug, and events; different patient
FLUZONE QIV NP PFS, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA057733(CLUSTER) and 2023SA057309(CLUSTER).  This case involves adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  Outcome:  Unknown for both the reported events   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 has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Papular vesicular rash on trunk, scalp in crops fashion way, 10 spots so far after exposure to varicella.
Vaccine administered from vial which had been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 36-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial which had been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 36-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), reporting vaccine administered from a vial which has been punctured for more than 6 hours without any associated adverse events.
Burning itching red bumps starting on hands, then armpits and inner thigh.  Progressed within 24 hours to whole body except head.
My skin turned red. The rash spread all over my body and there were bumps all over my skin. There was swelling around my lips, eyes, and nose. I took Benadryl. Then I went to the doctor. I was diagnosed with urticaria hives. I was given a prescription of Cetirizine.
Shortly after vaccination patient experienced back pain, flushing, tight chest, nausea then vomiting.  After vomiting she started to feel better but requested EMS check her out.  BP was taken by pharmacist and was slightly elevated.  When EMS she was feeling better and they checked her vitals and released her.
Headache, Fever, influenza-like illness, fatigue, chill Narrative: MODERNA 1/19/21 LOT 013L20A LEFT DELTOID 2nd DOSE. C/O SYMPTOMS 1/20/21 NO FORMAL TREATMENT
No adverse event; Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no acute illness at the time of vaccination and upto one month before.  Concurrent medical conditions included Hypertension, Coronary artery disease, Hyperlipidemia and Enlarged prostate. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Coronary artery disease, TAMSULOSIN HCL for Enlarged prostate, ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, LOSARTAN POTASSIUM for Hypertension, PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021).    Treatment information was not reported.   This case was linked to MOD-2023-729605 (Patient Link).
I'm not sure the most polite way to state this but I shit myself about 2-3 times a week.
Pt with onset of vague sx 3d after vaccine administration. Headache, sore throat, cough, fatigue, nausea. Not responsive to Tx of sinusitis Ds'd via CT. Pt still with sx's.
a big old puffy bag under his right eye; face was swelling; left eye is a little bit swollen; lymph nodes are swollen coming down to his nose and down on his cheek; This is a spontaneous report from a contactable consumer reported self. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) on 18Mar2021 as single dose for covid-19 immunisation. Medical history included blocked artery that can't put a stent. None family medical history. None other vaccines administered on same date. Last vaccines were 50 years ago as a child and there were no issues. After his first dose, patient was asked to sit for 15 minutes and he was fine and got in the car and drove home which takes 5-7 minutes and by the time he got home, he had a big old puffy bag under his right eye which drew his attention to look in the mirror and he saw his face was swelling. It started under his right eye and his left eye is a little bit swollen and then on the side coming down to his nose and all the way down on his cheek, lymph nodes are swollen on both sides as well. He went to the pharmacist and they told him they don't recommend him taking anything so he left it alone thinking it would be gone when he woke up. His daughter asked him called an ambulance, so he did that at 2:00-3:00a.m. When they came they said that there is no swelling any other place, they could recommend to take Benadryl, following morning he got the tablets and has taken all 24 and it is still there. No emergency room or physician office visit. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
8/19/14 3:30 pm Mother called in, states that patient lower (L) arm (where she received VARIVAX) is slightly swollen - size of a fifty cent piece, red and itchy. Advised to put ice on the arm and if symptoms increased to contact physician immediately. 8/26/14 Mother called in regarding patient. States after she spoke with me she called the doctor. He had patient take BENADRYL. As the day progressed however, the redness increased in size to the size of a pancake, became hard in the center, had a rash, c/o pain, itchiness and couldn't move her arm. She also had a slight temp of 100 degrees. She said she attempted to call the doctor but was unable to reach him so she took patient to the ER. She was put on prednisone twice qd, and told to take BENADRYL 25mg tid. At present mom states that the arm is now just slightly swollen, no pain and looks like a bruise. She is able to move the arm. Questioned mom if child had a neomycin allergy. She states she is allergic to NEOSPORIN herself - unsure about patient. HD will complete a VAERS form.
Experienced some tingling in the left arm starts at the injection site and radiates down to the fingers. can feel the sensation in all 5 fingers, fingers feel cool to the pt but her hands feel of equal temp to the examiner, was able to use her phone to text
Chills, fever, every inch of body aching, intestinal AGONY, rash, headache, nausea, incredible fatigue, shot site pain - full blown flu/virus.  Day 8 and still so fatigued cannot DO anything.  Diarrhea has stopped, thank goodness, but headaches remain and arm still aches.  I HAVEN'T BEEN THIS SICK IN YEARS.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Dec2021 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm 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 relevant medical history (not specified). The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Tested positive on 18May2022; (23May2022) Negative, notes: Tested Negative on 23May2022; (27May2022) Positive, notes: Tested Positive on 27May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started Paxlovid (5-day course) on 18May2022 as a treatment for COVID-19 and completed Paxlovid course on 23May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On July 19, patient received pre-travel vaccinations, Hep A#1, IPV, JEV, Rabies #1, and Typhoid vaccines. The next morning she was ill and remained ill for 10 days with fever, occipital headache, vomiting, and dizziness. She had only a mild residual occipital HA when she received Rabies vaccine #2 July 26th.  Within about 36 hrs she was ill as before with headache, vertigo, palpitations, chest heaviness, and sweating. About 14 days post the earlier vaccinations and 3 days following Rabies #2, while seated, she passed out.  LOC lasted less than 5 minutes.  In the ER her HR was 248. She was Dx'd with SVT and treated with Adenosine. Since, the headache, chest pressure, and vertigo persisted. Cardiology cleared her and Rx with Diltiazem. Two days later with onset of chest pressure she suffered another acute LOC while seated lasting about 1 minute. Since then, she has had bouts of tachycardia, sweating, dizziness generally in the morning with arising.  She has had one bout of dyspnea, tachycardia, and chest pain which awoke her from sleep.  She no longer exercises as symptoms worsen. She awakes unrefreshed, feeling generally fatigued.  She feels anxious/tremulous most all the time and feels her concentration is impaired.  She was Dx'd with an adjustment disorder with anxiety for which she took hydroxyzine. She denies further vomiting, or history of dysuria, incontinence, constipation, diarrhea, postprandial syncope, flushing, neurogenic pain, or heat/cold intolerance.  Tentative Diagnosis: Dysautonomia.
Itchy skin; Itchy ears; Itchy eyes; Itchy throat; Wheezing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: En6201) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchy skin, ears, eyes, throat, and wheezing. The clinical outcome of the events itchy skin, ears, eyes, throat and wheezing were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted event onset dates, vaccination date, and age at vaccination details and updated vaccination facility details.
suspected immunological vaccine failure; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed with the additional information received on 16-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number 1808978) dose were not reported, 1 total, start therapy date was 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 patient had an antibody test coming back negative after vaccination (suspected immunological vaccine failure).  Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189367. The suspected product quality complaint has been confirmed to be disposition type: undetermined. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210822782-covid-19 vaccine-suspected immunological vaccine failure . This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
a few drops (around 2-3) of the vaccine came out of the needle; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA950A, expiry date 31-JUL-2024) for prophylaxis.   On 02-AUG-2023, the patient received Menveo. On 02-AUG-2023, an unknown time after receiving Menveo, the patient experienced incomplete dose administered (Verbatim: a few drops (around 2-3) of the vaccine came out of the needle). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 2-Aug-2023 Nurse reported that a medical assistant administered a dose of Menveo to a patient.  At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The medical assistant stated that just prior to administration, a few drops (around 2 to 3) of the vaccine came out of the needle, which led to incomplete dose administered.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapy included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute. The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
This case was reported by a physician and described the occurrence of a possible allergic reaction in a 35 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's past medical history included latex sensitivity. In early June 2003 the pt received the 1st dose of Engerix B that had been packaged in a single-dose vial. "A few hours" post-immunization, the pt experienced redness and itching of the arm, which then generalized. She also developed generalized hives. The vaccine provider considered these events to represent a possible allergic reaction to Engerix B. The vaccine provider did not prescribe any treatment; however, he did not know if the pt self-medicated. The hives resolved "after several hours." The redness and itching resolved after an unspecified period of time.
pt recv vax;lt arm became swollen red,hot to touch;enlarged lymph nodes under lt arm;to MD & given ATB
left upper arm with large induration 7 days following the injection.   no pain to site.  slight irritation to the injection site.
Pt received the varicella vaccine on 3/8/00. The child returned to the clinic on 3/22/00 with a reaction to the vaccine. Pt experienced vesicles on face and truck.
Patient complains of headache, pain in arm where injection was given, rash on same arm, slightly short of breath.  Day 3 with same symptoms.  Pt advised to take Benadryl, call PCP, and go to ER if face or mouth swells of breathing becomes difficult.
1 day after immunizations given, Pt developed warm, blanchable, red, induration that covered most of his left upper arm. Advil. Temp 99.6.
After shot could not move because of pain in shoulder. Went to urgent care received MEDROL dose pack 4 mg. NORCO 5-325 mg. FLEXERIL 10 mg after that course of treatment it did not help. Went to my orthopedic Dr and was given a shot of steroids.
injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In March 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Case was reported by a pharmacist for his/her daughter. The reporter asked if Bexsero injection had a longer than normal injection site pain. The patient's arm was still hurting at the time of reporting. The reporter would reach back to healthcare professional if the patient did not feel well by Wednesday.
Expired dose administered in error. Expired 8/8/2021. Notified manufacturer Sanofi Pasteur, spoke with Medical Staff dept. Per Sanofi does not endorse using vaccine past the expiration, states there have not been studies done on efficacy after expiration date printed on vial, expired doses are considered invalid, and per CDC recommendation dose should be repeated as soon as possible. Doctor notified, dose repeated with valid vaccine / current expiration date.
Patient had fainted about 2-4 min post vaccination with GARDASIL and VARIVAX. As family signed out in waiting room. Regained consciousness, 5 min post.
ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/9/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
very fussy 1/2 hrs p/vax, mom unable to calm down; pt returned to ofc: T102, crying constantly, eyes focus, stops very briefly, whole anterior thigh raised red & indurated w/in 2hrs;pt cried for over 3hrs;
Pt states "I woke up, ate breakfast and around 8:30am I started feeling dizzy and having blurred vision. I was working at the time and went to my local EMS station to get checked out. They checked my blood pressure and blood sugar. Blood pressure was normal but my blood sugar was low, around 68. They gave me a coke to drink and I went back to the Sheriff's office and about an hour later my blood sugar was around 90. I took the rest of the day off and come home. I took Extra Strength Tylenol and rested. I did have a headache a few hours later. I feel fine now but I have a mild headache."