chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a vaccine coordinator referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 12-SEP-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot# N012617, expiration date 18-OCT-2018 (strength and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (STERILE MRK) lot# N006325, expiration date 07-AUG-2019, used for reconstitution which did not undergo a temperature excursion. The doses of PROQUAD, were exposed to a temperature excursion of 6 Fahrenheit (°F) to 14°F for 2 hours, and 15°F to 46°F for one hour, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
RECEIVED OTHER COVID-19 VACCINATIONS AS BOOSTERS AFTER RECEIVING THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included covid-19 vaccine for prophylactic vaccination. On an unspecified date, the patient experienced off label use, and received other covid-19 vaccinations as boosters after receiving the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and received other covid-19 vaccinations as boosters after receiving the janssen covid-19 vaccine was not reported. This report was non-serious.
Had chills; In bed for two days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (In bed for two days) and CHILLS (Had chills) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (In bed for two days) and CHILLS (Had chills). At the time of the report, MALAISE (In bed for two days) and CHILLS (Had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
This happen within :15 minutes of the shot. Tongue tingle and swell with lips then nurse  gave benadryl took the ER to be checkout byt the doctors .  The observed and did an EKG  and sent home after observation .
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2018SA315884, 2018SA315883, 2018SA315878, 2018SA315885, 2018SA315886, 2018SA315887 and 2018SA315888 (same reporter). This case involves a 60-years old female patient who received 0.5 ml dose of FLUBLOK QIV lot number QFAA1815, expiry date-30-Jun-2019 via intramuscular route in the left deltoid on 07-NOV-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to incorrect product storage. Vaccines were exposed to a Max temp of 52 F for 27 hours. It was unknown whether patient experienced any adverse event following vaccination. 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 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. Documents held by sender: none.
The patient began experiencing a dermal reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (The patient began experiencing a dermal reaction) 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 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN REACTION (The patient began experiencing a dermal reaction). At the time of the report, SKIN REACTION (The patient began experiencing a dermal reaction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient had received the Moderna booster dose.  The patient found out via social media groups that others had also been experiencing the same dermal reaction (assumed as chronic spontaneous urticaria).
Patient received Pneumovax-23 and Fluad Quad both in left arm on 10/15/20 (she received both in left arm because she had lymph nodes removed under right arm).  Patient returned to pharmacy on 10/21/20 to tell me she had an infection at the injection site.  *Patient reported a severe headache  on Thursday(10/15/20) and Friday(10/16/20) *Arm became sore on Friday(10/16/20) *Saturday (10/17/20) she experienced fatigue, slight fever, exhaustion, and headache *Sunday morning (10/18/20) - headache went away, swelling of right arm occurred with large bump that husband marked with a pen.  Swelling kept spreading. *Monday (10/19/20)- she went to see Dr. - he prescribed Keflex 500mg qid & benadryl *Tuesday and Wednesday- arm was getting harder and severe pain so she returned to see Dr. on 10/21/20- she was given Ceftriazone IM and blood work ordered.  No infection in blood stream and told to continue Keflex and ibuprofen.
had diarrhea twice today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 16Mar2021, outcome "unknown", described as "had diarrhea twice today".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; This is a spontaneous report from Pfizer Sponsored Patient Support Program. A contactable consumer (patient) reported for himself that a 43-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration at the age of 43-year-old at arm left on 09Mar2021 14:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. The patient wasn't allergies to medications, food, or other products. Concomitant medications included metoprolol tartrate and vitamin D NOS. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) at left arm on 15Feb2021 6:00 PM for COVID-19 immunisation. The patient experienced chest pain as a result of elevated troponin levels caused by myocarditis on 27Mar2021 14:00. The events were serious for being hospitalized (duration 3 days). The adverse events result in Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests included nasal swab: negative on 29Mar2021. The patient was received treatment (Heparin, Nitroglycerin and Cardiac Catheterization) for events. The outcome of events was recovering.
Severe pain beginning in shoulder of arm months of injection site. This was followed by pain and swelling in nearly every joint in body lasting for approximately 2 monthsWas seen by 4 different physicians the last of which prescribed 60 mg prednisone for 5 days resulting in relief of most pain. Since that time I have had 2 more episodes of the same symptoms. Doctor has advised consult with rheumatologist and possibly neurologist as I also have some weakness and tremor since this began. Latest bad episode began 03/21/2014 and continues. Currently treating with Naproxen with some relief.
Received the vaccine on Saturday on Sunday night started getting a headache and woke Monday morning with a headache,  a stiff neck and swelling on my left side of my neck, trapezoid and my dowager hump. After 2 weeks most of the swelling is gone just a slight bit. Headaches have been every day until yesterday.  Went to dr the following Monday after the vaccine as was give some anti inflammatory shots in my neck as not allowed anything ( cortisone) due to vaccine. Taking Tylenol and Advil and using Valteran.  Dr was not sure if from exercise or the vaccine but have been exercising throughout the pandemic. Never had headaches when my neck would bother me only hand tingling and that was not this time.  The acupuncturist today said still a bit swollen and tender and feels that it is a combination of the neck and the vaccine as the vaccine attacked my most vulnerable spot.  I had a massage today to to try to stretch my neck.  Headache is doing better today and I can move my neck more.
Upper arm became swollen, red and hot, rash around injection site. Pt refused to see physician, ice applied.
dose of Hiberix was reconstituted with sterile water from a Merck product instead of the accompanying diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-month-old female patient who received Hib (Hiberix) (batch number MP29Y, expiry date 13-JUN-2024) for prophylaxis.   On 10-OCT-2023, the patient received Hiberix. On 10-OCT-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: dose of Hiberix was reconstituted with sterile water from a Merck product instead of the accompanying diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-OCT-2023 The medical assistant reported a dose of Hiberix was reconstituted with sterile water from a Merck product instead of the accompanying diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered  The reporter consented to follow up.
Swelling and redness still on 2nd day seems to be getting worse,not better. Also it itches.
Patient states she had shoulder pain and soreness that started the day after she received her Moderna bivalent vaccine.  She states it has bothered her ever since that day and has difficulty lifting her shoulder without pain and states its worse in the morning.  She has tried OTC acetaminophen, ibuprofen and lidocaine 4% cream with minor to moderate relief but she still has pain at the injection site over 2 months later.
Patient very fussy after vaccines. Fussiness continued for several hours intermittently, Mom very concerned and brought patient back in to clinic.
Sudden crying, blank staring, seizure like symptoms, spiked fever, disorientation, throwing up multiple times, pimple like rash over belly and back. Child was also seen by Pediatric facility on 2/29 and on 3/2. Developed 4 chicken pox like marks on lower back area after emergency room visit and redness and hard bumps at site where injection was given.
Generalized weakness, headache, lack of energy, feeling like brain is in a fog, and difficulty concentrating
This spontaneous report as received from a currently 59 years old female registered nurse reporting on herself. "Recently", on an unknown date, the nurse was vaccinated with a dose of ZOSTAVAX (Lot # not reported) under the fatty part of the left underarm. The nurse reported that she was experiencing adverse effects after vaccination. The nurse stated that she had developed redness, itchiness and perfect round silver dollar swelling at the injection site, flu like symptoms, no rash. The nurse stated that her husband had a milder of the symptoms, but hers were more pronounced. The outcome of itchiness and perfect round silver dollar swelling at the injection site and flu like symptoms was reported as not recovered/not resolved. This is one of several reports received from the same source. Additional information is not expected.
Arm hurt and itched a lot; Arm hurt and itched a lot; Rash all over her belly; A bit of rash around the injection site; This is a spontaneous report from a contactable retired emergency medical technician (HCP) who is also the patient. A 63-year-old female patient received BNT162b2 (BNT162B2), dose 2, via an unspecified route of administration, administered in arm, on an unspecified date, at the age of 63years old, as single dose, for COVID-19 immunisation. Medical history included ongoing early Alzheimer's with cognitive issues, stroke in 2020 with half paralysis of the throat causing a drop in her voice, ongoing chronic obstructive pulmonary disease with problems breathing, and ongoing incontinence. Concomitant drugs included 32 unspecified drugs. Past drug history included 1st dose of BNT162b2 on 14Jan2021 (lot number: EK2176), at the age of 63 years old, as single dose, administered in arm. The first administration of BNT162b2, her arm hurt and itched. After the second dose of BNT162b2, the patient's arm hurt and itched a lot, as after the 1st dose of BNT162b2. About 2 weeks after vaccination the patient developed a rash all over her belly and a bit of rash around the injection site. The event outcome was not specified.   Information about the Lot/batch number has been requested.
Patient had a syncopal event after receiving vaccines (approx 2-3 mm after MA left room). She was crying, anxious after administration. Mom reports she appeared to hold her breath then passed out briefly, fell to the floor. She regained consciousness quickly and mom placed her on exam table before staff arrived. She was assessed, found to have a small laceration inside upper lip and mild bruising of (R) forehead. No major injuries noted. Pt was anxious but alert and interactive. Monitored x approx 20 minutes, allowed to leave when she could stand  and walk w/out symptoms. Reviewed signs and symptoms to watch for with mom and they expressed understanding.
This spontaneous report as received from a Registered Nurse refers to a two patients of unkown demographics. The information on patients' concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, these two patients received doses of improperly stored VARIVAX (Merck) (route of administratio, dose and lot # not reported). No adverse effect reported. Additional information has been requested.
Information has been received from a medical assistant concerning a 66 year old female patient with breast cancer, osteoarthritis and no drug reactions or allergies, who on 20-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 667445/0993Z, expire date not reported), 0.5 ml, intramuscularly. Concomitant medication included "cholesterol, blood pressure and thyroid medications". On 20-OCT-2010, when patient received PNEUMOVAX 23, that same day developed a rash over her left breast that traveled up to her shoulder and down her left arm to the elbow. The medical assistant stated that "it was an inflammation of the tissue, it was red and the patient had some pain in her elbow". The medical assistant also stated that believed if she did not come into the office it could have been pretty bad. There were no laboratory diagnostic studies performed. The patient sought unspecified medical attention. At the time of the report, the patient was recovering "after initiating antibiotic therapy". Additional information has been requested.
3 hrs after getting the vaccine, she developed significant Right arm pain. She felt faint, had blurry vision, and looked pale to others. She lay down with resolution of symptoms. Continued to have pain and mild swelling of her Right deltoid muscle at visit 3 days ago.
REdness, swelling started in left arm 3 days after receiving 3 vaccinations, swelling spread, itched, was seen at urgent care, used topical treatment.  Sx resolved.
They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No temperature excursion was reported. No concomitant medications were reported.  Treatment information was not provided.
Due to Lupus I typically  have very slow matabolism, low appetite and sluggish, however after a few hours of receiving the vaccine  I experieinced unusual restlessness, pacing, high energy, fast speech and incredible appetite ( I had 3 separate meals in 2.5hrs as opposed to my usual 1 meal a day.  My family were the one's who first noticed the change. However next day I was back to my usual self. I thought it was important to share as I anticipated due to lupus that my exposure to a foreign vaccine would have caused the more common symptoms but it was quiet opposite and unusual.
This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face) and HYPOTONIA (face felt droopy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Soy allergy and Food allergy (American cheese). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face), HYPOTONIA (face felt droopy), EYE OEDEMA (eyeballs felt sort of swollen) and FATIGUE (dizzy fatigue where it felt like someone had drugged her). At the time of the report, CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face), HYPOTONIA (face felt droopy), EYE OEDEMA (eyeballs felt sort of swollen) and FATIGUE (dizzy fatigue where it felt like someone had drugged her) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and Treatment medications were not provided by reporter. Reporter did not allow further contact.
102.8 fever under arm approximately 6 hours after injection.  5ml infant tylenol broke fever to 101.  Following day, fever 100 unmedicated.  Confirm with doctor what hep-b vaccine as chart is listed as "unspecified formulation"
I have afib. After second dose, my Afib gradually worsened.; I have afib. After second dose, my Afib gradually worsened.; At 3 weeks out it peaked with very irregular heartbeat, flopping, skipping beats; flopping; skipping beats; This is a spontaneous report from a contactable consumer (Patient) or other non HCP.   A 70-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809, Expiry date was not reported), via an unspecified route of administration on 09Mar2021 (at the age of 70-years-old) in Arm Right as dose 2, single for COVID-19 immunization. The Patient Medical history included atrial fibrillation from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing known allergies Sulphur, shellfish. Concomitant medication(s) included propafenon; retinol palmitate, vitamin d nos (VIT A+D); colecalciferol, menadione (VITAMIN K+D); calcium; magnesium; acetylsalicylic acid (ASPIR) all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur for drug hypersensitivity. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EM9810 and Expiry date was not reported), via an unspecified route of administration on 16Feb2021, 06:45 PM in Arm Right as dose 1, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. The patient was not received other vaccines in four weeks. The Patient was not diagnosed with COVID prior vaccination and Patient was not tested COVID post vaccination. On 12Mar2021, 13:15, the patient experienced she have afib. after second dose, her afib gradually worsened. At 3 weeks out it peaked with very irregular heartbeat, flopping, skipping beats. Totally cut out caffeine and white sugar. 5 days later it finally got back to normal. Thinking it might be related to the vaccine. The Patient visited Physician office. The Patient visited emergency room for event Flopping. The Patient had not received the treatment for the events. The outcome for all the events was recovered with sequel on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
I had a red rash covering my chest, neck, back and arms. The rash was very itchy. I had tingling in my arms and hands as well as being nauseated and fatigued.