chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered MENACTRA yesterday and after the event, they found out that it expired on 13APR2022 with no adverse event; Initial information received on 05-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who experienced administered menactra yesterday and after the event, they found out that it expired on 13apr2022 with no adverse event while receiving vaccine Meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-May-2022, the patient received suspect Meningococcal a-c-y-w135 (d conj) vaccine at a dose of 0.5 ml once (strength, formulation :unknown) lot U6919AA expiry date :13-apr-2022 via unknown route in unknown administration site for immunization.  On 04-MAY-2022 the patient developed a non-serious administered menactra yesterday and after the event, they found out that it expired on 13apr2022 with no adverse event (expired product administered) (latency :same day) following the administration of Meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Developed fever 103 on July 23rd and chest and head erythematous blanching rash on July 25th that spread to full body.  Fever continued on July 25th.
Extremely painful body aches and cramping, fatigue, tossing and turning while trying to sleep. 100 degree fever.
Multiple siblings in the room during vaccination.  Called out the name and client sat down and was vaccinated.  Afterwards, client stated that he was not correct patient, but was sibling.  He received the vaccines that sibling needed so received a dose of Havrix which was unnecessary.
two month old baby received FLUZONE QUADRIVALENT vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (Reference number- 00523288) and transmitted to company on 17-Mar-2021.  This case involves a 2-months-old patient to whom nurse practitioner accidentally gave INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number, expiry date, route and site of administration not reported) (product administered to patient of inappropriate age) on 17-Mar-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  The caller is asking what can happen as a result of this. The caller had no information as to if anything happened as a result of this or any of the company adverse event questionnaire questions or smart script questions.  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Case number PHEH2012US006918 is a spontaneous report initially received from a medical assistant on 22 Mar 2012 with a follow-up received on 16 Apr 2012: This case refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: A10126A) intramuscularly on 22 Mar 2012. The reporter stated that this patient received only the MENCYW-135 liquid conjugate component of MENVEO; she did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this drug administration error. She was revaccinated with the correctly constituted MENVEO on an unknown date. Follow-up received from the medical assistant on 16 Apr 2012: Updated information about revaccination with the correctly reconstituted vaccine and updated patient details.
Chills, body aches, rigors, and nausea starting about 12 hours after vaccine with improvement about 24 hours after vaccine. No fever when checked.  OTC antipyretics used.
Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient described as an almost panic attatck reaction - shakiness, dizziness, blurry vision, nausea. Blood pressure and heart rate not elevated. SAt for 20 minutes and started feeling better then got the chills and more shakiness
After a few weeks of the vaccine I started to feel  Fatigue, headaches, brain fog, loss of smell and taste, muscle aches, shortness of breath,  and chestpain. It happens when its cold or hot.
Large adult fist sized lump at injection site. Parent noted redness, swelling and warmth at right thigh.  Pt did NOT c/o pain.
No additional AE reported. No PQC; the vaccine was administered while out of recommended range.; This spontaneous report was received from a registered nurse referring to a 5-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-MAY-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported; dose: 2 milliliter, lot # 1694410, expiration date was 19-DEC-2021) orally for prophylaxis. The vaccine was out of recommended temperature range (product storage error). The vaccines were stored in a temperature 89 Fahrenheit (F) with a time frame 24 hours. There was no previous temperature excursion. Data logger was involved. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Initial unsolicited report received from other non health care professional (CMA) on 09 August 2016. This case involves a 54-year-old patient (gender was unknown) who was vaccinated with a first dose of TYPHIM VI (Batch number: M0102-1, expiration date, dose was not reported) intramuscularly in the left deltoid and with a dose of TWINRIX (Manufacturer: GSK, Batch number, expiration date, dose, route and site of administration was not reported) on 02 August 2016. Patient's illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions included PCN (allergy to penicillin). Concomitant medications were not reported. On 02 August 2016, immediately after the vaccines, patient was observed to pass out with eyes to back of head, convulsions and shaking with disorientation. The patient was sent to ER. Laboratory investigations and corrective treatment were not reported. The patient was not yet recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event Convulsions. List of documents held by sender: none. Sender's Comments: This is poorly documented medically not confirmed case where convulsions reported after administration of TYPHOID VI POLYSACCHARIDE VACCINE. Time to onset is compatible with the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
she had a seizure; This is a spontaneous report from a contactable consumer (patient's mother). A 16-years-old age female patient (reporter's daughter) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated her daughter today had the first Pfizer shot, she will be 17 in July and she had a seizure. She had a seizure when she had the first shot (Unspecified Vaccine), she's only 16 she will be 17 years old. She wanted to know if there is any precautions she have to look for, should she have her sleep with her so she could watch her. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.
Patient felt weak and not able to drive home. EMS was called and patient was taken to  hospital for further evaluation.
Pt received vaccine. Pt was light headed, dizzy and feeling hot 15 min post vaccine. Crew arrived to pt. Vitals assessed. Crew brought pt to ambulance. ALS assessment and fluids given due to hypotension. Transport to hospital.
then blacked out and fell between the tub and bathroom vanity/unconscious; Severe paid in the abdomen just below my ribs; then blacked out and fell between the tub and bathroom vanity; Severe pain in my left side due to the impact with the vanity cabinet; This is a spontaneous report from a contactable consumer (patient himself).  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FH8020), via an unspecified route of administration, on 21Oct2021 14:30 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FF2589) via intramuscular in the left arm, on 30Sep2021 (at the age of 71-year-old) for COVID-19 immunisation and developed welts. The patient did not have a medical history and concomitant medications were provided. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Just over 48 hours after the second dose, on 23Oct2021 at 18:00, while in the shower, he had severe pain in the abdomen just below his ribs, then blacked out and fell between the tub and bathroom vanity. Not sure how long he was unconscious but finally managed to get his legs down from the tub and get on his feet. Severe pain in his left side due to the impact with the vanity cabinet. No treatments were given for the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101440721 Same reporter, different vaccine dose (1st dose), different event
The pt rec'd ZOSTAVAX 0.65 ml SQ x1 on 5/12/08, developed disseminated zoster and visited MD on 5/14/08.
This is a COVID breakthrough report - requested by CDC by phone call. I'm vacinated 2 course Moderna, 2 booters and a 3 bivalent booster just 2 months prior to contracting Covid.  First symptom (11/17/22) was a sore throat, followed by nasal congestion. Started intermittent dry coughing day 2. I felt like I had a cold for 3-4 days. Sore throat would resolve then return 3 times. I was tired, head and muscle aches. The 3rd time my tonsils were swollen so I went to urgent care (11/25/22) to get them checked out. Was told my lungs sounded clear. Took over the counter meds for the sinusitis. I never had a fever. Tested positive until 12/5/22
On the 27th of November, it started as a cold. I thought it was a cold, but it got heavier and it was harder to breathe. I found out 2 days later that my son was positive and we called my doctor. Because I take perezone, I could not take PAXLOVID. I went to my doctor and did an infusion treatment. After that, I got worse. The following days my oxygen had fallen down to 86. I went to the hospital and I was in the ER and my aerial count was worse then my oximeter. So I was in the hospital for 2 to 3 days, was on oxygen the whole time, and did various infusion. I was allowed to go home but with oxygen and still use it and sleep with it. Still have problems with fatigue, and breathing.
On 13 JUL 2007 we received from the Regulatory Agency the following information: A 32-year-old female patient was vaccinated with Rabies Virus vaccine (manufacturer and date of vaccination unknown). Further suspect vaccinations (same day?) included ENGERIX B, REVAXIS and Typhoid. Patient was likely to be conceiving just at the time of the second dose of vaccines. The fetus has trisomy 21 (DOWN's syndrome) and a cardiac abnormality. Patient has had a termination of pregnancy. After internal discussion on 24 JUL 2007 was decided to create an additional case for the fetus (see case MA2007-0753). We received a follow-up information from the Regulatory Agency on 06 AUG 2007 without new information. We received a follow-up information from the Regulatory Agency on 07 AUG 2007 without new information. Reference no. GB-MHRA-ADR 20139770. No. ADR20139770-001. The case was previously recorded as MA2007-0709. Follow up health authority report received on 09 Dec 2009: No new information reported.
Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of Varivax. Subsequently, the patient experienced shingles. Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 40, 88, 232, and 320 hours, with the lowest recorded temperature of 34, 30, 33, and 29 degrees Fahrenheit (1.11, -1.11, 0.55, and -1.66 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
COUGH; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from cough, and the outcome of chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210358675.
Patient received 1st dose of vaccine 1 month ago, at the age of 17 and 10 months.   Dose should not have been given until age 18.  Upon discussion, it was  determined that patient should receive 2nd dose as appropriately recommended, 28 days, which required the patient to receive 2nd dose at 17 years and 11 months.
hospitalized 26NOV92 to 21DEC93 presenting w/parasthesia & weakness; dx w/GBS requiring mechanical ventilation and plasmapheresis;
This spontaneous report was received from a registered nurse referring to a multiple unspecified patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dose, frequency, route of administration were not provided), lots # M031941 with expiration date of 27-DEC-2017;  M033209 with expiration date of 09-JAN-2018;  M037009 with expiration date of 21-FEB-2018; M015695 with expiration date of 26-SEP-2017; M040142 with expiration date of 27-MAR-2018 and N004631 with expiration date of 07-AUG-2018 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (25.8 degrees Fahrenheit) for 60 minutes. Lots # M031941, M033209, M037009, M015695 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (32.5 degrees Fahrenheit) for 5 hours, 50 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.2 degrees Fahrenheit) for 3 hours, 30 minutes and total time in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours, 10 minutes. Lots # M040142 and N004631 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit  (40.6 degrees Fahrenheit) for 3 hours, 10 minutes. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000708: US-009507513-1707USA000709.
Headache, fatigue. Local swelling, redness, & pain to site of injection.
high pitched continuous cry, poor appetite, lethargy, irritable hospitalized 2 days for evaluation;
Received Varivax on 7/8/96. Dx with Varicella on 1/5/00.
DEATH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; HEARTBURN; This spontaneous report received from a consumer concerned a 54-year-old white and non-Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included, non-alcoholic, and non-smoker. The patient had no known drug or non-drug allergies. The patient had a physical examination performed (in AUG-2021) a week or two before he received the Janssen Covid-19 vaccine and results were clear. He was pretty healthy, he rode his bike, and ate pretty well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, 01 total, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect vaccine included: Covid-19 vaccine (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had inappropriate schedule of vaccine administration (off label use). On 23-SEP-2021, the patient experienced chest pain/tightness. On 24-SEP-2021, he visited physician's office, the electrocardiogram (EKG) was performed and was diagnosed with heartburn. He did not feel comfortable with the diagnosis and booked another appointment for 25-SEP-2021. He did not make the appointment and on 25-SEP-2021, he died from unknown cause. He was not found for 2 days following his death. On an unspecified date, an autopsy was performed, one preliminary (unofficial) report with an undetermined cause of death from the funeral home was received and a more extensive autopsy was requested. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 25-SEP-2021, and the outcome of heartburn, off label use and inappropriate schedule of vaccine administration was not reported. This report was serious (Death).; Sender's Comments: V0: 20211103199-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Swollen arm/arm had swollen up; Swollen arm, It was also warm and hot/it is warm, has heat to it; it is hot and warm; It was long, swelling is like the shape of a football/swelling is from the shoulder and started to go downward; This is a spontaneous report from a contactable consumer (Patient's husband). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN0186), via unspecified route of administration in the Left arm, on 18May2021 at 12:00 PM (at the age of 55-year-old), as a single for COVID-19 immunisation. Medical history and concomitant medications were not reported. There was no family medical history relevant to AE. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any additional Vaccines administered on same date of the Pfizer Suspect.  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27May2021, Yesterday around the afternoon her arm had swollen up, it is warm a little, has heat to it and it was long (clarified it was long as for the swelling is in shape of like a football). The swelling was from the shoulder and started to go downward. They tried to put an ice pack on it because it was hot and warm. They were wanting to know if there was anything to worry about and what are the side effects if she would experience and whether she need to pay attention especially, since it was been 9 days of vaccination. And whether the patient wanted to go hospital or it would be fine. The reporter also stated that he also wanted to take the shot but had worries on how safe it is for him to take it for himself. The adverse event does not resulted in Emergency Room or Physician Office. There was none relevant tests. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
sore back; sore went to her upper chest, no breathing problems; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included blood pressure medication, cholesterol medication and anxiety medication for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 07-Feb-2021, the patient experienced BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Feb-2021, PAIN IN EXTREMITY (sore right arm) had resolved. On 09-Feb-2021, BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.