chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines given between 10 and 11 AM at 2 month well check-up. Husband and I were both present. Baby seemed exhausted but healthy until 3PM. Father witnessed babies body shaking (arms and legs simultaneously). Our baby didn't cry during the episode. He ask me if it was normal. Not having witnessed the first episode I said "yes, newborns do odd things." At about 5 PM I fed baby his bottle and he projectile vomited the entire feeding. I proceeded to take his temperature and he didn't have a fever. I handed our baby to my husband while I grabbed new clothes for him. On returning to our office I witnessed the second episode of trembling, blank stares and no crying. At that time I made a phone call to the pediatrician on-call. Dr's response after hearing our explanation was "if it happens a third time take him to the ER." He never had another episode. By 7 o'clock that evening our baby was exhausted not smiling or showing expression. By morning he seemed to be his normal self. I trust Dr. as a professional. She had been my daughters pediatrician until just recently. I do not believe she would have put my son in danger. We are waiting for a pediatric neurology appointment. We have left the practice for another office. My daughter, his biological sister, is fully vaccinated.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion were 64 and 32 hours and the lowest recorded temperature reported were 34 and 31 Fahrenheit (F) (1.111111111 and -0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Vaccination was administered to the patient, the patient was a little nervous at time of administration. After 5 to 10 minutes of waiting in the pharmacy the patient was lightheaded and dizziness. The patient passed out and fell over, hitting his head on the wall of the pharmacy. The patient was briefly shaking/convulsing per the mother for a few seconds until the patient woke up. The pharmacy staff rushed out to the patient's aid. The patient was confused when he woke up . We had him lay on the floor for a few minutes then helped him up to a chair to sit when he felt better.  The patient explained how this has happened to him before when receiving vaccinations, he gets lightheaded and dizzy when receiving vaccinations. The patient explained how he did not take any medications or has any health conditions. The patient refused medical attention and said he felt ok as we waited with him for 5 minutes. We recommended the patient to see a doctor if he as any symptoms. The patient waited for an extra 30 minutes and said he felt fine. The patient's mother and the patient left with the mother driving him home.
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unspecified dates, the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M035487, expiration date 23-FEB-2019; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccine data logger measured a temperature range from 0°C to 1°C for a total time frame of 36 minutes. Previous temperature excursions ranges were reported from 0°C to 1°C for 22 minutes, 0°C to 1°C for 39 minutes, 0°C to 1°C for 29 minutes and 0°C to 1°C for 18 minutes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011300: US-009507513-1704USA001657: US-009507513-1703USA011300.
A hx of GBS post vaccinations in 2007. Per medical records review the SM was vaccinated with Influenza, IPV, MCV4 and TD on 20 Apr 2007. On 25 Apr he received Hep-A #1 and on 19 May 07 he was evaluated for an URI. on 20 Jun 07, 8 wks post vaccination he was evaluated for viral syndrome with sensory changes to his fingers. Symptoms worsened and he was diagnosed with Bell's palsy on 23 Jun 07 and was hospitalized with GBS-Miller Fisher Variant on 25 Jun 07. He received his influenza vaccine in Nov 07 and Hep-A #2 on Dec 07 with no recurrence of symptoms. On 11 Mar 08 he received AVA #1, SPV, and typhoid. On 13 Mar he was evaluated for a 2 wk hx of flu like sx, and was diagnosed as having pharyngitis. On 07 Apr 08 he was due to receive AVA #2 (reports that AVA #2 was admin), he presented to immunizations but required a walk in visit for evaluation for headache for 2 days and facial tingling. Neuro was consulted and noted that sx likely related to recent AVA, which could unmask previous damage caused by GBS. Per T-con he was reported as doing well on 10 Apr 08, and on 14 Apr he denied any new numbness/tingling, no worsening of previous sx but did report generalized fatigue. On 15 Apr 08 he reported sx have resolved but is now having trouble breathing and SOB with activity. Sx were assessed as not being consistent with GBS and labs were ordered. On 17 Apr pt was told that he had mono with a pos heterophile Ab; his sx included fatigue, sore throat and malaise. Since Apr 08, he has not received any additional vaccinations, was deployed, and has had no recurrent symptoms.
entire body ache started chills, cold, shivering, fever unk last 48hr before totally recovered;
accidentally gave FLUBLOK to a patient under 16 (minor) with no reported adverse event; Initial information was received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old and unknown gender patient who was received accidentally influenza quadrivalent recombinant vaccine [Flublok QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrivalent recombinant vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization. The information on batch number was requested.  On an unknown date the patient was accidentally gave flublok to a patient under 16 (minor) with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly "Reporter wasn't able to obtain consent for the office to be contacted. Sales rep was informed that the office may call us to provide additional information. Sales rep has very limited information to provide as the event was just randomly mentioned. No further information provided by the reporter."  Action taken with QUADRIVALENT RECOMBINANT influenza vaccine (Flublok QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (accidentally gave Flublok to a patient under 16 (minor) with no reported adverse event).  At time of reporting, the outcome was Unknown for the event accidentally gave flublok to a patient under 16 (minor) with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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 case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd November 2018, 3 days after receiving SHINGRIX, the patient experienced anaphylaxis (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), lip swelling, eye swelling, facial swelling and difficulty breathing. On an unknown date, the patient experienced injection site swelling, injection site pain, headache and nausea. On an unknown date, the outcome of the anaphylaxis, passed out, lip swelling, eye swelling, facial swelling and difficulty breathing were unknown and the outcome of the injection site swelling, injection site pain, headache and nausea were resolved with sequelae. It was unknown if the reporter considered the anaphylaxis, passed out, injection site swelling, injection site pain, headache, nausea, lip swelling, eye swelling, facial swelling and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The patient reported that less than a week after receiving SHINGRIX vaccine the patient experienced swelling and pain at injection site, as well as headache and nausea. The patient reported that those issues resolved. The patient reported that he experienced anaphylaxis on the next Saturday, which included him passing out in the bathroom and being taken by ambulance to the emergency room where he had swelling of lips, eyes and face and had difficulty breathing. The patient reported that he was not admitted to the hospital and was released from the emergency room about 8 hours later to go home. The patient reported that his eyes and face were a little puffy as a result of the anaphylaxis, at the time of reporting. The reporter agreed to be followed up. The reporter had provided contact details of her physician.
He got his vaccine, felt absolutely nothing, and felt fine. About 4:00 AM he woke up, looked at the clock and was sick and in a puddle of sweat. He slept on the floor and left his door unlocked as he felt that he might not survive, he was like that for 2 days, could not move. His whole body including his arms, legs, and belly were sore. He had a stroke about 3 weeks after his vaccine in the summer. He was driving a friend to the airport and was walking back to his car and passed out. They called for help (ambulance) and was taken to the hospital, kept in the ER and determined to have had a stroke and released. He was then driving in November and had another stroke. Saw different doctors and then was able to leave after about 10 hours or so. He went to see if he could get the other manufacturer as he had a reaction and was told that he could not switch vaccines as it stayed in his body, so he was wondering how long the vaccine stays in your system, and wonders if that's why he had the reaction. He was in the military in 1989 to 1993, and had numerous vaccines and wonders if he had a reaction due to having those vaccines. He is about 95% improved, he still cannot whistle, and cannot use a spoon well and still feels like 1/2 his body is asleep. He does have slurred speech when he gets cold, and people feel that he may be drunk. He cannot hum some tunes as well.   He cannot swish water in his mouth when he brushes his teeth. He had to wear a patch on his eye for a while. Feels like he's walking in a daze, drunk type of feeling.
Pt received Moderna vaccines on 02/17/21 and 03/17/21. Pt presented to the ED on 10/15/21 with complains of a seizure from the nursing home. Pt was tested for COVID-19 on 10/16/21, which came back positive. Pt required supplemental oxygen.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vial initially stored in the refrigerator on 14 Jan 2022 and did not undergo temperature excursions.  No concomitant medications were reported.  No treatment medications were reported.
Transient Global Amnesia; A spontaneous report was received from a physician concerning himself,  a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Transient Global Amnesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07-Jan-2021, prior to the onset of the event, the patient received a dose of mRNA-1273 (Batch number: 011J20A) for prophylaxis of COVID-19 infection.  On 09-Jan-2021, the patient experienced the event Transient Global Amnesia(Medically Significant) which lasted for 8 hours.  Laboratory details provided were CAT scan, Echocardiogram and various other workups  Treatment for the event Transient Global Amnesia reported was evaluation at a hospital with a CAT scan, Echocardiogram and various other workups.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event Transient Global Amnesia was reported recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Immediate pain on injection, not abating over time. After about 3 hours arm pain was extreme on any movement.  After 11 hours pain is still intense even with minor movement. Unable to raise arm forward , lifting sideways is difficult and painful but can be managed. No redness  or swelling at injection site and no other reactions.
When I use my arm muscles of the arm where I got the vaccine, I get really weird nerve like(?) pain all along my arm.  It hurts more so when I pull my arm to the back and when I flex my muscles/grab something tight. It goes away in a few minutes but comes back when I flex my muscles again.
had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; This is a spontaneous report received from a contactable other healthcare professional. This other HCP reported similar events for 4 patients. This report is for 1st of 4 patients.  A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The reporter stated that, it is affecting 4 patients currently. They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test. The outcome of the events was reported as unknown.  Information about lot/batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event Drug ineffective and covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021307731 Different paitent, same drug, same event (split);US-PFIZER INC-2021307730 Different paitent, same drug, same event (split);US-PFIZER INC-2021307729 Different paitent, same drug, same event (split)
Patient seen 6/18/07 for report of chest wall pain - right side.  Patient had chest x-ray, ultrasound.  Had Zostavax 6/20/07.  Per patient had rash on right chest which started 6/22/07.  Not seen again until 9/24/07 at our office.  Patient had numerous tests and was referred to Gastro and Neuro.  Patient still reports pain right chest wall.
weakness, fatigue, w/flushing of arms & chest w/fine rash devel on chest;also c/o itching & feeling very warm;
Patient received vaccine at 11:15am, by 6:00pm she had broken out in hives on arms and back.  No facial swelling or difficulty breathing. Treated with OTC Benadryl and antihistamines.
sore arms on the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arms on the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 29L20A and 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arms on the site). At the time of the report, VACCINATION SITE PAIN (sore arms on the site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive in October. No concomitant medication details was provided.No treatment medication details was provided. This case was linked to MOD-2021-395722, MOD-2021-395711 (Patient Link).
Right at 24 hours I experienced chills and body aches, but noticed when I woke up the next morning that the lymph nodes in my right armpit are were swollen to about the size of a small clementine orange.  They lymph nodes are still very swollen and tender.  It hurts to simply let my arm rest on the side of my body.
Constant headache each day since shot. Had been in menopause before and now spotting frequently.
24 hours after vaccination (influenza) pt developed low grade fevers (99-100), diffuse joint pain, myalgias, nausea, diarrhea and localized induration and erythema at injection site (4cm x 3cm).
This spontaneous report was received from a physician and refers to a 1-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-FEB-2019, the patient was vaccinated with a dose of improperly stored VARIVAX, lot# R009820, expiration date 03-APR-2020, (dose, route of administration were not reported) for prophylaxis. VARIVAX was improperly stored between 6 to 14 (13.8 F) degrees Fahrenheit for 1 hour and 20 minutes and between 15 to 46 (27.1) degrees Fahrenheit for 2 hours (date was not provided). Previous temperature excursion was also reported to be between 15 to 46 degrees Fahrenheit for 1 hour and 30 minutes and between 47 to 77 (54F) degrees Fahrenheit for 12 hours (date was not provided). Data logger was not involved. No adverse effects were reported. This report is one of two reports received from the same reporter (MARRS #1902USA002295). Sender's Comments: US-009507513-1902USA002295.
headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the left arm on 24Dec2020 at 07:30 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing and a thyroid disorder from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took iodine for an unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Dec2020 at 15:30, the patient experienced headache, nausea, vomiting, chills, rigor, fever and fatigue. No therapeutic measures were taken as a result of the events. The clinical outcome of the headache, nausea, vomiting, chills, rigor, fever and fatigue was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Within 30 mins, began to have bad headache and very sore arm.  Headache continued through night.  Got up to use restroom around 3:00 am and had no movement in left leg and weak in left arm.  Rushed to ER and was diagnosed with stroke.
Patient was seen on 2/12/07 because where she recieved a vaccine she had developed atrophy of the subcutaneous fat. Patient was sent to dermatology and was given the diagnosis of lipoatrophy.
This case was reported by a physician via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient's age group was taken based on the product indication as no other patient details were provided. The healthcare professional reported that the patient developed Shingles sometime after the 1st dose of SHINGRIX, but prior to administration of the 2nd dose.
On 09/02/2000 the patient experienced chickenpox. The patient experienced 4 crusted lesions on a macular base under the right arm. At the time of the report, there were 5 new macular lesions forming a rash on the trunk and legs. There were 2 on the trunk and 3 on the right leg. There was no itching. The patient was seen by a physician on 09/06/2000. The physician later reported that no side or adverse events had occurred and that the patient had recovered without problems. No further information is expected.
Pt got flu shot on 10/13/2017, pt called back on 10/14/2017 saying that she got a flu shot in her left arm and she was experiencing left side numbness, left side ear pain, and a sore throat. She went to the Dr on 10/14/2017 and got a Rx for prednisone 20mg, 2 tabs Q AM for 3 days.
Patient developed a LLR to SQ anthrax with each vaccine given. Subsequent doses with less severe LLR.
Injection site became red and warm within hours of trt.  Red, itchy, warm blotches extended 6" down front of arm below injection site.
This spontaneous case, initially received on 19-Sep-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 13-SEP-2016 to 13-SEP-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 13-Sep-2016, the patient experienced severe bruising (outcome: unknown, special circumstances: wrong technique in drug usage process) after receiving the AFLURIA from the pre-filled syringe that had air bubble (the reporter wondered if the air bubble should have been removed). Reporter's assessment: The reporter considered the event(s) bruising as non-serious and related to the administration of AFLURIA.