chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (RN) concerning a 29 year old female who was vaccinated with a first dose as a child and second dose prior to college of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the patient recently gave birth and her serum antibody to rubella was negative.  Unspecified medical attention was sought.  Additional information has been requested.
Arm red, very tender to touch (redness approx. softball size as per patient). Swelling at site. Fever, chills, malaise. Reported 2 days after vaccine. Patient was sent to emergency room.
Uncontrollable shivers, body aches, and vomiting. Shivers (Rigors) happening even though there was no fever. Went to hospital ER about 30 minutes after shivers started since we were unable to stop them. Hospital monitored vitals and took blood to test for infection and other possible causes.  Gave IV with saline solution and ZOFRAN. Shivers stopped and stomach was settled before being discharged from hospital. Blood test was normal. ER Doctor suspected this was reaction from flu shot given earlier in the day. Very lethargic, no appetite, and body aches the following day. Second day after, more energy and appetite improvement with slight lingering body aches.
Joints hurt a lot; Headache; Tired; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included prenatal iron (MANUFACTURER UNKNOWN) and ARMOUR 90 mg, for unknown indications from unknown dates. The patient previously received aripiprazole (ABILIFY) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 10:00, the patient's joints were hurting a lot. She had a headache and was very tired. She had COVID less than one month ago and it felt like the beginning of it again. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events joints hurt a lot, headache and tired. The clinical outcomes of the events joints hurt a lot, headache and tired were recovering at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
+nausea, +feeling gassy, +runny nose +left throat itchiness/irritated +dry cough, +itchy/painful left upper arm, left upper arm swelling - these symptoms started after the shot.
Muscle aches and pains day after shot fatigue and weakness x 3 weeks SOB still ongoing.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 2:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 2:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 55.81. No concomitant medication was reported by reporter. Batch number 007C21A underwent temperature excursion on 29-Apr-2021 with temperature 33 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 29-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Tingling in extremities - it started with my toes and went up to my  hands. And continues to present. Doctor visit  ER. Have an upcoming visit to Neurologist hopefully.  No Treatment as of yet.
Pt recvd Engerix-B JAN91, FEB91 (probably), 24JUN91 & 10AUG91 & in JUN or JUL91 & in SEP91 anti-HBS was neg; pt was a non-responder;
1st dose on 01-APR-2020, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose of Shingrix vaccine on his left arm on 1st April 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments:  The patient reported that patient did not get the 2nd dose of the vaccine.  Patient would share medical information with health care professional/primary care physician and registered pharmacist for follow up with GlaxoSmithKline. The consent for follow up was not requested.  Additional Supportive Information: The patient did not get the 2nd dose of the vaccine, which led to incomplete course of vaccination.
Dizziness, SkinRash, Rash & HYPERtension Narrative:  Patient received vaccine 12/31/2020 and about 5 minutes after the vaccine, developed a rash on her anterior neck. Additonally, her systolic BP rose to 160 and then slowly went back. She denied pain, itchiness, SOB, headache, or chest pain. However she noted experiencing dizziness. Patient confirmed having an antihistamine allergy confirmed with allergen skin test. She was referred to the ED where she was offered steroids however she wanted to be observed in the ED instead. Upon discharge, she was given a prescription for prednisone to take at home if reaction occurred again. She was also offered a prescription for EpiPen but declined. Her symptoms began improving within 2 hours and was discharged home. ADR was entered into system.
p/vax pt walked to door & pitched forward hitting face & shoulder;color good, eyes open making contact, did not speak for 10min but nodded appropriately to questions;vasovagal response;referred to ER for eval;
This was my 2nd booster, the first being administered Sept 30, 2021.   Extreme fatigue resulted with this round.  I slept for 14 hours without stop for 2 days after the booster.  I was worried since I had not experienced this side effect with any of the 3 previous doses.  I was so worried I tested myself for COVID but it was negative.
Started 10/15 Red welt itchy warm at injection site. Started 10/9 Cough shortness of breath-ongoing.  Started 10/9 Palpitations-ongoing.
Mom reports when pt. got home from her appointment she complained of left sided chest pain radiating to her back. She woke up this morning not feeling well but went to school. She went to the school based health center around 8:30 due to nausea and dizziness. Mom plans to see MD today and will notify me of the results of that visit.
At 11:00am started w/arm itching, then after one hour it began to hurt and swell.  The redness 10cmX8cm started this morning around 8am(03/07/2014).
8 X 6.5 cm area of erythema & bruising at site of injection (R upper arm).
Severe rash all over body, admitted to hospital; This is a spontaneous report from a contactable other health professional (HCP). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via intramuscular route in left arm on 09Mar2021 at 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 for COVID-19 immunization. On an unspecified date, the patient experienced severe rash all over body, admitted to hospital. The patient underwent lab tests and procedures which included computerized tomogram: unknown result on an unspecified date, and sars-cov-2 test: negative on 09Mar2021. The patient received an unspecified treatment for the event. The outcome of the event was unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product, a possible contributory role of the suspect product BNT162B2 to the development of event Rash generalised cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
after recv vax pt devel fever 102, 6/1 temp 102 & broke out w/red blotches, ``regular chickenpox''
7 days post vaccine (approx 1/4/21)  pretty significant redness, swelling, soreness, itchiness near/below vaccine site, 1-2 days after very mild soreness.
Pt. developed neurologic symptoms, including weakness, ataxia, loss of motor skill and verbal skills, nystagmus. Diagnosed w/ Opsoclonus myoclonus syndrome.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient inadvertently received a fourth dose of GARDASIL 9 (dose, route, lot # and expiration date were unknown) following completion of the series. No adverse effects were reported in the patient. No product quality complaint (PQC) was involved. Additional information has been requested.
1230PM, 3 hrs p/vax sz, rigid, cyanotic, spontaneous recovery; then 5AM 16FEB94 another sz w/prolonged postictal confusion arms w/rhythmic tonic/clonic; t104.7 in ER;
12-36 hours after administration - Fever, Weakness, Dizziness - Treated with Naproxen - Resolved by 36 hours following administration 48 hours after administration - Hives over legs, back, abdomen, arms - Treated with Famotidine and Benadryl - Not yet resolved
Tested positive for Covid; A spontaneous report was received from a consumer concerning herself, a 64 years old female patient, who recieved Moderna's COVID-19 vaccine and tested positive for Covid a week later of vaccination.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received first of two planned doses of mRNA-1273:[Batch number not provided] on 07-JAN-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  The patient was exposed by a side coworker a week ago, lost her smell and taste and tested positive on 14-JAN-2021. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.
Information has been received from a health professional concerning a patient in tenth grade who was vaccinated with a dose of Varivax. In May 2006 the patient experienced chickenpox. Additional information has been requested.
Numbness and tingling in left foot after four days. Numbness and tingling spread to right foot after a week, then to both hands. Saw Dr on August 20 and received a Kenalog injection. Symptoms began subsiding within 3 days and are gone except for periodic numbness in left foot that remains today. Both Dr. and I have concerns about a stronger reaction with a second dose, so I do not plan to schedule that dose until there is better research on patients with existing chronic immune activation.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 04-FEB-2019, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis (product storage error). No adverse effect was reported. The LIQUID PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
bites broke out on my inner calves on both legs; itching; redness; Welts around 15 on each leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in Arm Left on 08Jan2021 13:30 (at the age of 77-year-old) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 29Jan2021 13:00 (Batch/Lot Number: EL9262) as dose 2, single for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex, allergy to animal from an unknown date and unknown if ongoing Known allergies: animal dander. Concomitant medications included metoprolol taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Jan2021 13:00, the patient experienced bites broke out on her inner calves on both legs, Welts around 15 on each leg up to her knee with extreme itching and redness. Same after 2nd vaccine 1week later other locations larger but fewer. One on under side of upper arm and 2 on upper thigh. Taking a Claritin helped itching but red blotches remain. Therapeutic measures taken as a result of events included claritin and Cortisone cream. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
1) facial numbness/tingling on L side that occurred about 1 hour after injection and lasted less than 15 minutes. resolved spontaneously. 2) L arm pain started several hours after vaccine and lasted 4-8 hours. resolved spontaneously 3) unsure if related to vaccine, but R eye twitching  began 1-2 days after vaccination until present, although less frequently. initially was several times per day day x several days. now occurs few times per week and is less intense.
After nurse gave FLUMIST and GARDIASIL, pt's face went blank and pt head deviated to the right, also pt's arms went stiff in extension; hands shook a little, legs extended also & loss of urine onto floor, lasted 30-60 seconds, pt was tired and nauseous afterward. No vomiting.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection, lot # J002641, expiration date 10-DEC-2015 (dose and route were not reported). Concomitant therapies were not reported. The reporter stated that GARDASIL vaccine was expose to a highest temperature of 12 degree centigrade for a time out of range of 159.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Approximately 5 hours after receiving his 2 month immunizations, the patient woke up from a nap crying. Assuming he was hungry the mother tried to breast feed him, but he wouldn't eat. He appeared to be going back to sleep and then she noticed his coloring changed to a bluish / green / gray color, his body went limp and it appeared that he was not breathing. She called 911, within about 1 minute after giving him a couple of breaths and tickling his feet, he became conscious again, but was lethargic and pale. He was admitted into the hospital that night. Several tests were done.
I DEVELOPED A COUGH, SHORTNESS OF BREATH, SEVERE BODY ACHED, SEVERE HEADACH AND I NEVER GET THEM, SEVERE THROAT PAIN, RIGHT EAR PAIN. ON 1/30/22 I WENT TO THE ER AND THEY GAVE ME A SHOT FOR NAUSEA, MUSCLE RELAXER.
Information has been received from a certified medical assistant (CMA) concerning a 2-month-old female with no medical history or allergies who on 11-JAN-2008 was vaccinated PO with a dose of ROTATEQ (Lot #658383/1389U). There was no concomitant therapy. The CMA reported that on 11-JAN-2008 the patient vomited right after the dose of  ROTATEQ was given. The patient was seen in the office and no other symptoms were noted. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. Additional information has been requested. Follow-upinformation received 06/18/2008 the patient projectile vomited right after the dose of rotavirus was given on 11-JAN-2008. No additional information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 04-JUN-2015, the patient was vaccinated with improperly stored GARDASIL (route of administration and dose were not reported) (lot # K023432, expiry date: 18-JUN-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
HYPOTENSION 11/21/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Immediately experienced pain and soreness in arm upon administration of vaccine.  Started experiencing additional side effects 9-10 hours after vaccine administration:  at night I developed a severe migraine, nausea and chills.   When I woke up the next morning, I still had a migraine, my nausea was less apparent, but I did begin to experience fatigue/exhaustion and muscle aches.  I've experienced chills and hot flashes in waves throughout March 11th.  I took my temperature for the first time at 4PM on March 11th and I have a low grade fever of 99.6. degrees Fahrenheit.
No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-AUG-2022, the patient was vaccinated with improperly stored 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (strength, and route of administration were not provided) lot # w004504, expiration date: 16-JUN-2023 or lot# W002562 which has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) expiration date reported as 12-OCT-2023, the same as internal validation (product storage error). The healthcare worker did not specify which actual lot the patient received. Administrated vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 11.3 Celsius degrees for 34 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse events).
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (manufacturer control number: 01031158). A contactable physician reported for a patient of unspecified age and gender received PREVNAR 13, (Lot Number: Unknown), via an unspecified route of administration in Nov2017, at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient hospitalized for 6 days (hospital unknown) with pneumonia in Jan2018. The outcome of the event was unknown. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Worsening shortness of breath over 4 days with accompanying vomiting and chills
24 hours later: fiery red circle (4 in), raised circle, mild pain. 48 hours later: malaise, tiredness, dizziness, loss of appetite, headache. Rash has spread to elbow (+ do/turned to red/purple color).