chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 6 month old patient. On 03-JUL-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
neurological event; had hard time walking; This case was reported by a physician via sales rep and described the occurrence of neurological symptom in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neurological symptom and walking difficulty. On an unknown date, the outcome of the neurological symptom and walking difficulty were unknown.   It was unknown if the reporter considered the neurological symptom and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a neurological event. The patient had hard time walking. The reporter consented to follow up.
I'm not a medical professional, I'm reporting this due to the proximity in which the events occurred. I am a 33 year female with no history or family history of blood clots. I received the 2nd dose of my Pfizer vaccine on Apr 2 and on Apr 5 I began experiencing pain in my right leg. I had not injured it, and by Apr 14 I felt compelled due to the increased pain to contact a medical professional. They ran a d-dimer and mine came back high at 0.89. I was instructed by my PAC to go to the ER and tell them about the elevated d-dimer results. At the ER they performed an ultrasound and confirmed "Acute occlusive deep venous thrombosis in the right calf involving the entire length of 1 peroneal vein.". They also performed a CT scan on my chest and discovered "Right lower lobe distal segmental and subsegmental pulmonary artery emboli". They also performed a series of blood tests, all of those came back fine. I am being treated with 15mg of rivaroxaban (Xeralto).
pregnant patient received an application of diphtheria, tetanus and acellular pertussis vaccine (unknown) with no reported adverse event; Initial information received on 21-Feb-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp(non-health care professional).  This case involves an unknown age female patient who was exposed to vaccine diphtheria, tetanus and acellular pertussis vaccine in context of pregnant patient received an application of diphtheria, tetanus and acellular pertussis vaccine (unknown) with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient received an application of diphtheria and tetanus and acellular pertussis vaccine (unknown) with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient had no past medical history. The patient medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of pregnant patient received an application of diphtheria, tetanus and acellular pertussis vaccine (unknown) with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  Action taken : not applicable.  Outcome: Unknown  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Developed shingles 4 days ago; Shingles rash on back and buttocks; Shingles rash on back and buttocks and "near hind end" / Rash is painful; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 14th July 2020, the patient received the 1st dose of Shingrix. On 16th November 2020, 47 days after receiving Shingrix and 125 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure, shingles and painful rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and painful rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was the wife of reporter. The Patient received 1st dose of Shingrix was in July of 2020 and her 2nd Shingrix shot was on 30th September 2020. Four days ago from the day of reporting the patient developed a shingles-type rash.  She had not been to the doctor yet but she had shingles in the past so she was familiar with what a shingles rash looks like.  She also said that the rash was painful. Still present now with rash on back and near hind end Consented to follow up
Severe Dizziness continuously starting 1/1/2021 has subsided to having dizziness every couple hours presently Vomiting all night 1/1/2021 nauseated until 1/18/2021 used zofran prn for symptoms Night sweats and chills 1/1/2021- 1/8/2021 Heart racing every couple hours to the point of hurting lasts about a half hr at a time started 1/1/2021 lasted till 1/16/2021 severe fatigue started 1/2/2021 lasted till 1/8/2021 only being able to stay awake for a couple of hours at a time confusion at times and not feeling completely with it lasted till 1/16/2021 Headache 1/1/2021-1/8/2021 used Tylonal
Rash on face, chest, back and arms. Small vesicles and fine papules.
Hypotension; fever; chills; body aches; severe arm soreness/tenderness; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received second single dose BNT162B2 (Solution for injection, lot number: EL3248, exp date not reported), intramuscular (vaccine location: left arm) on 12Jan2021 10:30 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took first single dose of BNT162B2, lot number: EL1284, intramuscular (vaccine location: left arm) on 23Dec2020 23:00 for COVID-19 immunization. On 12Jan2021 23:00, the patient experienced hypotension, fever, chills, body aches, and severe arm soreness/tenderness. The events were considered as non-serious by the reporter. No treatment was given for the adverse events. On 20Jan2021 Nasal Swab was negative. The patient recovered from the events on Jan2021.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration 07-may-2021.  No concomitant medications were reported.  No treatment medications were provided.
Chest pain, inability to speak, left-sided weakness.  We were also asked by military (DOD) not to discuss specific cases involving military personnel.
COVID 19 Vaccine EUA; One week after my vaccine redness, swelling and itching came back at my injection site.  It has lasted 3 days at this time.
exposed to excursion and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: Nurse reported that their Bexsero was exposed to 11 degree Celsius for 53 hrs and 1.09 degree Celsius for 150 minutes with no prior excursions and the vaccine was administered administered to the patient. HCP (Health Care Professional) was not aware of patient´s gender when asked. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Bexsero vaccine after temperature excursion, which led to Incorrect storage of drug. This was one of the 3 cases reported by the same reporter.; Sender's Comments:  GSK-US2022150627:Same reporter GSK-US2022150628:Same reporter GSK-US2022150629:Same reporter GSK-US2022150632:Same reporter
could not walk; episode of the gout; extremely tired; This is a spontaneous report from two contactable consumers (one of which is the patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Lot Number: EB6204, unknown expiration) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 18Feb2021 (Lot: EN6201, unknown expiration) for COVID-19 immunization and experienced sore arm. Upon receiving the second dosage on 11Mar2021, the patient was extremely tired for about 10 days in Mar2021. The two-week period after vaccination was 25Mar2021. On 28Mar2021, the patient had an episode of gout. The patient had to go to the hospital because the patient could not walk. The patient was diagnosed with gout and given medication which took care of it. The patient had never had any episodes of gout, so it was a surprise to the patient that suddenly would have an episode of gout. Since then on 13Apr2021, the patient has seen the primary care doctor. The patient had urine and blood test and the numbers were normal on unspecified dates. The patient was asked if this could have been a reaction to the vaccine. The patient recovered from extreme fatigue on unspecified date in Mar2021. Outcome of the remaining events was unknown. The events could not walk, and gout were assessed as serious (hospitalization). The event fatigue was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Extremely itchy knees, front of both foot , elbows, right side upper lip swollen ,  also headaches every day for a month after 4 weeks from the vaccine, went to the Emergency room at  for  the itching and swollen lip the very next day of vaccine was told to take Benadryl
Case initially received on Nov 17 2005. It was reported that a 13 year old female adolescent was vaccinated with a dose of inactivated polio vaccine (IPV lot not reported) into the left upper arm on Jul 26 2005. On Jul 28 2005 she experienced neuritis of the right lumbosacral plexus with paraesthesia and paresis of the right leg. She was hospitalised from Jul 28 2005 till several weeks (no exact dates were reported). Meanwhile the patient recovered completely. The treating pediatrician does not see any causal relationship to the vaccination. No further information is expected. File closed.
Patient came in to the Pharmacy and reported swelling and redness at the injection site, chills, joint pain, nausea and a few hours following administration
rash on both my lower legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash on both my lower legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced RASH (rash on both my lower legs). At the time of the report, RASH (rash on both my lower legs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count normal: normal (normal) normal results.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information include platelet test.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild
a child received an adult dose of Havrix; a child received an adult dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HAV (Havrix adult) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th April 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 8th April 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an adult dose of Havrix, which led to overdose and adult product administered to child. No symptoms reported. The reporter consented to follow up.
mom states pt cried incessantly, inconsolable x 3 days w/high pitched cry;finally stopped on 3rd day @ 3PM;
ON Jan 31st The day aFter vaccine I had a Temp 101 and Very achy FeeLing, aLso LeFt arM where They gave Me The shot was swoLLen + sore. The Most aLarming thiNg was that my LeFT Arm started shakiNg + JerKiNg For about 1 MiNute. This has Never happened iN My LiFe
tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (COVID vaccine), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller, a registered nurse, calling about the COVID vaccine. She explained there was no problem but more of a concern. It was explained that on 29Dec2020 she got her first dose and on 08Jan2021 she found out she tested positive for COVID. She would be on day 12 tomorrow when the facility would be giving the second dose. She was told she can't get the second dose by her administrator as she was going by the 14 day requirement. Caller wanted to know if this was true, was it 14 days or 10 days after testing positive before she can get the next shot. If this was true, where can she get the second dose as she would miss the dose at her facility. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of [COVID vaccine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [COVID vaccine] has submitted the same report to the regulatory authorities.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
SYNCOPE/PASSED OUT FOR A COUPLE OF HOURS; SEVERELY DEHYDRATED; FLU; INJECTION SITE WAS SORE; This spontaneous report received from a pharmacist concerned a 44 year old  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 06-JUN-2021) dose was not reported, frequency 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient was severely dehydrated a couple of hours after receiving the vaccine, syncope/passed out for a couple of hours (unsure how long), and injection site was sore. On same day, it felt like the patient had the flu, which was described as chills, fever and the patient's throat being sore at the same time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/passed out for a couple of hours, severely dehydrated, injection site was sore, and felt like patient had the flu on 04-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210411188-covid-19 vaccine ad26.cov2. s-syncope/passed out, severely dehydrated. 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).
On 11/7/12 reported to this RN that had onset of periodic tremors and weakness in right arm within 1-2 days of injection.  Evening of 11/7 had additional tremors of face.  Advised physician care.   Continues to experience some symptoms though to lesser degree as of 12/5.  Worsen with fatigue/stress. Neurology refer made by primary care physician; appt pending this month.  No clear association ID'd by primary physician.
Pt received ZOSTAVAX on 7/16/09.  Within seven days, she states she developed a blistery rash on both sides of her face.  Pt did not seek medical treatment as of yet (8/5/09).  She says the rash has mostly cleared up with the exception of "scarring".
Began as soreness, small pink patch, warm to touch. Progressed to larger, but lighter colored pink patch, itchiness, and continued soreness and warmth to touch.
Patient reports getting the flu shot at 4pm and experiencing extreme "hoarseness" at approx. 8pm. Patient states she could not talk at all.
I was sick to my stomach before leaving for work and had to leave work after 2hrs due to feeling sick to my stomach again.  Vomitted on the way home in my car.  Still feel sick to my stomach  during the day of 10/22/03.
I had no reaction to the Moderna vaccine for Dose 5. On 01/20/2023, I was exposed to COVID-19 at a crowded business. I tested positive for COVID-19 on 01/23/2023. My primary symptom was feeling lethargic. I contacted my doctor, but he did not give me a prescription. I don't remember taking anything to help me with my COVID-19 symptoms. On 03/24/2023, I had nerve tingling on my right thigh but no rash. On 03/26/2023, the tingling was more intense, and the rash appeared. I called my doctor on 03/27/2023 and gave me a prescription that I can't remember the name. On 03/30/2023, the rash got better but the tingling/nerve pain was worse. In 04/2023, I got a prescription for Gabapentin, and I felt much better.
Didn?t feel good in general, had a headache and a stuffy nose.  In the afternoon I developed a fever peaking at 103.3.  Headache was very severe.  Slight cough.  3/28 Tested with At Home COVID-19 Test, Positive.  3/29 Televisit with Doctor.  Who proscribed Molnupiravir.  Fever lasted several days peaking at 102.  Lost most of sense of taste, only able to tase very sweet or very salty things.  On 4/1, the fever dropped to 100.9 or 100.6.   headache diminished as well, but fatigue lingered.  Nasal congestion led to coughing more than any other reason.  Went back to work on 4/3, and the symptoms were greatly reduced.  Taste returned after 2 weeks with fatigue lingered for about 3 weeks.
Left deltoid site hot to touch, swollen, hard and reddish extending 2 inches. Above elbow used ice pack on Saturday then hot packs on Sunday Thru Monday all signs and symptoms subsided except burns at site on Tuesday.
Arm starting severely itching a few hours after injection. Arm became very sore that night, was unable to sleep on my right side. the next afternoon, almost 24 hours after getting the vaccine my arm was extremely inflamed and swollen. Since my doctor was off that day I went to our walk in clinic where they administered a shot and gave me a prescription for Methylprednisolone tablets
TREMORS IN HANDS THAT STARTED THE DAY AFTER VACCINE AND HAVE CONTINUED TO GET WORSE.  THE PATIENT'S ONCOLOGIST TOLD HIM THAT THIS IS NOT A COMMON SIDE EFFECT FROM TREATMENT OR RADIATION.  HIS PCP HAS REFERRED HIM TO A NEUROLOGIST FOR FURTHER EVALUATION.