chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suffered a neurological setback following the first injection; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the nursing home/senior living facility. Relevant medical history included multiple sclerosis (advanced stages), diabetes, and COVID-19 prior vaccination; all from an unknown date and unknown if ongoing. The patient had other medications in two weeks, which included diabetic medications (meds, pills), anti depressants, etc. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. On an unspecified date in Dec2020, the patient suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time. The event was considered serious as it resulted in disability or permanent damage. The patient underwent lab tests and procedures, which included an unknown COVID-19 test via nasal swab: negative on an unspecified date in Jan2021. It was unknown if the patient received any treatment for the adverse event (AE). The patient was not recovered from the event.  Information on the batch/lot number has been requested.
Pt recvd vax & exp burning during inject of Hep B vax; No further details were provided;
Seconds 20 - 30 (1/2 minute) of seizure like activity and stiffening and generalized shaking.
6/10/08 Head ache, sore throat, fever, fatigue, vomiting.
Went into convulsions approximately 12 hours after receiving the first dose of the vaccine.  Thought he was going to die.  Attempted to dial 911, could not pick up phone due to convulsions.  Is more scared of dying of COVID than of dying of vaccine, so will be going in for 2nd dose and wishes to remain anonymous.
UNUSUAL SEIZURE--NOT LIKE NORMAL PATTERN --STOOD UP AND WOULD NOT SIT DOWN --RECOVERED WELL THOUGH NO TREATMENT OTHER THAN SOMEONE WITH ME UNTIL i CAME AROUND .i HAD NOT HAD A SEIZURE IN 7 MTHS.
Info has been received from a nurse concerning a 12 y.o. female child w/unknown allergies and medical history who on unspecified dates, was vax'd w/doses of Hep B vax recombinant. Subsequently the PT developed vomiting and diarrhea after her 2nd dose of Hep B vax, and fever of 102 deg F w/achiness after her 3rd dose. Unspecified medical attention was sought. Add'l info has been requested.
Sore throat, cough, watery eyes, body aches, sinus congestion, sinus pressure, fatigue. Treated with Azelastine nasal spray, Nasacort, Allegra, Benadryl with no improvement of symptoms. 10/3/2015 started Medrol pack. Symptoms improving as of 10/3/2015.
Sl fever, achy all over, red, raised lump on arm, itchy 2 cm x 4 cm (R) deltoid. KEFLEX 500mg TID x10 days.
Started with onset of fever, chills, couldn't get warm and all over body pain which seemed to be normal side effects and then progressed to develop a red body rash from the neck down to the ankles which made my skin hot and I had to run a fan to cool my skin and make clothing comfortable.  Lasted two and a half days.
Expired Menveo administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 31st March 2022) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th August 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter stated that the patient received an expired Menveo vaccine. The reporter asked how to proceed, patient should revaccinate. The reporter confirmed that the expired vaccine was administered in their facility. The reporter inquired how to proceed, and should they revaccinate the patient. The reporter consented to follow up. Additional supportive information: The patient received a Menveo which was already expired, which led to expired vaccine used.
Patient reported on 3/18/13. 48 hours after shot: heavy/stiff feeling at the base of the skull and throbbing jaw pain. Symptoms subsided after 3-4 weeks, but returned and has persisted through present. Large hematoma on arm x 3-4 weeks. No fever.
Morning after he got the shot....Wave of severe fatigue, had to lay down as he thought he would fall over.  Temperature went up a 1/2 degree celius.  Went back down later that day.   12/17/2020 2:34 am he woke up with rigors and chills, went away in 3-4 min.  Had abdominal pain later during the day.N
Headache inecjtion site pain, chills Narrative:  Other Relevant History:
suspected Parkinson disease; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's second dose is due on 16Apr2021. A day before her second dose she will undergo a nuclear scan for suspected Parkinson disease. It is a dots nuclear medicine scan that will inject radioactive tracer in her system. Asking if this will counteract with the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
itching on arms, feet, ankle, heartburn: rash spread, upper lip swelling, throat itchy, tonguevswelling,  body aches
Rash at injection site which continued to spread after 3 days.  Went to physician (1/28/2021) who prescribed Triamcinolone 0.1% cream.
3 day p/vax pt devel fever,V,refuse to eat.Very tired,sleeping a lot.
Symptoms noted upon diaper change at 7:30pm. Both legs red with welts from waist to feet.  Rash also noted on buttocks, but not on or around genital area.  Symptoms still present when child put to sleep at 11:00pm.  He slept well through night.  Upon awaking, the welts were gone.  Legs had "blotchy, 50-cents sized red areas" on both legs.  He attended day care the entire day on 2/5/10. Child slept 13 hours on Friday night (2/5).  Mom did notice that a tooth was erupting on the morning of 2/6/10.  Described him as "cranky" and irritable on 2/6.  Given Tylenol at that time, mainly for oral pain.  Rash resolved by the evening of 2/6.  No breathing or fever concerns ever noted by mother.  Mom did contact "Ask A Nurse" via telephone on 2/4/10 when symptoms noted and instructed to monitor without use of medication.  Seek further treatment if symptoms continued or became worse.
Presented via EMS w/ SOB, hypoxia and recent Covid + test. Tx for covid pneumonia (steroids, Remdesivir, O2)
a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-May-2022, the patient experienced ACCIDENTAL OVERDOSE (a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine). At the time of the report, ACCIDENTAL OVERDOSE (a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  It was reported that, the patient has not received their 2nd dose yet but will be receiving Pfizer because that's what their practice is giving moving forward.
Third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third shot of Moderna, 2 Pfizer shots previously) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third shot of Moderna, 2 Pfizer shots previously). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third shot of Moderna, 2 Pfizer shots previously) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning a 60 day old male who on 25-SEP-2007, was orally vaccinated with his first dose of Rotateq (lot# 647100/0875N). On 02-OCT-2007, the patient was seen in the office by his physician after he had developed mucousy diarrhea with occult blood. His stools tested positive for rotavirus. He was initially breast fed, then switched to a soy formula, and on 02-OCT-2007, was switched to Nutramigen. He did improve on "therapy" and is recovering. No product quality complaint was reported. No further information was available. Upon internal review, haematochezia was determined to be an other important medical event. Additional information has been requested.
Following the SARS-CoV-2 vaccine, I developed tinnitus in the left ear.  It was a gradual process, but it is now present 24/7 without any relief.
Expired dose had been given to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 8:31 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 8:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. No treatment information was provided.  The Moderna vaccine was pulled from freezer on 16-Dec-2021 and the beyond use date of the vaccine of 15-Jan-2022 was printed in red and taped to the top of the boxes of vials.  On 26-Jan-2022, the staff brought it to the reporter's attention that it was still in the fridge and had expired.  On 31-Jan-2022, the reporter was informed that revaccination was not required for the patient. The patient was notified that revaccination was not required and the patient denied having any adverse effects.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received included non significant information.
my life is scrap since then; Difficulté of breathing; Chest pain; Not even capable to talk; Not even capable to clean the house/have no revenue since the vsccine/Can t work neither; No life quality when you must stay at home; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (my life is scrap since then), DYSPNOEA (Difficulté of breathing), CHEST PAIN (Chest pain), APHASIA (Not even capable to talk) and IMPAIRED WORK ABILITY (Not even capable to clean the house/have no revenue since the vsccine/Can t work neither) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (my life is scrap since then), DYSPNOEA (Difficulté of breathing), CHEST PAIN (Chest pain), APHASIA (Not even capable to talk), IMPAIRED WORK ABILITY (Not even capable to clean the house/have no revenue since the vsccine/Can t work neither) and QUALITY OF LIFE DECREASED (No life quality when you must stay at home). The patient was treated with FORMOTEROL FUMARATE, MOMETASONE FUROATE (ZENHALE) for Chest pain, at a dose of 4 inhalation 2 times a day. At the time of the report, FEELING ABNORMAL (my life is scrap since then), DYSPNOEA (Difficulté of breathing), CHEST PAIN (Chest pain), APHASIA (Not even capable to talk), IMPAIRED WORK ABILITY (Not even capable to clean the house/have no revenue since the vsccine/Can t work neither) and QUALITY OF LIFE DECREASED (No life quality when you must stay at home) outcome was unknown.            Treatment drug used Ventlolin: 4 to 8 doses . Ecg angio poumons chest ray, Blood test : No clots.
No additional adverse effect reported; PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-FEB-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T027115, expiration date: 07-FEB-2022 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was stored improperly for the time frame of 22 hours in the temperature between -10 degrees Celsius (C) and 8 degrees C (-3.7 C). There was no previous temperature excursion. Digital Data Logger was involved.  There was no additional adverse effect reported.
03/14/2021: Presented to the emergency department due to fall which occurred prior to arrival. Patient states he climbed up his attic, lost balance came down rolling the stairs and hit the back of his head. He did not lose consciousness, but is taking a blood thinner. The patient is currently still admitted with subarachnoid hemorrhage and pelvic hematoma.
Injection site - red (size of a softball), hot to the touch and swelling. The redness was present for over a month. It did "fade" over a month to pick, then very light pink.
Arm turned red, was swollen, hurt and she ran a fever --was much worse that night--- told she could  take tylenol or ibuprofen for pain or fever --she said she was a nurse.
General paralysis, cloudiness of mind, breathing difficulties, bloating, chronic colds, flu, runny nose, phlegm, aches, pains in muscles, excessive diarrhea, nervousness, headaches, fever, anaphylaxis and more, etc.
Late evening/night of 1/16/21, noted soreness of L arm pit. Morning of 1/17/21, felt mild headache and fatigue. Left arm pit pain continues but seemed to be less as the day went on on 1/17/21. Took temperature earlier in day and was 99.1. Took temperature at around 4pm and temperature was 101.1 and took acetaminophen 500 mg. At time of this report, left arm pit pain more mild. Called primary care provider for advice and will continue to monitor self at home.
Nurse calling to ask about what regimen she should follow for GARDASIL 9 for a patient who received her first dose at 12 years old and is now almost 18 years old and has not received any subsequent doses. No additional AE/PQC.; No Adverse Event; This spontaneous report was received from an other health care professional refers to a 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (at 12 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the patient received her first dose at 12 years old and is now almost 18 years old and has not received any subsequent doses. The nurse calling to ask about what regimen she should follow (inappropriate schedule of product administration). No additional adverse event reported (no adverse event).
lump at the injection site; injection site bruise; injection site redness; patient got a subcutaneous injection instead of intramuscular route; needle that was on the syringe did not go all the way in; Initial information received on 11-Nov-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (under reference: US-SA-SAC20211116001392).  This case involves adult female patient who experienced lump at the injection site (vaccination site mass), injection site bruise (vaccination site bruising), injection site redness (vaccination site erythema) also got a subcutaneous injection instead of intramuscular route (incorrect route of product administration) and needle that was on the syringe did not go all the way in (wrong technique in product usage process) when received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 21-Oct-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, lot number: U6846AA and expiry date: 16-OCT-2022) via subcutaneous route in deltoid muscle of the arm for prophylactic vaccination.  It was an actual medication error due to inappropriate route of vaccination and wrong technique in product usage process (same day).  On an unknown date the patient developed a non-serious lump at the injection site (vaccination site mass), injection site bruise (vaccination site bruising), injection site redness (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  The patient believes that the needle did not go into the muscle.  It was reported "The caller would like to know if they need to repeat the injection. The caller also would like advice regarding how to treat the lump at the injection site."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for all the events.  The reporter assessed the causal relationship for events (vaccination site mass, vaccination site bruising, vaccination site erythema, incorrect route of product administration) with the ADACEL as not 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 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 solicited report was received from a consumer enrolled in a Market Research Program and refers to a patient of unknown age and gender. The patient's current conditions, medical history, known allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot number and expiration date were not reported) and was affected by it (onset date was not provided). The reporter stated that was why they did not feel it was safe (in response to the question "For what reason(s) are you not open to consider vaccinating your children against HPV in the future?"). The reporter also stated that they felt it was preventable by safe sex and routine doctor visits/monitoring. The outcome of adverse event was unknown. The causality between the adverse event and suspect therapy was reported as related. Additional information has been requested.
17 year old patient presented to clinic with parent for  his first Covid vaccine, patient was administered Moderna instead of Phizer. Parent was notified and no additional adverse signs and symptoms reported by parent.
Information has been received on 31-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 21-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered unexplained rashes, arthralgias, fatigue, tremors, headaches, unexplained weight loss, and hair loss and was diagnosed with Lupus Erythematosus. In addition, the patient's vision gradually decreased to the point that it was severely blurred, and she could no longer drive or read any longer. As a result, the patient was diagnosed with strabismic amblyopia, cataract, dry eye syndrome, blepharospasm and nuclear sclerosis. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Lupus Erythematosus, strabismic amblyopia, cataract/nuclear sclerosis, dry eye syndrome, and blepharospasm were considered to be disabling. Upon internal review, Lupus Erythematosus and cataract/nuclear sclerosis were considered to be medically significant. Additional information has been requested.
At the site where the vaccine was administered, my four-year-old son developed a very red and raised/swollen circle around the injection site, about two inches in length across. The injection site also felt hard underneath the skin when I pushed on it with my finger and the skin felt chapped at that location as well. The injection site bled a bit after the shot was administered so I don't know if the reaction was due to that or if it was a reaction to the vaccine. My son had no other symptoms, however (no fever or sluggishness, rash, or anything else).