chrisvoncsefalvay/vaers-outcomes huggingface dataset:
took an entire bottle of Tylenol PM. I wanted to die; emotionally unstable even suicidal; emotionally unstable even suicidal; Emotions became violently unable to control/a day where I was PURE rage; feel sick and run down; feel sick and run down; Throwing up; unable to eat; The dreams of my ex abuser I escaped are prominent in my mind and dream's again now too; I genuinely feel the vaccine did something to my brain/chemical balance/emotional state; Other vaccine same date product: Covid-19/moderna, 06Sep2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on Arm Right on 06Sep2021 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history was reported as none. No COVID prior to vaccination. Not tested for COVID post vaccination. No known allergies. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 07Sep2021 03:00, the patient took an entire bottle of Tylenol PM reporting that "I wanted to die." At the same time, the patient became emotionally unstable even suicidal, emotions became violently unable to control, there was a day where I was pure rage, feel sick and run down, throwing up everyday for no reason, unable to eat for days, had dreams of my ex abuser I escaped are prominent in my mind and dream's again now too and the patient genuinely feel the vaccine did something to her brain/chemical balance/emotional state. The patient added that "I know it sounds crazy but there's no other correlation, nothing else odd happened to me. Can a shot do that to me?" The patient considered the events as life threatening and have case disability or permanent damage. The events required emergency room visit. No treatment was given for the events. It was also reported that other vaccine same date product: covid-19/Moderna on 06Sep2021. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
12:15 PM ? Received Covid vaccine #1 and was to stay in observation x 30 mins. 12:25 PM (approximated time) ? Pt. reports hot face, scratchy eyes, anxiety per RN who was at patient?s side.  Pt. in seated position.  Vitals: B/P 130/70, HR 100 12:27 PM ? Vitals: 124/80, 100% O2sat, HR 97, R 20.  Pt. appears anxious, mild bilateral eye redness, tongue pruritis, ?face still feels warm?, sinus congestion developed, lungs auscultated and clear all fields, no respiratory distress, can speak in full sentences, A&O. EMS called.  Epipen at patient?s side, not given at this time. RN's and Pharmacist by patient?s side.   12:34 PM ? Epipen advised and pt. agrees to administration.  Epipen administered R upper thigh ? tolerated well (Mylan Lot #0FM407, Exp. 2/2022) by Pharmacist. 12:35 PM ? HR 88, 99% O2sat 12:37 PM ? Pt. reports, ?I feel like I?m going to pass out?, ?feeling faint and jittery.? Pt. appears weak, pale without respiratory distress.  RN stabilized pt. and pt. was transferred safely to the ground.  Pt. remains A&O but weak.  Vitals: 130/70, HR 115, R 20, 100% O2sat.  12:44 PM ? EMS arrived 12:45 PM ? EMS reported vitals:  180/110 12:50 PM ? Pt. continues to present with weakness.  Pt. assisted to gurney with EMS support. Pt. had one episode of emesis while on gurney, airway clear.  Patient?s partner arrived per pt.?s request. 12:55 ? EMS departs to transport patient.  Patient alert, eyes tracking.
Pt hx of panic attack-after shot of hep B panic attack increased. Had sweating. Seen in ER 11/6/02 started on Alproyolam and shot Atavan. To see MD 11/13/02 will check with her if she should continue.
Patient has hx of dermatitis herpetiformis, complains of rash on back. First dose 3/8/21, patient reported rash on 3/18/21. Received 2nd dose 04/05/21. Reported again to PCP on 5/17/2021. Currently takes antiviral (famciclovir) every day
1st dose/ on 10/08/2020 and Dose 2 on 5/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th October 2020.).   On 13th May 2021, the patient received the 2nd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows:  The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The 2nd dose administered was later informed to the 2nd line agent. No other details of the vaccine were available. The reporter consent to follow up.
Hot, red, raised rash at injection site. Body aches all over. Every joint and muscle aches. Even my eyelids hurt. Had a fever of 100.4 earlier (day after 2nd shot) and now at 99.5. Very painful arm at injection site. Extremely tired.
Bell's Palsy two weeks after first dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bell's Palsy two weeks after first dose of Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy two weeks after first dose of Moderna vaccine). At the time of the report, BELL'S PALSY (Bell's Palsy two weeks after first dose of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported.   Treatment information was not reported.   The reporter did not want to disclose any of the patient's personal information and wanted to know if other patients have developed Bell's Palsy after receiving the Moderna vaccine.  The reporter also wanted to inquire about recommendations for the patient's second dose of the vaccine.; Sender's Comments: Based on the current available very limited information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022; provided doses of Moderna COVID-19 vaccine after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (provided doses of Moderna COVID-19 vaccine after the beyond use date) and PRODUCT STORAGE ERROR (The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022 at 7:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-May-2022 at 7:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (provided doses of Moderna COVID-19 vaccine after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (provided doses of Moderna COVID-19 vaccine after the beyond use date) and PRODUCT STORAGE ERROR (The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vials initially stored on 31 Jan 2022, and thawed expiration date was 2 Mar 2022. The vial did not undergo any temperature excursions.           No treatment medication was reported.
feeling hot; flushed with chills; strong stomach pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion hydrochloride (MANUFACTURER UNKNOWN) 150 of unspecified units and omeprazole (MANUFACTURER UNKNOWN) 20 of unspecified units, both from an unknown date for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 12:00, the patient experienced feeling hot, flushed, stomach pain and chills. Its reported that the patient felt hot and flushed with chills and strong stomach pain lasting all day (it was day 12 of it at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included treatment with tylenol (MANUFACTURER UNKNOWN) and pepto bismol (MANUFACTURER UNKNOWN). The clinical outcome of the events of feeling hot, flushed, stomach pain and chills were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Experienced (R) arm pain within an hour of injection, with increase of pain in arm. On day 3 experienced decreased sensitivity in (R) arm with decreased finger grip strength and arm numbness.
TINGLING; NUMBNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tingling, and numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling and numbness was not reported. This report was non-serious.
On day of vaccinations, developed local reaction at site ( swelling and red) which is gradually resolving. 2 weeks after vaccine had rash develop on legs, then arms which is consistent with eczema. Recovering.
Patient received vaccine and after a few minutes reported feeling dizzy and  said her heart was racing, she was afraid of dying and asked me to call an ambulance. I called an ambulance but patient ultimately did not go to hospital. When followed up with her relative told us that while she was waiting 15 minutes patient was told on phone by relative  that a patient just died after getting the vaccine and so she had a panic attack thinking that she would die.
I initially felt unease then I felt swelling in my throat with dry mouth and some difficulty swallowing
Fainted; Sudden light nausea; Full body chills; Muscle weakness in legs; Lightheadedness; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 26Feb2021 12:15 (lot number EN6203) and on 19Mar2021 12:00 (lot number EN6208), respectively, both via an unspecified route of administration in the right arm (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included: fluoxetine hydrochloride (PROZAC), lorazepam, and pantoprazole. The patient had an allergy to contrast dye. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced sudden light nausea, then full body chills, followed by muscle weakness in legs, and lightheadedness, then she fainted. Then she was fine. This whole reaction progression took place within 60 seconds, plus about 2 minutes for full leg muscle strength to return. No treatment was received for the events. The patient had a negative nasal swab COVID test on 04Mar2021. The outcome of the events was recovered on an unspecified date.
"I have a huge red spot where the virus was injected. It is raised and has been sore plus a little itchy".
no adver event; Patient was administered an improperly stored PROQUAD.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided.       On 21-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S021324, with an expiration date in 05-JAN-2021), for prophylaxis (strength, dose, frequency and route were not provided), that underwent two temperatures excursions, the first from 6 degrees Fahrenheit to 14  degrees Fahrenheit , during a time frame of 11 hours and 30 minutes, and the second, from 6  degrees Fahrenheit to 14  degrees Fahrenheit, during a time frame of 18 hours. The dose was reconstituted with properly stored sterile diluent. digital data logger was not involved, and no additional adverse events were reported.
The beyond use date was noted 2/24/23, but the lot number of 057A22A had expired on 2/6/23 at the time of administration (2/11/23).   Per the manufacturer?s lot number assessment, the specific lot number maintained the activity to provide protection. Therefore, the patient is being contacted to be notified of the event and also being informed that she would not need to repeat the series.
off label use of GARDASIL; patient was administered GARDASIL (4 valent) for 3 doses prior to the age of 9; This spontaneous report was received from a physician who was reporting on 8-year-old female patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 23-SEP-2013, 03-DEC-2013 and 07-APR-2014, the patient was vaccinated with three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route of administration, anatomical location, strength lot number and expiration date were not provided), prior to the age of 9 years, for prophylaxis. On 24-JUL-2019, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, strength lot number and expiration date were not provided) also for prophylaxis. It was reported that the use of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) on 29-SEP-2013, was off-label.
Pt given FluMist intranasally. She had no URI or illness symptoms preceding and temp=98.2. 10-15 minutes later she developed mild substernal pressure/tightness that persisted for about 1 hour and 20 minutes. She was given ibuprofen 800mg and Zyrtec 10mg 15 minutes before resolved. No recurrence and didn't go on to infectious symptoms.
Information has been received from a physician concerning a female who on 22-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). The same day, the patient's mother called the office to report that her daughter was experiencing vomiting and her nipples were cracked and bleeding. Additional information has been requested.
Fluzone HD was accidentally administered to someone under 65/no AE; Fluzone HD was accidentally administered to someone under 65/no AE; was pregnant/no AE; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involved less than 65 year old female pregnant patient (Exposure during pregnancy) for whom it was reported that quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) was accidentally administered to someone under 65/no AE (adverse event) (Inappropriate age at vaccine administration and overdose).  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. The patient did not receive any other vaccinations or medications   On 19-Oct-2020, the patient received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) (batch number: UJ491A and expiration date: 30-Jun-2021)  at a dose of 0.7 ml via unlnown route in the left deltoid for prophylactic vaccination.   On 19-Oct-2020, same day after initiation of quadrivalent influenza vaccine, accidentally administration of quadrivalent influenza vaccine to someone under 65 and was pregnant with no adverse event (AE) was reported.   It was a case of overdose and also a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
ON DAY 8 POST VACCINATION, I DEVELOPED 24 HOURS OF IRREGULAR (MID-CYCLE) VAGINAL BLEEDING
Pt recv vax on 4/10/97; on 4/7/99 pt exp lesions over body w/ scabbing
No adverse symptoms at time vaccine was given.  No adverse signs noted at the time the vacine was administered.  No calls from parents to report adverse effects.  .25 cc adult flu vacine given instead of pediatric flu vacine.  This report is being filled out per call to VAERS by supervisor who stated that vacine was not recommended in children under 4 years of age and VAERS report should be completed.
Generalize itching (face and scalp); anorexia; nausea; mild headache; fatigue; insomnia; numbness on legs; Throat swollen up; This spontaneous case was reported by a physician and describes the occurrence of PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea) and HEADACHE (mild headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (Throat swollen up). On 11-Feb-2021, the patient experienced DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs). On 15-Feb-2021, the patient experienced PRURITUS (Generalize itching (face and scalp)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; PEPTIDE LOPHE at a dose of UNK dosage form and MULTIVITAMINS & MINERALS PLUS LUTEIN at a dose of UNK dosage form. At the time of the report, PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
On day 1 - 2 I had "normal" reaction of sore arm, and some redness.  On day 3, reaction went away.  On day 8, I woke up with a rash on my arm (surrounding the injection site).  As the day went on, I experienced redness, warmth, and swelling in the same area.  Today is Day 10  and I am still experiencing the redness, warmth, and swelling.  I am taking Benadryl to try and alleviate symptoms.  No fever is experienced.
First pregnancy, diagnosed at 32 weeks pregnant with IUGR, previous ultrasounds showed baby as normal size for fetal age. Due date 02/07/2022
INCORRECT PRODUCT STORAGE; JANSSEN COVID VACCINE DOSE GIVEN AFTER 6 HOUR; This spontaneous report received from a health care professional concerned a 49 year old female. The patient's weight was 133 pounds, and height was 64 inches. No past medical history or concurrent conditions were reported.  The patient experienced confusion and dizziness when treated with isoniazid for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-JUL-2021 03:45 for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, the subject experienced incorrect product storage. On 13-JUL-2021, the subject experienced janssen covid vaccine dose given after 6 hour. The outcome of the incorrect product storage and janssen covid vaccine dose given after 6 hour was not reported. This report was non-serious.
The Menveo Vaccine was mixed with the wrong diluent.  Menveo comes with a diluent to mix with it.  The nurse mixed it with the wrong diluent.
This spontaneous report as received from a other health professional refers to a 2 year old patient. On 08-JUL-2014 the patient was vaccinated with a dose of M-M-R II (lot # J015503, expiration date: 05-DEC-2015, dose and route not reported) and a does of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported), both vaccine were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Pt was given two injections in right thigh. First DTaP #5 no previous reaction & MMR first dose. Pt had 6 mm size circle that was red and hot to touch. Pt mother also noted fever of 101.0.
Vertigo symptoms gradually become severe when laying down 2-3 weeks after second dose of Moderna. Symptons resolve themselves in 1-2 weeks after peak. Then, approximately 5 weeks after second Moderna dose I began experiencing heart palpitations occurring frequently (approximately ever 20 minutes) over the span of 3 days. Symptoms resolve completely after approximately 1 week.