chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stevens-Johnson syndrome; allergic reaction; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation. The patient medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient stated that 'I had an allergic reaction to the Covid vaccine. Stevens-Johnson syndrome. Due to my past experiences with it, I knew what was going on and got treatment. Doing some googling I learned that those with sulfa allergies shouldn't get the shot. I told the pharmacy about the allergies. Please educate the pharmacies. I'm not taking this anywhere, because people should get the shot if they can'.  Outcome of events was unknown.
Patient received vaccine. Proceeded downstairs to office. Became nauseated and got a bad metallic taste in mouth. Got up to get help then passed out, someone caught her. She shaked for a few seconds and broke out in hives. No loss bowel/bladder function, no postictal state likely vasovagal syncope.
hair loss; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ovarian cancer" (unspecified if ongoing), notes: Patient is a less than 5 year ovarian cancer survivor; "flu" (unspecified if ongoing), notes: Patient reported having the flu 2 weeks prior to the COVID-19 booster. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "hair loss".  Additional information: Patient experienced "significant" hair loss 2 weeks after COVID-19 bivalent booster. Event took place after use of product. Concurrent medications were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to 3 temperature excursions (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and the second lasting for 176 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius), and the last one lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 29-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt diagnosed 10/28/02 by MD saw as having chicken pox. Mom reports "very-light case." Being treated with Zovirax.
Almost debilitating; Inappropriate schedule of vaccine administered; EYE TWITCHING; OCCASIONAL STRONG HEARTBEAT; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), EYE IRRITATION (EYE TWITCHING), HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT), ASTHENIA (Almost debilitating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 048F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Amoxicillin, Amoxicillin, Pseudoephedrine and Caffeine. Past adverse reactions to the above products included Abdominal discomfort with Amoxicillin; Heart racing with Caffeine and Pseudoephedrine; and Vomiting with Amoxicillin. Concurrent medical conditions included Drug allergy (Augmentin), Heart racing and Ear infection (Bacterial , Fungal Ear infections.) in December 2020. Concomitant products included L-METHYLFOLATE from 15-Jun-2021 to an unknown date for Anxiety.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ANXIETY (Anxiety). On 22-Sep-2021, the patient experienced EYE IRRITATION (EYE TWITCHING) and HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT). On an unknown date, the patient experienced ASTHENIA (Almost debilitating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ANXIETY (Anxiety), EYE IRRITATION (EYE TWITCHING), HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT) and ASTHENIA (Almost debilitating) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had anxiety on a daily basis as that happend once thirty years ago due to OTC pseudophedrine, Afrin use and caffeine. Lasted a few weeks and also happend a second time  a couple weeks after flu vaccine several years ago and lasted 2- 3 weeks.  Treatment information does not provided.   This case was linked to MOD-2021-291669 (Patient Link).
Vaccine given before 2 month interval between last the booster dose. Last booster dose was given 7/22/2022 and the bivalent Moderna vaccine was given on 9/12/2022.
Left arm slight soreness > Expected. No fever or raise in heart rate. Mild Fatigue for two days.   About 10 days later was doing regular workout running. I have been biking and running and swimming for years on regular basis  Very sore hamstring pull and unusual muscle soreness in legs after normal workout that has never happened. Legs took several days to recover which is not normal for me.  Seem to be ok now, but strange that I would have that type of soreness.   I am retired teacher of exercise physiology who taught college and also worked in cardiac rehab and with back injuries in past , so found this unusual
Tested + for Covid 19 home test after being exposed by family member who was also vaccinated and boosted x4 doses.  Developed sneezing, cough, runny nose w/o fever.   Consulted primary care provider, Dr at the clinic and was prescribed Paxlovid twice daily for 5 days.  Tested negative 3 days after completing paxlovid treatment.  Continuing to have cough runny nose.
Fever (T max 104 degrees F) and rash on bilateral lower extremities for 4 days, including day of vaccination.  No treatment necessary.
Opened IPOL MDV at a high of 47.5F out of range for 20 minutes with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who experienced opened ipol mdv at a high of 47.5f out of range for 20 minutes with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP),  HEPATITIS A VACCINE (HEPATITIS A,  MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) all for Immunisation.  On 15-Jul-2022, the patient received a  0.5 ml dose of suspect IPV (VERO) vaccine once (lot Z1A024N; expiry date: 17-Feb-2024) via intramuscular route in the left thigh for immunization.  On an unknown date the patient reported opened ipol mdv at a high of 47.5f out of range for 20 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken :not applicable.   At time of reporting, the outcome was Unknown for the event opened ipol mdv at a high of 47.5f out of range for 20 minutes with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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 spontaneous report as received from a registered nurse refers to a male patient of unknown age with autism. On 07-APR-2013 the patient was vaccinated with the first 0.5ml dose of VAQTA intramuscular for work purposes (strength and lot# unknown). On 07-SEP-2013, the patient was vaccinated with the second 0.5ml dose of VAQTA intramuscular for work purposes (strength and lot# unknown). Nurse stated patient received vaccination at unspecified pediatrician's office. Nurse stated she has no patient details and no vaccine lot information. No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Right upper arm: 9cm x 7cm redness, no pain with palpation or much in duration; Left upper arm: very slight redness with mild pain with palpation.
Insomnia.  Can?t stay asleep.  3 nights in a row.  I?m so tired I can?t function today.
Severe headaches and sharp pains in my head. Minor confusion and fogginess. Wake up slightly disoriented.
HYPOTENSION ACUTE PULMONARY EMBOLISM HYPOXIA 12/10/2022,  12/30/2022,  1/3/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection(strength, dose, lot number, expiration date, route of administration were not provided). It was reported that the patient was vaccinated with PNEUMOVAX 23 "every year". There were no concomitant medications reported. No adverse effects were reported and no product quality complain was involved. Additional information is not expected as the reporter did not consent for a new follow up.
atrial fibrillation; tachycardia; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer from pharmaceuticals (as reported). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized due to atrial fibrillation and tachycardia after a week of administration of the first shot of Pfizer-BioNTech vaccine. Hospitalization date was not reported. She believes the adverse events are related to the vaccine. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Papular lesions with an erythematous halo over exposed body areas mainly left leg, one on right foot, one on face, and 2 on low back. Mother gave ibuprofen. Pt. also had a fever, Tmax 100.5 degrees F.
received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 006M20A and 03DL20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 22-Oct-2021. The vial did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment medications were reported.  The vaccine was expired on 24-Oct-2021.
Period delayed two weeks. My cycle is very regular but after the vaccine it was delayed two weeks from the expected date. Additionally, I had a cold sore outbreak starting on April 11.
received a dose of and expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of and expired vaccine) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of and expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of and expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned.  No treatment medication was mentioned.
Rash / hives developed on the inner left thigh.  Itchy, red skin discoloration, small bumps with dime sized hives.  Covers about a 9 inch by 3 inch area of skin.
Injection site became red; Injection site became / warm; Has not received the second dose yet; Lump near her right breast / diagnosed to be a lipoma; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of lymphadenopathy (dose received 25 years ago).   On 12th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In January 2020, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lipoma. On an unknown date, the patient experienced injection site erythema, injection site warmth and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema, injection site warmth, lipoma and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and lipoma to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and  and experienced injection site erythema, injection site warmth,lipoma. The patient did not receved the 2nd dose yet which led to incomplete course of vaccination. The patient stated that she received flu vaccine 25 years ago but did not remember the name of vaccine and after that never received any other flu vaccine. The patient stated that around the end of January 2020 she noticed a lump near her right breast and after ultrasound it was diagnosed to be a lipoma. The reporter consented to follow up. No further information was available.
Unprovoked crying for about 20 minutes,followed by chills and shivering for about 1/2 hour.
CHEST CONGESTION, COUGH, SCRATCHY THROAT, EAR PAIN
Heat; Hardness; This case was reported by a consumer via interactive digital media and described the occurrence of feeling hot in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling hot and induration. On an unknown date, the outcome of the feeling hot and induration were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot and induration to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-JUL-2022. Reporter's Comments: The case was reported by the patient via interactive digital media. The patient had heat and hardness. The patient wanted to know if he or she can do anything to relieve heat and hardness. The follow-up could not be possible as no contact details were available
No adverse effects were reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On 04-NOV-2019 or on 05-NOV-2019, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S000352 with expiration 17-OCT-2021 for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of lowest temperature below 36°F/2 degrees Celsius (1.3C) for 2 hours and 18 minutes with no previous temperature excursion.  There was no adverse effect reported. This call was because of a data logger.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1911USA001917: US-009507513-1911USA002263: US-009507513-1911USA004087: US-009507513-1911USA001946: US-009507513-1911USA002198: US-009507513-1911USA002043: US-009507513-1911USA001926: US-009507513-1911USA002053: US-009507513-1911USA002033:
Administered DTap RD 18/02/2005, IPV RD 08/02/2005. Mother reports 08/03/2005 Child complained of burning, but no redness seen. 08/04/2005 woke up, upper 1/2 of RD Erythemia, warm and generalized induration no change in general energy/behavior
Mother noticed swelling of left upper arm 8-21-07 at 8:30 pm. She applied an ice gel pack to arm. On 8-22-07, at 10:00 am, she came to the health department where nurses noted a swollen, raised, reddened area 4.5 x 2.5 " below deltoid muscle.
Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the left arm on 31Mar2021 at 14:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medication was not reported. 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 31Mar2021 at 21:00, the patient experienced insomnia. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the insomnia was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine given 10/29/02. Hives began 10/31/02 08:30PM. 4:00 AM 11/01/02 having some difficulty breathing. Called doctor 06:00 AM, was told to take 2 Benadryl. Went to hospital shortly thereafter. Given adrenaline plus 2 other medications.
#Covid-19 infection - Positive test at HCF on 12/18/2021 - VSS, afebrile - Asymptomatic at present - Outside of modified droplet period; d/c isolation
Report rash to both inner thighs, left has improve but right getting worst. Treatment: Oral antihistamine with no improvement. Outcome: Does not interfere with ADLs.  Recommend to use OTC hydrocortisone cream for irritation and itching.
Patient felt light headed and fell to floor. Her parents stated she has sstrong aversion to needles. Was given water, and patient walked out on her own.