chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his wife took the shot and she had no reaction, just a little soreness; This is a spontaneous report from a contactable consumer (husband). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The husband reported that his wife took the shot and she had no reaction just a little soreness. His wife also mentioned that his needle didn't go in as much as when she got her injection, so he was wondering if his vaccine was administered in the right way. The outcome of the event was unknown.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021075865 Same reporter/drug, similar events, different patient
Mom states child lethargic around 5:30 pm, 6 pm while strapped in highchair-arms straight out, whole body shaking (probably lasted 20-30 seconds).  911 called-ambulance to hospital.  Postictal "came to quite quickly".  1-15-08-11:30 flu with pediatrician, temp 101 degrees ear.  1-16-08-3 family members with fevers, runny nose.
expired QUADRACEL was administered to a patient, with no reported adverse event; Initial information received on 03-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4-year-old male patient to whom an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation.  On 03-Apr-2023, the patient received 0.5ml total dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection (strength: standard) (lot number: C5862BA, expiry date: 01-Apr-2023) via intramuscular route in the right thigh for Immunization and on the same day expired quadracel was administered to a patient, with no reported adverse event (expired product administered).  It was reported, caller requesting next steps to take.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  At time of reporting, the outcome was Unknown.  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.
her chest was broken out with raised red blotches; itchy; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient (also reported as age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 13Jan2021 at 08:15 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and azithromycin (AZITHROMAX) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient took the shot on 13Jan2021. When she woke up the next morning (14Jan2021), her chest was broken out with raised red blotches. She also felt itchy on 14Jan2021. She visited her physician on the 15th and was given Benadryl as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
3 doses of Hepatitis B in the past / 1 dose of Twinrix; received 1 dose of Twinrix when she was when she was 16 or 17 years old / administered pediatric Havrix yesterday; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received HAV (Havrix pediatric) (batch number Y4FL4, expiry date unknown) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 3 doses of Hepatitis B in the past on an unknown date) and Twinrix (received 1 dose of Twinrix when the patient was 16 or 17 years old).   On 31st March 2021, the patient received Havrix pediatric. On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Havrix pediatric and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination 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 age at vaccination was not reported. The patient received Havrix Paediatric, which led to wrong product administered. Till the time of reporting, patient did not received further doses of twinrix, which led to incomplete course of vaccination. The reporter stated that, the patient had received 3 doses of Hepatitis B vaccine in the past. The reporter consented to follow up.
shocklike sx p/vax BP 64/30, cyanotic, diaphoretic, incoherent approx 1 min blowing resps, P 60 regular, pupils dilated; recovered p/administration of 02 per nasal canula @ 4 1/2mins & trendelenberg position over period of 1 hr;
Patient received vaccine on 4/30/14. On 5/6/14 patient noticed her arm to be red, warm and swollen. Patient went to the ER on 5/6/14 and was diagnosed with cellulitis. The ER couldn't confirm it was from injection.
diarrhea, diaper rash to include blisters, cracking & bleeding, stomach cramps, irritability;diarrhea cleared p/several days;other sx still occurring
Son had a seizure in my arms, turned pale, lips blue, lasted 5mins or so.  No treatment, called ambulance, took to doctor after.
Feet were slightly swollen; full body rash; Hives; fever; Eyes very red, the sclera were pink, no oozing; Soreness at injection site; This is a spontaneous report from a contactable consumer or other non hcp. An 86-years-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single (13:20-13:30 2nd Dose (24-hour clock) for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 24Feb2021, patient had Soreness at injection site. On 04Mar2021, patient experienced fever, Eyes very red, the sclera were pink, no oozing. On 05Mar2021, patient had full body rash and hives and on 07Mar2021, patient experienced Feet were slightly swollen. Reporter states the patient has been taking Prednisone. She states that usually with a food. allergy, after a couple of days it should be better or almost gone. Therapeutic measures were taken as a result of fever and hives. It was reported that, 8 days after receiving the second dose of the vaccine, reporters mother broke out in hives from head to toe for a week. It started in her eyes and it looked like conjunctivitis then it appeared on her arms then all over the body. She also had fever 8 days after receiving the vaccine. In Feb2021, patient was recovered from the event Soreness at injection site. On 09Mar2021, patient recovered from the event Feet were slightly swollen. At the time of report, patient was recovering from eyes very red, the sclera were pink, no oozing while she was not recovered from full body rash and hives. The outcome of event fever was reported as unknown.  Follow-up (27Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a patient.  No follow-up attempts were possible; information about lot/batch number could not be obtained.  No further information was expected.
Patient is fully vaccinated.  COVID positive 1/1/2022.  Presented to the ED 1/1//2022.  29-year-old female with history of cerebral palsy and anxiety states that she has been experiencing diffuse, generalized body aches, sore throat, dry nonproductive cough, and intermittent fevers and chills for the past 4 days. Positve for nausea. She denies any chest pain or shortness of breath at any time. CXR:  No acute pulmonary process. Given IV fluids and zofran. set up for monoclonal therapy as an outpatient.  Stable and discharged.
pt recvd vax;high pitched cry for 2 hrs on day of vax;exam 13mar nl;still brief episodes of high pitched crying 1-2/day;
10/11/12 PNEUMOVAX and Flu vacc. admin. right bicep. 10/13/12 pt presented at Express Care with redness, swelling and pain right arm. Diagnosis: Allergic Reaction, cellulitis of the arm. Treatment: Cephalexin 500mg 1 tablet TID, BENADRYL.
Pt reports facial droop to left side, inability to speak/slurred speech, 'fat' tongue, tremors to left arm, generalized tingling, and 'racing' heart.  A&Ox4, denies lightheadedness/dizziness, chest pain or shortness of breath
passed about 1 cup of blood in her stool from her rectum; passed about 1 cup of blood in her stool from her rectum; sore arm; temperature/fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum) and RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum) in a 38-year-old female patient 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.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum) (seriousness criterion medically significant), RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum) (seriousness criterion medically significant), PYREXIA (temperature/fever) and MYALGIA (sore arm). At the time of the report, HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum), RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum), PYREXIA (temperature/fever) and MYALGIA (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum), RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum), PYREXIA (temperature/fever) and MYALGIA (sore arm) to be possibly related.    Concomitant medication included was Sedatives for the colonoscopy. No treatment medication was provided by the reporter. Lab test included was Colonoscopy performed - No results were provided.  The patient received her second dose of the Moderna COVID-19 vaccine by injection at the end of May. After receiving the vaccine, that day she had a sore arm and fever which lasted about 4 hours. She also went to the restroom that night and passed about 1 cup of blood in her stool from her rectum. The patient talked to her primary care doctor and sent a picture. She was referred to a gastroenterologist who performed a colonoscopy. The gastroenterologist stated that her symptoms were likely vaccine related. Besides sedatives for the colonoscopy, no medications or treatments were given.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
right leg, arm, and cheek felt strange; Slight tingling in face which spread throughout out body/ One week after woke up to right hand asleep/pins and needles; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 24May2021 11:30 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Not pregnant at time of vaccination. No other vaccine in four weeks. Medical history included insomnia, Penicillin allergy, Liquid IV Contrast allergy. No COVID prior vaccination. Concomitant medications included ibuprofen; zaleplon. The patient experienced slight tingling in face which spread throughout out body beginning one day after receiving 1st dose on 25May2021 08:00. One week after woke up to right hand asleep/pins and needles and right leg, arm, and cheek felt strange. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization with duration of 1 day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31May2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fatigue, malaise, headache, confusion, copious rhinorrhea, somnolence. "3 days not fit for duty".
Fever, chills with uncontrollable shaking, whole body muscle fatigue and soreness, swollen lymph node with extreme pain. On 4/16/21 the pain from my left armpit lymph node almost made me vomit. Swelling has persisted through today 4/20/21. Chills started on 4/15/21 and ended 4/18/21. Fever from 4/15/21 to 4/17/21.  Treated with bedrest and ice pack / warm compress.
pt recv vax & w/in 24hr post vax pt exp swollen arm @ inj site, fever to 102, listlessness, & flu sx; sx resolved;
Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.
delayed reaction - hard, raised, itchy welt at injection site.  approximately two inches in diameter.  lasted three days
At approximately 15:00 on day of 2nd Moderna Vaccination Shot (given in LEFT UPPER ARM), I developed posterior mid-thoracic level back pain (atypical for me) which was extremely tender to palpation and 'dull, achy pain' at around the T7-T9 region and mainly located within T7-T8 and T8-T9 intervertebral joint region.   At approximately 23:00, the evening of the 2nd Moderna Vaccine Shot (evening of 1/27/21), I developed a fever of 101.0 F. At around 01:00 AM on 1/28/21, my fever spiked to over 102.2 F and I was vigorously shaking with 3 layers of sweatpants, 3 layers of sweatshirts and 3 heavy blankets over me. I also developed RIGHT sided lower 'tooth/jaw' discomfort, as if I had an abscess in my lower posterior teeth on the RIGHT side.   The fever broke to around 100.0 F at around 9 AM the morning after my 2nd Moderna Vaccine. But, again, at ~15:00 on day post-2nd shot (1/28/21), I developed a 101.0 F fever and was exhausted. By 9:00 AM on 1/29/21, I felt 100% better and remained asymptomatic.  I have never, in my life, experienced anything like what I experienced the night of and the early morning of the day after my 2nd Moderna vaccine. I have been sick before, hospitalized with high fever, and I have never felt the way I felt during the post-vaccine period. I also believe I was somewhat 'delusional' as I remember waking up at around ~3:00 AM on 1/28/21 and I was screaming, for no reason what so ever, which was quite worrisome.
Experienced thrush after COVID 19 booster shot; Experienced thrush after COVID 19 booster shot; Experienced thrush after COVID 19 booster shot; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date not reported) via an unspecified route of administration on unspecified date as dose 3, single for COVID-19 Immunisation. Medical history included kidney transplant from 2020. Patient also had kidney transplant last year and is on immunosuppressants. Patient concomitant medications were not reported. Historical vaccines included dose 1 and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date was not reported) via unspecified route of administration received on unknown dates for COVID-19 immunization. Event took place after use of product. On an unspecified date the patient experienced thrush after COVID 19 booster shot. The Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient presents to the ED today (4/27/21) with c/c left arm numbness and pain after receiving the second Moderna Covid-19 vaccine. Patient states she got the vaccine on Sunday 4/18. Patient states she has has pain in the arm since receiving the vaccine and has been taking ibuprofen which helps a little. Patient states that the pain and numbness is radiating up into her neck and chest, notes clumsiness in left hand. It initially began on the 20th then improved but returned 3 days ago.  We discussed potential empiric treatment with Flexeril and Medrol with plan for follow up.
strong flu like sickness 4 or 5 days horrible hives all over body except face, hands and feet 2 weeks  loss of energy dexamethasone one shot, prednisone 5 days, a few loratadine I feel better now still have some lingering hives
patient received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time; 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 PRODUCT DOSE OMISSION ISSUE (patient received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-JUL-2021 and reporter information was updated
Temperature 99.4 and chills sustained for 14 hrs beginning @ 0430 on 03/06/2021 /  Body aches, stiff neck, significant pain in left arm 7/10 sustained until 03/08/2021 / unable to complete usual daily activities until side effects subsided on 03/08/2021
Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body; Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) and FEELING ABNORMAL (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body). 11-Feb-2021, the patient experienced FEELING ABNORMAL (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) and FEELING ABNORMAL (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) had resolved.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-133172 (E2B Linked Report). This case was linked to MOD-2021-132767, MOD-2021-133270 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133172:Case for patient second dose
She had pain at the injection site for a few days after vaccination. Roughly one week later, she started some weightlifting (she states not very heavy weights, does not sweat during lifting) and noticed pain in the injection site again. The pain has continued and impacts her sleep. The pain radiates from her injection site down into her fingers and up into her shoulder. Ibuprofen and acetaminophen provide some relief but do not eliminate it completely. She stated that before she started lifting, she had no pain whatsoever after the first few days after the vaccine. She also stated that her left arm does not hurt at all, but the right arm (vaccine site) does.
3 hours after the vaccine, back started feeling hypersensitive and couldn't stand anything touching back.  Then became painful and developed and there was a welt on back. Found out that it was Shingles.
Within 30-60 minutes after receiving flu shot patient experienced hives and excessive itching no other symptom reported. Patient contacted primary care provider whom told her to visit ER. Patient was treated with BENADRYL at ER. DC home same day.
Patient is a 23 year old female presents complaining of right arm pain, fever. Patient states 6 days ago had Pneumovax shot right arm. States 5 days ago started to have pain right arm and difficulty moving arm because of pain. States now able to move the arm but pain has spread to right axilla. + fever 101.8 last night. Denies headache, cough, rhinorrhea, sore throat, vomiting, diarrhea, numbness, weakness + nausea. Denies abdominal pain. No dysuria. No rash.