chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erythema & pruritis on head, trunk and arms. Tingling on tongue, no visible angioedema. No hives. Epinepherine 0.3mg IM given.
The initial spontaneous report was received from a registered nurse referring to patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 12-JAN-2016, the patient received a dose of improperly stored PNEEUMOVAX 23 injection (lot # K021030 with expiration date 22-JUN-2016; dose and route were not provided). It was exposed to temperature of 48.9F for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several report received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 09:00 as dose 1, single (Lot number: EWO153), in left arm, on 29Apr2021 at 09:00 as dose 2, single (Lot number: EWO167), in left arm and on 16Nov2021 at 09:00 as dose 3 (booster), single (Lot number: EWO173) at the age of 61 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: FLUOXETINE, start date: 08Mar2022; ALBUTEROL HFA, start date: 11Jun2022; ALVESCO, start date: 11Jun2022; VITAMIN D [COLECALCIFEROL], start date: 08Mar2022, also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: I tested positive for COVID via PCR and antigen test on 13Jun2022 pm after waking up with a cough; (20Jun2022) Negative, notes: Tested negative on antigen test on 20Jun2022 am with lingering intermittent cough and slight drainage; (23Jun2022) Positive, notes: Woke up morning of 23Jun22 with sinus congestion and sneezing and tested positive on antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 13Jun2022 and stopped on 17Jun2022. Clinical course was reported as, Patient was exposed to COVID via husband. She tested positive for COVID via PCR and antigen test on 13Jun2022 pm after waking up with a cough. Began Paxlovid on 14Jun2022 am. Tested negative on antigen test on 20Jun2022 am with lingering intermittent cough and slight drainage. Covid rebound symptoms started on 22Jun2022 at 07:00. Woke up morning of 23Jun2022 with sinus congestion and sneezing and tested positive on antigen test. Continuing symptoms are runny nose, sneezing and light congestion as of 24Jun2022. Patient not received any treatment for symptoms and was recovering from symptoms.
Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination client complained of Intermittent chest pain in Left Upper Chest.  Pulse regular, strong rate of 68. Resp 20, regular. BP138/90. 911 called. Pt now complaint of jaw pain on left side and throat soreness. Client was pale with no sweating. Fidgeting in seat. At 10:48 am EMS arrived. Client immediately transported to Hospital.
Beginning on Thursday I had pain in my left arm neck shoulder hand area. It is worsened with any weight bearing activity. Even non-weight bearing movement causes the pain to increase. The pain was sharp electrical pot but it moved. It came and went. But generally worsened throughout the day and was best in the morning. It began the day after the shot and worsened for 4 days becoming the most painful on day 5, which was Monday following the shot. When I finally saw it treatment from a massage therapist and made an appointment for a physical therapy. The pain improved dramatically after Wednesday when I received physical therapy treatment. However, as of Friday, the second Friday following the shot, I can continue to experience mild symptoms of pain in the neck, shoulder and bicep and hand of the left arm.
Headache; Pain in arm; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in the right arm on 11Feb2021 at 12:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included Graves' disease. The patient has known allergies to penicillin and erythromycin. The patient was not pregnant at the time of the events. The patient did not have COVID prior to vaccination. No other vaccines in four weeks. Concomitant medication(s) included ascorbic acid (VITAMIN C), sambucus nigra fruit (ELDERBERRY), and multi vitamins. On 11Feb2021 at 13:30, the patient experienced headache and pain in arm. No treatment was received for the events. The patient had not been tested for COVID post- vaccination. The outcome of the events was not recovered/not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives appeared on right arm, then left wrist starting around 6:00pm on Sunday 1-17-21. It slowly began to progress to my legs, torso, and feet by 8:30pm.  The rash was raised, hot, and red. Blanchable to touch and extremely itchy.  I used Benadryl 50mg (taken at 8:45pm) and hydrocortisone cream to alleviate the rash. This helped until  Monday 1-18-21 at 06:00am. The rash began to return so I took another  50mg of Benadryl. The rash again cleared until 10:00am, at which point I scheduled a virtual visit through portal. I was prescribed prednisone and Famotidine. The rash continues to reappear once the Benadryl has worn off.  Today I have taken one dose of  prednisone and  a total of 3 doses of Benadryl.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 16-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # H013181, 0.5 ml, subcutaneous. No concomitant medication was reported. On 16-AUG-2014, the patient experienced patient was inadvertently administered a dose of (Oka/Merck) VARIVAX that had expired on 05-JUL-2014. No adverse event was reported. Product quality complaint was not reported. The outcome of events was unknown. Additional information has been requested.
20 expired doses administered to 20 patients; 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 EXPIRED PRODUCT ADMINISTERED (20 expired doses administered to 20 patients) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 expired doses administered to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 expired doses administered to 20 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
Information has been received from a registered nurse concerning a patient who on 03-JUN-2010 was vaccinated with a first 2ml dose of ROTATEQ orally. The patient would receive the second dose today on 24-AUG-2010. No adverse effects were reported. Additional information has been requested.
About 39/40 hours after shot, I developed all the pre-menstrual symptoms that I would get in my teens and twenties (bad cramps in front and back; big (half of my nose big), painful cyst/zit on face; grumpy mood; blah energy), and then 1-2 hours later I started a period like I would get in my teens and twenties (very heavy and very red).  Still going after 5 days though finally slowing.  Never heavy enough that I was worried, but I have not had a period like this in a couple of decades.  And I have been peri-menopausal for 2 years now -- get my period very infrequently and sometimes its very light, sometimes its heavy.  But I never get cramps any more.  I don't get "PMS" grumpy-moody crap any more.  It is never "red" any more.  And it never starts in a rush like this one did any more (even when it is heavy).  And it usually peters out after 3 days -- hasn't lasted 5 days in years and years.
This spontaneous report as received from a pharmacist refers to the seventeen patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the seventeen patients were vaccinated with an expired PROQUAD (Merck) (doses, routes of administration, lot numbers were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from the medical assistant refers to a male patient of unknown age. No information about medical history concurrent conditions and concomitant medications were reported. On 24-APR-2014 the patient received a dose of PROQUAD on 24-APR-2014 when he was suppose to receive a dose of MMR II. No dose of MMR II administered. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
p/vax pt devel tingling from hips down w/nl neuro exam;MRI L5 spine negative;NLV c/w GBS;pt last seen 11/15/99 w/resolution of tingling in leg but w/c/o tingling in finger tips;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pmr" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Treatment of COVID-19; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: other medication in 2weeks: Yes. Other medication in 2 weeks product reported as Prednisone 3 mg. Rebound five days after finishing paxlovid and tearing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 15 mins itching on upper body/neck area. Within 5 hrs large welts/hives on upper body. Within 24 hrs hives/welts covered entire body (head to bottom of feet).
Dizziness, Fever, RespDepression, CoughWheeze & Diarrhea Narrative:
Symptoms started with a high fever for a few days, then a bumpy rash developed and behavior started to change.  He was a very happy baby until around 1-2 weeks after the vaccines he became very serious and appeared scared frequently.  Decreased eye contact and social behavior.  Regressed in the physical use of his hands.  He stopped holding his bottle for himself, stopping holding onto the shopping cart for balance.  Started to hold hands in tight little fists at his waist and overall decreased the use of his hands.  During the night 5/15/19 he woke up screaming and seemed frightened, while nursing him at the breast  his body started jolting around like a seizure and then he fell asleep.  This happened twice that same night.  Went to doctor the next day and he ordered an EEG that was completed on 5/24/19 and came back normal.     My little boy continued to behave differently for around 2 months post vaccination.  He now seems like he is returning to his normal self.
nausea & abd cramping w/cramping in arms & legs p/2nd dose of post exposure series;
No adverse event; HBP calling on behalf of HCP to report AE for patient that received expired dose of PNEUMOVAX 23.  Expiration- 9/30/2023.  Per Expiry Memo dose supported for 1 month.  No adverse reaction noted.  No additional AE.; This spontaneous report was received from a non-medical healthcare worker refers to a 78-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with expired, single dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # W019533, expiration date: 30-SEP-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no averse event).
9 month old received an adult dose of Hep-B vaccine; 9 month old received an adult dose of Hep-B vaccine; This case was reported by a other health professional via patient support programs and described the occurrence of overdose in a 9-month-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details provided were as follows: The 9 month old patient received an adult dose of Hepatitis B vaccine (Engerix B), which led to overdose and adult product administered to child. The reporter was told by the pediatrician that, there was nothing to worry about and the reporter therefore did not fill the PAE (patient adverse event) form and ended the call. No further details provided.
Headache lasting 24 hours; Nose bleed at 8:00pm lasting 10 minutes; Back pain lasting 24 hours.
For the last 5 or 6 months I get bad headaches in the afternoon daily. Last one to two hours. I never had this problem before the vaccine. No way am I going to get a third shot.
Patient was here for shingles vaccine on 01/08/2014 then patient came in on 2015 and requested shingles meaning pneumonia and extra dose of shingles was given. Old records from 2014 was not found on this day so patient received extra vaccine.
Diagnosed with COVID-19 one and a half weeks later; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Diagnosed with COVID-19 one and a half weeks later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced COVID-19 (Diagnosed with COVID-19 one and a half weeks later). At the time of the report, COVID-19 (Diagnosed with COVID-19 one and a half weeks later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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.
After stopping my menstrual cycle with birth control with the help of my doctor for 2 years, in April I began gushing blood and have been bleeding now nonstop for 22 days straight.
Patient received expired vaccine. Vaccine expired 3/26 and received on 3/30. No adverse effects noted. Patient opted to not receive re-dose.
PATIENT REPORTS WAKING IN THE MIDDLE OF SLEEP WITH ARM PAIN AT APPROXIMATELY 3 AM AND COULD NOT RETURN TO SLEEP THIS LASTED THE WHOLE DAY OF 7/27/2018 BUT RESOLVED BY NEXT DAY.
No adverse event.  Patient was given Pfizer instead of Pfizer Bival.  Her father also got same vaccine.
left arm swollen; left arm painful; left arm reddish; diarrhea; stomach pain; heaviness in the body that does not go away; excruciating pain in her legs; nausea; terrible fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful), ERYTHEMA (left arm reddish), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0381321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful) and ERYTHEMA (left arm reddish). In June 2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), LIMB DISCOMFORT (heaviness in the body that does not go away), PAIN IN EXTREMITY (excruciating pain in her legs), NAUSEA (nausea), FATIGUE (terrible fatigue) and HEADACHE (headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful), ERYTHEMA (left arm reddish), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), LIMB DISCOMFORT (heaviness in the body that does not go away), PAIN IN EXTREMITY (excruciating pain in her legs), NAUSEA (nausea), FATIGUE (terrible fatigue) and HEADACHE (headache) had not resolved.            This case was linked to MOD-2021-229837 (Patient Link).
Patient = single white female Initially, the patient developed symptoms of fever (up to 101.2), diarrhea (onset 3/31), nausea and vomiting (onset 3/31), headache, fatigue, heart palpitations (onset 3/29/03), sore throat (onset 4/4/03), generalized joint and bone aches/pains, itching, a hollow chest feeling, and excessive sleep in her eyes.  The patient went to a physician and reported being prescribed finegrin, lamodal, frova, and vicadin.  All symptoms lasted approximately 2 weeks.  After two weeks, the fatigue, generalized aches and pains, and heart palpitations persisted.  As of the submission of this report, the patient was still experiencing occassional heart palpitations and aches/pains from her knees down.   The patient's PCP is planning to schedule an appointment with a cardiologist. The patient's vaccine site was ruled a take, but was not considered robust.  A pustule developed at the vaccine site after day 3, and a small amount of drainage was evident at day 7.   This case has already been reported to the CDC, and a CDC investigation has been ongoing.
Swelling of (R) arm after injection - was seen in emergency room - supportive care.
This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of arm pain at injection site in an unknown number subjects of unspecified ages and genders who were vaccinated with FLUARIX (GlaxoSmithKline). In October 2012, the subjects received a dose of FLUARIX (.5 ml, unknown details). On an unspecified date, months after vaccination with FLUARIX, the subjects experienced arm pain at injection site, and feeling sick. One subject reported fever of 99.3 degrees Fahrenheit. The nurse stated that "some nurses" reported "arm pain" 'more than usual' and 'feeling sick' following administration of FLUARIX vaccination in October 2012." The nurse stated that "the same product was given in the hospital with no complaints as the same product given in the clinic." The lot numbers were not reported and it was unknown "if it was the same lot number." At the time of reporting the outcome of the events were unspecified. The GSK sales representative reported another case on the same date. See case AA1012706A for details on the other case.
Imz. 8/31/10, mom called 9/2 to report red, swollen area at vaccine site - dime sized. Several small splotches around site as well.
A few hours after receiving second COVID vaccine, pt became very confused and altered. He was brought to the ER, and a CT head showed nothing acute. An MRI ordered the next morning showed a large right MCA territory infarct. The pt did not receive tPA or other intervention at the regulatory authority. The pt was due for a right carotid stent on 11/3/21. The regulatory authority called the hospital where the pt would be receiving his stent, and the cardiologist requested he be transferred to the ICU for ongoing monitoring.
Half dollar size knot at injection site with redness, warmth, and itchy rash. Reported to us 2/3/10 but patient says it started the night following the injection (1/22/10). Knot is not painful. Pt advised to talk to physician.
Pt. presented requesting new vaccine card at drive-thru, also requested influenza.  Upon screening, it was discovered that the patient received their bivalent Pfizer booster dose about 2.5 weeks early.  Pt. contacted to repeat dose per guidelines.
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced red spot, silver dollar size, painful still in pain 2 days later at injection site. On 13th June 2018, the patient returned to report.
No additional AE reported; a patient was inadvertently administered a second dose of Pneumovax 23 on 9/1/2020 after having received an initial dose 11/6/2018; This spontaneous report as received from a pharmacy technician refers to a 65 year old patient of an unknown gender. No information regarding concurrent conditions, pertinent medical history, drug allergies and concomitant therapies was provided.   On 01-SEP-2020, after having received an initial dose on 06-NOV-2018, the patient was inadvertently vaccinated with  a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 05 milliliter (route of administration, lot # and expiration date were not provided) for prophylaxis. No additional adverse event was reported.
GIVEN VACCINES IN PEDIATRIC OFFICE. TOLERATED WELL. MOM REPORTS THAT EVENING HE HAD DIFFICULTY BREATHING, THROAT, FACE AND LIP SWELLING, NAUSEA AND VOMITING. MOM TOOK HIM TO THE ER.
Pt devel what babysitter desc as high pitched unusual screaming on 6DEC91;
Fever of 101.2F. Cold chills. sweats. Muscle aches. Headache. Lasted for 14 hours and treated with OTC tylenol and advil.