chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient who has received the first dose, and then tests positive for COVID-19; A patient who has received the first dose, and then tests positive for COVID-19; This is a spontaneous report from a contactable pharmacist reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist asked if there any information available for scheduling the second vaccine dose of the series in a patient who has received the first dose, and then tests positive for COVID-19 after already receiving the first dose. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patients symptoms began to improve within 24-30 hours, and were resolved at the time of reporting. This case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 62-year-old male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 12 hrs after receiving SHINGRIX, the patient experienced chest pain, pain in arm, neck pain, fatigue and fever. The patient was treated with TYLENOL. In April 2018, the outcome of the pain in arm, neck pain, fatigue and fever were recovered/resolved. On an unknown date, the outcome of the chest pain was recovered/resolved. It was unknown if the reporter considered the chest pain, pain in arm, neck pain, fatigue and fever to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter was unsure if the patient received the vaccine on 12th April 2018 or 13th April 2018. The patient received SHINGRIX in an unknown deltoid. The patient experienced pain in the chest, arm and upper neck. The healthcare professional described the symptoms as 'felt like he got into a kicking contest with a rather large mule.' The patient had to miss one day of work, but healthcare professional was unsure if the symptoms were considered disabling. No physician visit or hospitalization was required. As treatment, the patient used TYLENOL which did not help. The patients symptoms began to improve within 24 to 30 hours, and were resolved at the time of reporting.
Could not move right or left arms after shots.  After 2 shot of Hep B went to the doctor, meds for 3 months ok now.
Burning in chest while exercising; Reduced lung capacity; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history and allergies were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. On 21Apr2021, at 16:00, the patient experienced burning in chest while exercising and reduced lung capacity. On21Apr2021, the patient underwent total lung capacity test and the result was found to be reduced. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events burning in chest while exercising and reduced lung capacity. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events burning in chest while exercising and reduced lung capacity was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Donor states a few hours after injection he felt all over body aches; fever/chills with some tingling in hands that have persisted for 2 days so far; no Shortness of breath; No rash
This spontaneous report has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates in March 2017, the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB, (0.5ml, lot# M039642 with expiration date 03-JUL-2019, lot# L025738 with expiration date 14-AUG-2017, intramuscular) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature excursion of 25 degrees Fahrenheit (unsupported) for 10 days. Data logger was involved. There was no previous temperature excursion.
Chest tightness/heavy pressure, tickle or scratchy throat, cough, arm soreness
Stuttering started the following morning after receiving the MMR and has continued frequently since. Prior to vaccine patient did not stutter and has excellent speech and vocabulary for a 22 month old.
2 month old patient immediately vomited after receiving a dose of ROTATEQ; This spontaneous report was received from a nurse and refers to a 2-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 08-JUN-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml by oral route, lot # U037810, expiration date 28-MAR-2023 for prophylaxis (also reported as routine vaccination). Immediately after receiving a dose, the patient vomited. The outcome of vomiting was reported as recovered.  The casual relationship between the event and suspect vaccine was not provided.
BODY ACHES; NAUSEA; 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 was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 12-APR-2021, and had not recovered from body aches. This report was non-serious.
17:50 - mild tingling on tongue. Denies any itching, tightness, or other symptoms. Gave water 18:00 - Mild tingling in throat and tongue. Gave Benadryl 50 mg PO at 18:02. O2 sats 97%, heart rate 89 18:24 - vomited, no other GI complaints. No progression of tingling on tongue or throat. Gave crackers. 18:46 - Slight tingling in throat and tongue resolving 18:55 - symptoms all resolved. No distress or further symptoms noted. Discharged with instructions to call 911 if any signs of respiratory distress, or new/worsening GI, or cardiac symptoms.
vaccine administration error regarding Pfizer lot # GJ5342  administered on 02/08/2023 with beyond use date of 01/18/23 with recommendation to get booster at local pharmacy
Administered Moderna instead of Pfizer BioNTech  for completion of COVID-19 vaccine 2 dose series. Prescreening form that was filled out by patient documented Moderna as the first dose. When presented with the vaccination card after administering the Moderna  injection, the nurse discovered that the first dose was actually Pfizer.    The error was explained to the patient and attending parent and that no additional vaccinations were required. Both appeared to understand and were not upset.
Within a few seconds of receiving vaccine I experienced rapid heart beat/palpitations. This lasted for about 15 minutes then subsided.
Information has been received from a consumer regarding her daughter who was vaccinated with her first dose of GARDASIL (date, route of administration and lot number not reported). The consumer's mother reported her daughter experienced mononucleosis one month (no onset date reported) after she was administered her first dose of GARDASIL and sought medical attention (unspecified). The consumer's mother said her daughter will not be administered her second dose of GARDASIL. The consumer's mother said she does not have anything else to say and refused to provide additional adverse event information. No additional information is expected.
The patient stated she woke up the next morning after her immunizations and her face was very swollen. She took BENADRYL and the swelling improved. Patient consulted her primary doctor.
Hives were found on left flank, left elbow and bilateral thighs approximately eight hours after administration.  We are not sure of when exactly the hives appeared as they did not seem to bother her.  Benadryl was given every 6 hours for the next 5 days since the hives would return.
I tested positive for COVID-19 on 06/05/2022. I had a terrible cough, chills, I didn't have a fever. I just had flu like symptoms and started feeling really bad. I started testing myself once a week and I took 1 test and it was negative, and I took another test and it was positive and I wasn't able to go to church.
9/29: (day of vaccine) Sore arm (I don't consider this "adverse") 9/30: Overnight developed fever, chills, aches, sweats, ringing ears.  Fatigue/sleepiness.  High fever was 100.7; my normal is 97.5.  Symptoms lasted all day and into the night. 10/1: I felt good today, a bit tired 10/2: Relapse of symptoms overnight from 10/1, soaking wet sweats, fever 100.3, chills, aches, tiredness.  Felt better on arising, still a bit tired. A few days later I noticed swollen lymph nodes under my left arm and a bruise on my left breast.
Initial report received on 11 August 2010 from a health care professional. An female patient (age at time of vaccination not reported), who was 33 years of age at the time of the report, had received a flu vaccine (manufacturer, lot number, route and site of administration not reported) "seven years ago in November" and the following April she experienced Guillain-Barre syndrome (reported as GBS) with "complete paralysis for one week". No additional information was available at the time of this report. Documents held by sender: none.
Heartrate jumped above 150 and would not drop below 110.  Severely short of breath on 3L oxygen, HR thready, severe dizziness , unable to ambulate without holding on to something sturdy.
injection site warmth; injection site redness; hard lump underneath the injection site approximately 2 inches in size/lump increases to 3.75 in size; arm Sorenes; This spontaneous case was reported by a nurse and describes the occurrence of   in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMINS [VITAMINS NOS] for Immune disorder (NOS), CALCIUM CARBONATE, MAGNESIUM CARBONATE (MAGNESIUM CALCIUM) for an unknown indication.    On 02-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Treatment medication includes ice packs and Ibuprofen400mg one tablet; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Shingles (zoster) on right arm in C6 dermatomal distribution--same arm that she received the varicella vaccine in.
Confirmed Breakthrough  1st Dose -- Pfizer - 5/13/2022 - EW0158 2nd Dose --Pfizer - 6/16/22022 - EN6207
Waves of nausea since I woke up this morning at about 7:00am. Also feel a mild fatigue and tiredness.  I drank lots of water and ate a full meal at 12:00 and feel slightly less nauseous now at 3:30pm. This is after 2 days with no side effects except a little bit of a sore arm.
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The pt experienced hard, swelling and red left thigh. The pt was taken to the MD and was told the pt had an infection to the injection site. The pt was placed on Ceftin. Pt has recovered.
After receiving the vaccine, my arm was sore as expected. Initially, my arm would hurt when I slept and extended it outwards, but now it hurts all the time throughout the shoulder area as well.
suspected vaccination failure; experienced cases of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. It was reported that the patient had completed the series of Shingrix but experienced cases of Shingles after that and now Physician indicated a 3rd dose. Also Pharmacist reported that physician told her to re start the series. No vaccination details. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
04/28/04 T.C from parent. Reports child was taken to clinic today for c/o elevated temp of 103.8 degrees F. Temp resolved when child was observed by RN. Child was given Carolec DM and went home. That same day after child returned home mother noted red blotchy areas on forehead, neck , shoulder, and hand areas
Breakthrough Covid 19 infection; Breakthrough Covid 19 infection; woke up with a cold; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as a dose 2, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient experienced breakthrough Covid 19 infection on 02Oct2021. Stated that, the patient was a healthcare professional and has her second dose of Pfizer vaccine on an unspecified date in Jan2021. On 30Sep2021, the patient woke up with a cold. On 02Oct2021, the patient was tested positive. Seemed to have a mild case optional information, Healthy otherwise. The events took place after use of product. On 02Oct2021, the patient underwent lab tests and procedures which included on 02Oct tested positive (SARS-CoV-2 test), resulted as positive. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Based on the information in the case report, a possible causal association between the events decreased drug ineffective, COVID-19, nasopharyngitis, and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authoritie, as appropriate.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNIZATION (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 ADVERSE EVENT FOLLOWING IMMUNISATION (side effects). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Rash determined as shingles activation. Treated with oral and topical steriods and shingles medication.
flashes in the right eye like lightening flashes; he got sick; congestion; developed terrible cough; shortness of breath on exertion; heart palpitations; blurred vision; he was administered the Pfizer COVID vaccine booster shot on 31Aug2021; he was administered the Pfizer COVID vaccine booster shot on 31Aug2021; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable male consumer (patient) and physician. A 78-year-old male patient received comirnaty (BNT162B2, solution for injection, Lot Number: FC3180; Expiration Date: 31Oct2021:  number: unknown) dose 3 (booster dose) via an unspecified route of administration, administered in the right arm on 31Aug2021 (at the age of 78 years old) as dose 3, single for COVID-19 immunisation at pharmacy. Vaccine was not administered at military facility. Medical history included hypertension (his mother had high blood pressure and passed from age in a home), arteriosclerosis from 1950 to an unknown date (father died when patient was real young from what they used to call hardening of the arteries back in the 1950s), cancer surgery (he is being treated for cancer, onset date of cancer is unknown, 3 years ago maybe). Historical vaccine includes BNT162B2 (Moderna Covid-19 Vaccine, Lot number: 027L2GA) dose 1 on 22Jan2021, administered in right shoulder as dose 1 single and dose 2 BNT162B2 (Moderna Covid-19 Vaccine, Lot number: 02UM20A) dose 2 on 24Feb2021, administered in right shoulder as dose 2 single for COVID-19 immunisation. Historical vaccine also included flu shot (patient takes every year). Concomitant medication was not reported. No PQC was present. Investigation assessment was not provided. On Sep2021 the patient experienced congestion, he was administered the pfizer covid vaccine booster shot on 31aug2021, developed terrible cough, shortness of breath on exertion, heart palpitations, blurred vision, flashes in the right eye like lightning flashes, he got sick. Patient had not visit to emergency/physician room. The clinical outcome of the events congestion developed terrible cough, shortness of breath on exertion, heart palpitations was reported as not recovered and clinical outcome of the events he was administered the pfizer covid vaccine booster shot on 31aug2021, blurred vision, flashes in the right eye like lightning flashes, he got sick was reported as unknown.
Fainting (hit head and needed a few stitches) was out for a few seconds.
pt recv vax & mom states pt began crying x 3hr given APAP;28JUL98 pt fussy but stopped crying p/3hr;
hives; body aches; shortness of breath; heart was racing; Fever; chills; headache; A spontaneous  was received from a healthcare facility staff member (United States) who was a 27-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced fevers, chills, body aches, broke out in hives, headache, shortness of breath and her heart was racing.   The patient's medical history included a positive diagnosis of COVID-19 on 19-Jul-2020 for which she remained quarantined for approximately three weeks.  Concomitant product use was not provided by the reporter.   On 01-Jan-2021, approximately 3 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 01-Jan-2021.  She reported that 32 hours after receiving her injection, on 03-Jan-2021, that she experienced chills, body aches and that she broke out in hives.  She also stated that on the same day she had a headache, shortness of breath and that her heart was racing.  On an undisclosed date, she reported that the hives went away along with the shortness of breath and fever.  She wanted to know if it was safe to receive the second dose.   Treatment for the event included diphenhydramine for the hives and shortness of breath per her primary physician's recommendation.   Action taken with mRNA-1273 in response to the events, fevers, chills, body aches, broke out in hives, headache, shortness of breath and her heart was racing, was unknown.    The events, fevers, broke out in hives and shortness of breath, were considered recovered/resolved.   The outcome of the events, chills, body aches, headache and her heart was racing, were not reported. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.