chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states got up @ 430AM to use bathroom; States was going back to bed & felt cold & started shaking & felt like she lost consciousness for a split second; Has not had any other occurrence.
Swollen, red, hive-like reaction at the site of injection (Size: 3.5 x 7 cm)
Breakthrough case admission after 3 vaccines  Pfizer 4/16/21 Lot# Ew0162;  Pfizer 5/7/21 Lot# Ew0164;  Pfizer 11/19/21 Lot# 330268D
patient reported Hands itching 20 minutes after vaccine was given  no other complaints  Patient monitored for 45 minutes  in total  Benadryl 25 mg cap x 1 dose given - resolved , discharged
pt starting screaming p/put down for noc, when went into room pt was on hands & knees w/very little muscle control, pt was disoriented lasting a few min, then went limp, shallow breath, unresponsive-parent took pt to ER;poss pertussis rxn
soreness at injection site; pain under arm; tired; This is a spontaneous report from a non-contactable consumer (patient).   An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. First dose was administed in left arm in Feb2021. The patient medical history was not reported. No known allergies. The patient's concomitant medications were not reported. The patient experienced soreness at injection site, pain under arm, tired, all on an unspecified date. No treatment. No covid prior or post vaccination. The events outcome was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received the vaccine at 10:00 AM on 12/11/17 and started feeling ill (nausea) around 3:00-4:00 PM on 12/11/17. Around 7:00 PM that same day, patient started having diarrhea and vomiting. That same evening he experienced leg cramps throughout the night. He continued to feel ill and have muscle cramps until about 11:00 AM on 12/13/17. The illness subsided on its own - the patient did not seek medical treatment or take any medications for the illness. However, he was unable to eat or drink much during the course of the illness.
Information was received on 14-JUL-2017 from a medical assistant who reported that a 16 year old female patient had received the three dose series of COMVAX (dosage and lot#/expiration not reported) on the following dates (20-JUL-2001, 13-OCT-2001, 27-AUG-2002). Medical assistant reported that patient had "lab work drawn" on 13-JUL-2017 and that "titers for Hep B came back negative". No adverse reactions reported. No further information reported. Additional information has been requested.
Redness/tender/warmth at (L) deltoid/AUGMENTIN 400mg/57mg/5m.
angioedema; raised red bumps on upper right deltoid / diffuse hives across torso, right leg and arm; Booster; This is a spontaneous report from a contactable Nurse (patient). A 37-year-old no pregnant female patient received third dose of bnt162b2 (BNT162B2) (vaccinated at 37-year-old), via an unspecified route of administration, administered in left arm on 12Oct2021 09:30 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Patient received first dose of BNT162B2 in left arm with Batch/Lot No: EL1283 on 05Jan2021 10:00 AM, second dose of BNT162B2 in left arm with Batch/Lot No: EL8982 on 27Jan2021 10:00 AM. No other vaccine in four weeks. Medical history included sports induced asthma. No covid prior vaccination. Concomitant medications include Multivitamin. On 12Oct2021 17:30, approximately 8 hours post 3rd dose booster vaccine patient developed raised red bumps on upper right deltoid (vaccine was on left arm). Approximately 12hrs post booster dose, developed diffuse hives across torso, right leg and arm, relieved by Zyrtec. Zyrtec was taken for 4 days following incident. 9 days following (21Oct2021) booster dose vaccination developed angioedema relieved by Zyrtec and Pepcid. 15 days following (27Oct2021) booster dose, hives continued on right arm, torso and right hip. Relieved by loratadine. Event resulted in professional office/clinic visit. The outcome of events was recovering. No covid tested post vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.  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.
Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient took vaccine on 28-Oct-2021, after the expiration date on 22-Sep-2021. The BUD date was reported as 22-Sep-2021. All 45 patients were adults, who received the Moderna vaccine beyond the 30 day use by date and no additional information provided. Doses was stored in standard freezer for the lot 031B21A 2 degrees F high -1 degrees F low on 31-Mar-2021 was reported.  No treatment medication was reported. This case contains information for the 39 of 45 patients described by the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 88-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on an unspecified date received 1st dose). On 31st May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th June 2018, 6 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The initial caller was the  pharmacist. The pharmacist was unable to provide lot number for the doses provided. The reporter stated that the patient developed shingles approximately one week after 2nd dose of SHINGRIX. After the initial reporting the call was placed to the patient and patient reported that she developed a rash on 6th June 2018, the rash progressed and then the patient saw her physician on Thursday (7th June 2018), and was diagnosed with shingles and physician given course of medication to take. The patient was unable to provide name of medication. The patient reported that the rash resolved within 3 to 4 days, after starting the medication.
PATIENT HAD CHILLS AND REPORTED CHEST PAIN.  WHEN I ASKED IF HEART OR LUNG, THE PATIENT WASN'T SURE.  SAID STARTED AT STERNUM AND WENT TO BACK AND SHOULDER.  PATIENT REPORTED COULD BE ANXIETY, BUT REPORTING JUST IN CASE PER PATIENT.
Information has been received from a physician referring to a male patient (reported as teenager) with medical history of inflammatory bowel disease and had no drug allergy. Concomitant therapies included HUMIRA. On 09-AUG-2018, the patient was vaccinated with Oak/Merck VARIVAX (indication reported as requirement for camp; dose, route, lot # and expiration date were not reported) for prophylaxis. On 09-AUG-2018, after administration of Oak/Merck VARIVAX the patient was hospitalized. On 09-AUG-2018, the physician reported that the patient was started on acyclovir therapy (dose unknown by reporter) for unspecified reason. None lab diagnostics/studies were performed. At the reporting time, the outcome of the event was not recovered. The causality was not provided.
This spontaneous report as received from a nurse refers to a 60 year old female patient. On 17-AUG-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous, 19400 PFU (plaque-forming units) for prophylaxis. In August 2017, the patient experienced, in area of 2 inch by 1 inch, injection site swelling and injection site erythema. The patient was treated with cortisone cream (brand and manufacturer unspecified) and BENADRYL. The outcome of injection site swelling and injection site erythema was reported as recovered/resolved. The relatedness between the events and ZOSTAVAX was not assessed by the reporter. Product quality complaint was not involved.
Stomach pain & vomiting 8 hrs after injection, sores on lips, fever.
flu; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (age and gender unspecified) who had flu (Influenza), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date (this year and last year), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   The patient have not seen any significant number there yet. Patient took flu shot this year and last year just before got the flu.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
expired Moderna vaccine administered to patients; Product was placed in refrigerator on 5Apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 5Apr2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 5Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 5Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Reporter reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patients had not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021 Vial was initially placed in refrigerator on 5-Apr-2022. The product did not undergo any temperature excursion issue.  Reporter wants to know if the patients need to be re-vaccinated. No treatment drug information was reported.   This case was linked to MOD-2022-538688, MOD-2022-538614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Patient details were added. Updated reporter information. Added dose of Suspect drug and updated suspect product coding.
2 months old baby received PENTACEL, PREVNAR, hep B vaccine - Developed hives swollen eyelids.
Dizziness, heard hurts, throat and nose burn chest is tight, aches and pains
forgetfulness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "forgetfulness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Refrigeration excursions identified/undergone several temperature excursions; No adverse event; vaccines have undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.     On 25-Sep-2022 at 12:49 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 12:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient).    No concomitant products reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The body site was mentioned as deltoid for administration.  No adverse reactions reported for the patient.  No treatment products reported.
Initial report was received 13 October 2011 via a company sponsored web site from a consumer, who is the patient's parent. A female patient (who was 49 years of age at the time of this report) had received all her recommended shots, including a DTP vaccination series as a child (DTP manufacturer, lot numbers, route, site and dates of administration not reported). Two years ago, the patient developed pertussis and pneumonia at the same time. Subsequently, for the last couple of weeks, she had a deep cough and felt exceptionally tired. She received unspecified blood tests and it was determined she again had whooping cough. The patient had been taking an antibiotic and was feeling better. The patient had a history of rheumatoid arthritis and a compromised immune system. It was not reported if the patient fully recovered. Documents held by sender: None.
red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination.   Information on the Batch/Lot number has been requested.
Pt received his first dose of the Moderna Covid-19 vaccine 12/26/2020. That day he noticed a rash forming around the injection site. He was seen urgently in Dermatology 1/14/2021 stating that a week after his injection he noted more rash on the scalp, trunk, arms and buttock areas. He started treatment with oral antihistamines. Biopsies confirmed eczematous dermatitis. He was treated with topical and oral steroids. His second dose of the Moderna Covid-19 vaccine was 1/23/2021. He noted more flaring of the eczema after the second dose, but less severe.
He got the Vaccine he had 102 Fever; then after the fever he broke out in hives; He got the Vaccine he had 102 Fever; then after the fever he broke out in hives; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received bnt162b2 (BNT162B2, solution for injection) dose 1 via an unspecified route of administration, administered in left deltoid (left shoulder) on 06Apr2021 (Batch/Lot Number: unknown) as DOSE 1, SINGLE (age at vaccination was 58 years) for covid-19 immunisation.  Medical history included covid-19 from 01Mar2021 to an unknown date. The patient's concomitant medications were not reported.  When probed for if COVID happened after the first Pfizer shot, reporter stated that they had COVID before it. She had COVID on 27Feb2021 and her husband (patient) had on 01Mar2021. But by 16Mar2021 they both were better. Patient had fever when he had COVID. It was like a low grade fever. When the patient got the Vaccine he had 102 Fever (pyrexia), it faded but then after the fever he broke out in hives (urticaria). The reporter was just wondering does the patient need to take something before getting the Vaccine tomorrow the second Vaccine. It was reported that the patient did not take any treatment for the fever. The outcome of both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient alerted pharmacy on 9-1-20 that she had been seen by her PCP for pain, heat and redness extending down her right arm beginning and inch or two below injection site and stopping just above elbow. she had no injection site reaction. she experienced stomach upset, nausea, and vertigo for which prescriber gave her meclizine.  patient believes the illness is vaccine related although she said she has never experienced a reaction to flu vaccine in the past. she was vaccinated at same time as 2 other family members by same vaccinator and said neither of the other family members became ill. the patient's arm continued to be visibly red and warm to the touch today. she is not sure why she experienced this unusual response but we will report in hopes it may become clear.
Vaccine  EUA  cold sweat chills,headache,dizziness,light headed,muscle cramps.
She is now experiencing nausea, fatigue and body pain.; She is now experiencing nausea, fatigue and body pain.; She is now experiencing nausea, fatigue and body pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), FATIGUE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "She is now experiencing nausea, fatigue and body pain.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1700 on day of vax pt became flushed, had diarrhea & reported rash on upper lees who was seen by MD & MD felt rxn was vax related & instructed;