chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 15APR97 & mom report pt devel hives 2 days later;seen on 2MAY97 for  unrelated problem;mom reported hives then;
Pfizer / BioNTech Dose Number: 4 30Mar2022 / Treatment of COVID-19 5Jun2022; Pfizer / BioNTech Dose Number: 4 30Mar2022 / Treatment of COVID-19 5Jun2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 76 years 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 was not reported. Concomitant medication(s) included: LISINOPRIL/HCTZ, stop date: 05Jun2022; SIMVASTATIN, stop date: 05Jun2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech Dose Number: 4 30Mar2022 / Treatment of COVID-19 5Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Negative; (19Jun2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical information: Anti-viral details: Product: Covid-19 treatment, Brand: Paxlovid, Treatment start date: 05Jun2022, Treatment stop date: 09Jun2022, Indication: Treatment of Covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the vaccination failure, covid-19 cannot be completely excluded.
Rash started on Sunday on face and spread everywhere. Pink maculopapular rash almost confluent on face, scattered pink papules on trunk and extremities, few spots on palm: no vesicles or petechiae.
After 45 minutes to 0100 hours, numbness in side of face opposite from injection site. Persistent for 1-2 days. Pain in jaw when chewing. After 18-24 hours, tremor in hands worse than prior to vaccination. Can not raise glass of water to mouth without a significant tremor. The greater the weight of the item being lifted, the more significant the shaking of my hand
Blood clot; Fatigue extreme; muscle soreness; loss of appetite; Unable to get out of bed for four days so then they took her to the ER; Lack of circulation on legs due to blood clot produced a wound to develop in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) and FATIGUE (Fatigue extreme) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant), FATIGUE (Fatigue extreme) (seriousness criterion hospitalization), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg). The patient was hospitalized on 22-Mar-2021 due to FATIGUE and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clot), FATIGUE (Fatigue extreme), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Mother asked me to report the following events: Patient has had 6 outbreaks of shingles over left lower back/buttock from March through July 2002; 4 of these with secondary infections. In November 2002, his mother had a single episode of shingles on her buttock, also with a secondary infection. She feels this may be related to his varicella vaccine (given 4/3/00 at a different office).
Breast were getting sore; Entire body itchy; One week after my first shot I started my period.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05May2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 vaccination. Concomitant medication taken within two weeks of vaccination was not reported. On 17Apr2021, a few days after the shot the patient experienced breast were getting sore and then one week after her first shot, she started her period. The second dose she received on 5May2021 and a few days after her breasts are sore again and expect to start another period in a few days. Each shot additionally made her entire body itchy for a few hours after. She had zero known allergies. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken for the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events entire body itchy was resolved on an unknown date of Apr2021.The clinical outcome of the event breast was getting sore and one week after her first shot, she started her period was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt fainted about 4 minutes after receiving the first covid vaccine, pt was warm, sweating.  He was light headed and dizzy for about 10 minutes, his girl friend came to pick him up.
Migraine and hives starting the evening after the vaccinations into the following day. Hives were widespread on arms, legs, back, neck and torso. Migraine was severe. Patient states a low grade fever that broke after more than 24 hours. Some bruises on elbow of left arm. Fluid retention in legs and hoarseness. Patient called pharmacy at 4:37pm on 9/2 with initial migraine and hives and fever being reported. Patient then came into pharmacy on 9/3 to show severity. Patient was advised to seek medical attention the evening of 9/2 when she called the pharmacy.
had to start supplementing formula bc milk production dropped drastically; Exposure via Breast feeding; Exposure via Breast feeding; had menthol taste/feeling in mouth/throat; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection and lot number: ER8727) via an unspecified route of administration, administered in arm right on 19Mar2021 08:15 (age at vaccination: 36-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma. Concomitant medications included loratadine (CLARITINE), received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took dilaudid and had known allergies: Dilaudid. The vaccine exposure via Breast feeding on 19Mar2021 08:15. The patient experienced had menthol taste/feeling in mouth/throat on 19Mar2021. The patient had to start supplementing formula bc milk production dropped drastically on 21Mar2021. The patient was not received treatment for the events of had menthol taste/feeling in mouth/throat and had to start supplementing formula bc milk production dropped drastically. The outcome for the event of had menthol taste/feeling in mouth/throat was recovered on 20Mar2021 and other event of Lactation decreased was recovering.  No follow up attempts are needed. No further information is expected.
The patient received the vaccine in (L) top part of deltoid muscle - she had sharp shooting pain down her arm and the pain progressed over eve and difficult to move arm - pain severe.
Not sure if my symptom dates are correct but about a day after getting my second shot, I started developing welts on the left side of my body. Specifically on my hip/waist area and a little bit on my arms. It has now been almost a week and I am developing welts on the right side of my body and the ones on my left have not gone away yet. They are very itchy!
In the 24hrs after receiving 3rd dose in an immunocompetent patient, patient developed L shoulder pain (received dose in L upper arm) and then developed L pleuritic chest pain. Found to have bilateral segmental and subsegmental non-massive pulmonary embolism, improving with heparin and transition to eliquis. No evidence of DVT.
Night sweats, hormonal acne, mood swings, feverish, chills, nausea, fatigue, swelling at injection site, injection site pain
Fever, Body aches, Unable to sleep night of 7/10/06 thru 7/11/06. 7/11/06 ordered Amoxil, nasal congested, erythema throat.
Elevated heart rate and intermittent chest pain. Took doubled dose of regular steroid for approx 3 days which improved chest pain. Chest pain resumed following return to regular steroid dose. Intermittent elevated heart rate and chest pain continues at time of submission of this form on 5/27.
Pt requested Moderna Vaccine , when asked whether or not this was her first dose pt stated she has not received a Covid vaccination this was stated to the intake worker as well as the vaccinator.  Pt ended up receiving a third Covid vaccination of Moderna. When her paperwork was filed it was noticed by a team member that  she had already received 2 doses of Pfizer back in December earlier this year.
Patient said that around 8:00 pm on 9/28/19 he noticed some redness and a bump at injection site and this morning on 9/29/19 he said it changed to this fluid filled blister a little less than a dime in size at the injection site only. He said he has some tenderness at the site also.  The patient does not have a primary doctor so I instructed him to go to an urgent care or ER if the reaction gets worse or does not go away in a couple days. I also told him to keep the area clean and cover the blister with a gauze pad to help keep it from opening. I also instructed him to take benadryl tablets if  the reaction gets worse.    The patient will be contacted within a couple of days for followup.
vial expired but a dose was given to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial expired but a dose was given to the patient) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial expired but a dose was given to the patient). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vial expired but a dose was given to the patient) had resolved.        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.   No concomitant medication was reported. No treatment was reported.
Patient, 11 years, was given Pfizer Bivalent 12 and up.
achy; very sleepy; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received first dose on an unknown date also experienced sleepiness, refer US2021AMR179243).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, and sleepiness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain and sleepiness were unknown.   It was unknown if the reporter considered the pain and sleepiness to be related to Shingles vaccine.  Additional details were provided as the patient self reported this case. The age at vaccination was not reported. The patient received the shots which made the patient achy and very sleepy. The patient stated that it was so worth it. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179243, 1st dose.
I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 4/1/2023 DYSPHAGIA I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/3/2023 DYSPHAGIA I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 4/1/2023 ESRD (END STAGE RENAL DISEASE) I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/3/2023 ESRD (END STAGE RENAL DISEASE) I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 4/1/2023 DM 2 W EYE MANIFESTATION I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/3/2023 DM 2 W EYE MANIFESTATION I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 4/1/2023 ESRD (END STAGE RENAL DISEASE) I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/3/2023 ESRD (END STAGE RENAL DISEASE)
pt recv vax 15APR99 on 22APR99 began breaking out w/red rash on face;it then spread down neck & arms-rest of body;no fever, not fussy, good appetite but rash does bother pt scratches a lot;pt mom & sibling devel rash;
Extremely itchy red rash with tiny raised bumps on chest & around breasts beginning about 28 hours after injection.  Topical Ciclopirox & Benadryl ointment did not help.  Took one Benadryl tablet at bedtime on  Feb. 1 which calmed the itching.  Discontinued Ciclopirox on Feb. 1.  Began treatment with Triamcinolone evening of Feb. 2.   Red rash began to fade around Feb. 4. Continuing to use 1 Benadryl tablet per day and Triamcinolone since then.
Information has been received from a physician concerning a 23 year old female, who on 02-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (Lot# 655618/0186U). There was no concomitant medication. On 07-AUG-2007 the patient developed a lump in the axilla of her left side which was causing pain that radiates to her left breast. The patient was given a breast examination that showed to be normal. A pea size nodule was found in the patient's left axilla. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. There were no illnesses at the time of the vaccination. No laboratory diagnostics were performed. At the time of the report the patient's outcome was unknown (previously reported as had not recovered). No product quality complaint was involved. Additional information is not expected.
Mild swelling, mild redness upper (L) arm. Diameter 25.5 c, redness 3 c x 5 c, mild tenderness to palpation.
When they wake up they cannot move; Both their knees are sore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (When they wake up they cannot move) and ARTHRALGIA (Both their knees are sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes (use an insulin pump). Concomitant products included INSULIN for Diabetes.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (When they wake up they cannot move) and ARTHRALGIA (Both their knees are sore). The patient was treated with MELOXICAM ongoing since an unknown date for Inflammation, at an unspecified dose and frequency and HYDROCODONE ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (When they wake up they cannot move) and ARTHRALGIA (Both their knees are sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got the second dose on the right arm. After that they did not notice to much change, but the issues continued. They have consulted with several doctors and were prescribed medication for the inflammation and pain, that helped a little.   This case was linked to MOD-2021-367043 (Patient Link).
This spontaneous report as received from an health care worker refers to an unspecified number of patients of unknown age and gender might have received GARDASIL (Lot# unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
exposure via pregnancy; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and neonate. This is the mother case.  A 32-year-old female patient (pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history was not reported. No known allergies. Last menstrual date Nov2020. Delivery date Aug2021. Concomitant medications were not provided. The patient experienced exposure via pregnancy in 2021 and after vaccination sequence of body changes happened, which led to preterm delivery in Jun2021. Gestational period was 30 weeks. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event was preterm delivery. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering. This report was assessed by the reporting consumer as serious with hospitalized.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021805560 baby case
rt upper arm-itching, warm to touch, erythema 4 cm x 3 1/2 cm, hard in the center. Seen by Lt Col who prescribed Benadryl.
feeling faint, diaphorertic, clammy, pale,  hypotensive, bradycardic, ten min after receiving first dose moderna
At 12:30 p.m. on October 9, 2019, I received the flue vaccination.  Two hours after receiving vaccination, I became dizzy and head felt heavy for 24 hours.  I went to bed early due to discomfort.  The dizziness subsided with sleep.  The next day, I became short of breath after slight exertion,  This continued for the next 9 days.  After a week, (the last 3 days) I became better each day until I felt normal.   Normal by October 19.  II've never experienced this prior to this flu vaccintion.  My asthma is under control using Flovent and Flonase.
Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 28-Jan-2021, Pfizer (Dose 2) on 18-Feb-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was stated that, the data logger was not set with correct parameter and excursion happened for 15 mins at the site + 1.9 Celsius (C). The storage condition at the time of the excursion was refrigerator and maximum or minimum temperatures reached, as applicable was +1.9 C to +6.4C for 15 minutes. On 15-Jun-2022, the vial moved from freezer to refrigerator. At 09.15 am, the vial was initially punctured. Vial was currently fridge quarantined in portable fridge. The visual inspection noting any vaccine state change stated thawed. The proposed desired Use by Date was stated as afternoon of 15-Jun-2022.  No treatment medications were reported.
Complained of soreness L arm with touch and movement. Has persisted x 2 weeks lasted longer than expected.
Within 8 hours of the vaccine I began to feel body aches, fatigue, chills and sweats. This lasted about 72 hours and peaked right at about 36 hours. I had no respiratory issues. This was the same for dose 1, 2, 3, and 4.
Case number PHEH2014US018889 is an initial spontaneous report from the health care professional (nuclear technologist)via medical communications on 18 SEP 2014. This report refers to a 49-year-old ale patient. The patient was accidentally vaccinated with an expired FLUVIRIN 2013/2014 vaccine (batch number: 1309701), expiry date: May 2014), intramuscularly on 22 AUG 2014. No adverse event reported following this medication error (expired vaccine used).
On 9/20/06 pt had rash and swelling on right arm at site of Dtap with intermittent hives on neck with rash. Seen in office 9/21/06 for rash and hives. Treatment Benadryl. No difficulty breathing seen by Dr, no further office visits at this time.
injection site was red and spread about an inch in diameter, area was slightly warm to touch. pt. reports no pain.
Had my first Shingrix vaccination on Oct 29 2019 GSK Lot number 3099 Also had Prevnar 13 Pfizer Lot AP2987 same day Developed shingles diagnosed by my doctor on Nov 5 2019 Treating with valacyclovir 1 gram TID for 7 days.