chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Repetitive episodes of tingling; numbness occurring in left side of body including side of face; Possible TIA; This is a spontaneous report from a contactable consumer reporting for himself.  A 73-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unspecified route of administration in the left arm on 02Feb2021 16:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included amlodipine (unknown manufacturer). On 02Feb2021 16:00 the patient experienced repetitive episodes of tingling and numbness occurring in left side of body including side of face; possible TIA with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient was hospitalized for 3 days due to the events. The events were serious as life-threatening and due to hospitalization. It was unknown if the patient received treatments for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
Significant local swelling right deltoid and upper arm - prednisone and BENADRYL.
Left thigh upper lateral aspect developed 6 inch Erythema & mild tenderness. No induration. No Fluctuation. Fading away by 4th day.  Supportive cold soaks.
Severe chills, body aches, fever, minor shortness of breath, and I generally feel like I'm dying or a thousand years old. May I ask why the FDA approved this poison? You literally poisoned me with a vaccine, no wonder there's so many anti-vaxxers. I wasn't one until your Moderna shot made me sick as a dog.
15 mins after vaccination-face and feet tingling, tongue feeling swollen, fast heart beat, dizziness, anxiety, increased blood pressure and shaking. I was given Benadryl by the pharmacist at the grocery store where I received my vaccine. At 10:30 pm the exact same symptoms restarted and with left arm burning.
New onset forehead pruritus 2 evenings after immunization, followed by/progressed to forehead rash next AM. Spread to post. neck and (R) scapula over next 3 days.
Received KINRIX on 7/23/09, grandparent noted localized reaction 24 hrs later. Came into the office on 7/26 for unrelated issue & showed us her arm; raised area (10cm x 5cm), warm to touch; mom notes it's improved". No impaired ROM* no fever did not receive treatment of any kind. Told family to call if worsening of injection site or other symptoms related to injection.
Presented to ER with weakness, syncopal episode and SOB was admitted to the hospital. COVID+ and was hospitalized for evaluation and treatment.
A4 office visit for pre kindergarten assessed catch up needs DTaP, IPV, MMR. Medication error given Pediarix (DTap,IPV,HEP B), IPV, MMR instead of Tripedia (DTap) IPV and MMR. Mother notified at time of visit, information provided. Re:immunization follow up. 07/28/2008 Telephone call to mother. Reports child had sore leg last night. Walking around fine today. 08/02/2005 tc to mother, child doing fine.
Patient came to Employee Health at 1 hour post injection. Her right arm was red, swollen and itching from her shoulder to her hand. She was shaking. The injection site was HOT to the touch. No SOB at the time. She was taken to the ED for evaluation and treatment.
Moderna COVID-19 Vacine EUA   had shot went home  arm swelling & pain & sore   crawled in bed and slept for 3 days and nites  ONLY to get up to go to restroom and sip water   NO food    No energy to move.     Friday, 12/07/21  went to local Hospital and they ran blood tests  +++   blood tests very different in results from previous blood test and need Potassium which they gave me in ER.
Both my ankles were very swollen, droopy, and pitting. Kind of like how I sometimes get with certain medications but I hadn't taken anything that would have caused that. And since the vaccine was the only thing I had taken, I looked it up and saw that was a potential reaction. It went away in 4-5 days. I had never seen my ankles that swollen before.
Broke out in bullseye rash. Itches and burns at injection site. Rash is on side of body that injection was on. Sought treatment from her provider and they deemed it to be a drug reaction due to her recent Covid vaccine. She received Prednisone treatment.
ON MY FIRST SHOT 3/13/21 IN MY RIGHT ARM SHOULD AREA, I EXPERIENCED SORENESS/STIFFNESS FOR ABOUT 2 DAYS, BUT THEN I NOTICED WEEKS LATER THAT I WAS  STILL EXPERIENCING SOME SORENESS AND ACHING. I CANNOT LAY ON THAT ARM FOR TOO LONG OR IT STARTS TO ACHE, CARRYING ITEMS IN THIS ARM, I CANNOT DO FOR TOO LONG OR IT STARTS TO ACHE, THE JOINT DOWN BY MY ELBOW TO BEND BACK AND FORTH ACHES. I WAS NOT EXPERIENCING ANY OF THIS BEFORE MY SHOT. I RECEIVED MY 2ND DOSE ON 4/13/21 IN MY LEFT ARM, NO ISSUES. I CAN SAY THAT MY FIRST SHOT I FELT THE PERSON GIVING IT TO ME JUST JABBED IT WITH NO WARNING. THE SECOND SHOT WAS GIVEN BY SOMEONE WHO WAS GENTLE AND IT DID NOT HURT, NO ISSUS SO FAR IN MY LEFT ARM.
This spontaneous report was received from a physician's wife refers to a patient of unknown age. On 29-DEC-2014 the patient was inadvertently vaccinated with ZOSTAVAX, subcutaneous (lot # unknown) that had expired on 26-DEC-2014. No adverse effects reported. Additional information has been requested.
pt recvd vax; exp severe soreness, pain , warmth & redness in arm; flu like sxs;
chest pain; itching rash; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 16:00 (Lot number: EN5318) at the age of 41 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "Hypothyroidism" (ongoing). There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Allergic to Keflex". The following information was reported: RASH (non-serious) with onset 28Jan2021, outcome "unknown", described as "itching rash"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain". The events "itching rash" and "chest pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: Caller clarified that she was a Nurse and called to report this patient was administered 1 dose of Pfizer-BioNTech Covid-19 Vaccine on 28Jan2021 and developed adverse allergic reaction including itching rash, chest pain with diagnosis of acute bronchitis. Nurse called to ask if there is any way that the patient can obtain exemption forms for the Pfizer-BioNTech Covid-19 Vaccine because of this experience if Pfizer can provide a form like that. Time of onset provided as 30 minutes after Pfizer-BioNTech Covid-19 Vaccine, later provided from notes as immediately following administration of Pfizer-BioNTech Covid-19 Vaccine on 28Jan2021 patient developed itching rash across her body and cheeks. They called dr. office who advised her to take Prednisone and an Antihistamine and if symptoms progressed to go to the emergency room. The patient's symptoms progressed to the point that she had to go to emergency room for the itching rash and chest pain. She was evaluated and released from the emergency room where she was diagnosed with acute bronchitis related to chest x-ray performed while at the emergency room at "Privacy". She also had a pulmonary function test which was normal and the same as the pulmonary function test done by prior pulmonologist. Caller mentioned that the telehealth notes from 11Feb2021 note 2 weeks ago after receiving first dose of Pfizer-BioNTech Covid-19 Vaccine patient got the rash 30 minutes after first dose. Outcome and seriousness criteria unknown by reporter, they were just calling it adverse reaction; they saw her for the first time in Mar2021, when she was seeking a second opinion after different pulmonologist was seen. Caller's site released her 22May2021. Patient called them back because her job was mandating that she get additional dose of Pfizer-BioNTech Covid-19 Vaccine, so she called to ask for exemption information. The adverse events were resulted in emergency room and physician office. The patient was not admitted to hospital, seen in emergency room. Follow-up attempts are completed. No further information is expected.
pt recv vax 10OCT95 & devel warmth & a pink area around the inj site;no tx was necessary;pt recovered;
Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received medication (UNSPECIFIED) within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 the patient experienced arm soreness. No therapeutic measures were taken as a result of the reported event.  The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event arm soreness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Tested positive for COVID-19 on at home test.; Tested positive for COVID-19 on at home test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 3-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2022 as dose 1 (maroon cap), single (Batch/Lot number: unknown), on 12Jul2022 as dose 2 (maroon cap), single (Batch/Lot number: unknown) and on 08Sep2022 as dose 3 (maroon cap), single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Aug2023, outcome "recovering" and all described as "Tested positive for COVID-19 on at home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: The patient did not receive other vaccine in four weeks. Patient had no known allergies. Patient had no other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RN accidentally administered 2 doses of TDaP vaccine to patient.  Second vaccine was thought to be Polio.  Realized mistake and informed parent immediately.  Patient observed for 20 minutes with no reaction noted, and family sent home with instructions to inform physician or public health immediately of any reaction.  Family subsequently returned to clinic 2 hours later with patient experiencing vomiting x2, chills, and shaking.  Contacted medical officer for clinic immediately and sent patient to physician's office for follow-up. Physician reported that poison control confirmed no risk of adverse reaction from receiving 2 doses of vaccine at same time.  Patient recovered in office and was sent home with no concerns. Follow-up phone call to family next day (8/25/06); reported patient doing okay and slept fine through the night.  Was no longer experiencing adverse symptoms.
Vaccine adm Fri 10/06/2006 with local redness inj site. R arm Sat 10/07/2006 developed h/a & chills, increased redness inj site. Sun 10/08/06 nausea, fever up to 101.8, chills, pain in L middle side with inspiration, dizziness, R arm swollen very sore to touch red area 7 cm across x 5cm lengthwise. achy & unable to get out of bed until Tues 10/10/2006. Talked with Dr. on Sunday & treated symptoms with pain medication, phenergan supp, & tylenol for fever. Ice pack to arm. Went to prescheduled appt with allergist Wed 10/11/06 & was put on decreasing doses of prednisone for next 6 days. Redness, swelling & soreness remained same in R arm. Today Thurs 10/12/06 feeling a little better, no fever, nausea, slighter h/a, pain rednes swelling in R arm starting to ease, and able to move about the house freely.
The patient reported to the pharmacist that she was feeling sweaty and nauseous after receiving the vaccine today. She stated she got sweaty immediately after administration and experienced nausea during her 15 minute observation period. The pharmacist requested patient to stay for observation for another 15 minutes which she did. At the end of that period, the patient stated she felt fine and was ready to go home and sweating and nausea had gone away.
Tested Positive For Covid Chills /  Night Sweats /  Fatigue / Cough with heavy Phlegm / Muscle Aches
Arm still hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-SEP-2023, the patient received Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm still hurt).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient's wife via interactive digital media. The patient got the vaccine three days ago and less than a week after vaccination, the patient 's arm still hurts.
32 yr old male had a 2yr old daughter who recv 1 dose vax 03Feb98. 15Feb98 the 32 yr old male devel varicella w/greater than 50 papule type lesions. Tx w/acyclovir. PCR analysis of skin lesion performed. Child had no apparent adverse rxn.
When I went to my ortho for knee surgery, and my vitamin D was 17 and should of been 30. So I went to my pcp, they gave me some meds to run it back up. Jan 12,2022 is when you have numbness from waist down to my toes. I thought my feet was sleep, they never wake up though. So they started running test. I thought it was my hip cause of my hip surgery, but it wasnt my hip, the ortho said it was my back. So I was ordered an MRI on feb 7th, 2022, on my complete spine. I went to the neurologist, he stated that there was damadge to the top portion of my spine, there is a spot on my spine. I didnt have any urges for bowel movements. I had several MRI's. I was diagnose with Acute transverse myelitis. Numbness for several months and constipation.
sore throat,  myalgia,  subjective fevers, weakness, diarrhea for one day, and cough.  Sore throat and weakness and cough persists after one week.
Catch / grinding right shoulder.  Went to Dr, x-Rays negative.  Exercise recommended and performed through today,  seems worse, no improvement.
Patient complained days later on 10.16 and 10.8 of arm pain from flu shot.
Breakthrough case after 4 vaccines Pfizer 2/2/21 Lot# EM9810;  Pfizer 2/23/21 Lot# Lot# EN6202;  Pfizer 10/1/21 Lot# FC3181;  10/21/22 Moderna Lot# 057F22A
pt was noted by family to have generalized hive-like rash almost 6 hrs p/vax;
redness at the injection site; Fever; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2021) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, fever and chills. On an unknown date, the outcome of the injection site erythema, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced redness at the injection site, fever, chills. The physician wanted to know the prevalence of these adverse events and how long they could last. The follow up consent was granted.
Pt felt dizzy after receiving Hep A vaccine. He left the immunes room and walked to the dental room across the hall. Pt passed out and hit head on door several times until someone noticed he had passed out. On assessment post vaccination, skin was unremarkably warm and dry. Not on any medications. Pt then told us, he had not eaten or drank much over past 48 hours. Lungs clear, temp of 102.9. EKG done. MD assessed. EMTS came to evaluate pt. Did not go to hospital.
This spontaneous report was received from a physician via company representative, referring to a 15 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On an unknown date, the patient was vaccinated with the first dose of regimen of GARDASIL 9 intramuscularly, for prevent human papilloma virus (HPV) (strength, dose, frequency, lot#, expiration date were not reported). In November 2018 (reported as "about two months ago"), the patient became unconscious and fell (loss of consciousness) after received a shot of GARDASIL 9. The physician reported that the patient was wearing glasses and the glasses broke and the patient received a scratch above her nose (scratch). The Physician also reported that on an unknown date, the patient was taken to an unspecified emergency room for treatment; it was unknown if diagnostic laboratories were performed. The Physician also reported that on an unknown date, they did follow up with the patient and the patient was fine, reported as recovered. The causality assessment was not provided. Upon internal review, loss of consciousness was determined to be a medically significant event.
SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine; Sored arm; felt tired; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine), PAIN IN EXTREMITY (Sored arm) and FATIGUE (felt tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine), PAIN IN EXTREMITY (Sored arm) and FATIGUE (felt tired). At the time of the report, COVID-19 (SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine), PAIN IN EXTREMITY (Sored arm) and FATIGUE (felt tired) 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) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  It was reported that the patient was received the Moderna Covid19 vaccine first primary dose in Jul2021 then she got a SARS-CoV-2 infection. And she still has not gotten the second primary dose.  Company Comment: This is a spontaneous case concerning a 61-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, and non serious events of pain in extremity and fatigue. The events occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, and non serious events of pain in extremity and fatigue. The events occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Abrupt onset sore throat and low-grade fever bodyaches and pains runny nose stuffy nose cough Upper back pain
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (173415). A 27-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), May 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (arm soreness for a couple hours), onset 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive for Covid-19). At the time of the report, COVID-19 (Positive for Covid-19) 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) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided; Sender's Comments: This case concerns a male patient of unknown age with no relevant medical history reported who experienced non serious unexpected event of special interest COVID-19. The event occurred unknown time after the first dose of Spikevax. Rechallenge was unknown since there is no information regarding the second dose. The benefit-risk relationship of drug is not affected by this report. The patient experienced COVID-19 prior to second dose administration.
This case was reported by a physician via sale rep and described the occurrence of injection site redness in a adolescent patient who received MENVEO (batch number M16002, expiry date October 2017). Concomitant products included BEXSERO and ADACEL. On 28th September 2016, the patient received MENVEO (intramuscular). In September 2016, less than a week after receiving MENVEO, the patient experienced injection site redness, injected limb mobility decreased and injection site pain. In September 2016, the outcome of the injection site redness, injected limb mobility decreased and injection site pain were recovered/resolved. The reporter considered the injection site redness, injected limb mobility decreased and injection site pain to be probably related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. On 28th September 2016, the patient also received BEXSERO and ADACEL vaccines concomitantly along with MENVEO. MENVEO was the only vaccine given in the location of the injection site reactions. The other two vaccinations were given in another unknown location on her body. The patient experienced injection site redness, injection site soreness and was not able to lift her hand .