chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/23 fever onset, abnormal gait with decreased weight bearing on right leg. Diarrhea, rash on face and shoulder.  Fever resolved in 1 day. Diarrhea after 2 days. Appetite returned after 2 days. Still intermittently has limp
back pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number), via an unspecified route of administration from an unspecified date at a single dose for an Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for Covid-19 vaccination. The patient wanted to know if he can take an over the counter drug like ibuprofen because he is experiencing severe back pain after taking the 2nd dose of Covid-19 Vaccine today. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
1106-Vaccinated 11:19-C/O Tickle in Throat, Throat  11:23-Epi 0.3mg/0.3 ml given and was transferred to ER
started feeling funny; tired; This spontaneous case was reported by a consumer and describes the occurrence of STRESS URINARY INCONTINENCE (started feeling funny) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS URINARY INCONTINENCE (started feeling funny) and FATIGUE (tired). At the time of the report, STRESS URINARY INCONTINENCE (started feeling funny) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
The Pfizer bivalent 10 mcg/0.2 ml (properly diluted and mixed by the pharmacist), was given intramuscularly to patient. Patient's guardians was appropriately counseled after the vaccine and left the vaccine room with no questions. Approximately 15 minutes later, patient fainted and hit her head and vomited outside the pharmacy vaccination room. Immediately, pharmacy staff went over to assist the patient and guided her to sit down in the immunization room. Patient and guardian sat in the immunization room for ~30 minutes and nausea resolved. Patient and family left with no questions. Pharmacist will follow up with patient's guardians the following day after the vaccination. VAERS report was filed.
After administering the 4 vaccines, the patient fainted. She was always breathing, EMS was called and they took her to the hospital.
Could be a minor brain injury; Left side of the body got paralyzed on his leg and whole arm; Some pain in the right arm; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) and BRAIN INJURY (Could be a minor brain injury) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) (seriousness criterion hospitalization), BRAIN INJURY (Could be a minor brain injury) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (Some pain in the right arm). The patient was hospitalized on 02-Apr-2021 due to HEMIPLEGIA, and then on 02-Apr-2021 due to BRAIN INJURY. At the time of the report, HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) and BRAIN INJURY (Could be a minor brain injury) outcome was unknown and VACCINATION SITE PAIN (Some pain in the right arm) 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 provided.  Treatment information mentioned post hospitalization rehab and physical therapy. Due to the paralysis, patient mentioned walking using a cane. Treatment medications included Aspirin 81mg one per day, Atorvastatin 80mg one per day, Lisinopril 10mg, Amlodipine 10mg, Hydralazine 25mg.  He mentioned was thinking of cancelling the second dose.  Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events hemiplegia and vaccination site pain, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety profile.  There is not enough information to assess the event of brain injury as it was not specified.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events hemiplegia and vaccination site pain, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety profile.  There is not enough information to assess the event of brain injury as it was not specified.
The patient received the vaccine and a few hours later, her daughter called and said that her arm was painful and that she would bring her to the emergency room.
No symptoms for first 24 hours, but removed Band Aid from Rt deltoid at 24hrs significant redness and swelling with decreased range of motion. Looks better 6/1/18 am.
REDNESS AND SWELLING AT INJECTION SITE. FEELING OF WARMTH IN FACE.
I had a shingles outbreak that began 6 days after my 2nd vaccine.  Online reports show that there is an increased amount of people who are experiencing shingles within 14 days of the vaccine.  I experienced the onset of shingles 6 days after the injection.
major swelling of all cheeks and lips area; major swelling of all cheeks and lips area; This is a spontaneous report from a non-contactable other healthcare professional. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, it was reported that the patient had 1ml of VOLUMA T1. 4 months later patient had COVID-19 2nd vaccination. 2 days later the patient complained of major swelling of all cheeks and lips area. Patient started 40 mg prednisone for 5 days and fexofenadine for 7 days. Patient symptoms have improved. Update that HCP feels event was not device related. Symptoms on going. Outcome of event was not recovered.  No follow-up attempts are possible. No further information was expected.
severe dry, constant, unproductive cough p/ER dx & p/x-rays pneumonia; date of exam 10DEC92;
right calf pain x1 week followed by an ER visit with doppler study. Right lower extremity POSITIVE for politeal DVT. Patient needing 6 months of xarelto prescription.
tinnitus, buzzing  in ear, not constant, but frequent After the next booster on 9/12/22, same location, Moderna lot AS71443, intramuscular, left arm. the tinnitus became constant and at times is louder than others, and difficult to ignore
sweatiness; Arm  hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweatiness) and PAIN IN EXTREMITY (Arm  hurt so bad) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021E21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-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 HYPERHIDROSIS (sweatiness) and PAIN IN EXTREMITY (Arm  hurt so bad). At the time of the report, HYPERHIDROSIS (sweatiness) and PAIN IN EXTREMITY (Arm  hurt so bad) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, COVID-19: positive (Positive) Positive.         No concomitant medications and treatment information were reported.
2 month old was inadvertently administered a dose of Fluzone Quadrivalent with no adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 2 months old female patient who was inadvertently administered a dose of fluzone quadrivalent with no adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj (pneumococcal conjugate vaccine) for immunisation; and rotavirus vaccine live reassort oral 5v (rotateq) for Immunisation.  On 14-Jun-2022, the patient received 0.5 ml dose of suspect influenza quadrival a-b vaccine (batch lot UT7347MA,Expiry date:30-Jun-2022) prefilled syringe via intramuscular route in Left Vastus Lateralis.  On 14-Jun-2022 (latency :same day) the patient developed a non-serious event of  2 month old was inadvertently administered a dose of fluzone quadrivalent with no adverse event (product administered to patient of inappropriate age) following the administration of influenza quadrival a-b vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
DIZZINESS; BODY ACHE; GENERAL MALAISE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced dizziness, body ache, general malaise, fever, nausea, headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, headache, dizziness, body ache, and general malaise. This report was non-serious.
Patient wrote year of birth as 2005, patient stated he was 16, and parents stated he was 16. We found he was 15 only after submitting vaccine information to the state.
This spontaneous case was initially received on 24-NOV-2015. The case report was received from a(n) Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and condition surrounding the onset of reaction(s)/event(s): The patient received AFLURIA. Indication not provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, the patient received AFLURIA, batch number: not provided) from the boarding home for the mentally disabled. The patient then went to a pharmacy and got the flu shot again. No adverse reactions experienced. The patient's doctor was aware of the event. No further information available. The outcome was reported as recovered. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment. The HCP reporter reported "overdose".  Case correction (08-MAR-2016) AE 2 "overdose" deleted.
complained of some soreness then redness on 10/22/08 and increase soreness with some swelling.  I told her to use heat and take tylenol.  I looked at her arm on 10/23/08 and it did have some redness, arm felt tight but could not determine if it was swollen.  She was still having pain in her arm and she was going to see the nurse practitioner at the doctor office.  She stated the heat helped.  Practitioner said it looked like cellulitis.  This is Adacel Tdap vaccine unable to pick that from list below.
Felt as if she was hit by a truck; Fatigued; Muscle aches; Could not sleep all night after the vaccination because of severe pain; Arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep all night after the vaccination because of severe pain), PAIN IN EXTREMITY (Arm started hurting), FEELING ABNORMAL (Felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Muscle aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) and IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced INSOMNIA (Could not sleep all night after the vaccination because of severe pain) and PAIN IN EXTREMITY (Arm started hurting). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, INSOMNIA (Could not sleep all night after the vaccination because of severe pain) had not resolved. At the time of the report, PAIN IN EXTREMITY (Arm started hurting), FEELING ABNORMAL (Felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Muscle aches) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
pt recvd vax 13JUL94 & w/in 10mins presented in office w/urticaria which started on rt cheek,then rt arm&leg lt leg;rx included po DPH;w/in 30mins hives subsided;DPH given q6h;15JUL presentation of hives while nursing;resolved p/?allergy
Client developed hives to the arms, chest, and back approximately 5 minutes after vaccination.  Paramedic checked lungs and temperature, both WNL.  Client's mother provided Benadryl.  Stayed for approx 45 minutes for observation.  Advised client's mother that she should not receive 2nd COVID vaccine and she verbalized understanding.  Prior to departure, client's hives improved.
With red macule on the left arm; with slightly raised red patches around 1cm by 1cm, 2 on the right forearm; 3 on the right anterior thigh with redness, around 1.5cm by 1cm.
May be completely unrelated but wanted to note that patient did have CVA on 12/20/2023 then readmitted 1/29/2023 again for CVA
Information has been received from a physician concerning a patient (age and gender unknown) with Crohn's disease who on 10-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine (yeast) (Lot # 653978/0955F). On 11-NOV-2006 the patient had a flair up of Crohn's disease after receiving the Gardasil vaccine (yeast). The flair up was so severe that the patient had to be out of school for a month. The patient sought unspecified medical attention. No product quality complaint was involved. At the time of this report, the patient was recovering. The flair up of Crohn's disease was considered to be disabling. Additional information has been requested.
Next day post vax, the pt developed fever and chills, pt's left arm was red, swollen, and painful at injection site. There was also some numbness like arm is falling asleep above left elbow. She has felt colder since getting the shot; wearing light jacket to work.
Narrative:  Patient reported slight itch at site of injection of Pfizer covid vaccine. Patient required no intervention and was able to leave on their own.
Tingling started in the left hand/arm after the injection. Tingling experienced in arms and legs 3-5 days after the first vaccine dose. The tingling persisted for 6 weeks.
Rheumatoid Arthritis Flare; 54-years-old male patient received 3rd dose of BNT162B2; 54-years-old male patient received 3rd dose of BNT162B2; This is a solicited report based on information received by Pfizer from a contactable consumer (patient) (Mfr. Control No.: 21K-163-4102312-00). A 54-years-old male patient received bnt162b2, intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single, intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 2, single, intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 3, single for COVID-19 immunisation; adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for moderate to severe rheumatoid arthritis. Solicited report from the a consumer of a 54-year-old adult male with an event of rheumatoid arthritis flare with HUMIRA (adalimumab). There was no reported medical history. The patient's concomitant medications were not reported. On an unknown date, the patient experienced rheumatoid arthritis flare. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer/BioNTech. Primary reporter did not have the lot number information, because the packaging was discarded. The outcome of the event rheumatoid arthritis flare up was recovering/resolving. The reporter's causality for the event of rheumatoid arthritis flare was not provided to Humira, was possible to bnt162b2.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Rheumatoid arthritis and BNT162B2.  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.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter   Reporter did not allow further contact
Fever, chills, dizziness, nausea, headache  and fatigue started at about  10 hours after injection lasted for 16 hours.  Dizziness was anytime I moved my head or tried to stand which would trigger nausea.  Reporting because I was not expecting  onset of severe symptoms  at a 10 hour delay.
due to Covid they didn't get yet the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of social problem in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019, from batch ZP3P9 with expiry date 10th September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient got the 1st dose of Shingrix in October 2019 and due to covid she did not yet receive the 2nd dose. It had been already 9 months since 1st dose. No other information was provided. The reporter consented to follow up. The VAERS details were reported for 1st dose. The case is linked to case US2020144266, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020144266:same reporter
fever , SWELLEN LEMPH NODES ALL OVER THE BODY , NECL STILL SWELLEN , SKIN RASH OVER NECK TO THE MIIDLE BACK , REDNESS
Patient suffered a deep vein thrombosis in right lower extremity on 8/5/22, about 1 month after the vaccine administration. This may have been provoked given a recent long car ride while traveling.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), on 18Mar2021 as dose 2, single (Lot number: EN6205) and on 07Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Paxlovid treatment was started on 30Jun2022 to 04Jul2022.  No follow-up attempts are possible. No further information is expected.
Nausea, vomiting and bodyaches.  Employee states her Left arm is swollen from injection site down to her hand.  Arm is very painful to move.
Patient c/o chest pain, shortness of breath, headaches, sweaty and shaky. EMS was called and patient refused to go on ambulance and left building with  transportation.