chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a female patient of unknown age concerning her daughter. Patient's medical history and other drug allergic reactions were not reported. On an unknown date of February, the patient was vaccinated with recalled GARDASIL (strength, dose number, dose unit, route, lot number and expiry date unknown). On an unknown date patient still had a sore arm. Legal issue involved and adverse event sent to legal. The outcome of received the recalled GARDASIL vaccine in February and still had a sore arm was unknown. The reporter did not provide the causality of sore arm to GARDASIL. No further information was reported. Additional information has been requested.
a 9 month old was given FLUZONE HD with no AE; a 9 month old was given FLUZONE HD with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency (Reference number- 00395603) and transmitted to Sanofi on 16-Dec-2020.  This case involves a 9 months old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, batch number: unknown, expiry date: unknown, via unknown route in unknown administration site) on an unknown date in Oct 2020 for prophylactic vaccination (overdose and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication, family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  At the time of reporting, no adverse event was reported.  Reporter stated that the patient was in the office at the time of call for his 2nd dose and wanted to know how to proceed and requested to callback today.  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 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.  There will be no information available on the batch number for this case.
delayed cutaneous hypersensitivity reaction.  Rash appeared 11 day post vaccination. Duration approximately 1 week. Covered entire deltoid region. Raised rash and a little tender.
expired dose of pentacel was administered to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient and it was reported expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live oral 1V (Rotarix); and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) both for Prophylactic vaccination.  On 10-MAY-2023, an expired dose of 0.5 mL of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (batch/lot number: UJ663AAA; expiry date: 04-May-2023; Frequency = once; strength: unknown) was administered to a patient via intramuscular route in unknown administration site with no reported adverse event (expired product administered) (latency: same day).  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 guidelines. 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.
Immediately following injection, shortness of breath, sneezing, coughing, itching, redness and hives - treated with BENADRYL- back to normal a few hours after injection.
Since my 2nd shot, I have experienced exhaustion, joint and muscle pain, headaches. These have been an almost constant since about 20 hours after my 2nd dose.
Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal; Electrocardiogram: unknown result; Imaging procedure: unknown result; Magnetic resonance imaging heart: unknown result.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Myopericarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
This spontaneous report was received from a consumer referring to herself, a 76 years old female patient. The patient's concurrent conditions include diabetes, hyperthyroidism, gastro paresis and sleep apnea and concomitant medication included insulin, atenolol, SYNTHROID, spironolactone, FLOMAX, omeprazole and PYRIDIUM. The patient reported drug reactions or allergies to pain medications and opiates, general anesthesia and sulfa. In August 2018, the patient was vaccinated with PNEUMOVAX 23 single 0.5 ml dose, intramuscular, to prevent pneumonia (anatomical site of injection, lot # and expiration date were not provided). In August 2018, the patient experienced pain in her right arm, and it felt like every bone in her body was broken from her fingertips to the base of her cranium and she had to put her arm in a sling. The patient reported that she had struggling to use her right arm so much that she cannot even pull her continuous positive airway pressure (CPAP) machine. The patient did not seek for medical attention, any laboratory test was performed and she not received any treatment for the adverse events. At the time of this report, the patient had not recovered from the adverse events. The causality assessment between PNEUMOVAX 23 and pain in extremity, musculoskeletal disorder, injected limb mobility decreased was not provided.
about 24 hours after the vaccine i became very ill.  I was up all night vomitting , was nauseous and had very high fever, with very bad pain in my right side, stomach area.  A few days later i still had the pain in my right side, so i went to the clinic where i was told it was my appendix. Was sent to the ER were I was told i had appendicitis and needed emergency surgery to remove my appendix before it burst.
shortly after ward experienced chest pain or tightness in chest; shortly after ward experienced chest pain or tightness in chest; This is a spontaneous report from a Pfizer.A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 11Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and Concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced Chest pain or tightness in chest. It was reported that patient received first dose of vaccine 8/11/21 and shortly after ward experienced Chest pain or tightness in chest and would like to know if this is normal and going to pass. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Non itchy rash on stomach, back, arms, chest, legs - some of them were bigger and there was peeling.  Others were small.; Non itchy rash on stomach, back, arms, chest, legs - some of them were bigger and there was peeling.  Others were small.; This is a spontaneous report from a contactable consumer (parent). A 15-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 15May2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications within 2 weeks of vaccination included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccine within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. The reporter reported that, on 15May2021, after vaccination, the patient experienced non itchy rash on stomach, back, arms, chest, legs; and some of them were bigger and there was peeling. Others were small. The patient received treatment for the adverse events. The events resulted in doctor or other healthcare professional office or clinic visit. The outcome for the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Pt received first and only dose to be fully vaccinated with the J&J Janssen vaccine on 4/7/2021.  Pt began to have symptoms of COVID and tested positive on 9/6/2021 at a local ED.  He was then transferred later that day for inpatient care.  He is still currently inpatient being treated for covid on our general med unit.
other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 60 years old. No information was reported regarding the pt's medical history, concurrent conditions or concomitant medications. On or about 03-JUN-2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who in the summer of 2007 was vaccinated with a dose of GARDASIL (lot # not reported). Following the vaccination, the patient visited an urgent care center, and was diagnosed with cellulitis at injection site (details not reported). Treatment included an unspecified antibiotic. At the time of this report, the outcome of cellulitis was unknown. Additional information has been requested.
received first dose of GARD ASIL 9 in 2017 but has not received second dose until 2021; No additional AEs or PQC reported; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On an unknown date in 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route, lot# and expiration date were unknown) for prophylaxis.   The patient had not received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route, lot# and expiration date were unknown) for prophylaxis until 2021 (inappropriate schedule of vaccine administered). No additional adverse events.
Extremely painful and weak bicep and forearms both right and left arms.  Both arms with reduced weakness by 50%. Weakness improved in left arm.  Right arm continues to have muscle weakness.  Both arms are still very painful.
Felt fine day of vaccine, Sunday, just minor arm pain. Woke up the next morning with pretty severe fatigue and more arm pain. Around 11am I had pretty bad chills that lasted about an hour, along with minor nausea. Additionally,  throughout most of the day my heart rate was usually between 90-100 bpm, even while lying down and doing nothing.  Going to sleep on Monday night I woke around 3 times during the night with cold sweats. Waking up on Tuesday morning, my heart rate is still elevated, arm is still sore, but the fatigue isn't as bad. However, at around 9am on Tuesday morning I started to develop itchy hives and a rash on the back of my legs.  After the first dose I only had a sore arm, no symptoms like these, and I do not have any known allergies.
Initial minor pain at the injection site that became worse after the 3rd day. Pain radiating up the arm and shoulder into the neck area. Tingling in thumb and 3 fingers. Never have had any issues like this. Went to Orthopedic doctor who found arthritis in neck. Given Prednesone but did not help at all. Called doctor again and asked if tingling in hands was associated with arthritis and told not normally and what else I could do?  Suggested an MRI which did not have yet. Pain is diminished today but tends to flare up. Pain is worse at night. Never had any symptoms like these before the 2nd Covid shot.
Moderna Covid-19 Vaccine EUA Severe site pain that lasted 5 days - radiated down to elbow area and spanned full deltoid Severe vertigo that started middle of the  night/early in the morning of day #7 (March 15 2021) and persists
COVID test -tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID test -tested positive) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a, 044a21a and 031m20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID test -tested positive). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID test -tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.         The medical history was not provided by the reporter. Patient had a cataract surgery on 25-Jul-2022 (Monday). Patient took COVID test that was expired on 22-Jul-2022. Concomitant product reported as Vitamins.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 which occurred unknown number of days after receiving a dose of mRNA-1273 Vaccine, first booster in COVID-19 vaccine series. The patient received the primary series of mRNA-1273 vaccine given 28 days apart, the second dose administered about 7 months 22 days before the first booster dose. She was given Zyrtec tablet as treatment. There is no available information regarding clinical course and treatment medication. The patient's elderly age remains a predisposition risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-615736 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 which occurred unknown number of days after receiving a dose of mRNA-1273 Vaccine, first booster in COVID-19 vaccine series. The patient received the primary series of mRNA-1273 vaccine given 28 days apart, the second dose administered about 7 months 22 days before the first booster dose. She was given Zyrtec as treatment. There is no available information regarding the clinical course. The patient's elderly age remains a predisposition risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Information has been received from a 76 year old male patient referring to himself. The patient had no pertinent medical history, drug reactions/allergies. Concomitant therapies included irbesartan, hydrochlorothiazide (reported as "Hcpz"), metoprolol succinate (TOPROL XL), allopurinol, finasteride (manufacturer unknown), tamsulosin hydrochloride, lovastatin and "Nyzan". On 27-FEB-2017 the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date unknown) via "vaccine" route in the left arm to prevent shingles. On 01-MAR-2017, the patient noticed that redness at the site of injection on his left arm, as well as headaches. No treatment was given for the adverse events. The outcome of the events injection site erythema and headache was reported as not recovered. No product quality complaint (PQC) was involved. The causality assessment was not provided.  Additional information is not expected because there is no consent to contact the physician.
2 other people had the same pain on the side of the breast where they got the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot). At the time of the report, AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
An hour 3/4 after receiving the over 65 flu shot the shivering and shaking started. My teeth was shattering. I started throwing up and diarrhea. I couldn't eat for a few days and I ached all over. Finally a week later I felt better.
Severe chest pain, dizziness, headache, severe joint pain, shallow breath, extreme weakness, fever for a day and a half.  In the first week, 3 separate events of rapid, pounding heart rate, chest pain, sweating, chills, weakness and shortness of breath. Also, difficulty breathing while laying down. 2 weeks after dose trying to resume warmup for normal exercise caused severe pain, rapid heart beat, sweating, and dizziness.  Doctor recommended rest and referral to cardiologist, cardiologist evaluation pending.
Headache-immediately lasting 4-7 days intermittently  Fever-4 days Nausea (Weakness and Dizziness) Muscle spasms and joint pain Fever -4 days  Chills Fast heartbeat Cotton mouth/tightness in throat Chest tightening  Tiredness Injection site pain, swelling of arm glands/nodes
Became very ill for 48 hours after injection. Chills, fever, severe myalgia, unable to stay up for more than 10 min at a time ,severe unrelenting headache.stuffy nose. Gradually subsided after 2nd day . Headache lasted a few days longer as well as stuffy nose.
Developed shingles ten days after the Covid injection. Dr. treated with an anti viral medication. Developed a rash under left arm and across left breast in area where I had radiation treatment for breast cancer. The rash lasted for three weeks.
Health network received telephone call at 755 AM on 3-26-07. "Client/ child having symptoms of fever, swelling and redness to Left leg since 3/23/07 around 5pm. Wants to know what to do?" Health network recommended ice packs and infant/children motrin as recommended by container. Ice packs to Left leg as tolerated by child. "Mom, already did that since 03-23-07. Health network recommended Primary medical doctor or ER of choice, since symptoms still occurring, mom agreed.
Pt has red welt on right arm, extending just above where vaccine was given, extending to just above elbow region. Patient states she went to doctor's office on 1/29/19, doctor took one look at arm from across room and said, "Your arm is infected." Dr. lined borders with Sharpie and told patient to monitor for 24 to 48 hours and if welt exceeded borders, to proceed to er for iv antibiotics.
I had a shingles vaccine on November 30, 2020.  On Dec 30, 2020 I had my first dose of Covid vaccine.  On Jan 6, 2021 I went to the ER for severe abdominal pain, 2 days later broke out with rash and diagnosed with Shingles.  I took steroid, Valtrex and Gabapentin.  Rash on abd and around to lower back, left side.  The rash was not bad but the nerve pain was horrible.  2nd dose was due Jan 22, 2021, I was advised to wait due to still having shingle pain.  I was getting better, pain was subsiding so I got my 2nd dose on Feb 5, 2021.  I experienced an increase in my shingle pain, from a 2 up to a 5, for about another week.  It is still some pain, I am still on Gabapentin and Tylenol to keep the pain at about a constant 1-2 (Feb 18, 2021).
This spontaneous report as received from a health care student refers to a patient of unknown age. In July 2011, the patient was vaccinated with GARDASIL dose 1. Lot number, expiration date, anatomical location and route of administration were not reported. On 05-APR-2013 the patient was vaccinated with GARDASIL dose 2. Lot number, expiration date, anatomical location and route of administration were not reported. No adverse event was reported, treatment information was not reported. Additional information has been requested.
tired; dizzy; nauseous; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date prior to vaccination. Concomitant medications were not reported. On 13Feb2021 the patient experienced being tired, dizzy and nauseous. It was unknown if a treatment was received. Events outcome was unknown. Information about lot/batch number has been requested.
incorrect diluant volume (i.e., the vial contents were diluted with a diluent volume more than 1.8 ml, but a 0.3 ml dose was still administered
The first evening (Friday) I had a slight pain in my left arm at the injection shot but it went away. The following Tuesday evening my upper left arm was very itchy. Wednesday afternoon it continues to itch but a rash about 2 inches in diameter surrounds the injection area.