chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3OCT91 AM red welps/blotches inner forearms; that PM red raised rash w/pruritis on face, trunk & upper thighs; as if throat closing up; "couldn't breathe"; as if heart not beating right; blurred vision; ER; rx DPH shot & pills; other shot;
High Fever (>104.0 axillary), extreme fatigue, swollen neck/face glands.
Painful, swollen red bumps on Left arm.Ran temp of 103.  Shoulder and  left arm sore.  Went to MD on 10/19 received antibiotics and advised by physician not to get pneumonia shots.
Patient just wanted to give feedback on SHINGRIX series - after first dose on 5/14/18, she had a fever over 101* and flu like symptoms for 2-3 days. She reported a more severe reaction after the second dose on 09/04/2018. Patient stated she got a fever again and had severe joint pain - she said it was the worst in her hands and she felt like they were very difficult to move.
pt recv vax; devel approx 20 lesions on face,trunk,arms & legs;HA & itching; seen by MD;tx w/ meds;lesions crusted over & pt recovered;
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old male patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). Concomitant products included simvastatin. On 30th April 2018, the patient received SHINGRIX. On 30th April 2018, 1 hr after receiving SHINGRIX, the patient experienced shivering, muscle soreness, headache and influenza-like symptoms. On an unknown date, the outcome of the shivering, muscle soreness and headache were not recovered/not resolved and the outcome of the influenza-like symptoms was unknown. The reporter considered the shivering, muscle soreness and headache to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The patient describes the events experienced by him after vaccination with SHINGRIX as almost flu-like events. Only the physician name was known at the time of reporting.
rashes in body; This is a spontaneous report from Pfizer Sponsored Program. A contactable female consumer (Patient) of an unspecified age received bnt162b2 (Pfizer Covid-19 mRNA Vaccine, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rashes in body. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
its hot; swelling; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events vaccination site swelling, and vaccination site warmth.  The patient's medical history was not reported.  Concomitant products information was not reported.  On unspecified date prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (batch number:unknown) for prophylaxis of COVID-19 infection.   On unspecified date, the patient reported to have taken the second dose of the vaccine in the same arm and the arm have swelling and hotness.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   On 16 Feb 2021 the outcome of the events swelling and hotness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
RIGHT ARM SWOLLEN FROM SHOULDER TO ELBOW AND WARM TOO TOUCH, STARTED ON SATURDAY 3/21/09
SIGNS AND SYMPTOMS: RASH, HIVES, REDNESS ON FACE. TIME COURSE: 10/27/16 UPTO 10/29/16.
Moderna COVID-19 Vaccine EUA Sore arm - 3 days Flu like symptoms - 8 hours Ibuprofen taken 5 times
A spontaneous report has been received from a Health Professional concerning a 4 year old patient of unknown gender. The relevant history and concurrent disease were not reported. Patient had received FLUMIST QUADRIVALENT (intranasal) 0.2 millilitres, yearly 5 days prior to hospital admission with critical illness, pneumococcal empyema, right lung necrosis, and a positive adenovirus test. The action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the events of pneumococcal empyema, positive adenovirus test, right lung necrosis and critical illness was unknown. The company physician identify pneumococcal empyema, right lung necrosis, critical illness and positive adenovirus test from narrative and assessed it to be serious due to important medical event and hospitalization.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX. Concurrent medical conditions included penicillin allergy (since 1961). Concomitant products included Levothyroxine, NASACORT, SINGULAIR and ASMANEX. On 11th April 2018 16:33, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain, contusion and pruritus. On 17th April 2018, the patient experienced erythematous rash. On an unknown date, the outcome of the pain and contusion were recovering/resolving and the outcome of the pruritus was not recovered/not resolved and the outcome of the erythematous rash was unchanged. The reporter considered the pain, contusion and pruritus to be probably related to SHINGRIX. The reporter considered the erythematous rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient developed soreness, itching and a little bruise initially. In the morning of reporting day, 6 days after receiving SHINGRIX, the patient experienced itching and a red rash of the size of half a clementine.
terrible joint pain,lasted for a week; muscle pain,This has lasted for a week; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (terrible joint pain,lasted for a week) and MYALGIA (muscle pain,This has lasted for a week) 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.   In April 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (terrible joint pain,lasted for a week) and MYALGIA (muscle pain,This has lasted for a week). At the time of the report, ARTHRALGIA (terrible joint pain,lasted for a week) and MYALGIA (muscle pain,This has lasted for a week) had resolved.            No concomitant medications provided. The patient stated that after vaccination she did not have these events and after 6 months now is she experienced those events.The patient wants to know if that could be from the vaccine because it's been over 6 months. The patient states she had a test done (unspecified), but she doesn't understand what it means. No treatment medications provided.
crying and scare; sharp body pains in her body; that food is tasting like ashes / has a  nasty taste in her mouth; chills; symptoms are getting worst with time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sharp body pains in her body), DYSGEUSIA (that food is tasting like ashes / has a  nasty taste in her mouth), CHILLS (chills), CONDITION AGGRAVATED (symptoms are getting worst with time) and CRYING (crying and scare) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039d21a and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN (sharp body pains in her body), DYSGEUSIA (that food is tasting like ashes / has a  nasty taste in her mouth), CHILLS (chills) and CONDITION AGGRAVATED (symptoms are getting worst with time). On an unknown date, the patient experienced CRYING (crying and scare). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (sharp body pains in her body), DYSGEUSIA (that food is tasting like ashes / has a  nasty taste in her mouth), CHILLS (chills), CONDITION AGGRAVATED (symptoms are getting worst with time) and CRYING (crying and scare) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   This case was linked to MOD-2021-339129 (Patient Link).
Appendicitis. Had to have appendix surgically removed at midnight, July 11th.
Diarrhea, nausea, vomiting- new dx microscopic colitis from flu shot
shot has effected the mussel in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization. The following information was reported: MUSCLE DISCOMFORT (non-serious), outcome "unknown", described as "shot has effected the mussel in my arm".  Additional information: Caller stated that, shot has affected the mussel in arm. When brushing teeth arm falls. He cannot hold arm up good. It has done something to the mussel in that arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a big oval shaped rash below the injection site on the arm. No treatment. It disappeared in a few day.
4 days after vaccine patient developed acute ataxia. He was seen at Hospital and had an MRI that was read as normal. He was diagnosed with Cerebellar inflammation. This was thought to be a result of a possible virus but due to the proximity of the vaccine I decided to report.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of injections site redness in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to Phenergan. Concurrent vaccination included BOOSTRIX; GlaxoSmithKline; intramuscular; right deltoid given on 29 November 2012. Concurrent medications included Birth control. On 29 November 2012 at 17:30 the subject received a dose of BOOSTRIX (.1 ml, intradermal, right forearm) and experienced inappropriate route of vaccination, wrong vaccine administered. The reporter stated that "she had the BOOSTRIX and Tuberculin test sitting beside each other. She picked up the BOOSTRIX and withdrew 0.1 mls which was administered intradermally in the right forearm." On 29 November 2012, within minutes of vaccination with intradermally administered BOOSTRIX, the subject experienced injections site redness. The reporter stated that the subject "started rubbing her forearm and the area turned red." On 29 November 2012, the subject received a dose of BOOSTRIX (0.5ml, intramuscularly, right deltoid) and experienced overdose. The subject received more BOOSTRIX antigen than indicated on the same date. The nurse practitioner provided subject with the BOOSTRIX intramuscularly when she realized what she had done. At the time of reporting the event was resolved. The reporter stated that "after 5 hours, there was no problem with her right forearm where the BOOSTRIX was accidentally administered intradermally."
Patient had a stroke post Bivalent vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Feb2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Scoliosis" (unspecified if ongoing); "lumbar radicals-Arthur" (unspecified if ongoing), notes: lumbar radicals-Arthur; "Hypertension" (unspecified if ongoing); "chronic atrial fibrillation" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Lumbar Fusion post surgery" (unspecified if ongoing), notes: Lumbar Fusion post surgery. The patient's concomitant medications were not reported. Past drug history included: Eliquis, notes: Px was restarted on Eliquis post surgery. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 02Feb2023, outcome "unknown", described as "Patient had a stroke post Bivalent vaccination".  Clinical information included as event took place after use of product. Pfizer Bivalent given on 02Feb2023. Patient had stroke same day.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events CEREBROVASCULAR ACCIDENT and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, between 03-JAN-2017 and 06-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M007298, expiration date 19-NOV-2017 and lot # M011832, expiration date 25-JAN-2018. No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature of 35 degrees Fahrenheit for 24 hours. Data logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
At approximately 09:30 A.M., client was questioned by nurse regarding allergy to medication.  Pt. states allergic only to Penicillin, and she is diabetic but does not have to take meds/insulin.  No breakfast this A.M. Pt. here for Td, and MMR.  09:40 A.M. --Pt's daughter came into immunization dept. states her mother the Pt. is complaining that her throat is closing-up, itchy, tongue feels fat, abdominal pain like "diarrhea", feel that her body is getting very hot, and feels like she is dying.  Immediately immunizaitons nurses headed out to the health dept. parking lot where the pt. was in the car.  Pt. was slumped over, and was sweating profusely.  Pt. was nonresponsive to the ammonia inhalants/shaking of shoulders.  Pulse non-palpable.  Pts. head repositioned as not to compromise airway.  Shallow up and down chest movement.  Does not appear to have trouble breathing. Lung auscultation---clear.  Immunization sites examined---no arthus reaction.  As a precaution and standard, a tourniquet was placed above injection sites.  Initiated Code Blue and 911.  B/P-non-readable.  Epinephrine 1:1000.30cc sub-q. (rt.arm).  After five minutes, pt. vaguely responding via moaning and answering questions per yes and no head movement.  Pt. placed in recumbent position and elevated lover extremities.  (B/P--86/42, Pulse--40) Paramedics and ambulance arrived on site. Benadryl 100mg IM administered (rt.arm). Informatin and Pt. status given to paramedics--placed Pt. on gurney.  Pt. transported to hospital via ambulance.
Vaccine refrigerator experienced an unreported temperature excursion greater than 72 hours/no AE; stability data of product was not provided.
Seizure; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 1-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 SEIZURE (Seizure) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). The patient died on an unknown date. The reported cause of death was Seizure. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.            The concomitant medication was not reported by reporter. It was reported that patient died two days after Moderna with previous severe seizure. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 1-year-old patient of unknown gender, with no reported medical history, who experienced the unexpected serious fatal AESI of Seizure after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. It was reported that patient had severe seizure and died 2 days post vaccination with the reported cause of death was seizure and unknown if autopsy was done. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 1-year-old patient of unknown gender, with no reported medical history, who experienced the unexpected serious fatal AESI of Seizure after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. It was reported that patient had severe seizure and died 2 days post vaccination with the reported cause of death was seizure and unknown if autopsy was done. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Reported Cause(s) of Death: Seizure
Local swelling, redness lt deltoid w/nodule; (not abscess); 3/4" diam; rxn DPH & Ibuprofen;
Client received the wrong covid vaccine for his age. He was 11 years old at the time of vaccination, and he received SARS Cov-2 Pfizer(12yr+) for his 2nd dose. No symptoms reported.
tingling and numbness down my right leg, into my left leg; tingling and numbness down my right leg, into my left leg/tingling sensation in my right lateral thigh; weakness in both legs from back of the buttocks into hamstrings; nerve pain down the back of my hamstrings; This is a spontaneous report from a contactable Other HCP (nurse reported for herself). A 54-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EL9262), dose 2 via an unspecified route of administration, administered in Arm Right on 28Jan2021 11:00 AM (at the age of 54-year-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient other medical history was none. The patient had no Known allergies. The patient did not have COVID prior vaccination. Concomitant medication(s) included Estradiol (ESTROGEN) and Progesterone (PROGESTERONE), all taken for an unspecified indication, start and stop date were not reported. The patient previously received her first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EL01470), via an unspecified route of administration, administered in Left arm on 07Jan2021 11:00 AM, as single for covid-19 immunisation and about 1 1/2 weeks after the first dose of the COVID vaccine, she had a numb/tingly tingling down her right leg into the foot. No other vaccine in four weeks. On 28Jan2021, within several minutes after receiving the 2nd dose of the COVID vaccine, the patient experienced tingling and numbness down her right leg, into her left leg/tingling sensation in her right lateral thigh, weakness in both legs from back of the buttocks into hamstrings and nerve pain down the back of her hamstrings. The clinical details of the events as follows: Within several minutes after receiving the 2nd dose of the COVID vaccine, she had a rush of tingling and numbness down her right leg, into her left leg and weakness in both legs from back of the buttocks into hamstrings which was lasting about 1 1/2 weeks after the vaccine. She had nerve pain down the back of her hamstrings for about 1 1/2 weeks. It was reported that she had to be seen by a neurologist and have an MRI the days following. She had been referred to a spine Dr. to discuss the findings, but she has to get workman comp approval before she can make this appointment. She continued to have a tingling sensation in her right lateral thigh. The sensations in her buttocks, hamstrings and left leg had resolved. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received to treat the events. The patient underwent lab tests and procedures which included antigen test (Nasal Swab) was negative on 09Feb2021. The patient outcome of the events was Resolved with Sequel (resolved with lasting effects).   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 15 month old female patient with no pertinent medical history or drug reactions who on 30-APR-2010 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 666057/1450Y). There was no concomitant medication. On 17-MAY-2010, the patient developed 10 red, vesicular lesions on the left shin. On 24-MAY-2010 the patient was seen in the office. The lesions were "crust over and the patient was prescribed BENADRYL. No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering . Additional information is not expected.
2 weeks post immunization, pt developed vesicular rash in excess of 50 lesions, discrete and randomly distributed over torso, accompanied by fever 101x36hours.
Pt reported a rash on the right shoulder, upper arm a few hours following the shot. No medical appt after the reaction. Resolved on it's own.
3/27-Patient started to experience chills last night, prior to which, the patient put on a sweatshirt. During the night, the patient was experiencing tingling in both hands. Patient's chills resolved at approximately 04:00 today; patient's temperature was 99.3 degrees Fahrenheit at around 09:00-10:00 today. At 13:28 today, the patient's temperature was 98.4 degrees Fahrenheit. Patient was experiencing sluggishness a great deal yesterday, and is now only experiencing a little sleepiness/sluggishness. Patient took Tylenol to help with symptoms.