chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigued; sick to the point of vomiting; sick to the point of vomiting; got first about 5 years ago, has not received second; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, sickness, vomiting and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and vomiting were recovered/resolved and the outcome of the sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fatigue, sickness and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The reporter was the patient and reported that she got her first Shingrix vaccine, in an unknown arm, about 5 years ago and had not received her second Shingrix vaccine yet.  The first Shingrix vaccine made her very fatigued and sick to the point of vomiting. The reporter did not remember the details of when the symptoms started or ended. The reporter was now having surgery was 2 months and wanted to get the second Shingrix vaccine.  The reporter health care professional told her it was fine to get. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient received the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
4 days after receiving the vaccine the patients arm swelled up and was painful. Arm is bruised from deltoid to above the elbow . Purple and yellow bruises are still visible 3 weeks later.  Patient did see physician and physician advised patient to receive the second dose
Patient received second COVId 19 vaccine on 4/9/21 @ Health Department. Was admitted to hospital on 5/18/2021 with SOB, Nausea, Vomiting, and Headache. Diagnosed with COVID 19 infection and COVID 19 Pneumonia. Patient expired on 5/19/2021 at hospital.
INSOMNIA; TINNITUS; CHILLS; SEVERE HEADACHES; MILD FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 01-APR-2021, the subject experienced insomnia. On 01-APR-2021, the subject experienced tinnitus. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced severe headaches. On 01-APR-2021, the subject experienced mild fever. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, chills, severe headaches, mild fever, and nausea on APR-2021, and was recovering from tinnitus. This report was non-serious.
Fever 101 Body aches Chills  Headache Nausea All started  18 hours after injection and lasted 15 hours after onset Still continue to have redness, swelling and tenderness at injection site
Patient was sweaty and lightheaded. I fanned her and had her lay down till she felt better. She also stated her blood pressure runs low normally.
Left arm pain for 48 hours; Weakness for 48 hours; Lightheadedness for 24 hours; This is a spontaneous report from a contactable other hcp. A 56-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:15 as SINGLE DOSE for an unspecified indication. Medical history included depression, bipolar i disorder, insomnia, hypercholesterolaemia from an unknown date. Concomitant medications included asa (ASA); atomoxetine hydrochloride (STRATTERA); escitalopram oxalate (LEXAPRO); gabapentin (NEURONTIN); trazodone. The patient experienced left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness) on 04Feb2021 at 12:00. Therapeutic measures were taken as a result of left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness), acetaminophen was provided. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of the event lightheadedness was recovered on 05Feb2021 at 12:00 and event left arm pain and weakness was recovered on 06Feb2021 at 12:00.  Follow-up attempts are completed. No further information is expected.
Chills for 3 hours, then fever and body aches, bad headache in morning, nausea and vomiting
Approximately 2 hours post-vax the patient's cheeks began turning red and swelling. The mother states the patient became limp and "felt hot". The mother treated with Tylenol. The patient was diagnosed at the ER as having had an allergic reaction to the immunization. The patient was treated with Benadryl and was better the next morning.
Slight lip swelling noted 5 min after vaccine adm. Doctor informed, rec'd advise to have pt transfer to urgent care.  Pt in stable condition, no respiratory distress.
No additional AE reported; Medical assistance reported 1 administration of ROT ATEQ following a temperature excursion; This spontaneous report as received from a medical assistant concerning  a patient of unknown age  and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.      On 15-OCT-2021, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot #: 1694405, expiration date: 06-DEC-2021 for prophylaxis following a temperature excursion (dose and route of administration were not reported)  (product storage error). No additional adverse event reported. No product quality complaint reported.
Infant was lethargic and vomiting starting from next day, noon. No diarrhea. She would get irritable in between lethargy and is not interested with feeding.
Headache, Myalgia, Arthralgia, ErythemaMultiform, FATIGUE Narrative:
A 37 year old female completed the series of RabAvert treatment for post-exposure and experienced increasing joint pain, muscle soreness, stiffness, throbbing throughout her body, anxiety, and tension. She received RabAvert 1ml IM on 4, 7, 11, 18 July and 1 Aug 2002 after being attacked by a wild cat. The attack resulted in multiple severe puncture wounds on both of her legs, right hand and forearm. After the first dose the pt complained of increasing joint pain, muscle soreness, stiffness, throbbing throughout her body, and a sensation of anxiety and tension. She reported that the symptoms lasted for approximately two weeks and that subsequent dosing resulted in increased throbbing at all of the bite wound sites was worse in her right hand and sometimes radiated to her neck. The nurse reporter assessed the events as possibly related to treatment drug. Follow up received on 12/19/02: On 7/4/02, the pt received tetanus/ diphtheria three hrs prior to receiving BayRab and first RabAvert dose IM. The pt was mildly sedated and went home to sleep. At that time, she noted increased joint pain, stiffness, throbbing joints, and muscle soreness in the morning, along with anxiety and tension. With each succeeding dose she had throbbing pain at all sites but most concentrated on right hand and occasionally felt up to her neck. The symptoms persisted for two weeks after initial RabAvert dose. She received subsequent doses on 7 Jul , 11 Jul, 18 Jul, and 1 Aug. The pt completely recovered without medical intervention. Follow up received on 5/1/03: lot numbers and expiration dates for administered RabAvert were received for injections 1 and 5.
didn't have taste; fever; body aches; chills; COVID-19 diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (didn't have taste), SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis). On an unknown date, the patient experienced AGEUSIA (didn't have taste), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, AGEUSIA (didn't have taste), SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, SARS-CoV-2 test: positive (Positive) got COVID-19 diagnosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Tylenol and Advil to alleviate the symptoms
Scattered rashes like that caused by Poisson ivy, Toxicodendron radicans.
Patient presented to the ED on 4/25/2021 and was subsequently hospitalized for COPD exacerbation. Patient presented to the ED on 5/27/2021 and was subsequently hospitalized for lower extremity edema. These visits are within 6 weeks of receiving COVID-19 vaccination.
Initially some soreness and swelling which went away by day 3.  Then 9 days after injection, here was a swollen warm, itchy, sore,  2-3 cm red spot at injection site.  It slowly faded over the next few days and is not visible on day 12.
Pain that expands from thighs to knees/Sored thighs; Really sored right arm; Sored knees/Sored thighs; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain that expands from thighs to knees/Sored thighs), VACCINATION SITE PAIN (Really sored right arm), ARTHRALGIA (Sored knees/Sored thighs) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 022J21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 07-Jan-2022. Concurrent medical conditions included Blood pressure high.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced PAIN IN EXTREMITY (Pain that expands from thighs to knees/Sored thighs), VACCINATION SITE PAIN (Really sored right arm), ARTHRALGIA (Sored knees/Sored thighs) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain that expands from thighs to knees/Sored thighs), VACCINATION SITE PAIN (Really sored right arm), ARTHRALGIA (Sored knees/Sored thighs) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking medication for her high blood pressure as concomitant medication. The lot number for second dose was also reported as 022J21A.  It was mentioned that pain symptoms got better on 23 FEB 2022 when she took painkillers. The headache came back on the day of reporting. And she was feeling more pain.
Fever 100.2, body aches, prickly skin, headache, sore throat, swollen glands.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "all caught Covid-19". Clinical Course: Recently, despite receiving the three shots, reporter's daughter, son-in-law, and himself all caught Covid-19 from his unvaccinated 2 year old granddaughter. Fortunately it was very mild for all of us and we recovered quickly. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200460138 same reporter/drug/event, different patient.
Red inflamed circle on left arm, about the size of a tennis ball or so with heat, and a knot under the skin.  Given antibiotics, steroid shot, and allergy meds.
No longer having a menstrual cycle. One 1 period since my vaccination. Not pregnant.
About 2 weeks after receiving the J&J Covid-19 vaccination, I became ill with confusion, lethargy, and disorientation.  Taken to hospital in town to rule out possible CVA.  MRI, CT, Carotid sonograms, were  all negative.  While waiting on lab, the preliminary DX was metabolic Stroke.  After all lab returned, the diagnosis  was Hemolytic Uremic Syndrome  (HUS).  Transferred to ICU in different town for dialysis and plasmapheresis.   Hospital  in another town had closed their department for holiday.  I spent about 2 weeks at hospital.  My Hgb on admission was 7.0 and kidney function was 20%  .  the platelets were being destroyed in the glomeruli.  Blood transfusion and platelets were contraindicated.
Pt. states that after receiving the 3rd Booster of Phizer 10/06/2021, started experiencing symptoms 10/07/2021 of fever (101.5) and weakness. Emergency Room *transported visit 10/07/2021 observation. Blood Work, chest X-Ray came back normal. 10/12/2021 Primary visit with no recommendations.
Pt came into clinic for covid booster. He did not have original vaccine card with him at the time. Immunization information system was checked and RN determined pt was due for booster based on current criteria at the time.  Last dose based on immunization information system was on 04/12/2021 Administered booster w/o incidence. When pt returned home he found his vaccine card and realized he had received his booster dose back of 08/2021 by  pharmacy.  Per immunization information system the pt has 2 different charts and booster was not listed on pt's chart that was viewed by RN.   Pt did not exhibit any symptoms or side effects. Provider aware.
Hives on arm (resolved with benadryl), fever, aches, swollen lymph nodes in left armpit.
LOCAL REACTION, FEVER, CHILLS, MYALGIAS, NAUSEA, VOMITING, PNEUMONIA.  8/25/09 Received ER records of 8/16/2009 to 8/25/09. FINAL DX: anthrax allergy, RML/RLL Pneumonia Records reveal patient experienced weakness, nausea,  N/V, dehydration, fever/chills, sweating, sore throat, nasal congestion, cough, HA, tingling, SOB, rash on arms, abdominal pain, anxiety x approx 10 days. 8/28/09 ICD9 codes: 780.79; 786.05; 486. 10/1/09 Military medical records received DOS 8/7/09 to 8/25/09. Assessment: Bronchopneumonia. Drug Toxicity Vaccines Bacterial. Adverse Drug Effect of Vaccines Bacterial. Redness and swelling at injection site. Fever, chills, fatigue, muscle aches, nausea, vomiting, productive cough. Oral intake decreased. Chest / rib pain. Cervical adenopathy. Decreased breath sounds. Sore throat. Insomnia, difficulty getting to sleep.
This spontaneous report as received from a consumer referring to herself, a 75 year old female patient with high blood pressure but running very normal. On 08-JUN-2012 the patient was vaccinated with ZOSTAVAX single dose (lot number, expiration date, therapy route and anatomical location unknown) (prevent shingles). Concomitant therapies included losartan potassium (manufacturer unknown), gabapentin (manufacturer unknown), aspirin 81 mg (manufacturer unknown), pravastatin sodium (manufacturer unknown) and metoprolol (manufacturer unknown). In September 2012 the reporter stated that she developed a rash 3 months later but no in area where injection was given, rash was on stomach, back, arms and upper legs, the patient sought unspecified medical attention and a dermatologist prescribed a compound for rash. It was reported that the adverse event improve but rash reappear on back little bumps. The outcome of generalized rash was reported as recovering. Additional information is not expected.
Information has been received from a consumer, concerning her 17 year old daughter, who on an unknown date was vaccinated with the third dose of Gardasil.  There was no concomitant medication.  On 29-AUG-2007 the patient had a Pap smear that was positive for human papilloma virus.  At the time of this report, the patient had not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 74-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 3rd April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional information was received as follows: On 5th April 2018, the patient was seen in the emergency room. The health care professional was unsure if the patient was admitted.
pt recv vax 11OCT96 & 10NOV96 pt devel severe pain in back & was hosp on the same day for 8 days;dx w/transverse myelitis;pt is paralyzed from waist down;
On 10/11/00, the pt received the vaccines, reportedly on the same day, the pt experienced a transient ischemia attack and was admitted to the ICU of the hospital for observation. From a follow-up correspondence received on 11/1/00, it was reported that the pt was hospitalized for 4 days. The pt's recovery status is unknown.
FEELING SLEEPISH; SLUGGISH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced feeling sleepish. On 16-SEP-2021, the patient experienced sluggish. The action taken with covid-19 vaccine was not applicable. The outcome of the feeling sleepish and sluggish was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931931.
Overnight started to feel minor chills; Joint aches; Tiredness; A bit of a temperature; Did not sleep well; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number EP-6955) via an unspecified route of administration, administered arm left on 24Mar2021 11:45 (age at the time of vaccination 58 years) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient's medical history included high blood pressure and cholesterol. List of any other medications the patient received within 2 weeks of vaccination included lisinopril, atorvastatin (LIPITOR), multivitamin, acetylsalicylic acid (ASPIRIN LOW), multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. He was not diagnosed with covid-19 prior vaccination. The patient experienced on 25Mar2021 at 4:00, overnight started to feel minor chills, joint aches and tiredness. He did not sleep well last night, woke up this morning with chills and a bit of a temperature. He was not received treatment received for the adverse event. Since the vaccination, the patient was not tested for COVID-19. The patient underwent lab test and procedure included body temperature: a bit of a temperature on 25Mar2021. Event took place after use of product. The outcome of chills, joint aches and tiredness was recovering and outcome for other events was unknown.  No follow-up attempts were needed. No further information was expected.
second shot; allergic reaction  on left side (shot in left arm) - swelling of face, tingling fingers and toes, mild throat swelling, droopy eye; took Benadryl per recommendation of pharmacist   side-effects occurred 30 mins post shot
High fever, N&V x 8 hours , shaking chills,  hives right upper arm
Day 9 broke out in raised bumpy itchy red rash both posterior arms and both inner and outer thighs,  and hip. Researched issue and consulted info sheet from Hospital. Took Benadryl and applied hydrocortisone cream. Annoying but manageable and did not report to PCP. Began March 3 and persist today March 5.
Patient stated that she felt dizzy and her right arm (vaccinated arm) hurt. She took TYLENOL but it still hurt. The pain in her arm started to spread toward her back and neck in the evening. She was advise to seek medical help. Called patient back in the morning and she was told by ER to take MOTRIN and to go back if pain is still there in 2 days.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208: