chrisvoncsefalvay/vaers-outcomes huggingface dataset:
kinrix administered to 9 month old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 237c4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: A 9 month old patient was administered one dose of Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Cyclical vomiting from 6hr after vaccination until 12hpurs post vaccination, as well as diarrhea from 12 hr post vaccination to 4 days post vaccination, headache pain and disorientation for two days following vaccination, chills, hot flashes, muscle pain and weakness.
SUDDEN ONSET OF DYSPNEA PRURITUS FACE WHEEZING BILATERAL
Anal itching, inflammation between rectum and scrotum, dry itchy peeling skin on skin folds of scrotum since third Anthrax injection 9 June 2000 (Suspected).  Since fourth Anthrax injection 21 June 2004 have soreness, swelling, and tender joints in feet, hands, wrists, knuckles, shoulders, elbows and toes.  20 April or approx was diagnosed with Rheumatoid Arthritis with RF Titer of 1:2560.  Taking Piroxicam and seeing Rheumatologist for treatment and changing diet and developing a holistic view for treatment.  Praying and meditating and changing diet to make body more alkaline vs acid based and hopefully to eradicate the toxins which caused this disease.  This injection has changed my life and unable to exercise (run, golf) due to soreness in joints or perform the most simple tasks without pain.
The pain shoots down the arm all the way to the fingers; Disables the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In March 2019, the patient received the 2nd dose of Shingles vaccine. In April 2019, 30 days after receiving Shingles vaccine, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that about a month after receiving the vaccine began experiencing extreme pain at the injection site if raised arm above the shoulder. The patient stated that, the pain shoots down the arm all the way to the fingers and disables the arm for a period of 1 minute. The patient did some research on side effects of the shot and have found that approximately 1 in 6 people who get the shot experience a similar reaction.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions/allergies were reported. On an unknown date these patients were vaccinated with improperly stored dose of ROTATEQ (lot # L042215, expiration date 02-JUN-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
pt recv vax 3PM high pitched scream then very pale w/dec activity (mild hypotonic-hyporesponsive episode
COVID-19 symptoms Per report, employee "got COVID-19 symptoms, began 01/08/2021." Per Agency, employee had a COVID-19 positive test result on 01/10/2021. Reports other members of family also experienced symptoms prior to employee's positive test result.
Chest pain that started in the left back and then became precordial.  Started around 1 week after her second dose of moderna.  She then had severe chest pain, nausea and vomiting as the symptoms progressed. She collapsed and was pulseless for a time on the morning of 8/4/2021 and was taken to the ER and diagnosed with acute pericarditis. She had bradycardia and hypotension evidenced in the ER. EKG was abnormal for pericarditis and labs were negative for cardiac enzyme elevation.
Patient had vaccine on the 12th, Stelara shot on 15th, and symptoms of diffuse erythroderma on the 16th. Seen in ER on 18th and admitted for further treatment.
tired; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Pneumonia vaccine with an associated reaction of pain in extremity (received dose on an unknown date).   On 21st October 2021, the patient received the 1st dose of Shingles vaccine. On 22nd October 2021, 1 days after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient had the first shot last night, only felt tired a little bit today. The patient did not have arm pain like the pneumonia shot.
On Thursday, September 16th, 2022, at Healthcare, we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure.
did not feel well; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (did not feel well) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 24-Feb-2021, MALAISE (did not feel well) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Vaccine is given at 3pm. Reaction began Thurs later. Last evening lip, tongue and chin swelled and felt numb - shortly after her throat was tight. She called office and was advised to go to the ED. She declined, came to office 1/17/20 @ 11:30A.
Immediately after shot felt a very slight numbing on right side of tongue - almost like numbing gel dentist uses.   Half hour later I can feel this same numbing feeling all over my mouth.
This case was reported by a consumer via call center representative and described the occurrence of white blood cell count increased in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 28 days after receiving SHINGRIX, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported as an adverse event via click to chat. The patient had undergone a blood test four weeks after receiving SHINGRIX and 4 months later and the white blood cell count was elevated. The patient asked if the vaccination was responsible and also asked how long would the elevation last. The patient had an another test two months later and still the white blood cell count were elevated. Lab Comments: on an unknown date, the white blood cell count was increased.
Pt developed wheezing about 5' after the shot. But responded to PULMICORT AND Alb. H
Developed an allergic reaction;  reaction I had sort of looked like eczema, was a skin reaction; Rash up and down my both legs from my hip to my ankle; Developed an allergic reaction;  reaction I had sort of looked like eczema, was a skin reaction; Developed an allergic reaction;  reaction I had sort of looked like eczema, was a skin reaction; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation; bromocriptine mesilate (BROMIDINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNKOWN for glaucoma. Medical history included hypertension from an unknown date and unknown if ongoing, Blood pressure high, blood cholesterol from an unknown date and unknown if ongoing, Cholesterol, glaucoma from an unknown date and unknown if ongoing Verbatim: Glaucoma. Concomitant medications included losartan (LOSARTAN) taken 100 mg for hypertension, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken 10 mg for blood cholesterol, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken 5mg for an unspecified indication, start and stop date were not reported; timolol (TIMOLOL) 2mg,  Brimonidine taken Two mg for glaucoma, start and stop date were not reported. The patient experienced developed an allergic reaction; reaction I had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown, developed an allergic reaction;  reaction i had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown , developed an allergic reaction;  reaction i had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown. Therapeutic measures were taken as a result the events. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
An itchy rash all over her torso, buttocks and back - it was red, inflamed and very itchy, needing Benadryl to decrease the symptoms.
ADMINISTERED VACCINE THAT HAD BEEN OXPOSED TO A TEMPERATURE BREACH.  REQUIRED RE-VACCINATION
COLD SYMPTOMS, SINUS CONGESTION, CHEST CONGESTION, FATIGUE
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 38 months old patient who was vaccinated with 0.25 ml once dose of FLUZONE QUADRIVALENT (Batch number: UT6259LA and expiry date: 30-Jun-2019) via intramuscular route in the left thigh on 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.  It was a case of actual medication error due to vaccine under dose because 0.25 ml (pediatric dose) was given to a 38 months old patient. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by the sender: None.
PATIENT CAME FOR JANSSEN BOOSTER AND AFTER THE NURSE ADMINISTERED THE VACCINE AND TOLD THE PATIENT THAT MAKES HER 2ND DOSE THE PATIENT SAID NO THIS IS MY 3RD DOSE. SUPERVISOR NOTIFIED AND REVIEW OF VACCINE CARD REVEALED THAT 1ST DOSE WAS ON FRONT OF CARD AND GIVEN 03/21 AND ON THE BACK OF THE CARD A DOSE WAS GIVEN 11/21. PATIENT MONITORED A TOTAL OF 25 MINUTES WITH NO ADVERSE REACTION NOTED.
Rash all over body within 1 hour of the shot, Severe Lower Back pain Rash got worse and trouble breathing day after the shot
Slight sore throat; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Apr2021, the patient experienced slight sore throat for over 7 days now (at the time of report). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event slight sore throat was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies. The nurse reported the patient received ROTATEQ, 2 ml, orally, lot # R012954 and expiration date 04-DEC-2019 for prophylaxis on the following dates: 15-AUG-2018, 17-OCT-2018, 26-DEC-2018 and on 30-JAN-2019 (inappropriate schedule of product administration) and (extra dose administered). The outcome of inappropriate schedule of product administration and extra dose administered was unknown.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 02-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
ACUTE NON ST ELEVATION MI MYOCARDITIS ACUTE PULMONARY EMBOLISM 11/6/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
feeling extreme fatigue that remained until around 6:00 PM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization completed), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "feeling extreme fatigue that remained until around 6:00 PM".  Additional information: It was reported that on the next day, the patient woke up feeling extreme fatigue that remained until around 18:00. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen right subclavicular lymph node, clearly visible as large raised bump about 2 inches diameter, sore to touch. Lasted about 5 days post vaccination. Returned to normal after that.
sick; fever; cough; sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing Low Thyroid, blood cholesterol increased from an unknown date and unknown if ongoing High cholesterol, type 2 diabetes mellitus from an unknown date and unknown if ongoing Type 2 diabetes mellitus. Concomitant medications included metformin (METFORMIN) taken for type 2 diabetes mellitus, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported; ezetimibe (EZETIMIBE) taken for blood cholesterol increased, start and stop date were not reported; glimepiride (GLIMEPIRIDE) taken for type 2 diabetes mellitus, start and stop date were not reported; enalapril (ENALAPRIL) taken for hypertension, start and stop date were not reported; estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause, start and stop date were not reported; insulin detemir (LEVEMIR) taken for type 2 diabetes mellitus, start and stop date were not reported. The patient stated that on 22Mar2021 she took vaccine, and two days later on 24Mar2021 the patient experienced being sick with fever, cough and sore throat. She was not hospitalised but was on bed. It was given that it looked like EN6208 for lot no but (Further not clarified hence not captured in tab). The outcome of the events was unknown. No follow up attempts are needed. No further information expected.
Fainted at about 09:50 AM on 8/18/11, was taken to holding area in the clinic, vitals signs/ACCU-CHEK were stable. Given 2 cartons of apple juice, 2 cookies, ADVIL 100 mg for abdominal cramp, she was having her periods and had not eaten breakfast. Recovered well and sent home.
7JAN99 5-6PM mom noticed generalized tiny, red, rough rash-rash comes & goes;had temp of 101 for 30min;7JAN99 evening no fever since then just fussy;rash now on face, back, under neck & sl in sides, had been giving APAP;
under 50 years old; This case was reported by a consumer via (Shingrix ) interactive digital media and described the occurrence of inappropriate age at vaccine administration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, received shingrix vaccine at the age of under 50 years old, which led to inappropriate age at vaccine administration.
pt recvd Td vax in lt deltoid 14JUL92 that evening devel swelling, redness, & pain @ site of inject; pt seen 17JUL92; pt already on ATB for cellulitis of foot, extended tx;
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt has a history of fainting with needles.  We do not think it was the vaccine but the needle.  We did call an ambulance to check him out.
Received AVA #2 on 10/28/08.  Reported to clinic 2 weeks later (11/11/08) for AVA #3 and showed positive HCG test.  Third AVA held.  Symptoms:  Amenorrhea.  First OB visit was 12/11/08 and placed on Iron supplements.  Iron panel and 2nd trimester US ordered.  PT seen in ER in other country X 2 with vaginal spotting and abd cramping.  Diagnosed w/threatened AB and anemia (12/19 and 12/27).  Email from pt on 12/27/08 4:38 AM stated preg and baby were well, then in ER that evening 1903 with 5 minutes of vag spotting.  No active bleeding noted but test results showed decreasing Quant hcg: 12/19 = 56,337 and 12/27 = 39,133.68 and anemic: RBC 3.56, hgb 33.5 and hct 35.8.  Current GC/KOH/wet prep and chlymadia all negative.  TV 12/19/08 = IUP w/active fetus.
Hospitalized (11.10.21 - 11.12.21);  COVID-19 positive (11.10.21);  Fully vaccinated  Admission Date: 11/10/2021 Discharge Date: 11/12/2021 Details of Hospital Stay PRESENTING PROBLEM:  AKI (acute kidney injury) (HCC) [N17.9] HOSPITAL COURSE: Patient is a 60 y.o. male  who presents to hospital with shortness of breath and cough.  Patient does complain of a brown yellow productive sputum.  He also states that he has had increasing cough and dyspnea on exertion over the last 4-5 days.  He has had a low-grade temp on and off and presents in with diaphoresis.  He also complains of diffuse abdominal pain however there is no rebound or guarding and not suggestive of a surgical abdomen.  This pain did state he states he has had since his multiple previous abdominal surgeries.  He also complains of chronic low back pain states that he takes ?Tylenol ?at home.  Patient is mildly dyspneic on room air during examination.  Patient had some wheezes and was managed with bronchodilators.  He received regeneron due to COVID as well as steroids given mainly for his COPD.  His condition improved and he felt well enough for discharge.  He was noted to have some hyperglycemia while in the hospital.  He was instructed to limit carbohydrate intake, particularly refined carbs, and to follow up with his PCP as this may indicate diabetes.  HbA1c testing is pending at the time of discharge.
6 days, post vax, the pt awoke at 07:00 and appeared upset and vomited. She leaned back, body rigid, eyes rolled back, pale color, body stiff and then no movements. ER discharge dx was seizure of unknown etiology.
Fever of 100-101 for several days, lethargic, crying, refusal to eat, began limping during the afternoon of 11/6.
Information has been received from a healthcare professional concerning a 7.5 month old infant who on an unknown date was vaccinated with a dose of ROTATEQ (dose and route not reported). The reporter stated that he patient received the vaccine "outside of the recommendations of ROTATEQ) prescribing information". No adverse effect was reported. Additional information is not expected as no contact information is available.
1429 head pressure,nausea. Blood Pressure 151/99, HR 60, Sats 97%, Resp 16 1450 symptoms resolved left ambulating with family.