chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a county health registered nurse concerning a 6 year old male who on 22-JUL-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 08-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Patient hospitalized 6/13-6/13/2022  with weakness and GI symptoms following positive COVID test on 6/6/2022
Gave patient injection, he walked to waiting room to check out. Wife came and got me. Pt was shaking with severe chills. Was brought back to room. Along with chills c/o headache and tongue being numb. All vitals normal within 30 min. pt ok. And walked out of office ok.
pt recv vax 1MAY96&p/1hr pt devel severe crampy collicky abd pain;this lasted for about 4-5hr;pt was fine in between bouts;no n/v,diarrhea;
patient received Daptacel vaccine after it expired/ no adverse event; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case is linked to case 2019SA179270, same reporter.  This case involves an 18 months old patient with unknown gender who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided.  Concomitant medication was not received.   On 11-Jun-2019, the patient received a fourth dose in series 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019 via intramuscular route.  It was an actual medication error due to expired vaccine used.  It was reported that patient received Daptacel vaccine after it expired.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Rash on hands/it went on both arms, neck, and ears; raised red patches and they itch; raised red patches and they itch; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL9267) via an unspecified route of administration in right arm on 17Feb2021 at 12:00 (at the age of 67-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Controlled high blood pressure, Heart arrhythmia. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested for covid post vaccination. Patient previously took Cipro antibiotics and experienced allergy. On an unspecified date in 2021 after receiving vaccination, patient experienced rash on hands which went away in approximately 1 week, 2nd week it went on both arms, neck, and ears. Patient was still having it and she was scheduled for second shot tomorrow. On an unspecified date in 2021, patient experienced raised red patches and they itch. Patient have an appointment to see her Primary Care Doctor in 2 days. AE resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills; headache; muscle pain; tired; feel bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FL3209) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FL3182, Location of injection: Arm Left), administration date: 26Sep2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Left), administration date: 11Feb2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 21Jan2021, when the patient was 74-year-old, for COVID-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022); FEELING ABNORMAL (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022), described as "feel bad"; HEADACHE (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022); MYALGIA (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022), described as "muscle pain"; FATIGUE (non-serious) with onset 06Apr2022 at 23:00, outcome "recovered" (Apr2022), described as "tired". Therapeutic measures were not taken as a result of chills, headache, myalgia, fatigue, feeling abnormal.  Additional information: No other vaccine in four weeks. Patient had no known allergies. No covid prior vaccination. The patient was not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
sore throat, headache, fever, chills, cough;  was in hospital for 1+ day, discharged with antibiotics;  improved with some lingering fatigue
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
11 x 9 cm dark red, tender, warm, itchy, slightly indurated rash. Reaction was around injection site on right deltoid. Resolved in 72 hours with Benadryl.
Within 24 hours of receiving the vaccine, I experienced fluid in my left ear/impaired hearing.
An 18-year-old female patient, one minute after the administration of the Pfizer BioNTech vaccine in her booster dose, suffers from syncope, in which the patient appears pale, sweaty and with involuntary movements. The patient reacts in approximately 20 seconds, she is alert and oriented in time, place and person. The patient is transferred to a stretcher and treatment area for evaluation and vital signs are taken; B/P 100/60, Pulse 73, Breaths 18, Dextro 99mg/dl and 99% SPO2. The patient is placed with elevated legs and Doctor is consulted, who refers that the patient be kept with elevated legs under observation for 30 minutes and the patients vitals and status are re-evaluated. At 30 minutes vital signs are reassessed, which were, B/P 110/70, pulse 72, Dextro 79 and 99% SPO. Patient reports feeling well and being recovered from the event. Doctor is consulted, who indicates that the patient can be removed from the vaccination center. Patients refers to the vaccination center accompanied by her mother and brother.
Initial report received on 01 Nov 2005 from a patient. A 53 year old female patient with a medical history of allergy to cats and intravenous iodine developed coughing for 15 minutes and her eyes began to feel gritty and turned blood shot red around 3:00pm following the influenza vaccine (Fluzone SV '2005-'2006) administration on 26 Oct 2005 at 11:00am. It was reported that, by 6:00pm she had a hard time seeing. Lather in the evening, she reported to have flu like symptoms with nausea and feeling weak. She was on prevacid from an unspecified time for gastroesophaeal reflux disease. She went to bed at an unspecified time and next day she was fine. Follow up information received on 27/Mar/2006 from the patient. There was no illness at the time of vaccination, and the patient was on no other medications. Additional information was not provided.
Pt recvd 2 doses of Engerix-B & w/in 12 hrs could not walk; hospitalized overnight;
back pain; Losing voice; pain in check bones; neck swollen; Rainy day blues; Tiredness; Muscle pain; extreme pain in bones; Chill; Hot; Cold; joint pain; fever; runny nose; nausea; throwing up; lack of appetite; weird dreams; sleep for short times; glands swollen in neck; sore throat; sore mouth; earache; vision poor; extremely rough 15 to 20 on pain scale/ every part of her body hurt; lost 7 and 1/2 pounds; feeling sick; weak; rash/ rash under chin, on arm; tender to the touch; Injection site pain; Injection site redness; Injection site hot to the touch; This is a spontaneous report from a contactable consumer. A 87-year-old non-pregnant female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER2613), dose 2 via an un-specified route of administration, administered in Arm Left on 18Mar2021 11:15 as dose 2, single for covid-19 immunisation (at the age of 87-year-old). The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On 18Mar2021 patient experienced Injection site pain, Injection site redness, Injection site hot to the touch, Thursday 11:15 am shot felt ok through dinner and supper by 8pm feeling sick till Saturday 20Mar then just week , rash and tender to the touch. Friday was extremely rough 15 to 20 on pain scale lost 7 and1/2 pounds. On 20Mar2021 Saturday patient experienced tiredness, Muscle pain, extreme pain in bones every part of her body hurt. Chill, Hot, Cold, joint pain, fever, runny nose, nausea, throwing up, lack of appetite, rash under chin, on arm, weak, weird dreams, when she did sleep and only sleep for short times, glands swollen in neck, sore throat sore mouth, earache, vision poor. Sunday finally ok. Monday (23Mar2021) still week and tired. Tuesday (24Mar2021) Slept late, rashes gone, neck swollen, Rainy day blues. Wednesday (25Mar2021) much back pain during the night took a pain pill (Naproxen) Unger Menthol ointment. Losing voice, feeing weak, need asthma inhaler, pain in check bones, Still feeling weak on the 09Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The treatment was not received for adverse event. The patient underwent lab tests and procedures which included pain assessment: 15 to 20 on 19Mar2021, weight decreased: 7 and 1/2 lbs on 19Mar2021. The outcome of the event rash/ rash under chin, on arm was recovered on 24Mar2021. The outcome for other events was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 02-JAN-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
It's warm to touch; Just noticed around the injection site on her right arm, there's is a red area; Little rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's warm to touch), VACCINATION SITE ERYTHEMA (Just noticed around the injection site on her right arm, there's is a red area) and VACCINATION SITE RASH (Little rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021 at 3:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (It's warm to touch), VACCINATION SITE ERYTHEMA (Just noticed around the injection site on her right arm, there's is a red area) and VACCINATION SITE RASH (Little rash). At the time of the report, VACCINATION SITE WARMTH (It's warm to touch), VACCINATION SITE ERYTHEMA (Just noticed around the injection site on her right arm, there's is a red area) and VACCINATION SITE RASH (Little rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
As Pt neared 24 hours post-second COVID vaccine, he developed severe chest pain, shortness of breath,  severe activity intolerance, and anxiety.
The patient's daughter states the patient went in for a chemotherapy treatment and was unable to get the treatment due to a low ANC. She stated this is the first time the patient has been unable to get his monthly chemo treatment for this reason .
Patient inadvertently received vaccine after published expiration date.  Moderna Company analyzed lot 007B21A and advised this vaccine maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
No adverse event, but patient had already received the Janssen COVID-19 vaccine a few months previously.
Patient got the Janssen Covid-19 vaccine at 11:30 am. After getting the shot he complained  about itching, He was not having any other symptoms, his breathing was normal, no rashes , no swelling . His BP (128/88)  was normal . We administer Benadryl 50 mg  and monitored him for 1 & 1/2 hrs. He was doing good. Asked patient to get Paramedics , but patient denied to get them and call his docotr to get advice. His doctor asked him to go to medical ER to have him checked. He was feeling good and he left at 12:50 pm. from pharmacy. We counseled him to seek immediate medical help , if any symptoms persist. spoke to him around 4:30pm over the phone and he said he was doing good. He mentioned that ER said he is fine.
This spontaneous report as received from a physician via other company letter (Pfizer) refers to a currently 39 years old female patient. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient experienced allergy to PNEUMOVAX 23 (allergy to vaccine). The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to PNEUMOVAX 23.
This is a spontaneous report from a contactable physician (Pediatrician) communicated to a sales representative. A 17-year-old female patient received TRUMENBA NDC number: 0005-0100-10, UPC number: 30005-0100-102, Lot Number: N11904, Expiry date: Jul2017, intramuscular in right deltoid on 16Sep2016 03:00 at 0.5 ml, single for prevention of meningitis, HAVRIX NDC number, UPC number: 3581-608-25118, Lot Number: 4RX3D, Expiry date: 27Apr2018, intramuscular in left deltoid on 16Sep2016 at 1 DF, single for immunisation.  The patient medical history was not reported.  There were no concomitant medications. The patient experienced feeling fever up to 103, some trouble with the breathing, nausea, weak feeling, headache, pale, didn't want to eat on 17Sep2016 with outcome of not recovered. The events required doctor visit. Physician stated that the events could be related to Trumenba or may be due to some virus. Physician further added that the young lady (patient name) also had Hepatitis A vaccine with meningococcal group b rlp2086, if that could have caused the events.
The 11 year old student has accidently received a Pfizer covid19 vaccine.  The student was under the age of approved indication.  No adverse reaction was reported
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 13-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of minus 40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Itchiness on scalp, neck and shoulders starting 11/17/2021. Hives all over body, including dermatographia, starting 11/18/2021. Hives continued since that date. Treated with daily Zyrtec, steroid shot on 11/21/2021 and 11-day course of prednisone starting 12/6/2021.
long vertical bruise on inner thigh along the saphenous vein; ultrasound confirmed that patient had superficial thrombosis; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 13:15 (lot number: EW0150) as SINGLE DOSE for COVID-19 immunization. Medical history included polycystic ovaries and penicillin allergy. Concomitant medications included metformin; loratadine, pseudoephedrine sulfate (CLARITIN-D); acetylsalicylic acid, caffeine, paracetamol (EXCEDRINIL); calcium carbonate, colecalciferol (VITAMIN D 2000); zinc. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 11Mar2021 at 08:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Apr2021, the patient developed a long vertical bruise on inner thigh along the saphenous vein. The event resulted in  emergency room/department or urgent care as this can be a sign of clotting. Upon arrival at the ER, the doctor checked the patient's platelets and palpated the area and determined that an ultrasound is needed to rule out deep vein thrombosis. The ultrasound confirmed that patient had superficial thrombosis. Therapeutic measures were taken as a result of the events which included treatment with Baby aspirin for two weeks. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Pt vaccinated with DTP/OPV mother put to bed at 10PM for the night. Found pt. at 5AM cold & stiff on 21OCT90.
Tested positive for COVID-19 on 2/27/2023 I had fever, fatigue, headache, runny nose and congestion Prescribed a course of antiviral medication for 5 days. Tested positive for 17 days.
Information has been received from a physician concerning a 5 year old male who on 24-APR-2007 at 14:55 was vaccinated SC with first dose of Proquad. Concomitant therapy included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. On 24-APR-2007 "within 30 minutes) of vaccination with Proquad, and while still at the doctor's office the patient complained of itching. It was reported that the child was experiencing "throat pain" and "throat tightening". The child was treated with two teaspoons of BENADRYL, 0.3ml of 1:1000 epinephrine, and 35mg of prednisone in a syrup formulation. The parent brought the child home and at 16:30 the child was brought to the emergency room. It was reported that child was in the Emergency Room until 21:00. At the time of report, child's symptoms had resolved and he was at home. A product quality complaint was not involved. Additional information has been requested.
Pt states that his right arm has been sore for the last month after the flu shot. The flu shot was in August. Also, from our records, the flu shot was administered on the left arm. Pt is seeing md tomorrow for an unrelated condition, but will mention the arm pain as well.
Patients who stated they received the first dose 6 weeks ago or longer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer) 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 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported   Reporter did not allow further contact