chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; Headache was severe at first and described as a spinal headache; shivering; fever; not feeling well since she got vaccine; History of thin blood but usually measures between 2.0 -3.5 and sometimes even 1.0 but today her INR was 4.2 and last week it was 4.1; Dizziness; Vaginal issues / Started with itching; Vaginal issues / clear discharge; Vaginal issues / Burning; open ulcers in the vaginal area; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included clotting disorder (history of thin blood but usually measures between 2 to 3.5, sometimes even 1). Concurrent medical conditions included multiple sclerosis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. On 4th February 2020, 9 hrs after receiving Shingrix, the patient experienced headache, shivering and fever. On 12th February 2020, the patient experienced nausea. In February 2020, the patient experienced feeling unwell, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder. In February 2020, the outcome of the nausea, shivering, fever and dizziness were resolved with sequelae and the outcome of the vaginal itching, vaginal discharge, vaginal burning sensation and vaginal ulceration were recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown and the outcome of the headache was recovering/resolving and the outcome of the clotting disorder was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, nausea, headache, shivering, fever, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. At 1:00 PM, the patient receieved a dose of Shingrix on the left arm. Most of the symptoms presented by 10 PM that night. The patient was not feeling well since she got the vaccine. The patient experienced nausea which was resolved at time of reporting. The headache was severe at first and described as a spinal headache.  It has improved but was still present in between her temples. The fever lasted for 4 days. The dizziness lasted 5 days. The onset date of the vaginal issues was unknown.  It started with itching and clear discharge and 24 hours later burning presented which was caused by open ulcers in the vaginal area.  The issues resolved within 3 days.  The patient had a history of thin blood but usually International normalised ratio measures between 2 to 3.5 and sometimes even 1 but on day of reporting her International normalised ratio was 4.2 and a week ago it was 4.1
63-year-old female patient was given DAPTACEL instead of ADACEL, no AE; 63-year-old female patient was given DAPTACEL, no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 63 year old female patient who received 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], (Wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 14-Oct-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5624AA and expiry date: 10-Jun-2021) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong product administered (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a nurse via company representative concerning her 64 year old husband who in the middle of December ("2nd or 3rd Friday of December"), on approximately 09-DEC-2005 was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot# not provided).  The night after receiving vaccination, on approximately 10-DEC-2005 the patient experienced chills, feeling of malaise and developed fever.  The patient was given acetaminophen (TYLENOL) to take care of the symptoms.  The patient was reported as recovered.  There was no product quality complaint involved.  Additional information is not expected.
Patient received the second dose 17 days after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 17 days after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 17 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 17 days after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Patient received zoster vaccine 02/01/16. Patient call c/o redness and swelling at injection site 02/03/16. Patient seen in office instructed comfort measures.
Left elbow shows signs of Arthritis like symptoms and pain to move throughout the day/night.
headache; upset stomach; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of headache 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 headache and upset stomach. On an unknown date, the outcome of the headache and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the headache and upset stomach to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient asked was it ok to take Tylenol after getting the Shingrix shot, because the patient got a headache and upset stomach.
Fullness in both ears morning after the second vaccine, followed by moderate tinnitus in both ears. Fullness feeling subsided within a day but tinnitus  has not improved to date.
Vertigo: mild at first / peaking on 3/21 / edging after that
Information has been received from Merck pregnancy registry through a health professional concerning a 16 year old female with a medical history of tonsillectomy 4 years ago, and with no allergies, who on 23-JAN-2008 was vaccinated IM with the first dose of GARDASIL (lot# 659657/1487U). Concomitant therapy included Tdap and MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD). On 28-Feb-2008 it was determined that the patient was pregnant with a LMP of 09-Dec-2007. The patient will be seeing the physician. The patient's outcome is unknown. Follow up information was received from a physician who reported that the patient was taking prenatal vitamins during her pregnancy. On 02-MAY-2008 the patient had ultrasound test for sex of baby and the result indicated within normal limits. On 01-SEP-2008 due to the baby was breech, the patient underwent c-section and delivered a normal, but small male baby whose weight was 4 pounds and 9 ounces and height was 17 inches. Upon internal review, c-section due to breech presentation was determined to be an other important medical event. Additional information is not expected.
Gout-like reaction (self-diagnosed) at joint of large toe of right foot. No previous history of gout. Symptoms include significant swelling and joint pain, redness and warmth at affected area. Condition persisted 3 days; condition has begun to subside (at present date, only minor swelling remains).
The pt experienced a fever of 101F. Two days later the pt was seen in the physicians office and diagnosed with varicella. Pt had pox with vesicles on her trunk, face, arms  and neck. Pt was treated with Zyrtec for pruritus. It was reported that the varicella was due to vaccine failure.
Information has been received from a health professional concerning a patient (29 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
This spontaneous prospective pregnancy report as received from a physician, refers to a 19 year old female patient without pertinent medical history or drug reactions/allergies. On 13-NOV-2013, the patient was vaccinated with a first dose of GARDASIL, 0.5 ml, intramuscular, lot # H017698; Expiration date 02-JUL-2015. No concomitant medications were reported. The patient became pregnant with Last Menstrual Period (LMP) of 15-APR-2013. On 16-DEC-2013, the physician was informed that the patient was pregnant. The method to use to confirm pregnancy was unspecified. Estimated Delivery Date (EDD) of 20-JAN-2014. Gestation "about 35 weeks". The foetus exposition was during the third trimester. The pregnancy outcome was unknown. On 16-DEC-2013, the physician was informed that the patient was pregnant. The method use to confirm pregnancy was unspecified. No treatment was given for the event. On an unknown date, the lab diagnostics studies performed: Glucose - normal, Cholesterol - 213, Liver enzymes - normal, Hemoglobin: 9.5, Hematocrit: 29.0. The patient did not seek medical attention. Additional information has been requested.
This spontaneous case, initially received on 01-Jul-2016, was reported by a health professional and concerns a(n) male patient. Weight: not provided; Height: not provided. Past medical history included Measles at the age of six years (without any prior immunization). Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for Indication not reported in Nov2010. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. Non-company suspect drugs: MMR II (MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE), Indication: Indication not reported, received in Nov-2010. Adverse reactions/events and outcomes: On Dec-2010, the patient experienced Pneumonia (Hospitalized, outcome: Not Reported), Relapse of sickle cell (Hospitalized, outcome: Not Reported). The patient was hospitalized in Dec-2010 with relapse of sickle cell and pneumonia. The patient received unspecified pneumonia vaccine while hospitalization. No immunological testing was completed on the patient but may happen in the future. The patient was now 25 years old and was doing great. Sender's Comments: Company comment: Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine, Relapse of sickle cell(anaemia) and chest infection are unlisted. Causality: Not related. Sickle-cell disease is autosomal recessive inherited illness characterised by relapses. There are several triggering factors which include infection, dehydration but in most instances, there is no identifiable predisposing cause. Acute chest symptoms with symptoms very similar to pneumonia (chest pain, fever, pulmonary infiltrate or focal abnormality) is also well known complication. Causality is considered unrelated for both events and most likely that patient immunocompromised state from underlying illness (sickle cell disease) is most likely causal factor.
The child became sick about 9:00 PM on 9/5/01. She complained of a sore arm with elevated temp to 103. Parents administered Motrin. The pt slept though the night but called the doctor again and was given Motrin. The pts temp went back to 105. Advised to use a cool liquids, popsicles, etc.
Intense pain, could not lift arm to even hold a pen, could not lift arm left or right/up or down.
No additional AE reported; an expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 24-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S030210 with an expiration date on 25-MAR-2021) for prophylaxis.        Strength, dose, anatomical location, and route of administration were not reported. The suspect vaccine did not experience any prior temperature excursión.  No additional adverse events had been reported.
Reported to have fallen asleep very soon after immunization during the car ride home; parent tried to stimulate him to wake up but he did not respond; they were very concerned, pulled over, and mom tried to stimulate him with no response; then took him out of car seat, and he appeared to 'wake up.'    From then on seemed at baseline.
Fever, unresponsive to Tylenol, seizures/infantile spasms.
No additional AEs or PQC reported; Caller reports vaccine administered after temperature excursion.; This spontaneous report was received from a source, from a Medical Assistant reporter.   With patient initials and name, unknown information (no date of birth, nationality, age or gender or patient ID.  The patient medical history, current conditions, historical drugs and drug reactions or allergies and concomitants therapies were not mentioned.  On 09-JUN-2022 at 04:14pm it was information received that described according to the caller that a vaccine was administered after temperature excursion. No other information provided. No additional AEs or PQC reported.   Therapy information: Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) lot# U034712 validated, expiration date: 7/30/2023, dose 0.5 ml, route of administration intramuscular, temperature 34.2F, time frame 12 hours, no previous temperature excursion. Indication for prophylaxis. Unknown start date, strength, formulation, and frequency.  There were no adverse events reported related to the situation described. No lab data, other medications and treatments reported.   The action taken, dechallenge, rechallenge and causalities were not reported.  No outcome, reported causality, cross reference, serious criteria or downgrade stament were described.
This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, 21 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was reported by the office manager. The patient (worker in this office) took FLUARIX QIV and 2 to 3 weeks later got the flu. This case was considered as a suspected vaccination failure case as the lab test confirmation for influenza were unknown. The reporter agreed to follow up from GlaxoSmithKline. This is 1 of the 3 linked cases reported by the same reporter. The contact details of the physician were provided.
Rash on back 10am 6/5/14 and itching. Temp 99 on 6/4/14pm. Baby otherwise well.
Within minutes I had heat/tingling in my right foot. It comes and goes. It has been happening since I got the shot almost a month ago. It happens at least a few times every hour to sometimes many times in just 10 minutes.
slight sore arm; This is a spontaneous report from a non-contactable consumer reported for a 12-year-old male patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as second dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the second dose of the Pfizer Covid vaccination on 03Jun2021 and experienced a slight sore arm the following morning (i.e., on 04Jun2021). The event took place after use of the product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) Negative, notes: Testing positive 9 days after negative test; (01Jan2023) Positive, notes: Testing positive 9 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Dec2022 to 25Dec2022.  Clinical Course: Patient did not received other medication within 2 weeks of COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Date removed from freezer 8/9/22 . Thaw expiration date 9/8/22 @1100. Dose administered 9/19/22. Doses administered after 30 day thaw expiration. Moderna was contacted for assessment of vaccine activity for both doses. Based on the assessment vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration per Moderna.
Received vaccine at 1545; c/o itching and rash at 1556  bp 186/82-78  anxious; 1559 Benadryl 50 mg po given; rash red and raised scattered across hand and torso; 1606 146/74-68-20 rash is flat and better less itching; 1623  165/66- 84;  1630 pt itching on right upper extremity and whelps noted.  Soumedrol 125 mg IV given; 1702 feels better and rash less red;  1711 resolved
Approximately several months after my vaccine I experienced the following symptoms: Breast pain (Right side), Large lump (Right breast), I saw a doctor regarding this issue and ever since I got the vaccine I had other swollen lymph nodes on other parts of my body. I did not take anything for treatment. The lump went away in December.
Information has been received from a physician concerning a 9-10 year old patient who was vaccinated with varicella virus vaccine live (SC). Subsequently, the patient's mother called the doctor's office and reported that her child had a pretty bad case of chicken pox. The patient's parent also reported that a few other children at the school also had chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
sluggish; mild fever of 99 degrees farenheit; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), PYREXIA (mild fever of 99 degrees farenheit) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, 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 experienced SLUGGISHNESS (sluggish), PYREXIA (mild fever of 99 degrees farenheit) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (sluggish), PYREXIA (mild fever of 99 degrees farenheit) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-211787 (Patient Link).
No adverse event; TE evaluation on VARIVAX reports 3 total doses have been administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 01-AUG-2022, the patient was vaccinated with improperly stored with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T032315, expiration date: 22-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Temperature was -14 Celsius degree (C) up to-10 C (-14.04 C) for time frame 0 hours 40 minutes 0 seconds. There was no previous temperature excursion. No additional adverse event details were provided (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006426: US-009507513-2208USA006350: