chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient developed a rash at the injection site/patient developed a fever of 101F/On 4/12/2019, patient visited physician, who diagnosed the rash as chickenpox.; Information has been received from a physician referring to a 59-year-old male patient. The patient's concomitant medications included atorvastatin calcium (LIPITOR) and fluvoxamine maleate (LUVOX). The patient was allergic to shellfish. The patient's pertinent medical histories included anxiety and gallbladder removal. The patient also got fatty liver disease and borderline hypertension, which got improved with weight loss.  On an unknown date, the physician drew pre-vaccination titers on the patient with the result of negative for varicella zoster virus (vzv), Immunoglobulin M (IgM) and Immunoglobulin G (IgG). On 28-MAR-2019, the patient was administered his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml once, lot# and expiration date unknown) with sterile diluent (dose, lot# and expiration date unknown) subcutaneously for the prevention of varicella. On 08-APR-2019, the patient developed a rash at the injection site. On 09-APR-2019, the rash began to spread to the patient's trunk and arms, and the patient developed a fever of 101 Fahrenheit (F). On 10-APR-2019, the patient's fever increased to 102 F. On 11-APR-2019, the patient's fever decreased to 101 F, but the rash continued to spread all over his entire body including his face. On 12-APR-2019, the patient sought medical attention by visiting the physician, who diagnosed the rash as chickenpox. The physician also drew repeat titers but the results were not yet available. The physician also reported that on 12-APR-2019, the rash had started to fade and the patient's fever had decreased to 100.6 F. There was no treatment given for the event. The patient did not overdose.  The causality assessment was not provided.
AN UNDER AGE PATIENT ( DOB:07/09/2009) RECEIVED THE FIRST DOSE OF Pfizer VACCINE DUE TO THE WRONG INFORMATION WAS GIVEN BY THE PARENT ON THE COSENT FORM. DATE OF BIRTH WAS GIVEN WAS 07/09/2008. PATIENT IS NOT EXPERIENSING ANY ADVERSE REACTION BUT WANTED TO REPORT THIS ERROR>
An MD reported the occurrence of non-response in a adult female who was vax'd w/Hep A vax inactivated. The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. On an unspec'd date, the subject received 2 injections of Hep A vax inactivated. The first injection (primary) was administered in the MD's office and the 2nd injection (booster) outside of USA. After the 2nd injection, the MD obtained a titer test NOS and the results were negative.
About a week after the vaccine, I developed swelling, a rash, and itching at the injection site. No treatment. Has lasted 3 days so far.
Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.; no adverse event; they administered an expired vaccine by 5 days; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.) and NO ADVERSE EVENT (no adverse event) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.).    Concomitant medication not reported.   The vial did not undergo any temperature excursions.  Treatment medication not reported.
Red spot where injection occurred on thigh. Also red bumps on knee. About three days later hard bump at injection site. Also rash still present.
DIZZINESS; FEELING "OFF" AND FEELING FOGGY; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. Concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, feeling "off" and feeling foggy, headache, nausea, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and the outcome of headache, tiredness, dizziness and feeling "off" and feeling foggy was not reported. This report was non-serious.
Developed fever immediately p/getting vax; Seen by MD states ear infect; Still fever & vomiting;
pt recvd vax APR93 & 18MAY93 was hospitalized w/pain in the rt upper quad, nausea, vomiting & pain that radiated to back; lab tests 18MAY93 showed elevated neutrophils & low lymphocytes; WBC nl; liver profile showed SGOT 1564, LDH 6786;
A female (age not reported) received OncoTICE for an unknown indication on 1/28/04. She reports that she is experiencing higher abdominal pain after the treatment.
This case was reported in a literature article and described the occurrence of hepatitis B antigenemia in a 111-day-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject was born at 25 and 4/7 weeks gestational age to a 31-year-old female via emergent C-section as a result of placental abruption. Maternal history was significant for ARNOLD-CHIARI malformation and preeclampsia. Prenatal testing revealed negative results including human immunodeficiency virus and rapid plasma regain. She was also rubella immune and her Group B Streptococcus status was unknown. After birth, the neonate required chest compressions, was intubated and received bovine lung surfactant in the delivery room. APGAR scores were 1 and 3 at 1 and 5 minutes respectively. The baby was admitted to the neonatal intensive care unit, where he stayed for the first 117 days of life. His hospital course was complicated by illness of prematury and multiple blood transfusions. On day of life 108, the subject received unspecified dose of PEDIARIX (unknown route of administration, lot number not provided). The vaccine was given at the appropriate time when he weighted 2310 grams. On day of life 111, 3 days after vaccination with PEDIARIX, as part of workup for persistently elevated liver function tests and increased direct hyperbilirubinemia, a hepatitis panel was sent. The results were negative for hepatitis B surface antibody, hepatitis B core immunoglobulin IgM, hepatitis A IgM and hepatitis C antibody; however the hepatitis B surface antigen was positive. This case was assessed as medically serious by GSK. Repeat testing in 3 to weeks was recommended by the pediatric infectious disease specialist. The infant was discharged home on day of life 117 to continue ursodiol for cholestiasis. The hepatitis B surface antigen test was repeated 5 weeks after the initial hepatitis panel was done and was negative. The subject did not have the blood work repeated until 5 weeks post vaccination. Therefore it was difficult to determine exactly how long the antigenemia persisted. However, the fact that it was short term supported the diagnosis of antigenemia caused by the PEDIARIX vaccine.
diagnosed with Guillain-Barre Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 2nd October 2021, the patient received Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 31-Jan-2023 This case was self reported by the patient. The patient reported that advised to get the shingles vaccination and flu vaccine (unknown flu vaccine) by her former place of employment.  The patient reported that because of the vaccinations had been diagnosed with Guil-lain-Barre Syndrome.  The reporter consented to follow up.
PT HAD COLD LIKE SYMPTOMS/RUNNY NOSE/NASAL CONGESTION/FEVER/ACHES AND CHILLS.
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  Patient got the first dose of Moderna COVID-19 vaccination on 22/Sep/2021. That same week she tested positive for COVID-19 (25/Sep/2021). As she was going to schedule her appointment to get the second vaccination, she ended up testing positive for COVID-19 a second time on 26/Feb/2022. It had now been more than 42 days and she had not received her second Moderna COVID-19 vaccination. Patient also reported that her weight Fluctuates.  Company Comment: This spontaneous case concerns a 25-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The patient tested positive for COVID-19 3 days after administration of the first dose of the Moderna mRNA-1273 vaccine. The patient took Tylenol (paracetamol) for an unknown indication. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 25-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The patient tested positive for COVID-19 3 days after administration of the first dose of the Moderna mRNA-1273 vaccine. The patient took Tylenol (paracetamol) for an unknown indication. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
post herpetic neuralgia; herpes zoster outbreaks; Information was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 01-DEC-2016 the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiry date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered and continues to suffer from herpes zoster outbreaks and post herpetic neuralgia. As a result of these symptoms, patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, patient  have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
When removed a Band aid, whole large amount of liquid came off; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (When removed a Band aid, whole large amount of liquid came off) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (When removed a Band aid, whole large amount of liquid came off). At the time of the report, PRODUCT ADMINISTRATION ERROR (When removed a Band aid, whole large amount of liquid came off) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The pharmacist states it was not underdose as it was like a small drop and 0.001% liquid came out. The patient did not experience any side effects after that. And reported there was no need for further follow up. Did not provide any contact information.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added new information for event.
sore arm for 2 days, then good for another 3 days except a bit tired, then GI issues, mild stomach cramps, lots of air. Next day still same and a bit of fever. Next day better but clearly still not good despite no food intake the day prior.
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients may have received an unknown number of improperly stored doses of PNEUMOVAX 23 (dose, route of administration, lot numbers and expiration dates were not reported) for prophylaxis. There were no adverse effects reported in any patients. Administered doses of PNEUMOVAX 23 were exposed to a temperature excursion of below 32°F/0°C for 105 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA010265: US-009507513-1703USA006286.
Tired; Had a headache for 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and HEADACHE (Had a headache for 2 days.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and HEADACHE (Had a headache for 2 days.). At the time of the report, FATIGUE (Tired) outcome was unknown and HEADACHE (Had a headache for 2 days.) had resolved.            No Concomitant product use was reported.  The reporter was reporting about their husband who was the patient. The patient received their Moderna Covid-19 booster dose sometime in the fall of 2021. The patient was tired and had a headache for 2 days.  The reporter mentioned that the patient's immunization card and other documents from Pharmacy said 1ml of Moderna Covid-19 vaccine for the patient's primary series. The reporter also stated that patient's records now said 0.5ml for the patient's primary series.  No treatment information was provided.   This case was linked to MOD-2022-525750, MOD-2022-525760 (Patient Link).
metal taste in her mouth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 60-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:00 (at the age of  60 years old) (Lot Number: El1283) as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medication within 2 weeks of vaccination. On 10Mar2021 10:30 (also reported as 11:00), the patient had a metal taste in her mouth within 30mins of having vaccine lasting about 10 mins then shorter duration of metal taste on day 2. The patient did not receive any treatment for the event. Since the vaccination, has the patient not been tested for COVID-19. The outcome of the event was recovered.    No follow-up attempts are needed. No further information is expected.
pt recv vax in 1994 & pt fainted & fully recovered w/o tx;
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA251082 (Same reporter). This case involves Adult patient (age and gender not reported) who was treated with 0.1 ml dose of TUBERCULIN TEST [TUBERSOL] intradermally (Batch number: C5474BA and expiry date: 29-Oct-2020) for skin test. The vaccine MENACTRA, ADACEL, DAPTACEL and IPV (VERO) [IPOL] was also kept in refrig temp was up for 48 minutes to 9.2 C. 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 incorrect product storage because the refrigerator temperature was up for 48 minutes to 9.2 Celsius which was no longer viable. 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 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 the sender: None.
post vaccine c/o nausea, hot and sweaty, dizzy, lightheaded, feeling faint
very mild soreness at the injection site when touched; This is a spontaneous report from a contactable consumer (patient) reported for himself. This consumer reported similar events for two patients (husband and wife). A 77-year-old male patient received bnt162b2 (Lot Number: En6204; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 77 years old) as single dose for covid-19 immunization. The patient previously received bnt162b2 (Lot Number: En6201; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in left arm on 18Feb2021 at 11:00 AM (at the age of 77 years old) as single dose for covid-19 immunization. Medical history included diabetes, enlarged prostate, and the patient had known allergies. The patient had no other vaccine in four weeks. Concomitant medications in two weeks included metformin, glimepiride, tamsulosin, latanoprost. Neither his wife nor he had any adverse event other than very mild soreness at the injection site when touched on 11Mar2021 11:00 AM. How can they be sure that the vaccine was viable or if it was not temperature controlled not effective. He was concerned. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. No treatment for the event. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021290939 same reporter/drug/AE different patient