chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This pregnancy case was reported by a physician via registry and described the occurrence of cerebral ventriculomegaly in a male infant exposed to MENVEO (batch number M17101, expiry date 31st August 2019) in utero. The mother received the product for prophylaxis. On 8th October 2018, the mother received MENVEO. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with cerebral ventriculomegaly (serious criteria congenital anomaly), corpus callosum agenesis (serious criteria GSK medically significant and congenital anomaly), septum pellucidum agenesis (serious criteria GSK medically significant and congenital anomaly) and supraventricular tachycardia (serious criteria congenital anomaly). On an unknown date, the infant experienced drug exposure in utero. On an unknown date, the outcome of the cerebral ventriculomegaly, corpus callosum agenesis, septum pellucidum agenesis, supraventricular tachycardia and drug exposure in utero were unknown. It was unknown if the reporter considered the cerebral ventriculomegaly, corpus callosum agenesis, septum pellucidum agenesis and supraventricular tachycardia to be related to MENVEO. Additional details were provided as follows: The patient's mother received a dose of MENVEO and mother was not aware that she was pregnant. The mother of patient did not receive any prenatal care. On 21st March 2019, the patient was born with several birth defects, such as ventriculomegaly, absent corpus callosum and absent cavum septum pellucidum. The patient also developed supraventricular tachycardia. Gestational age at delivery was between 33-37 weeks. Estimated date of delivery was unknown. See case US2019AMR072240 for details regarding the mother case.
A non-serious spontaneous report of "gave expired FLUMIST" was received form a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given on 19-Feb-2009 and had expired on 24-Dec-2008. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product from the previous season 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and event is considered resolved. Follow-up information received on 31-Mar-2009 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter that confirmed that no adverse events have occurred.
Sore arm at injection site within 3 hours. Fatigued and cold the morning post vaccination.
Swelling, heat, pain and itching/rash at injection site that lasted for 3 days then swollen lymph node under that arm for 3 days. Symptoms then repeated (swelling, redness etc) in a lesser degree one more time total affected time being about 9 days. Also experienced bad taste in my mouth during this time, similar to when I first got the injection
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:05 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.21 for dose administered on 03-Apr-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.
Confirmed with a case of Flu A; This spontaneous case was received on 04-Nov-2022 from other non-healthcare professional (patient's father) via Communications (reference number: SEQW22-05437) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, and anatomical location: not reported) for prevention of influenza disease caused by influenza virus subtypes A and B. The batch number reported was 348368 and the expiry date was 30-Jun-2023.  On 01-Nov-2022, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient was confirmed with a case of flu A.  The outcome of the event 'influenza A virus infection' was not reported.   The event of 'influenza A virus infection' was considered medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A female patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent in on an unknown date in September. On 01-Nov-2022 of the same year the patient developed as reported confirmed flu type A. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.; Sender's Comments: A female patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent in on an unknown date in September. On 01-Nov-2022 of the same year the patient developed as reported confirmed flu type A. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.
Horrible pain throughout my entire left arm. I took the band aid off and it's very swollen and hot on the injection site. I cannot hardly lift or use my arm. I have a slight fever and I'm very flush and fatigued. My cheeks and forehead are very red and warm.
but in between we caught the virus; We never got the second one; but in between we caught the virus; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on Jan2021 as dose 1, single for COVID-19 immunization. No medical history and concomitant medication were reported. Caller stated that "I'm calling for me and my wife we both had first dose of the Pfizer-COVID-19 Vaccine in January, we would do a try to get the second one 3 weeks later, but in between we caught the virus, we were treated for the virus and we tested negative the last time we had a test. We never got the second one (second dose of the vaccine). Caller asked what the protocol was and would they need to repeat the vaccination series. The patient underwent lab tests which included SARS-CoV-2 test and tested negative last time on an unspecified date. The outcome for COVID-19 was recovered on an unspecified date in 2021 and remaining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312736 same reporter/drug/event different patient
This spontaneous report was received from a Registered Nurse concerning a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot number M019646, expiration date 18-JUL-2017 (doses and routes were not reported) for prophylaxis. Concomitant medication included sterile diluent (STERILE DILUENT). The temperature involved was -14 degrees Celsius to -10 degrees Celsius for 1 minute. The previous temperature excursion was -14 degrees Celsius to -10 degrees Celsius for 9 minutes. A data logger was involved. This is one of three cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010469: Original Case : 1705USA010469 US-009507513-1705USA010561: Original Case : 1705USA010469.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. 09-SEP-2014 the patient was vaccinated with an improperly stored dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # was not reported). It was reported that the vaccine was exposed to 40F for one hour. No adverse effects were reported. Additional information has been requested.
Case number PHEH2014US010846 is an initial spontaneous report received from a nurse on 27 May 2014 with a follow-up received on 30 Jun 2014. This report refers to a 20 year old male patient. Concurrent condition included seasonal allergies. Concomitant vaccinations included TYPHIM, IPOL, Hepa-B, MMR, Tdap and Hep A. the patient received only the liquid component (MenCYW) of MENVEO (batch number: X13059) intramuscular into left deltoid on 24 May 2014 at 2:20 pm. The patient notified to return to clinic for revaccination with full MENVEO dose (both components). No adverse event was reported following this drug administration error (inappropriate preparation of medication). Follow-up received on 30 Jun 2014: Site of vaccination, time of vaccination, concomitant vaccinations, concurrent condition and patient's demographics were updated. Batch number was amended.
Information has been received concerning a pt who on 04/09/1996 was vaccinated with first dose of varicella vaccine. On 06/15/00 the pt developed a rash consistent with varicella. It was noted that this experience did not require prescription drug treatment and that the pt's rash is still being treated.
Severe headache, nausea, dizziness, light headedness, increased blood pressure, pain at injection site, neck pain, abdominal cramps, muscle aches
Information has been received from a nurse concerning an 18 year old female patient who was vaccinated with a second dose of GARDASIL. The nurse mentioned that the patient experienced menstrual changes after receiving her second injection, the nurse said "her period was off for several months". The patient was reported to be fine after her first dose of GARDASIL. The patient sought unspecified medical attention. No further information available. The outcome was unknown. Additional information has been requested.
Fatigue, headache, high fever, body aches, cold sweats, throwing up every 30 minutes (unable to stop), itchy/swollen arm,  crying spells, unusual heavy menstrual bleeding for two weeks (still haven?t stopped bleeding)
Left arm, fist sized reddened and raised area. Irritation and heat to the site.
Mom stated she noted full body rash the morning after vaccines was given, seen at doctor's office for rash on 4/11 and 4/12 and treated with oral steroids. Diagnosed with Angioneurotic Edema/Adverse Reaction.
Persistent (L) shoulder pain since flu vaccine on 9/30/13. Tx: ibuprofen 800mg TID since 10/13/13. MEDROL dose pack 10/28/13.
Information has been received from a nurse that on 16, Feb 2007, they administered a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) in a patient's hip. No adverse event was reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left 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 included: "spondylitis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: anti inflammatories, reaction(s): "Known allergies: anti inflammatories"; Known allergies: levaquin, reaction(s): "Known allergies: Levaquin"; Known allergies: codeine, reaction(s): "Known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 379 U/L, notes: My Alt levels got to 379 U/L; Aspartate aminotransferase: 119 U/L, notes: my AST level got up to 119 U/L; Lipase: 584, notes: my Lypase was 584; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5/10/2023 I had my annual physical with a telehealth visit. I took my blood pressure and it was much higher than normal.  I have not changed my lifestyle or anything else.  I was diagnosed with prehypertension. I used to have very normal blood pressure.  I was told to keep an eye on it for now, no new medications.
Cold chills; Fever; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on his left arm, intramuscular on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had Cold chills, fever and not feeling too well. He took one Tylenol for fever. The outcome of the events was unknown.
Delayed skin reaction (Covid arm) at site of injection and on upper arm; red rash; swelling; warm to touch; itchy; This is a spontaneous report received from a non-contactable consumer or other health care professional (patient).  A 66-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported /Lot number: EN6201, expiry date not reported) via an unspecified route of administration, administered in Arm left on 01Mar2021 08:00 AM as dose 2, single for covid-19 immunization. Medical history included autoimmune hepatitis and concomitant medications included other medications taken in two weeks as Azathioprine, Paracetamol (TYLENOL), Cannabidiol (CBD oil), Palmitoylethanolamide (PEA), Milk thistle all were unspecified indication and from unknown start and stop date. Patient had known Allergies which included Lactose intolerance. Historical vaccine included as patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown) via an unspecified route of administration and administered on in Arm left on 08Feb2021 08:00 AM as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. No other vaccines received on the same date of vaccination. On 05Mar2021 05:00 PM,  began on evening of 4th day after 2nd shot the patient experienced delayed skin reaction (Covid arm) at site of injection and on upper arm red rash, swelling, warm to touch, itchy. No treatment was received for the events caused. The outcome of the events was recovering.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Patient presented to the emergency room for evaluation of shortness of breath and chest pain that started two days prior (one day after receiving first Moderna vaccine). Symptoms worse with exertion. Chest pain is described as a heaviness, does not radiate.  EKG in the emergency room that showed ST elevations in III and aVF and his troponin was found to be 40.5 and so code STEMI was activated.  Patient had cardiac cath on an urgent basis and that showed triple-vessel disease, with a very short left main as LAD and left circumflex were almost coming from 2 separate ostia, subtotal occlusion of the LAD and left circumflex and 100% occlusion of the mid RCA.   Evaluated for CABG,  which was declined.  Patient's echocardiogram showed global hypokinesia with EF of 20 to 25%.  Patient underwent high risk PCI procedure using Impella support with 2 stents to the subtotally occluded LAD and 1 stent to the subtotally occluded left circumflex.  Patient's symptoms subsided following procedure, however patient suffered mild CHF on initial CXR secondary to ischemic cardiomyopathy, successfully treated with Lasix as displayed by downtrending BNP. Patient's labs also displayed shock liver with AST and ALT liver enzymes both above 1000 on arrival; hepatitis and HIV titers came back negative. Patient suffered from AKI on arrival secondary to ischemia, with an elevated BUN and creatinine; CKD suspected due to lab values showing chronic anemia.
red, hot area @ site @ 3 small blister;rx DPH for itching, cold compresses, SDS of site
(L) thigh red spots slightly raised approx 2.5 x 2 cm probably blisters
was administered Infanrix; was administered Infanrix instead of the Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 62-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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 provided as follows: The Nurse reported a patient was administered the Infanrix vaccine instead of the Boostrix vaccine inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021258434:same reporter
shoulder pain; diarrhea all day; drank anything it felt like it was affecting her kidney; Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before; more tired then she normally is; entire body hurt; second dose was awful; real bad headaches; running a fever; nauseated; got up in the night and felt like she was going to throw up; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), ARTHRALGIA (shoulder pain) and DIARRHOEA (diarrhea all day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Emphysema. Concomitant products included Ventolin for her COPD and emphysema for Emphysema, prescribed vitamin D for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (entire body hurt), MOOD ALTERED (second dose was awful), HEADACHE (real bad headaches), PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up), CHILLS (chills) and FATIGUE (more tired then she normally is). On 27-Apr-2021, the patient experienced URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), ARTHRALGIA (shoulder pain), DIARRHOEA (diarrhea all day) and MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before). On 27-Apr-2021, PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up) and CHILLS (chills) had resolved. On 28-Apr-2021, URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), DIARRHOEA (diarrhea all day), HEADACHE (real bad headaches), MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before) and FATIGUE (more tired then she normally is) had resolved. At the time of the report, ARTHRALGIA (shoulder pain) outcome was unknown.            Treatment Tylenol every 4-5 hours yesterday, 27Apr   This case was linked to MOD-2021-096197 (Patient Link).
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown in 2015, the patient was vaccinated with an expired dose of MMR II (lot # J010208 exp date 23-FEB-2015 also reported as 23-AUG-2015) (dose and route not reported). No adverse experiences were reported. Additional information has been requested.
Client began to feel fatigued about 1-2 hours after receiving shot. About 12 hours later, client began to experience nausea, vomiting, and fever of 103 degrees F.  The symptoms continue for 24 hours.
Febrile illness with viral symptoms.  Blood culture done in the ER.  Blood culture grew a Bacillus Species, identified as NOT B.Cereus or B.Antracis.  No antibiotics were given, and his symptoms resolved spontaneously.