chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
diagnosed as a mild case of Shingles/suspected vaccination failure; diagnosed as a mild case of Shingles; small rash to her chest wall; burning sensation to her left side / burning rash on her chest; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 80-year-old female patient who received SHINGRIX for prophylaxis.   Co-suspect products included SHINGRIX for prophylaxis.   On 2nd April 2020, the patient received the 2nd dose of SHINGRIX. On 16th January 2020, the patient received the 1st dose of SHINGRIX. On 21st October 2020, 202 days after receiving SHINGRIX and 279 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and burning sensation to be related to SHINGRIX and SHINGRIX.  Additional details were reported as follows: The patient received both doses in her left arm and developed a burning rash on her chest which was diagnosed as a mild case of Shingles.  The reporter wanted to know if the vaccine could have caused this and the percentage of patients who experienced these events. The reporter did not administer the vaccine to patient hence he did not have any of the lot/expiry date information. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were not not provided.; Sender's Comments:  US2020212016:same patient
Intussusception 7/20/09 - symptoms began. Required surgical reduction 7/22/09.  8/31/09 Hospital records received DOS 7/20/09 to 7/28/09. Assessment: Intussusception. Infant had increased sweating, drowsy, pale, not arousable or responding. having tremors all 4 limbs and shaking. Decreased urine output. Projectile vomiting decreased appetite. Dehydration. Greenish mucousy stools. Fever. Barium enema reduction unsuccessful. Laparotomy, ileocectomy, ileo ascending colostomy anastomosis.
30 second generalized convuls @ 2100 3JAN92 associated w/fever to 103;
Pain at site of injection, high fever, shivering/chills, nausea, fatigue, slight congestion and heavy breathing, wet cough for a day and dry cough two days later after all other symptoms disappeared.
R shoulder and site of injection (R delt) pain, sharp pain, radiates down arm, warm to the touch. Pt's in home supportive care giver was interviewed on 4-6-07. Unknown if pt has used any treatment, i.e. cold compress or Tylenol.
pt recvd vax & devel f & hives on stomach, arms & face esp around mouth;
This spontaneous report as received from the registered nurse (R.N.) refers to an unspecified patient of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot number, dose, frequency and route not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
I?ve been experiencing thrombosis- a lot of clotting during my period which I?ve never experienced before along with pains in my left side which do no feel like cramps. I took baby aspirin but it?s been going on a few days now. My period usually starts out heavy the first few days but it was the opposite I started clotting the 2nd/3rd day of my period multiple times throughout the day. I?m still experiencing it. I currently don?t have medical insurance which is why I haven?t been to the ER or a doctors office but I?m worried
first dose was bad; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccination and experienced awful and dad For tolerance to 2nd dose refer linked case US2020AMR215955, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215955:same reporter
Patient got small bumps on one arm on day one.  Then those bumps spread to through out the body the following day.  Lasted total of 4 days
Developed constant heartburn in mid to late May.  Prior to having an endoscopy, I needed an ECG.  ECG indicated a q wave abnormality indicative of a previous heart attack.  Referred to cardiologist.  Echocardiogram and stress echocardiogram conducted, no indication of a previous heart attack.  I have had ECGs in the past and there was never any mention of a q wave issue.
The two times i took flu shots i contracted the flu/suspected vaccination failure; Flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of influenza (received Influenza vaccine on an unknown date, refer case US2020AMR193663).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. 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 Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the patient took flu shots and contracted the flu. No shots, no flu. This case was considered as suspected vaccination failure, since the information regarding time to onset and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193663:same reporter
knee surgery after the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of KNEE OPERATION (knee surgery after the first dose of vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), LOSARTAN and ROSUVASTATIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced KNEE OPERATION (knee surgery after the first dose of vaccine). At the time of the report, KNEE OPERATION (knee surgery after the first dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Pediarix given instead of Boostrix; Pediarix given to an 11-years-old; Extra dose of DTaP, Hepatitis B and IPV; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (received 1 dose in 2017), Pediarix (received 1 dose in 2012), Pentacel (received 2 doses in 2012), Pentacel (received 1 dose in 2013), Dtap vaccine (received 4 doses on an unknown date), IPV vaccine (received 3 dose on an unknown date) and hepatitis B vaccine.   On 1st March 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose 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 Information: GSK Receipt Date: 2-Mar-2023 Reporter's Comments:  HCP called in to report that a 11-year-old patient was incorrectly given a dose of Pediarix when they were scheduled for a dose of Boostrix.  The healthcare provider gave information about the dose and patient.  They accepted to be escalated to second line.  Previous vaccination include 1 Kinrix 2017, 1 Pediarix 2012, 2 Pentacel 2012 and 1 Dtap 2013. Other vaccines include 4 doses of IPV and 3 doses of hepatitis B. the reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patients received Pediarix vaccine, which led to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered.; Sender's Comments:  US-GSK-US2023033996:Same reporter
Redness on her left arm at injection site down to her below that lasted 12 days; Severe itching on her left arm at injection site down to her elbow that last 12 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her below that lasted 12 days) and VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow that last 12 days) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her below that lasted 12 days) and VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow that last 12 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at a dose of Cortisone 10. On 30-Jan-2021, VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her below that lasted 12 days) and VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow that last 12 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details also included Icepacks.   This case was linked to MOD-2021-350425, MOD-2021-350426.
thrush infection on his tongue and his lips; thrush infection on his tongue and his lips and tongue are currently swollen; thrush infection on his tongue; thrush infection on his lips; experiencing a thrush infection on his tongue and his lips and tongue are currently swollen; sore arm; second dose not received in allowed time window; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen), INFECTIVE GLOSSITIS (thrush infection on his tongue), LIP INFECTION (thrush infection on his lips) and LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen), INFECTIVE GLOSSITIS (thrush infection on his tongue), LIP INFECTION (thrush infection on his lips), LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen), PAIN IN EXTREMITY (sore arm) and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window). At the time of the report, ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen) and LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen) was resolving, INFECTIVE GLOSSITIS (thrush infection on his tongue) and LIP INFECTION (thrush infection on his lips) had not resolved, PAIN IN EXTREMITY (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported .   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: live follow up : Events added
Started having a fever, sore throat and severe achiness. Took a home COVID-19 test and was positive. Went to a Care clinic and was prescribed Paxlovid and  Doxycycline.
CLIENT TAKEN TO EMS TENT DUE TO HISTORY OF SUNCOPE WITH INJECTIONS; FEW MINUTES FOLLOWING VACCINATION CLIENT REPORTED TIGHTNESS IN THROAT, NAUSEA AND COUGHING. NP ON SITE ADMINISTERED BENADRYL 25 MG LIQUID ORALLY. VITAL SIGNS AND HEART MONITORED. NOTIFIED SPOUSE OF SITUATION. CLIENT MONITIRED FOR 1 HOUR BUT REFUSED ANY FURTHER CARE OR TRANSPORT TO HIGHER LEVEL OF CARE. SYMPTOMS RESOLVED. CLIENT LEFT ON OWN AND AGREED TO SEEK ADDITIONAL CARE IS ANY SYMPTOMS  RETURN.
Fatigue, muscle aches especially in left arm in the morning after the shot.  Slight chills in afternoon and fever of 100 around 5p.m. I took one ibuprofen.  Slept well overnight and was fine the next day.
Diffuse skin reaction.  Elevated BP.  Hives, urticaria, raised wheals. Minimally responsive to steroids and antihistamines.
I had pink vaginal discharge once when I wiped. I went to the Doctor and it came back as endometrial cancer grade 1 and then they did a hysterotomy.
Patient was given Pfizer Monovalent Covid Booster instead of the Pfizer Bivalent Booster.  Patient was receiving his fifth booster at this time.  Patient was notified and no adverse side effects were reported.
pt recvd vax 14OCT93 & exp SOB a/leaving work @ about 1800; SOB gradually inc SAT & SUN; then early Monday AM pt came to ER 17OCT94 w/elevated BP, SOB, dysrhythmias; pt was admitted 17OCT94 to holding bed for heart monitoring;
Information has been received from a consumer concerning someone she saw on the television news, a female who was vaccinated with GARDASIL of unknown dose and frequency on an unknown date for an unknown indication.  The patient's relevant medical history, concomitant medications and relevant past drug history were unknown.  Subsequently the patient was crying and her skin was peeling and swollen really bad.  It was unknown if any laboratory testing had been performed.  As of 07-FEB-2009, it was unknown if the patient continued to take GARDASIL and the outcome of the crying, skin that was peeling and swollen were unknown.  The mother of the patient said that "she wished she had known, because her daughter would have never gotten GARDASIL".  Additional information is not expected.  Attempts made to verify the existence of an identifiable patient and reporter have been unsuccessful.  This is one of several reports received from the same source.
Patient states developing large dark spots on skin, around back of neck, chest, arms and inner thighs about 2 days after receiving vaccines.  Patient presented with doctor with darkening of skin, peeling.  Patient states affected areas are itchy.  Aristocrest cream, Atarax 25mg, someration solution prescribed.  Patient is to return 1-2 weeks.
This patient was administered 1.0ml of the COVID19 Moderna Vaccine instead of the recommended dosage of .5ml. All other procedures were followed correctly. After this event occurred, the patient was monitored and no adverse reactions were observed.
slight fever; the area is sore; Tired; This case was reported by a consumer and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever, injection site pain and tiredness. On an unknown date, the outcome of the fever, injection site pain and tiredness were unknown.   It was unknown if the reporter considered the fever, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had slight fever, somewhat tired and area was sore after vaccination with dose of Shingrix.
WEAKNESS, DIZZINESS, LIGHTHEADEDNESS, COUGH, SOB,  DIARRHEA, NO APPETITE, INCREASING WEAKNESS, LOSS OF TASTE/SMELL, BODY ACHES, FEVER
Some patients  / received / 1st or 2nd doses  / in 2020 and due to covid are / coming / to finish / series; This case was reported by a nurse via call center representative and described the occurrence of social problem in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st or 2nd dose of Twinrix in 2020).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patients did not receive the 3rd dose of Twinrix due to Covid-19 pandemic, which led to social problem. No further information was reported. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150415:Same reporter. "Some patients" who only got 1st dose. US-GLAXOSMITHKLINE-US2021149566:Same reporter. Only pt identified.
After getting vaccinated I was fine for almost a month, then I started getting tingling in toes and feet, I went to the ER and was x-rayed and CT, I had lose of feeling in left cheek. I saw a Neurologist that referred me to a nerve spesi9list that said I am having aggressive neuropathy in my feet, and now the tingling has traveled to my left hand also. I went to the ER 3 times.
Admission Date: 9/5/2022 Discharge Date: Sep 6, 2022  PRESENTING PROBLEM: Weakness COVID-19 virus infection COVID-19   HOSPITAL COURSE: The patient is a 71 y.o. female with PMH of essential hypertension, obesity, and depression/anxiety who presented for 3 day history of fever, headache, nausea, cough, and generalized weakness.  She was found to be positive for COVID-19 virus.  Laboratory workup was otherwise unremarkable.  She had no hypoxia.  Chest x-ray with no acute cardiopulmonary process.  Patient felt too weak to discharge so was admitted under observation status.  She felt significantly better the next day.  PT evaluated and recommended home.  Patient was noted to be mildly bradycardic with heart rate in the 40s to 50s.  She was asymptomatic and indicates a history of bradycardia.  She was resistant to stopping Her coreg due to reported history of resistant hypertension. Her coreg was thus reduced to 12.5 mg BID and she was instructed to follow up closely with her PCP for further dose adjustment if needed.  Patient in agreement discharge plan and discharged in stable condition.
Pain in injection site (expected). Tiredness, chills, joint and back pain. No headache. No nausea but weak appetite.
By night felt tired and cold. Shaking, freezing to death. Woke up at night with chest spasms and racking cough that was very hurtful. Felt like chest was going to explode. Couldn't move at all to call for help. At one point was sweating and felt delirious; not sure if had fever. By morning, came out of it with no problems since.
Patient presented to ED with c/o body aches, cold sweats, night sweats, coughing, weight loss, and fevers that have worsened since onset around 2 weeks ago.  Patient states his symptoms started after receiving the second Pfizer COVID-19 vaccination on 5/22/2021. Presents with fever of 101.4.  Patient was transferred to the hospital for a higher level of care. ED Diagnosis : Leukemia, acute
Received her second dose of the vaccine on 2/9 and reported having next day acute sharp pain in her arm interfering with her activities.  She was advised to apply cool compress to injection site and rotate between ibuprofen and tylenol and to notify me if the pain did not resolve in 2-3 days.  I received a phone call from her today 2/16 with reports that her arm pain is still present making it hard to work and sleep.  She was advised to follow up with her PCP which she agreed to call her doctor tomorrow.
only had fatigue, nausea and vomiting on day 3 after vaccination. no other symptoms. now resolved.