chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00710323) and transmitted to Sanofi on 04-Aug-2021.  This case involves a one-year-old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 28-Jul-2021, the patient received a 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (solution, lot UJ54ABA and expiry date: 18-Jul-2021) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "Medical office manager reporting that an expired ACTHIB vaccine was given to a patient on 28Jul2021, she is inquiring if the dose is valid."  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were 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 the 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.
Redness to site (injection site), (L) palm throbbing/HA, treated in Immed. Care with DURICEF.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L031271, expiration date 19-NOV-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reports R upper deltoid vaccine area, red, hot to touch. Size of a grapefruit 10x15cm area of erythema with central induration.
Redness, swelling to L deltoid, ? cellulitis vs local tissue reaction. Redness/pain to touch/4/06.
patient got a dose after temp excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 61-year-old male patient who received HBV (Engerix B) (batch number 29RN7, expiry date 25-FEB-2024) for prophylaxis.   On 24-JAN-2023, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: patient got a dose after temp excursion). The outcome of the incorrect storage of drug 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 Information: GSK receipt date: 9-Mar-2023 Adverse event contains all reported information. The patient received a dose of Engerix-B after a temperature excursion on negative 0.1 Celsius, which led to incorrect storage of drug.
Arm started swelling  with some discomfort  at injection site and  itchy rash developed .
Patient evaluated by the ER Dr. for c/o SOB and wheezing and being covid positive for 1 week.  Upon arrival pox was 67% on RA.  Oxygen was placed via NC at 3L with an increase in pox up to the 90s.  Patient was admitted for supportive treatment.
4 hours after receiving Flu shot in arm and pneumonia booster in right arm, arm swelled from elbow to shoulder.  Later in day and during night, pain.  Next day patient applied ice.  3rd day went to doctor at 10:00AM.  Doctor told patient she had staph infection.  Prescribed cefaoroxil 500 mg for 7 days.  Swelling and pain gone.  5 days later terrible sore throat.  Refilled prescription and as of 01/05/2005, still on meds.
Facial swelling, especially around the eyes (no history of facial injections or fillers). Symptom was present upon waking the day after vaccine administration, remained for a couple hours and dissipated on its own
Fast heart rate; very congested sinus; can not breath; very weak; sleepy; chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak) and SOMNOLENCE (sleepy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for Immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak), SOMNOLENCE (sleepy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak), SOMNOLENCE (sleepy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
On 5/29/21 and 6/19/21, patient received Pfizer Covid-19 >12yo  dose instead of pediatric (5-11yo) dose
Initial side effects were as expected. Sore arm and feeling like I had a mild flu the next day. Very sore mid back pain, headache, chills and a fever of 101.   I am now 6 days late for my period ( neg pregnancy test). This never happens. I am like clockwork. I had not received any warning about this side effect but I came across a Reddit forum where other women were reporting menstrual problems after the vaccine also. This needs to be listed as a side effect. And it needs to be studied further in case it impacts fertility.
Patient experienced syncope episode 6 minutes after vaccination and lost consciousness for a few seconds. Patient was taken to the hospital for further evaluations.
a serum sickness-like reaction; swelling; a faint rash; joint pain; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SERUM SICKNESS-LIKE REACTION (a serum sickness-like reaction), SWELLING (swelling), RASH (a faint rash), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SERUM SICKNESS-LIKE REACTION (a serum sickness-like reaction), SWELLING (swelling), RASH (a faint rash), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, SERUM SICKNESS-LIKE REACTION (a serum sickness-like reaction), SWELLING (swelling), RASH (a faint rash), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.
Admitted for fever, cough, decreased intake, and jaundice. Initially thought to have UTI due to positive urine culture at facility but further symptoms of Kawasaki's disease presented after admission: conjunctivitis with limbic sparing, continued fevers, transaminitis, truncal rash, elevated inflammatory markers, anemia, and thrombocytosis. Patient was treated with IVIG and high-dose aspirin prior to discharge. Echo revealed mild ectasia of coronary arteries. Upon re-examination outpatient 1 week after discharge, continued Kawasaki's physical symptoms were noted and aspirin was continued.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  Administration error:  Patient presented for Pfizer vaccine with consent form stating no previous doses of vaccine.  Patient received 1st and 2nd dose but it was later discovered the patient had already received a complete series of Pfizer Covid 19 vaccine.  No adverse events reported to date.
Unusual pain that spread to and around shoulder covering the deltoid muscle, heat nor inflammatory patches seem to help.  Ultrasound was negative for fluid.
Information has been received from a physician concerning a 17 year old white female student, with no previous medial history and no drug allergies, who on 19-JUN-2007 was vaccinated IM with a first dose of Gardasil.  The patient experienced no reaction after the first dose of Gardasil.  There was no concomitant medication.  On 20-AUG-2007 the patient was vaccinated IM with a second dose of Gardasil (lot # 658094/0524U).  There were no illnesses at the time of vaccination. On 20-AUG-2007 one and a half hours post vaccination, the patient was covered with a red pruitic rash over arms which spread to trunk (previously reported as rash).  Unspecified medical attention was sought.  No laboratory diagnostics were performed.  The patient was given diphenhydramine hydrochloride (BENADRYL).  On 21-AUG-2007, the patient recovered from rash.  Additional information is not expected.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 15-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
A patient was administered a dose of GARDASIL 9 when she was about 3 to 4 months pregnant; This spontaneous prospective pregnancy report was received from a medical assistant , concerning a 15 years-old female. The patient had no pertinent medical history, drug allergies, previously drug reactions or concomitant medications. The estimated last menstrual period was approximately on 02-MAR-2019 and on approximately 16-MAR-2019 (reported as 20 weeks ) the patient became pregnant.  On 13-JUN-2019, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number: R020949 with expiration date: 04-MAY-2021) (route of administration and anatomical location were not reported) for prophylaxis, when she was about 3 to 4 months pregnant (vaccine exposure during pregnancy). On 05-JUL-2019, the patient returned to the office to refill her unspecified birth control pills and an unspecified urine pregnancy test was performed which was positive. The patient received prenatal care. The due date would be on 07-DEC-2019. The patient had not recovered from the vaccine exposure during pregnancy.   The causal relationship between the vaccine exposure during pregnancy and the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Patient refers that on December 18,2020 developed headache (left side) and pulsatile pain in left eye, also generalized body ache associated  with hot flashes . She took Iboprufen , Relafen and Acetaminophen with improvement for about one hour  and pain later  returned. If condition worsen she was advised to   go to the nearest Emergency Room.
feel that the blood is thickness. In both feet; thickness of my feet; the hardening of my feet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERCOAGULATION (feel that the blood is thickness. In both feet), PERIPHERAL SWELLING (thickness of my feet) and MUSCULOSKELETAL STIFFNESS (the hardening of my feet) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERCOAGULATION (feel that the blood is thickness. In both feet), PERIPHERAL SWELLING (thickness of my feet) and MUSCULOSKELETAL STIFFNESS (the hardening of my feet). At the time of the report, HYPERCOAGULATION (feel that the blood is thickness. In both feet), PERIPHERAL SWELLING (thickness of my feet) and MUSCULOSKELETAL STIFFNESS (the hardening of my feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.   Reporter did not allow further contact
coughing; phlegm; congestion; runny nose; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), COUGH (coughing), RHINORRHOEA (runny nose), PRODUCTIVE COUGH (phlegm) and NASAL CONGESTION (congestion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #029A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for Diabetes.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced COUGH (coughing), PRODUCTIVE COUGH (phlegm) and NASAL CONGESTION (congestion). At the time of the report, OROPHARYNGEAL PAIN (sore throat), COUGH (coughing), RHINORRHOEA (runny nose), PRODUCTIVE COUGH (phlegm) and NASAL CONGESTION (congestion) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided
For about 1 month after receiving vaccine, skin was hyperactive to hand soap on hands up to wrist, and buttox. Skin broke out in hives after contact with hand soap and after contact with mother's hand after she had touched shellfish, although pt was able to eat shellfish. Hand soap ingredient list attached. Problems resolved pt has since used some soap.
27 yo F c/o dizziness and throat swelling 20 minutes after receiving her 2nd dose of the Pfizer vaccine. Patient stated she felt like it was difficult to swallow and that her throat felt num. Patient evaluated by on-site EMS and NP. Vital signs (129/78,84, 22) and EKG (NSR) started by EMS. Due to patient holding her throat, 911 called and Iv started. 50mg of Benadryl given per NP. No PMH. NKDA. EMS arrived, re-assessed and transported patient to Hospital for further evaluation.
Sore arm for threes days.  Since 2/17 body itching.   Site has been red and bumpy ever since the shot.  Getting better today
Pt complained of neck pain that restricted mvmt. Lasted 36 hrs. Used ibuprofen and heat to tolerate pain. Recommended going to MD if not feeling better after first 12 hrs but he said pain started to dissipate.
Site: Pain at Injection Site-Mild, Systemic: mild numbness on face-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: facial numbness on left side (side of vaccination).
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAY-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were  reported. This is one of several reports received from the same source. Additional information has been requested.
VACCINATED 2 TIMES WITH JANSSEN COVID19 VACCINE; POTENTIAL MEDICATION ERROR; This spontaneous report received from a health care professional concerned an 82 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN, and batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 11-MAR-2021, and dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination.  Concomitant medications included mrna 1273 for prophylactic vaccination.  On 27-JUL-2021, the subject experienced vaccinated 2 times with janssen covid19 vaccine.  On 27-JUL-2021, the subject experienced potential medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated 2 times with janssen covid19 vaccine and potential medication error was not reported. This report was non-serious.
her heart was racing and she was having an anxiety attack and started shaking; her heart was racing and she was having an anxiety attack and started shaking; her heart was racing and she was having an anxiety attack and started shaking; This is a spontaneous report from Pfizer-sponsored program from a contactable female consumer (patient). A female patient of over 65-year of age (exact age: not specified) received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not provided), via an unspecified route on an unspecified date in Jan2021 and second dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not provided), via an unspecified route on an unspecified date in Feb2021, both as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient heart was racing, and she was having an anxiety attack and started shaking. Her question was that she wanted to make sure she was fully vaccinated, and it was still effective after so much time had passed or if she needed to be revaccinated. The clinical outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Patient described extreme dizziness 2 days after the vaccine. She stated she could not get up to stand.  She said this lasted for 2 days.
started to have sleeping problems, has almost not slept in the past two nights; nervous; anguish; in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while; desperate; has been experiencing nausea and desire to vomit, but has not vomited; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), ANXIETY (anguish), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while) and DEPRESSED MOOD (desperate) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), ANXIETY (anguish), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while), DEPRESSED MOOD (desperate) and NAUSEA (has been experiencing nausea and desire to vomit, but has not vomited). At the time of the report, SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while), DEPRESSED MOOD (desperate) and NAUSEA (has been experiencing nausea and desire to vomit, but has not vomited) had resolved and ANXIETY (anguish) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.    This case was linked to MOD-2021-238968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: event details updated
This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that VAQTA exposed to 74F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates(strength, formulation, lot#, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.