chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 26-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Nausea, dizziness same day   Day 2 headache and all over malaise
This is the third dose which was given at 7wks and not 8wks after 2nd dose due to parent rescheduling  error. Correction Action Plan implemented to avoid future errors.
This spontaneous report was received from a licensed practical nurse and 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 an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA000781: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007711: US-009507513-1705USA007712.
Death / Death NOS; Had not eaten; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 6-week-old female patient who received HBV (Engerix B) (batch number 4RB3J, expiry date unknown) for prophylaxis.   On 1st July 2019, the patient received Engerix B. On 2nd July 2019, 1 days after receiving Engerix B, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and appetite absent. On 2nd July 2019, the outcome of the unknown cause of death was fatal and the outcome of the appetite absent was recovered/resolved. The patient died on 2nd July 2019. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Engerix B. It was unknown if the reporter considered the appetite absent to be related to Engerix B.  Additional details were provided as follows: The patient was not known to have any pre-existing health conditions. The patient had not eaten since the morning of 2nd July 2019 (for 12 hours) and died on the way to the hospital. The patient's parents believed that, the patient's death was due to the vaccine. But the physician stated that, the patient could had passed away due to other reasons, of which she did not provide. The reporter also stated that, two other patients received vaccines of the same lot and nothing had been reported. The physician would like to be followed up with as soon as possible so she would know what the next steps would be for investigation. No other details were provided.; Reported Cause(s) of Death: Unknown cause of death
Patient received TDAP Vaccination on 9/4/18 at 1:20pm. Patient is 32.5 weeks pregnant at present time, was sent for Vaccination by OB/GYN Dr. Patient called to Infectious Disease Office on 9/6/18 with complaints ranging over the past 2 days of receiving vaccination. Complaints include Fever 99.1-99.5 degrees Fahrenheit, chills, dizziness at times, fatigue, and nausea. Patient then stated that she had slight chest pain x2 starting 9/5/18 and then once again on 9/6/18. Patient instructed to follow up with OB/GYN in order to ensure wellbeing of baby and pregnancy, stated that she had been there on 9/5/18 and check up was good but that she would contact them once more. Patient also instructed to follow up with primary care MD or go to nearest Emergency Department for complaints of chest pain. Patient reports on 9/7/18 that she is feeling good, other than a possible sinus infection. States that she "slept solid last night, no fever, no chills, and no chest pain." States, "maybe it was just a thing and it's gone now."
Patient with Acute-flaccid myelitis. Patient presented with bilateral lower extremity weakness, truncal weakness, & upper extremity weakness, 3 days IVIG 2 g/kg 3 3 day 5 g/day steroids
Possible Incomplete dose; leaked onto patient's arm; needle attached to the syringe was loose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Possible Incomplete dose), EXPOSURE VIA SKIN CONTACT (leaked onto patient's arm) and DEVICE CONNECTION ISSUE (needle attached to the syringe was loose) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced UNDERDOSE (Possible Incomplete dose), EXPOSURE VIA SKIN CONTACT (leaked onto patient's arm) and DEVICE CONNECTION ISSUE (needle attached to the syringe was loose). On 09-Mar-2021, UNDERDOSE (Possible Incomplete dose), EXPOSURE VIA SKIN CONTACT (leaked onto patient's arm) and DEVICE CONNECTION ISSUE (needle attached to the syringe was loose) had resolved.        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.   Concomitant medications were not provided. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-jun-2021 with no new significant information.
Patient states there was a "knot" near the vaccination site for about 10 days. Became a dime size red bump, then a increasing black spot near site-painful. There was also rash-like area around site. When seen in office on 9/25- necrotic spot at site. Very painful, no drainage.
This spontaneous report has been received from a medical assistant referring to a 17 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an adult formulation of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported.
IPV vaccination on  dec10th and it expired  nov14/no AE; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who received an expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Dec-2019, the patient received a dose of suspect IPV (VERO) lot N1K921M via unknown route in unknown administration site.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not..  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. .
sore arm; lost sense taste; cold; fever; muscle aches; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ZIPRASIDONE, CLONAZEPAM and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-056649, US-MODERNATX, INC.-MOD-2021-048129 (E2B Linked Report).; Sender's Comments:  MOD21-056649:Crosslink father case US-MODERNATX, INC.-MOD-2021-048129:Crosslinked daughter case
Moderna COVID-19 Vaccine EUA. 09/14/2021: The patient called  Health Dept. to report a blood clot developed following receipt of one dose of Moderna COVID-19 vaccine. The patient was diagnosed on September 9, 2021, and physician instructed the patient to report the adverse side effect. 08/22/21: Patient received the first dose of Moderna COVID-19 vaccination at approximately 10:00. 08/24/21, a.m.: Patient reported he noticed pain in the back of his left leg, thought he had pulled a muscle, and the pain improved after walking. 08/25-08/27/21: The pain continued in the left leg, and swelling observed on august 27, 2021. 09/09/21: The patient was evaluated by his physician, an ultrasound was ordered, and a blood clot was found in the left posterior leg, behind the knee area. The physician prescribed Zoloft, patient unsure of the dose, and is currently taking the medication twice per days for 21 days, then one dose per day for 7 days. A follow-up appointment with the physician is to be scheduled in 5 weeks. No additional symptoms or adverse side effects reported by the patient as of this date.
This case was reported by a healthcare professional and described the occurrence of itching in a 45-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to CIPRO and penicillin allergy. There were no concurrent medications. On 5 January 2011 the subject received 3rd dose of TWINRIX in the left arm. On 6 January 2011, 1 day after vaccination with TWINRIX, the subject experienced itching followed shortly by hives. The subject contacted the office on the day of reporting stating that the condition had worsened and she was advised to go to the emergency room. It was not known if the subject had done so. The subject was administered the first two doses of the TWINRIX series without incident. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The healthcare professional considered the events were possibly related to vaccination with TWINRIX. Follow up information was received on 27 January 2011 via healthcare professional. The onset of the subject's hives and itching was 06 January 2011 and resolved on an unspecified date with ZYRTEC treatment. The reporting healthcare professional did not consider the event serious. Linked cases for this subject include A0853360A, A0853363A and A0900430A.
Pneumovax 23 vaccine administered 12/13/12 subcutaneously left upper arm using B-D needle 26G 5/8" length.  Received call ~ 9:30am next morning (12/14/12) from patient reporting redness, swelling and pain in left upper arm.  Instructed to come in right away - seen in office ~ 11AM -  Left upper arm noted with swelling from site of injection down to just above elbow - redness and painful to patient.  Treated Benadryl 25mg, 1 capsule orally 2-3 times per day and Prednisone 20mg, 1 tablet with food or milk, orally, once a day for 3 days - also to keep arm elevated and return to office next day for further assessment.   Patient returned to office 12/15/2012 and arm noted to be less swollen, less red and "pain is gone.   Plan is for patient to return to office 12/18/12 to see Primary Provider.  Spoke with patient on phone 12/17/12 and she remarked there is "no pain" "redness and swelling are much reduced"  -  patient will return 12/18/12 as planned for further assessment.
About 1 hr after vaccination, started to feel nauseous and bad headache, increased over 3 hr, felt "brain fuzzy" after  1 hr.; About 1 hr after vaccination, started to feel nauseous and bad headache, increased over 3 hr, felt "brain fuzzy" after  1 hr.; About 1 hr after vaccination, started to feel nauseous and bad headache, increased over 3 hr, felt "brain fuzzy" after  1 hr.; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:30, at a single dose, for COVID-19 immunization. Relevant medical history included atopic dermatitis, allergy to latex, nitrile, nickel, mint, mango, eggplant, tomatoes, coconut, some specific blue pigments. Concomitant medications included dupilumab (DUPIXENT), fluoxetine (FLUOXETINE), ibuprofen (IBUPROFEN), and vitamin D3). The patient previously received dexamethasone and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) in the left arm, on 18Dec2020 at 12:00, for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 21Dec2020, the patient showed a negative nasal swab. On 08Jan2021, at 13:30, about 1 hour after vaccination, patient started to feel nauseous, experienced bad headache which increased over 3 hours, and felt "brain fuzzy" after 1 hour. Three hours after onset, patient took Tylenol 1000 mg and Dramamine as treatment for the events. Outcome of the events was recovering. The patient underwent PCR test post vaccination with an unknown result.
* Initial pain in elbows, knees, shoulders, hips * Over course of several hours, the pain focuses completely into left hip to the point I could not walk without intense pain * Pain in hip lasted two full days; on third day I woke up and it was all gone
History: live births in 2008 and 2017. Abortion in 2016 using misoprostol. Miscarriage 12/20 at 6-7 wks. Received dose 2 around 4-5 weeks of pregnancy. At 6 wk 5 days, growth of growth of fetus stopped, as determined by ultrasound at what should have been 9 weeks (6/3). No heartbeat was ever detected. Yolk sac was determined to be enlarged and thin-walled, and blood tests showed a low progesterone level. Started daily Rx progesterone but on 6/5, spotting occurred and RX was discontinued. Spotting continued for one week on and off, with no heavier bleeding. Second ultrasound on 6/10 showed no change. On 6/13, miscarriage of gestational sac and fetal tissue occurred. Bleeding continued for about one week.
Information has been received from two healthcare workers referring to an unspecified number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot#, dose, route not reported). Concomitant mediations were not provided. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Red blotches on same arm as vaccination but not on vaccination site.  4 blotches approximately 1" in diameter located on side and under arm, about 1-2 inches apart.  Pain and sensitivity extending under arm down to elbow and to breast and nipple.  General malaise and slight nausea.  This reaction decreased in intensity on the following days, with the blotching and tenderness disappearing in about 4 days.  Patient contacted pharmacy but they said  it was not related.  No treatment. Photo of arm with blotches available.
The symptoms were headache, sever body pain, vomiting, diarrhea, dizziness, and fatigue. These symptoms lasted two weeks.
Expired; suspect SIDS-brought to Hosp p/being found unresponsive by babysitter; No fever, irritability prior;
Bells Palsy/Ramsey Hunt Syndrome-right facial paralysis followed by moderate to severe pain  in ear, face, headaches, pressure, SEVERE tinnitus   Ongoing symptoms- no resolve   Prednisone, Valtrex, Lyrica
1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lips, itchy all over." She was given 100mg total of Benadryl. Patient AOx3 1830: Continues with increased heart rate, complaining of swollen tongue. Patient's personal Epi pen given and EMS called. Patient AOx3 1845: EMS arrived 1855: EMS departed for Emergency Room.
Donor exper nausea, diarrhea, fever 24 hrs after receiving vaccine.
8-12 1st vaccination. 9-9 2nd vaccination. About 3 hours later after the vaccination, I got home. I nursed my son; 2 1/2 months old. I nursed him after the vaccine. Never had formula. His face and chest broke out in a rash. It went away within 10 minutes. Every time it would occur thereafter. If I gave him previous milk that was frozen from before vaccine, he did not break out in a rash. I contacted the pediatrician on 9-10-21. At the 10 hour mark, I personally felt chills, teeth chattering, horrible horrible lower back pain, super nauseous, dry heaving, low grade fever; lasted about 24hours. 9-10-12 Pediatrician office stated 1 of 2 possibilities; 1 allergic reaction to something in the vaccine or an immune response for my son. Told to keep a VERY close eye on my son. No crying, fussing, pain, sob, etc. He was having some sort of reaction, though. Son still has reaction when I breastfeed. I would not consider it the exact same; more blotchy. Son is currently 7 months next Monday.
Emergency room doctor gave diagnosis of Pericarditis. Since vaccination, currently monthly occurrence of chest pain on left side of torso with recommendation to take over the counter medication as needed for pain management.
Swelling and bruising of arm where vaccine was administered. Also caused entire body aches. Treating with Acetaminophen and Benadryl.
Information has been received from a physician concerning a male who on 10/12/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine (0.5ml), in the arm. Concomitant therapy that day included influenza virus vaccine (unspecified), in the opposite arm. On 10/14/05 the pts arm was swollen (arm vaccinated with Pneumococcal 23v polysaccharide vaccine). The physician did not think that the Pneumococcal 23v polysaccharide vaccine caused the swelling. The pt was prescribed an antibiotic and swelling was gone. Subsequently, the pt recovered. Additional information has been requested.
Patient received first dose of Pfizer COVID-19 vaccine on 3/22/21, the next day the patient reported feeling myalgia, diarrhea, and body aches and chills. The patient presented to the ED and was admitted with myocarditis and NSTEMI. Left heart cath did not show evidence of epicardial coronary artery disease. The patient was discharged from the hospital after receiving fluid resuscitation and supportive care. The patient returned to the ED with worsening myocarditis and was found to be in cardiogenic shock requiring vasopressor support. The patient developed VT storm and was intubated and sedated. The patient is currently in the ICU and remains intubated and sedated