chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Transplant; received 2 doses of Twinrix in 2010 / 2 doses of 3; This case was reported by a pharmacist via call center representative and described the occurrence of transplant in a male patient 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, HAB (Twinrix) for prophylaxis and 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 dose in 2010).   On an unknown date, the patient received the 2nd dose of Twinrix, Twinrix Pre-Filled Syringe Device, 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 and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced transplant and incomplete course of vaccination. On an unknown date, the outcome of the transplant and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the transplant to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made 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 reported for 2nd dose and was not applicable for 3rd dose. The reporter stated that the patient might have received 2 doses of Twinrix in 2010. He was not sure if the patient received Twinrix or other vaccine (in the chart said the patient a Hepatitis combo vaccine and 2 doses of 3, so pharmacist thought that it was Twinrix). Till the time of reporting, the patient did not receive the 3rd dose of the vaccine, which led to incomplete course of vaccination. The patient received a transplant afterwards (reporter was not sure of which type of transplant). The reporter consented to follow up.
Information has been received from a health care professional concerning a 5 year old pt who in approximately 1998 (at the age of 13 months) was vaccinated with varicella vaccine. In approximately January 2002, the pt developed herpes zoster. A specimen was collected and it was reported that the specimen was positive for VZV vaccine virus. Unspecified medical attention was sought. Additional info has been requested.
Systemic: pt fell but was still coherant-Severe, Additional Details: pt fainted in lobby after recieving vaccine pt has chf, and dm with a recorded bp at the time of 102/70 event most likely caused by reduced bloodpressure leading to diziness
pt recv vax;had gene tonic sz less than 24 hr p/ vax; in hosp & tx as a febrile convuls & released
Late for the 3rd dose, not administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient 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 (1st dose received on 2015) and Twinrix (2nd dose received on 2015).   On an unknown date, the patient did not receive 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 24-OCT-2022 Reporter's Comment: The reporter was a healthcare professional. The reporter reported that the patient was late for the 3rd dose. The reporter stated that there was no adverse event reported. The reporter reported that the patient identifiers, lot number, expiration date and vaccination date was not provided. No vaccination date provided for the third dose as it was not administered. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
pt. complaining of feeling nausea, light headed.   BP=84/54,  97/57;  HR-63;  O2=98
Tiredness, queasy, itching/rash, feeling of not being well. On days 9 & 10, arm was painfully itchy and a rash developed on my stomach and breasts. Exhaustion lasted 3 weeks.
Dose administered after 30-day Use By Date; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was initially stored in the refrigerator 31-May-2023.  Vial was individual vial with multi dose 0.5 ML. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 4th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (patient 1)
anaphylaxis; throat tightening; chills; 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 ANAPHYLACTIC REACTION (anaphylaxis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant), THROAT TIGHTNESS (throat tightening) and CHILLS (chills). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis), THROAT TIGHTNESS (throat tightening) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Approximately 10 minutes after shot was administered, I noticed no pain at the injection site; instead there was pain in my left forearm where there was a large hard lump. The pain traveled to other large muscles over the next two days, including legs, hips, back. It seemed the Fibromyalgia symptoms were extremely intensified.
EXTREMELY PAINFUL PAIN IN BOTH KIDNEYS; RINGING IN EARS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced extremely painful pain in both kidneys, ringing in ears, and severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely painful pain in both kidneys, and the outcome of severe headaches and ringing in ears was not reported. This report was non-serious.
On the 2nd day after receiving vaccine, I had some hives in the morning that we itchy. Then that evening, developed hives in different places and severe itchiness. The only other symptom feeling chilled on the day after the vaccination.  I also received flu vaccine at the same time in the opposite arm. I have never had a reaction to the flu vaccine.
Moderna Covid-19 Vaccine  Within 90 minutes, increased body aches, shaking, chills; this lasted thru the night and by morning-headache, fever, a smell of flowers (?); Fever started low grade that next day but then increased during the evening; I literally could barely bring my body out of bed due the pain and total exhaustion.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-MAR-2017, the patient was vaccinated with the second dose of PEDVAXHIB injection, lot# M036612, expiration date: 19-MAY-2019 (dose and route of administration were not provided) which was improperly stored. The temperature excursion ranged to 43 degrees Fahrenheit for 24 hours. No adverse effects were reported. No product complaint was involved. Additional information has been requested.
There was an opened unlabeled vial of Moderna in the VFC fridge. There had not been any mentions on the group chat of an open Moderna vial (as when we open each vial we let everyone in the chat know) . I grabbed the open vial along with an unopened vial of Moderna and proceeded to the Covid clinic. There were 7 doses of this vaccine given to patients. As of 9/27 we were off on our counts and now realize that the vial that was used on 9/24 to those 7 patients was an expired vial. The vial had originally been opened on 9/23 by RN. These 7 patients have been located and will be contacted once recommendations from CDC are reviewed.
Dose administered after 30 day use by date or after manufacture date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported Total number of doses were 102 doses and the vial did not undergo temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information
Pt reported facial itching after COVID-19 vaccination. Denied SOB, chest pain, throat swelling, rash and nausea. Reported itching at back o f throat.
My child has a dry skin rash from one side of her body to the other starting from her right arm's bicep/triceps to her back along side her left arm. The GARDASIL shot was given in her left shoulder. She also experienced shortness of breath. Chest hurts.
a patient received their first dose of the Moderna; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received their first dose of the Moderna) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received their first dose of the Moderna). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received their first dose of the Moderna) 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.   Description of Event or Problem was reported as : The syringe was drawn up on 27July2021 at 2:53 PM and administered on 28July2021 at 3:00PM . The syringe had been kept in the refrigerator prior to administration. No concomitant and treatment medications details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up document received on 02-AUG-2021 contain No New Information
Site swelling Site pain unable to lay on that arm and unable to move without high level of pain woke up during night due to pain in arm Fatigue  Nausea
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Subfertility (female), Anxiety and Headache. Previously administered products included for Product used for unknown indication: Metformin (First 10 weeks for getting pregnant.). Concurrent medical conditions included Hypothyroidism (Medication and well controlled), Polycystic ovarian syndrome and Gestational diabetes. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, PARACETAMOL (TYLENOL) for Headache, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-May-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 21-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2020, Pregnancy test: positive positive (Positive) positive. On an unknown date, Prenatal screening test: normal normal (normal) normal. On an unknown date, Ultrasound scan: normal normal (normal) 12 and 22 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date the patient experienced "a rash and blistering at the injection site". It was unspecified if a treatment was given for the events. The outcome of the events was reported as not recovered. The causality of the events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient described some swelling and tingling in her injection arm. Patient denied any pain or redness in the injection arm. Patient denied any trouble breathing, chest pain or any other symptoms besides the tingling and swelling. Patient denied any required treatment or transport to the hospital.
Red rash with bumps; severe itching; Rash mainly on arms, chest, and back; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration on 02Feb2021(at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination Concomitant medications were not reported. On 03Feb2021 the patient experienced red rash with bumps, severe itching, rash mainly on arms, chest, and back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red rash with bumps, severe itching, rash mainly on arms, chest, and back was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Left leg swollen, large, red, inflammed area. Ran fever within 6 hours of vaccine for 24 hours.
Pt seen today 6/12/06 with diffuse crusted pustules/papules over torso, face, arms, few lesions with large erythematous base.
pt recvd vax & shortly p/vax half of body started going numb & pt felt lightheaded & dizzy; resolved p/24 hrs;
body aches 7-8 hours later, worse body aches, chills and rigors 14 hours later for which 600mg motrin taken, chills and rigors improved one later, body aches continued until 22 hours after vaccination where 600mg motrin taken again, minor body aches and fatigue until 36 hours after vaccination
The injection site has become red and itchy, it is also hard to touch. I have also had diarrhea.
Myalgia, Nausea Vomiting, fatigue, nausea, body aches, soreness at injection site, decreased appetite, poor concentration Narrative:
12:20pm 9/18/09 patient returned to pharmacy to report deltoid muscle pain after 9/4/09 has not diminished. Hurts to move right arm especially painful taking off putting on sweaters.
Patient received COVID vaccine intramuscular in right arm. Patient was waiting in waiting area then notified the front desk  6 minutes after injection, that he was having dizziness and nausea.  APA advised patient to have a seat and went to notify RN about the patients status. Registered nurse went to see about the patient. Patient was slumped in the seat with labored breathing, gagging and eyes rolled back.  EMS was notified. RN removed mask, assisted patient to lean over,  to allow patient to vomit in trash can.  As patient continued to vomit and started regaining consciousness after about 30 seconds. Vomiting was complete.  Symptoms had subsided. EMS arrived and examined patient.
This retrospective pregnancy case was reported in a literature article and described the occurrence of pregnancy loss in a adult female subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed pregnancy loss. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of pregnancy loss was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. It was unknown if the investigator considered the pregnancy loss to be related to Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the pregnancy loss in a female aged equal to or more than 18-year who was vaccinated with unspecified inactivated trivalent influenza vaccine (IIV) during her pregnancy (manufacturer unknown). The patient was a part of the prospective observational study conducted during the 2013-2014 influenza season at a family planning clinic and three obstetrics and gynaecology practices which assessed the feasibility of recruiting pregnant women less than 20 weeks gestational age (GA) to participate in a text messaging based vaccine adverse event monitoring program after receipt of inactivated influenza vaccine (IIV) and utility of text messaging to monitor health events, including fever frequency on vaccination and next 2 days (Days 0-2), health events during pregnancy, pregnancy outcomes, and neonatal outcomes. All four sites were affiliated with hospital. The female was a pregnant woman with gestational age less than 20 weeks by last menstrual period and/or ultrasound. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient's medical or family history or concomitant medication was provided. On an unspecified date during the 2013-2014 influenza season, the patient received unspecified IIV (administration route and site unspecified; dosages unknown; batch number not provided) during the gestational age less than 20 weeks. Age at vaccination was unknown. (In this study, 70.5% had documented receipt of tetanus-diphtheria-pertussis vaccine during the same pregnancy). On an unspecified date prior to 18-weeks gestational age, an unknown period after vaccination, the patient had pregnancy loss. It was unclear whether it was a spontaneous abortion (SAB) or elective termination. It was noted by text message only. The authors did not comment on relationship between pregnancy loss and IIV. The authors concluded, "This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance throughout pregnancy. In addition, in these women receiving IIV during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes for pregnancies was observed." This is 1 of the 16 valid cases in the same literature article.