chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of "got H1N1 and now feeling like she has the flu" and nausea has been received from a consumer concerning an 19-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal on 27-Oct-2009. On 27-Oct-2009, within an hour of receiving vaccine, began feeling like she had the flu and nausea. Neither outcome nor causality has been reported for these events.
Received flu vax and started to drive home. about 10-15 minutes later started feeling dizzy and fainted while driving in the car. Only reaction had. Felt a little woozy for a while. Woke up fine the next day.
Information has been received from a Medical Assistant concerning a 23 year old female with no known drug or food allergies who, on 08-NOV-2007, was vaccinated with the second dose of Gardasil (Lot #659437/1266U). Concomitant therapy included a contraceptive ring. On 08-NOV-2007, the patient experienced a pruritic rash at the injection site. The rash was approximately the size of a "silver dollar." Subsequently, the rash improved, however, a lump remained at the injection site. The Medical Assistant reported that the patient tolerated her first dose of Gardasil well. As of 17-NOV-2007, the patient was recovering from the rash and lump. Additional information has been requested.
No additional AE's; The vaccine that underwent a temperature excursion (2C to 8C (12.6C) for 480 hours) and was administered.; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was not reported.  On 07-MAY-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687290 was confirmed to be valid, expiration date 06-SEP-2022 (dose, route and site of administration were not reported) for prophylaxis. The temperature excursion was reported as "2 degrees Celsius (C) to 8 C (12.6 C) for 480 hours. There was no previous temperature excursion. No additional adverse event was reported. The call was because of a digital data logger.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA003665: US-009507513-2105USA003677:
The patient had not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in December 2022 with batch no as 2KE55 and expiry date as 22nd September 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: The patient had not received the second dose yet). 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: 15-MAY-2023 The pharmacist asked for information about a patient who received the first dose of Twinrix and had not received the second dose yet. The reporter asked how to proceed with patient's vaccination. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Information has been received from a physician concerning a female between the ages of 11 and 18 who on an unspecified date was vaccinated IM with the first dose of Gardasil (Lot# not provided). Subsequently, post vaccination the patient developed hives. The physician referred the patient to an allergist. At the time of this report it was unknown if the patient had recovered from the hives. Additional information has been requested.
first dose: Oct2020, second did not receivd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never get  2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up
Enteritis (loose, mucousy stools x 10, some blood- probable fissure. 10/9/2009 MR from PCP for visit 9/18/2009. Patient received vaccine 9/17/2009, presenting with sx of increased # of mucuousy stools (12) w/in last 24 hrs. Mother also noted blood in stools.  Dx: gastroenteritis ? reaction to vaccine. 10/20/09 Medical records received for dates 9/17/09 to 10/13/09 DX on 9/18/09: Enteritis, possible reaction to vaccination. Assessment: pt. seen for routine exam 9/17/09 received vaccinations. Exam WNL. 9/18/09 pt. seen with parent complaint of increase stools x12 in 24hrs, mucousy, with blood visible. Pt. appeared uncomfortable. Exam was (+)guiac. Pt. seen 9/22/09 with parent c/o green mucous stools. (-)guiac. Labs ordered. 10/13/09 exam: issue resolved. Per notes pt "looks great".
Blurred vision; 1st dose 25Mar2021, no 2nd dose; Extreme Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Extreme Anxiety), VISION BLURRED (Blurred vision) and OFF LABEL USE (1st dose 25Mar2021, no 2nd dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced ANXIETY (Extreme Anxiety) and OFF LABEL USE (1st dose 25Mar2021, no 2nd dose). On an unknown date, the patient experienced VISION BLURRED (Blurred vision). In 2021, ANXIETY (Extreme Anxiety), VISION BLURRED (Blurred vision) and OFF LABEL USE (1st dose 25Mar2021, no 2nd dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       2 weeks after the vaccination, after having a 10 hour dental work, patient experienced extreme anxiety for 3-4 weeks and gradually faded. So he was advised not to take the 2nd dose to figure out what was going on. They were thinking it may have been the anesthesia that brought him to the anxiety state since he also had accompanying blurred vision.  Concomitant product use was not provided.   Treatment information was not  provided.
HEAR ISSUES, SEVERE CHEST PAIN, LEFT PECK WAS TENDER TO THE TOUCH, LEFT RIB CAGE WAS TENDER, PAIN FELT LIKE A STABBING SENSATION TO THE LEFT SIDE OF MY HEART, OVERALL TIGHNESS IN CHEST, RAPID HEART RATE (DOCTORS OFFICE RECORDED 180/110), TINGLING SENSATION DOWN LEFT ARM TO FINGER TIPS, TWO MIDDLE FINGER TIPS ARE PERIODICALLY NUMB (LOSS OF FEELING).  HEADACHES LASTING WEEKS, CURRENTLY RIGHT SIDE OF FACE FEELS NUMB OR TINGLING SENSATION, EYES HURT AND CONSTANT ACH EVEN AFTER TAKING ASPRIN. MY RIGHT LEG ACHES, ESPECAILLY IN THE HAM STRING AREA, GENERALLY SORE ALL OVER / ACHEY.
About an  hour after the immunization, the patient began having swallowing problems, felt itchy all over, rash on her neck chest. She came back to administering RN who escorted her to the Emergency Room for treatment.
p/vax pt had intussusception 4/26/99; air enema reduction
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated at a health care facility for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered significant medical expenses and pain and suffering, and other damages. Additional information has been requested.
deep vein thrombus; Suspected vaccination failure; Meningitis; This case was reported by a consumer via interactive digital media and described the occurrence of deep vein thrombosis in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, more than 2 years after receiving Meningococcal B vaccine, the patient experienced deep vein thrombosis (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the deep vein thrombosis was fatal and the outcome of the vaccination failure was unknown and the outcome of the meningitis was recovered/resolved. The reported cause of death was deep vein thrombosis.   It was unknown if the reporter considered the deep vein thrombosis, vaccination failure and meningitis to be related to Meningococcal B vaccine.  Additional details were provided as follows: After receiving Meningococcal B vaccine, the patient got meningitis at the age of 17 years. The patient recovered however the doctors made mistakes in the process and a blood clot went into his heart and he passed away of that.  The cause of death was deep vein thrombus.  It was unknown which type of meningitis the patient had.  The patient was in his senior year of high school. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for Meningococcal B vaccine and type of meningitis and laboratory confirmation for meningitis were not provided.; Reported Cause(s) of Death: Deep vein thrombosis
Pt began n,v,d, crankiness on 13JUN91 @ 4 was red around site, had some rxn to previous injection; vomited for 7 days, until 15Jun;
Several days after injection my neck started itching and broke out in a rash which appeared on front right dude of neck going around to back of neck and up back of ear.  Appear on up back right side and right shoulder.  Rash turned to blisters and became very painful.  Was told it looked like shingle and went to doctor where it was confirmed.  In pain for 3 weeks.  It eventually healed.  Still have scarring from rash.  Pfizer?s Covid 19 vaccine triggered this shingles outbreak.
Pt recvd vax & 1 wk later devel an urticarial rash & was seen by MD; treated w/DPH; rash is mostly resolved;
Fever up to 102 degrees 12 hours after vaccine admin, lasting for 3 days with nausea, severe headache, muscle and joint pain, light and sound sensitivity, severe total body pain flu like symptoms. Tylenol 1 gram every 6 hours started 12 hours after injection of vaccine: meclizine for nausea, 1 per day, with alternate ibuprophen 300 mg cap 3 hours after Tylenol for two days for pain. Gatorade, broth, toast, juice and water tolerated for two days, with crackers. Once fever broke on third day, extreme fatigue and mild nausea for following two days.
I have not had a menstrual period since 3/2021 due to taking birth control without placebo, which was prescribed by my doctor. Several days after I received the vaccine, I began to have a severe, heavy period / menstrual bleeding which was not normal or part of my regular cycle. The bleeding was significant?I changed a pad every several hours and bled for 3 weeks straight at this rate. I did not have money to go to the doctor about this and it eventually stopped. Now, every time I have sex with my husband, I bleed.
Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 20-Apr-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624801 (Patient Link).
Within 6-8 hours after injection I experienced severe diarrhea, and severe light headedness that almost caused me to pass out.  High Fever 103 that lasted 3 days.  Chills, body aches, and nausea lasting 3 and 3.5 days with severe fatigue and headache starting at the same time.   On day 4 Fever dropped to between 100-102 that lasted an additional 2 to 3 days.  Chills, body aches and nausea resolved by then.   Fatigue and headache continued.  Fever and headache ended on day approximately day 6.  Fatigue became less severe but was still considerable.  Fatigue tapered off and was gone by day 14.
On the evening of the date of injection she reported she was asleep and woke up and wandered to her restroom where she felt weak, fainted and fell and hit her head on the tile.  She had a headache and also reports vomiting, she said the injection site was sore for 2 days, she also developed a chest cold and says she has always been healthy and has not had a cold for years. Improved now.
Pt reported that her left arm was red and swollen after getting the Pneumonia shot. She reported the adverse event on 10/11/18, but she came to the pharmacy to show her arm on 10/12/18. Upon inspection her arm was red from the injection site all the way to her elbow.
Bell's Palsy - pain under left ear, facial drooping on left side, left eye lid swollen, pain in left eye, loss of facial muscle on left side
This spontaneous report as received from consumer, the patient's grandfather, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (dose, route and lot were not reported). The reporter stated that shortly after receiving the M-M-R II the patient "stopped talking and was later diagnosed with autism". The outcome of autism was unknown. Additional information is not expected.
Flu symptoms. Dizzy, crazy skin(painful) muscles, joints, all painful. Nausea. Had to leave work because of the dizziness. Fever and chills.
A report was received from a consumer on 11/24/03 concerning a vaccinee (gender unspecified) under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received Fluvirin. No adverse symptoms were reported at the time of reporting. Follow up pending.
No symptoms or side effects immediately following the vaccine. 1 week after receiving Moderna vaccine my right arm was swollen and it was hard at the injection site. I had a bright red rash that extended from below my shoulder down to my elbow that was raised and itchy. Rash did not develop anywhere else on the body; there was no difficulty breathing. Rash resolved on its own without any medications after three days.
circular area of redness (~2.5 inches), slightly raised , slight warmth all appearing over vaccine site over right deltoid.  small lymph node in axilla of same side
Resident had a breakthrough case of COVID-19 after receiving both doses of the Pfizer Vaccine.
Pregnant while receiving vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant while receiving vaccine) in a 36-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M204 and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Stillbirth (loss at 32 weeks, cause unknown but baby did have a knot in the cord and around neck) on 12-May-2015, Pregnant on 10-Mar-2017 and Pregnant on 04-Apr-2019. Concurrent medical conditions included Penicillin allergy.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. The patient's last menstrual period was on 13-Sep-2020 and the estimated date of delivery was 20-Jun-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant while receiving vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 29-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant while receiving vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal (normal) within range. On an unknown date, Ultrasound foetal: normal (normal) all normal.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Pregnancy form initial Received on 23 Apr 2021 included information of patient height, weight, prior pregnancy details, medical history and second vaccine dose.
1/6/2021- Fever, headache 1/7/2021- diarrhea, headache, sore throat
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. In approximately 2016 (reported as on or after 23-APR-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L026553, expiration date reported as 16-JUL-2107, lot # L030162, expiration date reported as 11-AUG-2017 (therapy type, dose, frequency, route and site administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 34.8 degrees Fahrenheit for 6 hours and 43 minutes and 53.2 degrees Fahrenheit for 8 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever (38.8C), malaise, myalgia, arthralgia, fatigue
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 30-JAN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798, expiration date 12-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Redness, swelling, and itchiness around injection site - about the size of a baseball. Symptoms began 7 days after receiving injection and lasted about 48 hours.
1NOV94 445PM onset of sore arm, leg pain; 2NOV94 2AM devel cramps, blood shot eyes & achiness;
Approx. 2 hrs after rec'ing flu vaccine dev'd gradual onset of dysarthria. No H/A or facial drop. Eval. in Occ. Health by Dr. & sent to ER to r/o poss. TIA. CT of head performed - no acute pathology. BENADRYL 25 mg given. Within 2 hrs. sxs resolved. Had prev. flu vaccines with no problems.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.