chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 1/15/02 concerning a 16 month old female patient who experienced an overdose and off-label use of Fluvirin on 12/5/01. On 12/5/01, the patient received 0.5ml (adult dose) of Fluvirin instead of the CDC recommended dose of 0.25ml (for children). In addition, this was an off-label use of Fluvirin, since Fluvirin is indicated for use in children 4 years and older. The patient did not demonstrate any untoward effects at the time of administration, and the mother was instructed to monitor the infants for unusual problems, behavior or symptoms. At the time of reporting the mother had not reported any adverse reactions.
Moderna vaccine vials (Lot#:002C21A, expiration 10/14/21) were removed from freezer and delivered from larger healthcare facility within enterprise to our facility with a fridge expiration date of 6/24/21. The fridge expiration date was written on the bag that the vials came in, but not directly on the vials. The nurse administering vaccines on 6/30/21, grabbed a vial from the pharmacy fridge without knowing about or looking at the expiration date on the bag. The nurse then administered 8 doses of the expired vaccine that day.  Pharmacy caught adverse event on 7/9/21 when reporting doses given. Notified Moderna  on 7/12/21 who recommended to report to  but not to administer additional dose as no studies done on patients receiving more than 2 doses. No further follow-up recommended. No adverse reactions noted.
pentacel product expired on 5/4, but was administered on 5/17 with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who was administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccine which expired on 04-May-2023, but was administered on 17-May-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) both for Prophylactic vaccination (Immunization).  On 17-May-2023, the patient received a dose of 0.5 ml once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ662AA; expiry date: 04-MAY-2023; strength: standard) via intramuscular route in unknown administration site for Immunization.  On 17-May-2023 the patient was administered expired pentacel vaccine which expired on 04-May-2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Caller wanted to know if patient need to be re-vaccinated."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
(04/12/21) Sudden onset of vertigo, followed by severe pain around left eye, then nausea.  Treated in ER; CT/artheriogram (negative), labs, xrays, IV's, medication.  Kept in hospital over night for testing and observation.  Physical therapy has been ongoing to treat vertigo, dizziness.
This literature marketed information has been received from a published literature article and refers to a 16-year-old boy with known beef, pork, milk allergy, no sIgE or alpha-gal results reported. The patient developed on an unspecified date in approximately 2016, disseminated urticaria, shortness of breath, respiratory distress within 20 min of M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccines, administered on the same date, included hepatitis b vaccine (recombinant)(manufacturer unknown), poliovirus vaccine and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. He was treated with antihistamines and steroids in emergency department. At the time of this report, the outcome of the events was unknown. The author considered the events as reactions associated to M-M-R II. Upon internal review the event respiratory distress was considered as medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012062).; Sender's Comments:  US-009507513-1809USA011156: Original Case : 1809USA011156.
Patient received the newly approved 0.5mL dose. There was redness at the injection site that occurred immediately, fever the next day up to 102 degrees Fahrenheit, lethargy, and anorexia.
mouth felt swelling; throat feels numb; fell; broke her right shoulder; felt a little bit dizzy; lips started to feel tingly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt a little bit dizzy), CHEILITIS (lips started to feel tingly), MOUTH SWELLING (mouth felt swelling), PHARYNGEAL HYPOAESTHESIA (throat feels numb) and FALL (fell) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (felt a little bit dizzy) and CHEILITIS (lips started to feel tingly). On 22-Jan-2021, the patient experienced FALL (fell) and UPPER LIMB FRACTURE (broke her right shoulder). On an unknown date, the patient experienced MOUTH SWELLING (mouth felt swelling) and PHARYNGEAL HYPOAESTHESIA (throat feels numb). In January 2021, DIZZINESS (felt a little bit dizzy) had resolved. At the time of the report, CHEILITIS (lips started to feel tingly) and MOUTH SWELLING (mouth felt swelling) was resolving, PHARYNGEAL HYPOAESTHESIA (throat feels numb) had not resolved and FALL (fell) and UPPER LIMB FRACTURE (broke her right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded.
This spontaneous report was received from patient's mother who is also a pharmacist and refers to her 15-year-old daughter. The patient's concurrent conditions included with migraine, asthma and severe food allergy. On 15-SEP-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, (dose, anatomical location, lot# and expiration date were not reported). On 05-FEB-2018, the patient received the second dose of the GARDASIL 9 intramuscularly (dose, anatomical location, lot# and expiration date were not reported). Concomitant therapies included SINGULAIR. On 06-FEB-2018, also reported as on Tuesday, the patient experienced a really bad headache. On 07-FEB-2018, reported as on Wednesday, the patient felt dizzy, had a headache, and was nauseous. On Thursday, the patient stayed home from school and still felt dizzy, had a headache, and was nauseous. On Friday, the patient felt a little bit better but on approximately 10-FEB-2018, (Saturday), she had hot flashes and nausea. Subsequently, on Sunday she dry heaved and threw up all day (onset date in approximately 11-FEB-2018). Since an unknown date in February 2018, the patient had a lump at the injection site. The patient was treated with EXCEDRIN MIGRAINE and ZOFRAN (detail were not provided). According to the reporter none of the treatments worked. At the reporting time, the patient had scheduled visit with the physician and missed three days of school. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 therapy was not provided.
pt recvd vax & devel shooting pains from the site of inject down into arm, numbness in middle, ring & little finger & weakness in arm; pain in arm would subside if arm was kept still; unable to use arm;
No known adverse effects; A patient received an expired dose M-M-R II; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medication and concurrent conditions was not reported.   On 12-APR-2019 the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N024696, expiration date 07-APR-2019, subcutaneous for prophylaxis.    No adverse event was reported.
had the shingles shot / have the shingles now/suspected vaccination failure; shingles; Muach pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles shot a few years ago from the date of reporting but had the shingles now.  The patient had never had this much pain in my life.  The patient praying that it would soon go away. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
3 days p/vax devel severe urticaria of the face, eyes swollen shot, then gen varicella rash ( <60 lesions);recovered in 7 days;
This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored PNEUMOVAX23 (lot number, dose, frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Woke with a swollen bottom lip on day 8 post injection.  Day 9 same swelling but additional numbness  and uncomfortable feeling. Day 10, still swollen and some numbness and upper lip is now tingling and slightly swollen.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot#M002063, expiry date: 12-JAN-2018 (dosing details was not reported). It was reported that the vaccines were exposed to the temperature of 24.3F during a time frame of 8 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen lymph nodes in right armpit causing pain in armpit and breast.  Armpit was swollen and nodule could be felt by doctor.  Took 10 days of antibiotics and swelling went down temporarily but flared back up before time for second shot.  Pain and swelling was back two days before second shot on 05/11/21.  Follow up doctor appointment scheduled on 05/19/21.
10:12 - Received 3 vaccines, TDAP, MCVY, HPV in that order - stopped talking and got pale, head lowered it protected safely in chair. LOC x about 15 sec, clammy cool cloth behind neck. Mom at side entire time during shot-went outside with daughter. Order-protect in chair x 5 min more. Mom gave water and power bar talking with us, sat in lobby x 10 more min, took 2nd 16 oz of water. Left ambulatory with mom and sister - encouraged to rest, eat and drink. Call ped if need or go to ER. Verbalized OK-1205 call placed to Mom's cell LMOM to call if any needs or questions to call ped or go to the ER.
Received call from patient next day with complaint of left upper arm swelling, redness and pain from injection site downward to elbow.   Advised Zyrtec 10mg for daytime and Benadryl 25mg 2 po for nighttime until better, continue cold compresses/ice off and on throughout day.  Can use ibuprofen for pain as directed otc.  Sent topical cortisone to her pharmacy. She can use it topically bid to red area. Outcome: 2/4-still treating
Received H1N1 on 1-14-10. Broke out in hives 1/16/10. Itches. Patient was instructed to take Benadryl by health care provider and to call if situation became worse. Patient states itching is slightly less and hives not as pronounced during the phone follow up on 1/19/10.
It was reported that a female pt experienced a febrile convulsion sometime after receiving IPOL, no specifics were provided. The pt's recovery status is currently unknown. Further info is expected. Seriousness criteria: other medically significant (OMIC). Follow up on 07/08/2003: "From additional information received on 06/30/2003, "This case was reported by a physician.  Attempts to contact the physician have been unsuccessful".  It was not reported whether this patient was seen in the emergency room or at doctor's office, but since this report came from the doctor, the outcome screen was checked as required doctor's visit.  No further information is anticipated, this case is considered closed."
Macular rash around mouth.  baby otherwise well appearing, eating well.  Of note, she had pentavalent rotavirus previously from different provider, so this was her first rotarix.
My right arm is swollen and tender to touch, pain radiates down arm and up to my neck, I cannot raise my arm, can't lift things, can't bend my arm behind me, its hard to get dressed, my arm is tight and cannot lay on my arm at night. It's gotten worse and I've tried hot and cold compresses and nothing alleviates the pain and it feels like it's in the rotator cuff, also the site itches on occasion. My second dose Pfizer 4/10/2021 Lot #EW0151 and it was done in the left arm and had no problems with it.
Patient  is not immunocompromised.  Patient received 2 Primary Moderna vaccines on 03/25/2021 and 4/22/2021.  Received first Booster Moderna 0.25 mg on 10/27/2022.  Received second Moderna 0.25 mg booster 04/29/2022.  Received 3rd booster of 0.25 mg of Moderna on 08/30/2022 ( this was an unauthorized booster provided.  Error found on 12/19/2022.  Spoke with patient who reports no affects from extra booster provided.  Department of Health was notified when error found.  Permission given to provide Bivalent Moderna per patient request on 12/20/2022.
Received vaccines @ 0915, felt bad @ 1600, skin hurt @ 2000(took tylenol), awakened @ midnight with chills, shakes, and temp of 101.8 F(took tylenol).  This morining temperature of 99.4.
18 month patient received 1 mL doses instead of 0.5 mL doses; 18 month patient received 1 mL doses instead of 0.5 mL doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-month-old male patient who received HAV (Havrix 1440) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 25-JUL-2023, the patient received Havrix 1440. On 25-JUL-2023, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: 18 month patient received 1 mL doses instead of 0.5 mL doses) and inappropriate age at vaccine administration (Verbatim: 18 month patient received 1 mL doses instead of 0.5 mL doses). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter reported that the new shipment of Havrix vaccine was came in and the office did not realized the new shipment was 1 ml doses instead of 0.5 ml. The reporter stated that the dose was given to the 18 months old male patient. The vaccine administration facility was the same as primary reporter. The infant patient was administered an adult dose of Havrix , which led to overdose and inappropriate age at vaccine administration. This case had been linked with US2023103051 by same reporter for different patient. The reporter did consent to follow up.; Sender's Comments:  US-GSK-US2023103051:Same reporter
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on body) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced RASH (Rash on body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency and CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on body) had not resolved. Concomitant medication was not provided. Additional information was provided that Cortisone 10 cream was used for rash treatment.
This spontaneous report has received from a physician via company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date the patient was vaccinated with a does of ZOSTAVAX (dose, lot# and expiration were not reported) subcutaneously for prevent shingles.  On an unknown date the patient experienced "pain and swelling at the injection site for five days". The patient contacted physician, but no treatment was given. The outcome of injection site pain and swelling was recovered. Causality was not provided. Additional information is not expected because the reporter does not want to be contacted further.
back pain; Arm got really sore; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and VACCINATION SITE PAIN (Arm got really sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced BACK PAIN (back pain) and VACCINATION SITE PAIN (Arm got really sore). At the time of the report, BACK PAIN (back pain) outcome was unknown and VACCINATION SITE PAIN (Arm got really sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
High Fever, body aches, headache nausea and diarrhea  All symptoms lasted about 36hours
Arm pain, breast pain, breast lump, pain radiating down arm. It has been 6 months post vaccine and I still have these symptoms.
Arm began to ache and swell at the site of the injection. The site got hot. I began to have flu-like symptoms- exhaustion, muscle aches. The pain kept me awake so I took a Tylenol 3 and put ice on the injection site.  I slept all night with ice on my upper arm.  Changed the ice bag once.  In the morning the arm ached, was hot and turned red.  The site is tender to the touch and hurts when I move my arm. I called the Medical Arts Building and talked with the Physician Assistant's assistant.  Later, around 1:30 PM someone from that office called me back.  She said to put ice on the site and take Tylenol.  She said if it doesn't go away by Monday come in so they can examine it.  She amended it and said come in tomorrow if it is worse.
Hives began one week after vaccine.  Went to urgent care on two different occasions, initially told to continue Otc antihistamines, given prescription at second visit.
PATIENT STARTED TO GET A RASH IN DAYS AFTER VACCINE BUT WOKE UP TODAY, 8 DAYS AFTER VACCINE, WITH FULL BODY HIVES. PATIENT WENT TO THE ER AND WAS TREATED WITH STEROIDS AND ANTIHISTAMINES. SHE IS HOME NOW AND RECOVERING.
Patient came to the emergency room with weakness.  Then patient was diagnosed with COVID-19 infection and chest x-ray and CT chest was negative.  Initially patient required some oxygen, but that got resolved.  Patient also had hyponatremia, but that also resolved.  Hypomagnesemia resolved.  on the CT chest, it showed patient has a compression T12 fracture.  I did discuss with the Neurosurgery nurse practitioner who  recommended since patient is asymptomatic patient can follow up as needed with the PCP.  So, since patient is stable enough, patient was discharged.
my blood sugars are very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (ongoing), notes: I am diabetic. The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 21Sep2023, outcome "unknown", described as "my blood sugars are very high". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased. Additional information: A couple of days ago, the patient had a Pfizer shot, a COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine and the patient had a couple side effects that would like to report. Since, the patient had the shot (COVID-19 Vaccine) on Thursday; the 21Sep2023 blood sugars were very high and the patient had to put more Insulin. The patient was diabetic. The patient took 4 shot of Insulin a day and blood sugars were high, was this shot affecting blood sugar? The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Symptoms started wtih headache, neck lymphadenopathy.  By 03/21/2012 progressed to diffuse myalgia, stiff joints, sore throat, and diffuse pruritic rash on face and trunk.  Rash spread to extremities on 03/22/2012 and cough started on 03/23/2012.
pt recv vax 2FEB98 10AM & about 3hr later pt devel rash all over body;took DPH & a nap & 3hr later disappeared no problems since;