chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 8 September 2013 the subject received a dose of BOOSTRIX (unknown details). Within months of vaccination with BOOSTRIX, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
ACHES; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative 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  (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 per procedure not requested. No concomitant medications were reported. On an unspecified date, the subject experienced aches, fever, and fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, aches and fatigue was not reported. This report was non-serious.
Information has been received from a registered nurse RN concerning a 5 year old white female who on 10JAN2000 was vaccinated subcutaneously in the left arm with a dose of varicella virus live (lot 632037/1355J). There was no concomitant therapy. The patient was noted to be well at the time of vaccination. The RN reported that, in March 2003, the patient developed 25 spots which were considered to be mild as per the patient's father. The patient was not seen at that time. The patient was treated with diphenhydramine HCl (Benadryl) , calamine+camphor+pramoxine (AVEENO) and acetainophen (tylenol). In March 2003, patient subsequently recovered. No further information is available.
L leg swollen with redness. No fever/chills. It occur 1 day after receiving the vaccine (DTaP). Tx-cool compreses/warm compress made appt with Dr.
Information has been received from a physician assistant concerning a 67 years old patient (gender was not provided). In 2009, the patient received a dose of ZOSTAVAX, (dose, route and lot number was not provided). On 07-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route and lot number was not provided) as vaccination. No other co-suspects were reported. No concomitant medications were reported. On 07-AUG-2012, about 10 hours after received ZOSTAVAX, the patient experienced myocardial infarction and was hospitalized. On 10-AUG-2012, the patient was discharged from the hospital. The reporter physician assistant was not the provider that administered ZOSTAVAX (name of provider unspecified). The patient's outcome was reported as recovering/resolving. The physician assistant considered the event as significant disability and life threatening. Additional information has been requested.
Arm pain; Neck pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. Since receiving the vaccine patient experienced arm pain that was radiating up to the neck from injection site. No further details were provided. The reporter consent to follow up.
Pain from upper arm pit to elbow joint. Swelling, redness, heat at injection site. Fatigue, nausea.
Havrix late booster; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Previously administered products included Hepatitis A vaccine (1st dose received on 09-FEB-2019, unknown if it was Havrix).   On 15-SEP-2023, the patient received Havrix. On 15-SEP-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: Havrix late booster). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 09-OCT-2023 The pharmacist reported that a patient received a first dose of Hepatitis A vaccine (unknown if it was Havrix) in 2019 and then a second dose (booster dose) of Hepatitis A vaccine (Havrix) in 2023.  The vaccine administration facility was the same as primary reporter. Lot number for first dose of vaccine was not available. The patient received booster dose of Havrix delayed than the recommended time interval, which led to lengthening of the vaccination schedule. Follow up via email agreed.
Fever sore arm body aches starting on 02/03/2021-02/04/2021
I started having irregular periods after the first dose and continued on after the second dose. It?s still not corrected itself.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored GARDASIL, measles, mumps (dose, route, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
A few minutes into monitoring patient stated she was getting a migraine. Asked patient if she had her medication with her and she did not. Patient stated she did pre-medicate with Tylenol prior to coming to clinic. Patient was offered water and ibuprofen was offered and given - 800mg po. Patients lights were dimmed and we monitored for additional reactions. Patient was monitored a total of 53 minutes when she said she was feeling a little better and was ok to leave. Patient reported she would follow up with her physician if needed. Instructed to register with the v-safe website to report any additional reactions.
Pt recvd vax 11FEB92 approx 1 wk p/vax devel parotitis w/fever which lasted only a few days & resolved;
Throat and mouth lesions; Throat and mouth lesions; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 27-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left,at the age of 27 years old,on 19May2021 18:15  as Dose 1,single for covid-19 immunization. Medical history included polycystic ovaries from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing Peanuts and tree nuts. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported.The patient experienced throat and mouth lesions and throat and mouth lesions on 19May2021 18:45.The outcome of the event was recovering.The patient had not received any other vaccine within 4 weeks.The patient received Zoloft as medication within 2 weeks.The patient had not received any treatment for adverse events.The patient had not been diagnosed with covid prior vaccination and not tested post vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-MAR-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2022 at 3:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022 at 3:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  On 30-Mar-2022 at 15:06:50, Patient administered booster dose.   It was reported that patient received lot its 30 day expiry date.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt last intake was 8pm, 3/16/21, felt lightheaded, dizzy, thirsty post injection. Pt fainted, but quickly recovered. 911 called. 02 saturation=92 then went up to 98 to 99 to 100. Blood pressure=134/100 initially then 107/80. Pulse=88-90
patient was given vaccine 19 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given vaccine 19 hours after vial was punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given vaccine 19 hours after vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given vaccine 19 hours after vial was punctured) 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.   No concomitant medications were provided. Pharmacist stated vial was punctured at 2:30pm 29-Apr-2021 and patient given dose around 9:30am on 30-Apr-2021. No treatment were reported.
Patient became clammy and pale. Felt like she was going to pass out. We apply cold compress and gave water. Got a mat for the patient to lie down, however patient wanted to remain in chair with cold pack on.
pt recvd vax 310PM-pt cried vigorously;grandma stated pt had never cried like that before;pt became pale, clammy, eyes rolled back in head, lose breath 10-20sec-pt turned to side & stimulated by moving;p120;apneic, choking, drooling;
Not reconstituting the vaccine; Only adjuvant administered; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-Feb-2023 Reporter's Comments: A physician stated in his office one day before the reporting date that a nurse that no longer worked at the practice, administered the Shingrix adjuvant only, without reconstituting the vaccine, to 3 different patients in the physician's office.  The reporter did not have any further information about this incident, nor any information about lot number, date this happened or any differing factors for any of the 3 patients.  The reporter told to the GlaxoSmithKline field representative that the physician's office did contact the 3 patients, and it had all been taken care of.  The reporter consented to follow up with health care professional was obtained.  Additional supportive information: The patient received only adjuvant of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This 2 of 3 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023025414:Same reporter US-GSK-US2023AMR026706:Same reporter
Pt was sent by school RN to update missing vaccines. Nurse visit appointment was made and RN reviewed missing vaccines and noted Hep B is what the school stated pt needed. RN looked in system and also showed Hep B missing. RN spoke with another MA about why this pt was missing this and MA stated pt did not have birth Hep B in EMR and informed RN to check another system. RN gave the Hep B and MA did a system check and inormed RN the Hep B was not needed but the RN had already given the vaccine. Re educated RN of checking both places for vaccine records as vaccines do not always cross into EMR
Information has been received from a health professional concerning a pt who on 21Jul1998 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 02Apr2003 the pt experienced breakthrough chickenpox which was described as a small, fluid filled rash all over the body with itching. The reporter indicated that 2 other pt's were vaccinated with a dose of varicella virus vaccine live and developed breakthrough chickenpox on 02Apr2003. Additional information has been requested.
Patient states redness and tenderness on injection site. Redness started off as small area around injection site and slowly expanded. The redness/tenderness around injection  site went away. Patients still has small band of redness/purple area below injection week later. The site also itches from time to time and is tender.
Fully vaccinated for COVID with infection breakthrough and inpatient hospital stay for mild illness.   Boosted on 11/24/21
Extensive DVT of right lower ext and pulmonary embolism. Taken to ER and initiated therapeutic heparin infusion. Now on outpatient treatment with Eliquis.
Date of Shingrix #1 was 10/22/2022; Pt received second Shingrix vaccine on May 1, 2023; also had test for H. pylori (breath test) during office visit. On the evening of May 2, the patient note a rash on her stomach, around the waist.  The next morning, she noted additional rash on her arms, upper and lower legs.  She presented to the clinic for evaluation of the rash.  Reported a headache, feeling chilled; was using some naproxen for her symptoms (has tolerated that medication in the past). Examination by Dr. revealed a non blanching petechial rash in the areas previously described. Pt reported finding a tick on her skin April 11, 2023, and with the rash and history, Doxycycline 100 mg twice daily was started.   Labs drawn; May 4 received notice her platelets were 81,000.  Repeated the labs, May 5, and the report received May 6 was 280,000 platelets.
Pt. began to have stiff neck on (L) shoulder - progressed to stiffness bilaterally in her trapezius muscle and base of skull. Feb. 10 - symptoms intensified to headache - extreme pain through Feb. 11. Subsiding today 2/12/209 with assist of 4 Ibuprofen every 6 hours, also experienced pain in biceps/triceps bilat 2/6 -2/8
Nurse understood that patient needed the bivalent Pfizer, instead of the start of the Pfizer series.  No adverse event reported so far.
received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration; improper syringe administration; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (improper syringe administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (improper syringe administration). On 15-Nov-2021, ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose, vanishing point syringe used, does not think patient got the full booster dose due to improper syringe administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (improper syringe administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Significant follow-up appended(event and gender updated)
Received MMR vaccine 3/15/17. Woke with 99.7 temp next morning. After nap woke very lethargic/limp. No LOC. Attempted to eat and had excessive drooling and choking vomiting. Mild drooling continued. Recent viral illness. Brought to office. Resolved as of 3/16/17 evening.
Information has been received from a physician concerning a 21 year old female with Asthma who on 03-OCT-2007 was vaccinated IM in deltoid with a first dose of GARDASIL (Lot# 658556/1060U). On 05-Dec-2007 the patient received IM deltoid the second (lot# 659435/1265U) and IM deltoid the third dose on 31-Mar-2008 (lot# 659964/1978U). The patient experienced arthritis like symptoms after receiving each of the three doses. The patient experienced pain and stiffness in both hands, feet and her right knee. The patient first experienced the symptoms after the first dose. The symptoms improved by the time the patient was due for the second dose but never completely resolved. When the patient received the second dose the symptoms returned and the same pattern of improvement and return of symptoms was experienced when the patient received the third. It was noted that the symptoms improved but never completely resolved. The patient was treated with anti-inflammatory medications VENTILAN and NAPROXEN. The patient was seen by a physician. The patient was recovering. Follow up information received indicated that on 10-Oct-2007, the patient experienced bilateral, symmetric joint pain and swelling in hands and feet. The patient was being evaluated by Rheumatology for rheumatoid arthritis. Diagnostic laboratory tests were pending. At the time of reporting the patient had not recovered. Additional information has been requested.  7/4/08 Reviewed GYN office records of 3/31/2008.  Requested additional vax records & office records. Records reveal patient experienced usual state of good health w/o complaints on day of final vaccination.   7/11/08 Received vax records & GYN office records.  No complaints noted on any vaccination dates.  5/12/2008 pt presented w/joint pain.  Stated 1 wk after initial injection, developed stiffness & swelling of right hand w/limited ROM of fingers & stiff throughout the day.  Also had bilateral foot pain & swelling, unable to wear high heel shoes.  Right knee pain.  Stated symptoms worsened after each Gardasil shot.  Was seeing a rheumatologist at that time.  10/10/08 Reviewed rheumatology medical records of 4/4-9/12/2008. FINAL DX: probable rheumatoid arthritis Records reveal patient experienced finger, knee & toe joint pain, AM stiffness & swelling since 11/2007 after received initial HPV4 vaccine on 10/3/07 which responded to steroid therapy.  Began methotrexate 5/2008 s/p labs (+) for RA.
Today I didn't go to work because I can't go like this, I cant drive to the work.; feeling as if I had my muscles stunted, without force.; started to feel my right hand that it didn't have any force, couldn't lift anything; deconcentrated; patient feels as missing breathing; patient had circulation tense and hard; difficult to make muslces react; headache; nausea; not feeling good and feel each time worse; feel it very tense; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard) and MUSCLE DISCOMFORT (difficult to make muslces react) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.     On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard), MUSCLE DISCOMFORT (difficult to make muslces react), HEADACHE (headache), NAUSEA (nausea), FEELING ABNORMAL (not feeling good and feel each time worse) and TENSION (feel it very tense). On an unknown date, the patient experienced FEELING ABNORMAL (Today I didn't go to work because I can't go like this, I cant drive to the work.) and MUSCLE DISCOMFORT (feeling as if I had my muscles stunted, without force.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard), MUSCLE DISCOMFORT (difficult to make muslces react), HEADACHE (headache), NAUSEA (nausea), FEELING ABNORMAL (not feeling good and feel each time worse), TENSION (feel it very tense), FEELING ABNORMAL (Today I didn't go to work because I can't go like this, I cant drive to the work.) and MUSCLE DISCOMFORT (feeling as if I had my muscles stunted, without force.) outcome was unknown. Not Provided      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 concomitant medications were provided.
Patient was given the Pneumococcal and Influenza vaccine twice over a two month period.
Patient received one intramuscular vaccine in left lateral thigh. One vaccine in right lateral thigh IM. One vaccine in both legs subcutaneously. No symptoms present. Given estimated 9/9/14 at 4:30 pm.