chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; product was administered in the right glute; This spontaneous report was received from an office manager referring to a 40 year old patient of unspecified gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 14-SEP-2021, the patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T030746, expiring on 16-MAR-2023, in the right gluteus for prophylaxis (product administered at inappropriate site).  The patient did not experienced any adverse event. 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; devicelotnumber: T030746; expirationdate: 16-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Information regarding PREVNAR was received from a healthcare professional regarding a patient between 12 and 18 months of age (gender not provided) who experienced pneumococcal bacteremia.  The patient received the fourth dose on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  On 01-Jan-2008, the patient experienced life threatening pneumococcal bacteremia (drug ineffective) and was hospitalized.  Testing revealed a blood culture positive for pneumococcus.  Information regarding treatment was not provided.  On an unspecified date, the patient recovered.  Blood culture (results: positive for pneumococcus) was done on 01-Jan-2008.  See related case(s): US-WYE-H02014208 (adverse event, expedited).  No additional information was available at the time of this report.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 16:00 (Lot number: EN6205) at the age of 73 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Ovarian cancer" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Carbo platin, reaction(s): "Known allergies: carboplatin", notes: Carbo platin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9266, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 18Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (disability, medically significant) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "Same time Cancer detected after being cancer free for 2 and half years."; SHOCK (disability, medically significant) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "shock like would travel from hamstrings to the toes of the right leg."; ARTHRALGIA (disability) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "After the second dose developed severe pain in posterior right knee."; NASAL POLYPS (disability) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "a polyp in my right nostril". The events "same time cancer detected after being cancer free for 2 and half years.", "shock like would travel from hamstrings to the toes of the right leg." and "after the second dose developed severe pain in posterior right knee." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) negative, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of neoplasm malignant, shock, arthralgia, nasal polyps. As reported the patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 12:00 (Batch/Lot number: EW0198) as dose 3, single for Covid-19 immunization. No Covid prior vaccination was received by patient. On 23Dec2021, she had her Covid test done post vaccination as RTPCR as nasal swab and the test results was found to be negative. No follow-up attempts are possible. No further information is expected
Anxiety; BP 113/76 (pulse 86), O2 sat 96%. Juice given to patient.
Patient had red area around vaccine.  By today it was red, warm to touch in a 6" by 3" area, hard to touch.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An adult female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported redness and pain at the injection site and up to 5 inches away from the injection site. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
AT 1040 AM PT RECEIVED VACCINE, APPROXIMATELY 15 MINUTES LATER PATIENT COMPLAINED OF TROUBLE SWALLOWING SIMILAR REACTION TO WHEN SHE HAD BEESTINGS WHEN YOUNGER. PT DIDN'T STATE SHE HAD ANAPHYLAXIS PREVIOUSLY. WE HAD THE EMT FROM  FIRE DEPARTMENT EVALUATE PATIENT AND THEY RELEASED HER FROM CARE SAYING SHE SHOULD BE OK IN 30 MINUTES . NO MED WAS ADMINISTERED.
Moderate joint pain, especially in shoulders, elbows, low back and hips. The next day very early in the morning lasting for 2-3 days
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 17-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect ws reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported. The case was reported for 12th out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
4/5/03: Complained of rash on left arm/hand and burning of eyes. 4/13/03: Seen in Urgent Care and given artificial tears and cream for rash. 5/7/03: Complained of pain left arm. Instructed to take OTC anti-inflammatory meds. 5/12/03: Evaluated by MD - Dx: trapezins muscle strain, costochronditis.
Mom states that approximately 13 hrs after receiving her immunizations, patient had 2, short duration seizures. She was seen at a local ER with a diagnosis of febrile seizures. This information was relayed to our office 10/26/12.
Hives treated with Benadryl. Onset of hives one hr after vax.
got her covid and flu shot. she has been getting rashes since the second covid shot. she got the covid shot on 11/23/21. had severe erythematous, urticaria with dermatographia that started on 11/26/21. no other symptoms of being ill, exposures to allergies. she had some shortness of breath associated. also had severe fatigue and upset stomach. the rash still comes and goes. the rash is hot to touch.
COUGH; CHILLS; FEVER 103 F; DIFFICULTY KEEPING EYES OPEN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced difficulty keeping eyes open. On 09-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever 103 f. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 103 f, cough, and chills, and the outcome of difficulty keeping eyes open was not reported. This report was non-serious.
This is a spontaneous report from a contactable consumer (patient). A 39-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6200, expiration date: not reported), at the age of 39, via an unspecified route of administration, in right arm, on Feb 19, 2021, at 11:15, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN5318, expiration date: not reported), via an unspecified route of administration, in the right arm, on Jan 29, 2021, at 01:00, single dose, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks. The patient's past drug included aspirin, which she experienced known allergies. It was unknown whether the patient had COVID-19 prior vaccination. Patient has not tested for COVID-19 post vaccination. On Feb 20, 2021, patient experienced swollen lymph nodes in right underarm causing pain and discomfort. Patient did not take treatment for the events. The outcome of all events: resolving. Follow-up attempts completed. No further information expected.
Patient tested positive for COVID 8/1/2022 after receiving two vaccines and one booster
Patient complains of persistent weakness on the left side of the body since the administration of vaccine, also complaining of pain and inability to dress herself and other activities related to daily routine.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 6 times with the following lowest recorded temperature: 34F (1.11 celsius degrees) for 88 hours, 33 F (0.555 celsius degrees) for 64 hours and 32 F (0 celsius degrees) for 264 hours, 31 F (-0.555 celsius degrees) for 88 hours, 33 F (-1.111 celsius degrees) for 152 hours and 29 F (-1.666 celsius degrees) for 184 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation. A male patient, age and history not provided, was inoculated at a physician's office with ZOSTAVAX in 2012 for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX was supposed to prevent. In 2015 the patient was treated at a physician's office and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the 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 and will continue to suffer significant medical expenses, and pain and suffering and other damages. Outcome of shingles was not provided. Additional information has been requested.
Pt received vaccine and was fine. After she witnessed her brother receive his vaccine she stated she felt dizzy and tired. She sat down and was white and sweaty then slumped off the chair. We put her in rescue position. She regained color immediately but didn't regain consciousness for about 15 seconds. She was coherent when she came to but did not remember fainting. She sat again and drank some juice but continued to feel dizzy so she lay on the ground in front of a fan and after about 10 minutes she felt well enough to walk out.
Suddenly low blood pressure, resulting in headache, dizziness, weakness, difficulty seeing, feeling short of breath, and feeling faint.
This spontaneous report has been received from a registered nurse, via a company representative, referring to a child of unknown age and gender. Information regarding medical history and concurrent conditions was not reported. According to the reporter, on an unknown date, the patient was vaccinated with either a dose of VARIVAX (Merck) (dose, frequency, lot #, and expiration date were not provided) or PROQUAD (Merck) (dose, frequency, lot# and expiration date were not provided) (the reporter could not determinate which of the vaccines was administered). Concomitant therapies were not provided. In March 2016, the nurse stated that she was notified of a case of breakthrough varicella in this child who was vaccinated with VARIVAX (Merck) or PROQUAD (Merck). At the time of reporting the outcome of breakthrough varicella was unknown. The relatedness between the event and VARIVAX (Merck) or PROQUAD (Merck), was not reported. This is one of two cases received from the same source. Additional information has been requested.
My son received the first 2 doses of GARDASIL when he was 14 years old and then received the third dose of the series as GARDASIL 9 when he was 17 years old; My son received the first 2 doses of GARDASIL when he was 14 years old and then received the third dose of the series as GARDASIL 9 when he was 17 years old; No additional adverse effect reported; This spontaneous report was received from the patient's father referring to his 17 year old son. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On unknown dates, when the patient was 14 years old, he was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. Then, on an unspecified date, when he was 17 years old, the patient received the third dose of the series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot # and expiration date were not provided). No adverse effects were reported.
I had shivering chills around 12am. Woke up at 3am to urinate. Checked my temperature 99.9°.  I began to feel very dizzy, my hands would not hold the glass of water and Iaid on the floor ASAP because I felt I was going to faint. I had trouble breathing and my whole body felt sweaty and I felt like I was blacking out. My bowels were clenching. My hands and legs felt like they are buzzing and I couldn?t hold onto anything. My left armpit is swollen and very sore. I have a horrible headache the next morning.
Information has been received from a office manager via a company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of GARDASIL (dose and route were not reported). No adverse effect was reported. Additional information has been requested.
vaccine 2nd dose 4/09. Hospitalized 6/16/2021 with unknown discharge date and then readmitted 7/22/2021 and is currently still hospitalized.
NONE EXPIRED COVID -19 VACCINE ON 11/22/2022 GIVEN ON 3/24/2023
Rash, Itching and swelling of left arm.  Progressed to tachycardia in the 150's, hypertension 200/114.  Tingling of lips, dizziness
vaccine site be hot to touch; redness big like a baseball size; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccine site be hot to touch) and VACCINATION SITE ERYTHEMA (redness big like a baseball size) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (vaccine site be hot to touch) and VACCINATION SITE ERYTHEMA (redness big like a baseball size). At the time of the report, VACCINATION SITE WARMTH (vaccine site be hot to touch) and VACCINATION SITE ERYTHEMA (redness big like a baseball size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
all tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-health care professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), via an unspecified route of administration on 13Mar2021, as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Mar2021, the patient experienced all tested positive for covid. On 22Mar2021, the patient underwent lab tests and procedures which included Covid test: positive. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA011925: US-009507513-1902USA011924: US-009507513-1902USA011927: US-009507513-1902USA011923:
Patient was administered the monovalent covid pfizer booster instead of the intended bivalent booster. Upon discovery of error, patient was contacted by the provider to discuss the potential impact, and options to receive the intended booster, if desired, after interval of  2 months.
Left arm red, swollen, painful and numb. Symptoms began 4 days, post vax. Seen in ER. Treated with Cephalexin 500mg X 5 days and Prednisone 10mg 2 BID X 3 days.
3 day 6"x6" swollen at site.  Very itchy.  Scattered red spots on back looked like solid red mass.  5th day redness decreased injection swollen/no itch.  10th day nausea, dizziness, no hunger.  13th day better.  14th day 2/19/08 still dizzy, no nausea.  No fever, had dry cough.  Rapid heart beat (3rd day) 151/90.  Hydrated throughout time.  Urine smelled like tomato plant.  Darker.
dose 1 4/4/21, dose 2 5/5/21, had a stroke on 6/1/21, no underlying conditions known, suspects possibly from vaccine, since then has relly ry eyes and is still in therapy from post- seizure
Pt recvd 4 doses of Engerix-B, 4th dose given 11APR91 & pt converted;
Itchiness on day of administration, after 9 hours later.  Area size of quarter and warm where shot (flu) given is reddened and itchy.
I woke up with chills, achy back and glute muscles, and a fever. These symptoms continued into the next day. I had a fever for the entire day after my vaccine and was extremely tired and weak. I had redness and soreness around my injection site up to 48 hours after my vaccine as well.
Chills; fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101F) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.  Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and FISH OIL for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (fever of 101F) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PYREXIA (fever of 101F) was resolving and CHILLS (chills) outcome was unknown.            Other Concomitant medications reported were Blood pressure medication, Cholesterol pill.  Action taken with mRNA-1273 in response to the events were not Applicable.
Tingling/numbness two middle fingers of same arm. Later had rash in same arm.