chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received GARDASIL quadrivalent and GARDASIL 9 vaccines outside of recommended intervals/ GARDASIL quadrivalent on 8/28/2013 when she was 15 years, GARDASIL 9 on 3/22/2016 and Gardasil 9 on 2/3/2022; the patient received GARDASIL quadrivalent and GARDASIL 9 vaccines outside of recommended intervals/ GARDASIL quadrivalent on 8/28/2013 when she was 15 years, GARDASIL 9 on 3/22/2016 and Gardasil 9 on 2/3/2022; no adverse event; This spontaneous report has been received from a pharmacist regarding a patient of an unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 28-AUG-2013 (also reported as when the patient was 15 years old), the patient received quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (Valid lot # H021861, expiration date not reported, but upon internal validation established as 09-OCT-2015) (strength, dose, frequency, route and anatomical location were not provided); on 22-MAR-2016, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, anatomical location lot#, and expiration date were not provided); and on 03-FEB-2022, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (valid lot #: T036444, and valid expiration date: 09-APR-2023) (strength, dose, frequency, route and anatomical location were not provided)for prophylaxis. Therefore, the patient received both vaccines outside the recommended intervals (Inappropriate schedule of product administration and Interchange of vaccine products). No additional adverse events were reported.
Pt called the reporters office on 4MAY90 c/o redness at the injection site after receiving TD. When the pt wa examined by MD a 6mm X 10mm area of erythema was observed at the site of injection. Pt treated w/ice packs for 2 days & recovered.
No adverse event; dose administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) 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. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD).    Concomitant drugs were not reported.  Dosage text for suspect product was reported as unknown.  It was reported that 4 bivalent doses in total were administered to adult patients after the 30 day BUD. Two doses administered on 04-Feb-2023, one on  05-Feb-2023 and one dose on 16-Feb-2023. It was also reported that patient had no reported symptoms. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No additional doses, medications or treatments were administered in response.  This case was reported for adult patient 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-711667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711667:Master case - 1st adult
Headache; Arm was red; Arm was hot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red), FEELING HOT (Arm was hot) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 027C21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D3), INSULIN HUMAN, MULTIVITAMIN [VITAMINS NOS], DESLORATADINE and AZELASTINE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced ERYTHEMA (Arm was red) and FEELING HOT (Arm was hot). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, ERYTHEMA (Arm was red) and FEELING HOT (Arm was hot) had not resolved and HEADACHE (Headache) outcome was unknown.            concomitant medication include Diabetes medicine. no treatment medication was given
Pt recvd 3 doses of Heptavax-B vax 12JUN87, 14JUL87, & 14DEC87; JUL to AUG91 pt exp non-response; Booster dose of Engerix-B given;
The next day follow the immunization, patient states he experienced a reaction with symptoms that included arm numbness/tingling, fever/chills, could not move arm and arm was red, swollen and hard to the touch on a 4-5 inch radius of injection site. He came in on Saturday, June 23, and said felt better but arm still sore, red, and hard on about 4 to 5 inches radius of injection site. I told patient to take it easy, apply ice, take ibuprofen, take some benadryl and if no improvement or symptoms worsen to call physician.
pt recv vax;RN reported pt passed out & exp "other AE" following vax;reporter stated there was a problem w/ the particular lot;
Pt devel t101 by evening 104; mom gave bath & pt had convuls, quit breathing, turned blue; EMS called & transferred to ER;
Information has been received from a physician via a pharmacist concerning an adult patient who in October 2006, was vaccinated with a dose of Pneumovax 23 (lot #651437/0899F).  The pharmacist reported that the vaccination may have been a revaccination.  In October 2006, the patient developed injection site swelling and fever of 102 F.  Unspecified medical attention was sought and the treatment was symptomatic.  Subsequently, the patient recovered.  Additional information has been requested.
About 40 minutes after receiving rabies vaccines, he noticed that his anterior cervical lymph nodes were palpable and tender and he began having difficulty swallowing and difficulty breathing. States the difficulty breathing/swallowing subsided after about 2 hours. Patient lives with me and told me this yesterday evening at home. Cervical lymph nodes were still enlarged and tender at this time.
Headache, nausea, and vomiting going on 2 days Taking Ibuprofin for headache. Loss of appetite due to vomiting.
Administered incorrectly.  given sub-q instead of IM. Followed up with patient 2 days later (Sunday 5/5).  Pt has no abnormal symptoms.  Informed her of mistake but dose is considered valid and does not need to be repeated.
Slight itch at injection site ,developed increased redness and warmth,became 4x3 inch raised red welt with demarcation ,swelling of upper arm  hard to the touch within 3-4 hours. Warm compress on day 2 Decreasing symptoms on day 3-diminished warmth and redness ,slowly resolving
Red spotted rash appeared on bilateral arms, chest, and back on 04/07/2021, the day after receiving the vaccine.  Rash had a "scalded appearance".  Pt also reports fever up to 102.9, nausea, chills, and fatigue.   Instructed patient to take Benadryl 25mg PO, Motrin, and Pepcid 20mg  PO per package dosing instructions.   On 4/8/2021, Rash is slightly improved but still present.  Pt continues to report fever up to 102.9, chills, fatigue, and nausea.  Instructed patient to follow up with her PCP.  We offered to schedule an appointment with our Express Care Clinic, but patient declined at present.
Throat closing, difficulty breathing Epinephrine 0.5mg 1:1000 SC Diphenhydramine 50mg IV, + 25mg PO qH + 2 days.
got real... real cold; coughing like no tomorrow; minor fleme from my lungs; shivering; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (got real... real cold), COUGH (coughing like no tomorrow), LUNG DISORDER (minor fleme from my lungs) and CHILLS (shivering) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced NASOPHARYNGITIS (got real... real cold), COUGH (coughing like no tomorrow), LUNG DISORDER (minor fleme from my lungs) and CHILLS (shivering). At the time of the report, NASOPHARYNGITIS (got real.. real cold), COUGH (coughing like no tomorrow), LUNG DISORDER (minor fleme from my lungs) and CHILLS (shivering) outcome was unknown.            No concomitant medications reported. No treatment information was provided.    Reporter did not allow further contact
Narrative: One day after receiving the booster, patient reported body aches but resolved one day after onset. Appears nasal drainage and cough also started after booster was given.
This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored M-M-R II (dose, route and lot number not reported) multidose vials were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports from the same reproter. Additional information is not expected.
Patient felt nauseous and vomited in restroom about 20 minutes after receiving vaccine.
flu-like symptoms; sick; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date unknown) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix. In April 2019, several hours after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional details were provided as follows: The flu-like symptoms began a few hours after the dose and the patient called out sick from work during this time.  The patient experienced flu-like symptoms for a few days after vaccination. The patient was uncertain about receiving the 2nd dose. The reporter consented to follow up.
had side effects; liver enzymes way out of site; he could not walk; weak,He felt like he lost all strength in his right arm and right side; Initial information received on 16-Jan-2020 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 73 years old male patient (169 cm and 84.82 kg) who experienced had side effects; liver enzymes way out of site (hepatic enzyme abnormal), he could not walk and (gait disturbance), weak, he felt like he lost all strength in his right arm and right side (asthenia), while he received vaccine INFLUENZA VACCINE and while treated with CRIZOTINIB [XALKORI].  The patient's past medical history included Cholecystectomy in 2019.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Lung neoplasm malignant which was diagnosed maybe 3 years ago.   On an unknown date, the patient started taking XALKORI (CRIZOTINIB) dosage unknown route unknown (with an unknown batch number) for Neoplasm malignant. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  In Nov-2019, the patient developed a serious side effects; liver enzymes way out of site (hepatic enzyme abnormal), he could not walk (gait disturbance), weak,he felt like he lost all strength in his right arm and right side (asthenia) (Unknown latency) following the first dose intake and (Unknown latency) following the last dose intake of CRIZOTINIB and unknown latency following the administration of INFLUENZA VACCINE The patient was hospitalized for this event in Nov-2019. The patient was discharged in November 2019 (admitted for 5 days).  (Other relevant tests included no laboratory data reported.)  Final diagnosis was weak,he felt like he lost all strength in his right arm and right side, he could not walk and had side effects; liver enzymes way out of site.  CRIZOTINIB (XALKORI) was discontinued on an unknown date for a month (not sure permanent or temporary). The patient was switched to Rozlyrtek and he felt better.  Corrective treatments not reported.  The patient was recovering from all events at the time of report.  Batch number was requested.; Sender's Comments: This case concerns a 73 years old male patient who presented with hepatic enzyme abnormal, gait disturbance and asthenia (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were reported as Cholecystectomy and Lung neoplasm malignant. Based upon the reported information, the role of a vaccine cannot be assessed.
Vomiting, diarrhea, fever, rash, fatigue, irritability, body aches and pains
aching, weakness, nosebleeds, fever, chest and nasal  congestion and cough, shortness of breath    hallucination/ strange dreams
Diffuse Petechiae- feet, hands, arms, chest, and upper back.  Several light bruises on extremities.
Patient had no adverse event. He was given the wrong dosage of COVID vaccine, he was given the 6mons-11 year old and he is 13.5 years old. Pt returned the next week and got another of the same to make up for the full dose he should have been given from the start.
chronic spontaneous urticaria, dermatographism, laryngopharyngeal reflux/strange throat sensations
Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report was received from a consumer refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-JUL-2023, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968392 and expiration date 24-MAY-2024, 2 milliliter for prophylaxis (dose number and site of administration were not provided) (product storage error). On 20-JUN-2023, temperature excursion was 34.9 degrees Fahrenheit (F) for 6 hours 34 minutes 0 seconds. On 03-JUL-2023, temperature excursion was 51.1F for 24 hours 0 minutes 0 seconds. On 05-JUL-2023, temperature excursion was 50.7F for 9 hours 27 minutes 0 seconds. No previous excursions.
Patient initially experienced pain in the right shoulder and numbness and tingling of middle fingers on right hand. Patient reported 10/21/19 that he is still experiencing stiff joints of his right middle fingers when making a fist. Patient also reports that his condition is slowly improving.
After the vaccine I didn't have anything. It was when I had COVID-19 I had a cough, runny nose, tired, body aches and 101 fever. It started with a sore throat and developed and I think it was more than mild. I was in bed for a couple of days and couldn't do my daily activities. Cough and everything lasted for 7 to 9 days. Sore throat was there for a long time so I went to see an Urgent Care doctor again on Feb 27, 2021. I was given an inhaler for the cough. March 14th, I saw the doctor again for the sore throat. I've seen the ENT again and said that I had a contact ulcer and I'm still taking medication.
BLOOD CLOTS IN BOTH LUNGS.  SHORTNESS OF BREATH. UPPER BACK PAIN. WEAKNESS. SWEATING AND COLD.  NO COLOR IN FACE --  GREY.  LOSS OF EYE SIGHT  -- STARTED WITH BLURRED VISION.
Pt developed a mass in right upper arm-was in to see the doctor on 10-16-01. had a MRI & was scheduled with orthopedic . He did a biopsy. Mom feels all related to immunization. Parents refused immunizations as infant for no reason.
Severe intestinal cramps...very sharp, caught my breath a few times!  Went away by the next night.  About 24 hrs.
it was surgically removed 2 days ago it looks like the infected; This is a spontaneous report from a Pfizer-sponsored program. A contactable unspecified age of male consumer reported that for himself that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had a glass on his legs, and it was surgically removed 2 days ago it looks like the infected. The patient took antibiotics by his doctor. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Information has been received from a health professional concerning her 16 year old daughter with no pertinent medical history or drug reactions/allergies who on 24-OCT-2007 was vaccinated with a first dose of GARDASIL 0.5 mL IM.  There was no concomitant medication.  On 24-OCT-2007 the patient fainted after receiving the first dose.  Medical attention was sought.  Subsequently, on 24-OCT-2007, the patient recovered.  On 06-FEB-2008, the patient received a second dose of GARDASIL and did not faint.  No further information was available.  Additional information has been requested.
HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Vaccine was administered to a patient after temperature excursion occured; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Vaccine was thawed at  on 4/12/21.  Received at clinic on 4/30/21 and put in freezer. Dethawed on 5/12/21 and given to pt on 5/13/21. Questioning viability of vaccine and if 3rd dose should be given?
Began with body aches night of 9/16/20, awoke next morning with 100.3 degree temperature, severe headache, along with body aches, inability to move right arm without severe pain, large red rash at site of injection on right arm that was very hot and tender to touch, chills, sweating, nausea, loss of appetite, and fatigue.  All symptoms remained, though gradually subsided through 9/21/20.
Extreme allergy/cold symptoms, everyday for almost a week  No fever but coughing, chills, runny eyes, itchy throat
a patient who received the first dose of shingrix 1 year ago and today (Sep 20th 2023) the patient received the second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 1 year ago).   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 20-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: a patient who received the first dose of Shingrix 1 year ago and today (Sep 20th 2023) the patient received the second dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 20-SEP-2023 The nurse called to ask for information a patient who received the 1st dose of Shingrix 1 year ago and today (on the day of reporting) the patient received the 2nd dose.  The health care professional (HCP) asked if the patient needed a third dose.  The reporter did not provide information about first dose given. The patient received 2nd dose after 1 year which led to lengthening of the vaccination schedule The reporter consented to follow up.
Information has been received from a physician concerning an 82 year old male with an unspecified urological condition and dermatitis of the hands during winter seasons and a history of photosensitivity with Hytrin who on 15-DEC-2006 was vaccinated SC with a dose of Zostavax (lot # 652946/1012F). Concomitant therapy included simvastatin (manufacturer unknown), Uroxatral, Adodart. On approximately 13-FEB-2007, the patient developed a non-VZV rash. The patient initially experienced itching of his face which then developed into redness and swelling. The rash progressed to his lower jaw, arms, and abdomen. The patient was being treated with Zyrtec and the physician gave him a prescription for a Medrol Dosepak. The physician told the patient not to fill the prescription unless the rash worsened. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. The physician did not think that the rash was related to therapy with Zostavax. A product quality complaint was not involved. Additional information has been requested.