chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles, received both doses/  Suspected vaccination failure; shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case was reported by medical assistant. The patient received 2 doses of Shingrix about 4 years ago from reporting. At the time of reporting the patient had active Shingles outbreak. The reporter was not sure why or how this happened but would like more information on that. The reporter consented to follow up. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100475:Same reporter
COVID-19; COVID-19; Rebound COVID- symptoms of sore throat after finishing Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), on 08Mar2021 as dose 2, single (Lot number: EN6208) and on 21Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "HLD" (unspecified if ongoing), notes: HLD; "White coat HTN" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing), notes: Known allergies: Nuts. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2022, outcome "unknown", described as "Rebound COVID- symptoms of sore throat after finishing Paxlovid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: It was reported that rebound COVID- symptoms of sore throat after finishing Paxlovid. Was still having symptoms of COVID on day 5 of Paxlovid. The patient had previously received a COVID-19 Vaccine.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported COVID-19 positive and disease recurrence after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Guillain Barre Syndrome- 5 days after H1N1 Vaccine patient experienced 2-3 days of bi-lateral upper and lower extremity weakness with difficulty swallowing.
Headache, Sedation, Fever, Diarrhea, NauseaVomiting, Intense pain, redness,swelling, itching, and rash at injection site Narrative:
Did not sleep for two days. Pain red and swollen at shot site. Water retention, could not breathe and heart beat rapidly. Had to call medics, they heard fluid in left lung.
Body aches; altered vision; Anxiety; felt sick; fever; she was dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick) and PYREXIA (fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CHOLESTEROL for Cholesterol, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick), PYREXIA (fever) and DEHYDRATION (she was dehydrated). At the time of the report, PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick), PYREXIA (fever) and DEHYDRATION (she was dehydrated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications includes Gastritis medication along with above mentioned medications. No treatment drugs were reported.   This case was linked to MOD-2021-092346 (Patient Link).
Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022; It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received a second booster dose. Concomitant drugs were not reported.  It was reported that the vial was moved from freezer to fridge on 10-May-2022 and should have been discarded on 10-Jun-2022 and was administered 2 doses to patient on  13-Jun-2022 and 15-Jun-2022. The vial did not undergo any temperature excursion. It was also reported that patients have not called to report any side effects.   This case was linked to MOD-2022-590656 (Patient Link).
Infection of gums; Chills; Fever; soreness at the injection site; This spontaneous case was reported by an other and describes the occurrence of GINGIVITIS (Infection of gums), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVITIS (Infection of gums), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, GINGIVITIS (Infection of gums), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       patient used zpak as treatment medication.
Menveo only liquid portion given; Menveo only liquid portion given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On 24-JUL-2023, the patient received Menveo. On 24-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid portion given) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 7-Aug-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient only received diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
It was reported that a pt who rec'd TD adult vaccination on 4/10/00. Reportedly on 4/11/00, the pt developed a local reaction of redness, warmth and induration.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing), notes: more than 20 years ago; "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a consumer of unknown age regarding himself. Concurrent conditions and medical history was not reported. On 21-NOV-2014, the patient was vaccinated with ZOSTAVAX (lot # K012785 and expiration date was 28-JAN-2015) (strength, dose, route were not reported). Concomitant therapy was not reported. The patient was now using a pacemaker (medically significant). The patient was enquiring if there was an antidote for ZOSTAVAX. The patient was enquiring a skin test should be given first before administration. On 24-NOV-2014, the patient fell off a 3 feet ladder (hospitalization) and his heart stopped (medically significant) (hospitalization) and went to hospital for a week. Also reported ZOSTAVAX was a dead cocked cannon. The outcome of events was unknown. Causality was not assessed by the reporter. Upon internal review, the event of pacemaker insertion and heart stopped were considered to be medically significant. Additional information has been requested.
7cm red, swollen, itchy, warm area on L thigh. No associated fever or pain or streaking from site.
This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in an adult female subject who was vaccinated with influenza trivalent (Flulaval, GlaxoSmithKline), influenza virus vaccine (flu vaccine) for prophylaxis. Concurrent medications included Diphenydramine hydrochloride (Benadryl). On either 15 October 2007 or 16 October 2007, the subject received unspecified dose of Flulaval at 0.5 ml. Following vaccination with Flulaval it was noted that the drug administered was last years vaccine which was expired. No adverse events were reported. It was also noted at the time of reporting that the subject received flu vaccine in the past (unknown manufacturer) and experienced shortness of breath and rash. The reporter stated that she had no further details on this past experience.
Extreme body rash all over my body.  I had never experienced rash in my life, and this is the first time, right after I got the vaccine. I took cetrizine for two days and it did not help. I also tried cold showers. I visited a doctor 2 days after I got the vaccine (second dose) for the rash and she recommended continuing the antihistamine and see her again if it don't get better.
07/31/2022 .  We had been camping and when we got home that evening, we noticed what looked like was bug bites throughout his body which we thought was strange because no one else had bug bites and there weren?t many bugs. The red spots had a white pimple looking appearance inside. The next morning there was a rash that looked like a viral rash, on his torso.  He had a rash that began on his neck and going up to his head and behind his ears which was mild.  He went to school. He had no fever and no other symptoms.  When he came home from school, the smaller rash had spread. We contacted his doctor and sent him pictures of the rash.  The next day, he had the same thing but with a more consistent spread, spreading to his thighs. There was no rash on his hand, feet, butt or genital area. There was a rash on his cheek and jaw beneath his chin. He seemed to be itching more, so we gave him Benadryl and sent him to school. When he came home, it had spread more.  It has been consistently spreading. He was given Benadryl this morning before going to school.
pt received PPSV23 and Fluzone-HD on 9/17/19. That evening he noticed feeling weak in bed. The following morning he experienced weakness and instability and fell several times at home.  He also developed redness, inflammation, and pain around the injection sites on his arm.  Pt also states he was mentally foggy and had some disorientation on the morning of 9/18. His caretaker took him to the hospital 9/18 where he was admitted overnight.  Pt was monitored and released the afternoon of 9/19 after improvement in strength and mental clarity. Pt states he continues to improve but still has pain, tenderness, redness in arm
Moderna covid-19 monovalent booster administered after 9/2/22.  On 9/20/22 monovalent booster administered, no adverse reactions noted, informed pt and counseled.
Patient received vaccine after allowed expiry time; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On 07-Jul-2021, PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
First dose 25feb2021 and never received second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 25feb2021 and never received second dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 25feb2021 and never received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose 25feb2021 and never received second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, COVID-19: positive (Positive) positive. On 15-Apr-2021, COVID-19: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. patient was unable to receive the second dose as scheduled on 25March2021 due to travel obligations. ..
Patient stated that about 24 hours after receiving the vaccine, patient did not feel well. Patient had nausea, muscle aches, chill, tickle in throat. Patient had to leave work on 09/28/2018 to rest at home.
high pitch cry for more than 3 hrs, according to mom; pt was seen by in office & did settle some; mom stated pt awake 7 irritable the noc of vax & 2 days later; no fever @ time of visit;
L arm pain throbbing into neck & down arm, decreased ROM Pt continues with significant pain and decreased ROM in affected extremity. It has improved minimally but not resolved as of 5/1/2019.
Injection site pain; Fever; Chills; Muscle pain; Joint pain; Extreme tiredness; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 15:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left leg on 17Mar2021 at 17:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 04:00, the patient experienced injection site pain, fever, chills, muscle and joint pain, extreme tiredness and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events injection site pain, fever, chills, muscle and joint pain, extreme tiredness and headache was recovering at the time of the report.   No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.
red rash face, neck, upper abdomen  patient took Benadryl 25mg/10ml , symptoms resolved with in 3 hours
- left armpit and left side of neck near the top of the collar bone really sore, hurts to touch/move - injection sight looks slightly red and raised, sore to touch  *today is one week from injection
Extreme fatigue; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1284) intramuscularly administered in right arm on 19Jan2021 at 13:00 (at the age of 57 years) as single dose for COVID-19 immunization. The patient medical history included asthma, osteoporosis, Raynaud's. The patient was allergic to birth control pills, sunscreen. The concomitant medications patient received within 2 weeks of vaccination included meloxicam (MELOXICAM), fluticasone propionate (FLONASE), ciclosporin (RESTASIS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0140) intramuscularly administered in left arm on 30Dec2020 at 08:00 as single dose for COVID-19 immunization. On 30Jan2021, the patient experienced extreme fatigue, muscle pain. Since the vaccination, the patient had tested for COVID-19. On 20Jan2021, patient underwent lab tests and procedures which included sars-cov-2 test which resulted negative. The patient did not receive treatment for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
he got pain, sore arm and redness after the 1st dose.; he got pain, sore arm and redness after the 1st dose.; he got pain, sore arm and redness after the 1st dose.; This is a spontaneous report received from Pfizer-sponsored program. A contactable male consumer (patient) reported that he received hist first dose of BNT162B2 on 12Apr2021 at single dose for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. The patient mentioned that he got pain, sore arm and redness after the 1st dose. His sister is a nurse so she gave him Ibuprofen and warm compress then it was gone. However he would like to know if this can also happen to his leg or other arm because he is working in the airport and he needs to lift heavy things.  Outcome of the event was resolved. He also mentioned that his neighbor experienced the same side effects like sore arm after getting the vaccine (vaccine detail unknown).    No follow-up attempts are possible, Information about lot/batch number cannot be obtained.
Chills; muscle aches; rash around injection site(s) and beyond. Received clindamycin Rx.
Pt states has continued Left arm pain since recieving flu shot and vitamin B12 injections.