chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe dizziness; Cannot do anything; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Severe dizziness) and MOBILITY DECREASED (Cannot do anything) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had covid two times prior to the vaccine).    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, the patient experienced DIZZINESS (Severe dizziness) and MOBILITY DECREASED (Cannot do anything). At the time of the report, DIZZINESS (Severe dizziness) and MOBILITY DECREASED (Cannot do anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 and positive (Positive) Patient had covid two times prior to the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 58-years-old and a second hepatitis B series at 61-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 65-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Approximately 6 hours post vax, pt experienced swelling, redness and heat in right leg. Pt developed a fever of 102 the next day. The third day post vax, the pts fever increased to 104 with crying and tremors. Fever was up and down for five days. Physician was seen on eighth day and pt was diagnosed with an ear infection.
When I wake up in the morning my left hand is swollen. It is hard to close and make a fist. These has been going on the last 2 months.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Cardioversion (had 2 cardioversion). Concurrent medical conditions included Heart disease, unspecified. Concomitant products included METOPROLOL, APIXABAN (ELIQUIS), LISINOPRIL, LISINOPRIL (TENSOLISIN), ATORVASTATIN, AMLODIPINE, VITAMIN E NOS and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No treatment medication were provided by the reporter.  Patient had no previous COVID diagnoses and no history of Myocarditis or Pericarditis.   This case was linked to MOD-2021-310651, MOD-2021-310836 (Patient Link).
Toxic encephalopathy; Toxic neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000000472.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOXIC ENCEPHALOPATHY (medically significant), outcome "unknown"; TOXIC NEUROPATHY (medically significant), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: ER8729), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reporte d. Past drug history included: Neosporin, reaction(s): "Allergic to Neosporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Paxlovid Treatment start date 13May2022. While taking this medication the patient reported a metallic taste in their mouth all day. Therapeutic measures were taken as a result of covid-19.   No follow-up attempts are possible. No further information is expected.
Metallic taste on the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste on the mouth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced DYSGEUSIA (Metallic taste on the mouth). At the time of the report, DYSGEUSIA (Metallic taste on the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was unknown.   Reporter did not allow further contact
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "SLE" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "thalassemia" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: depakote for Known allergies: depakote; Known allergies: trazodone for Known allergies: trazodone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid for COVID 19 Treatment start date was 21Jan2023 and stop date was 25Jan2023. Patient had known allergies of Depakote and trazodone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected drug cannot be completely excluded.
Shingles like rash on left side of body from buttocks to knee. Burning rash with joint pain.
On mid May 05/2022 after receiving my 3rd dose on 10/29/2021.  My adverse event started with  cough, fever, tired and weak and lost of appetite.  I did a telehealth with my doctor who prescribed me with Paxlovid.  After my 5 days of medication  I felt better but I had a rebound again. After 2 weeks later I woke up with double vison. I went to my doctor and he refereed me to a  Neuro Ophthalmologist he took 9 bottles of blood. My speech was affected. I  am taking prednisone 15mg tab once a day. Pyridostigmine Bromide 60mg 3 times a day for my vision.  I have to make sure to take the medication on time.
PATIENT HAS SWELLING AND WARM TO THE TOUCH OF THE RIGHT UPPER ARM WHERE SHE HAD FLUZONE-HD AND ITCHY. ADVISED PATIENT TO TAKE BENADRYL AND IF THAT DIDN'T RESOLVE THEN CALL MD MONDAY MORNING FOR ADVICE
APPROX 4 HRS POST VACCINATION, PATIENT EXPERIENCED FATIGUE, RASH, HIVES, GI DISTRESS IN THE FORM OF "DIARRHEA" AND "STOMACH ACHE" WHICH CONTINUED THE NEXT DAY WITH HIVES AT THE SITE OF INJECTION.  TYLENOL/ANTIHISTAMINES ADMINISTERED BY FAMILY MEMEBER WHO IS A NURSE PER PATIENT
I am experiencing numbness, tingling in all extremities worst in hands and forearms that make any minor activity like holding a phone etc very painful for hours after use. Vertigo and visual disturbances and decreased vision in R eye with pain, Severe fatigue and GI discomfort and loss of appetite.
No adverse events have occurred, reporting this to follow the vaccine administration error protocol.  The patient received this vaccine 11/10/2022, therefore the 2nd dose was administered at the 4 months and not the 6th months.
Suspected vaccination failure; I got the shot, then about two weeks ago I got a small case of them again / horrible thing; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (very painful took a month for them to leave).   On an unknown date, the patient received Shingles vaccine. In April 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got the shingles before vaccination and took a month for them to leave. The patient got the shot and then about two weeks before the time of reporting, got a small case of shingles again. The reporter hoped that they were done with that horrible thing of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/22/2022 & 2/23/2022  --  RECURRENCE OF SAME SYMPTOMS
about 15 minutes after receiving second covid vaccine, patient complained of feeling very hot,  heavy breathing, chills and chest hurting.  11:20a pulse 105.  Benadryl 25mg oral given.  BP difficult to obtain (132/84?)
pt recvd vax & devel vasculitis; pt exp itching; MD dx pt as having cellulitis of the rt ankle; pt was hospitalized; vasculitis reappeared w/fluid while in hosp;
Papular rash that then progressed to papulovesicles/ varicelliform rash.  Approximately 10 lesions total.
A week after the Booster shot,  I awoke at 12:30am to go to the bathroom.  When I went to the bathroom I passed out while urinating.  I have never passed out or fainted before.
Headache, body ache, tiredness for full day on the 4th.   Redness, swelling, warmth on upper arm again started on the 5th.
Patient vaccinated with PREVNAR 07/06/15, felt generalized weakness and ill next day significant such that nursing home staff wanted to take patient to ED. On 7/12, a crescent shaped rash appeared. An RN visited patient on 7/13 and reports pain in his rash in his groin and he has a rash on his L arm (deltoid) 26cm x 10cm at the widest area crescent shaped. Appears as a allergic reaction, not raised, no vesicles, patient states it burns and itches at the same time. NP visited next day on 7/14 and reported macular rash extending from deltoid to inner aspect of arm to a few inches above elbow. Rash has 1 papule, but predominantly flat, mild erythema-patient states pruritis and burning. Rash 4-5 inches in width. NP ordered hydrocortisone for application to arm site and reports patient responded well to it quickly.
I had severe nausea, fever (103), chills, and swelling/redness/pain at injection site.  It started just after the injection, and has persisted for 2 days.  The injection site is red, raised, and very painful.
Sudden loss of walking ability. I can not walk. My legs below knee are hurting a lot. This has escalated in last few days
pt recvd vax & 1 wk later exp itching, rash & devel blisters;
could not taste the coke/ lost sense of taste; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (could not taste the coke/ lost sense of taste) and ANOSMIA (lost sense of smell) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Norco allergy).    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced AGEUSIA (could not taste the coke/ lost sense of taste) and ANOSMIA (lost sense of smell). At the time of the report, AGEUSIA (could not taste the coke/ lost sense of taste) and ANOSMIA (lost sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was reported.
Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 27-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, SEIZURE (Seizure) had not resolved.            No concomitant medications were reported. Treatment medications were not provided.  Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Fever up to 102 - 24 hours; chills 12 hours; fatigue 24 hours Stayed in bed first day.  Second day able to shower, eat, etc.  Third day felt normal.  Did not see doctor.
17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
This case was reported by a healthcare professional, via a GSK representative and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 7 of 15 ( see case IDs A0860669A, A0860690A - A0860693A, A0860695A - A0860702A for the other reports).
Pt felt lightheaded and was pale about 10 minutes following vaccine. We laid him down in trendelenberg and he began to complain of numbness and tingling in feet, legs, hands and arms. Carpal spasms began in both hands. We placed him on O2 and enougraged deep breathing, including into a paper bag. He continued to experience symptoms and then complained of abdominal pain, which progressed to chest pressure. EMS was called at that point, an IV was started. On arrival of EMS, patient was feeling slightly better and patient and his family declined transport. Vital signs were stable throughout. WIthin about one hour patient felt "100% better" and was discharged home with family. Walked to car in stable condition.
Arm hurt a tiny bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt a tiny bit) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) and PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On 20-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 VACCINATION SITE PAIN (Arm hurt a tiny bit). At the time of the report, VACCINATION SITE PAIN (Arm hurt a tiny bit) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After the first dose they hardly had anything, their arm hurt a tiny bit.  Treatment medication was not reported.   This case was linked to MOD-2021-380167, MOD-2021-378552 (Patient Link).
c/o dizzy spell appeared pale soon p/vax;pt was observed & given DPH;VS stable;
Patient can not lift hand; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Patient can not lift hand) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (Patient can not lift hand). At the time of the report, JOINT RANGE OF MOTION DECREASED (Patient can not lift hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood calcium abnormal: (abnormal) doctors advised hand problems due to calcium.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Positive Covid test after feeling unwell; Positive Covid test after feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 as dose 1, single (Lot number: GJ6796) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2023 at 13:00, outcome "recovering" and all described as "Positive Covid test after feeling unwell". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2023) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.