chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Chronic Hepatitis; This case was reported in a literature article and described the occurrence of vaccination failure in a 27-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and chronic hepatitis b (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the chronic hepatitis b was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and chronic hepatitis b to be related to Hepatitis B vaccine.     Additional Information: GSK receipt date: 29 April 2022 Author comment: The patient was born in another country and did not receive the HBV vaccination in childhood. The patient reported 2 heterosexual partners in her lifetime. The patient had no history of other sexually transmitted infections, blood transfusions, needlestick injuries, or intravenous drug use. The patient was without pertinent medical history presented with elevated transaminase levels and a positive hepatitis Bsurface antigen (HBsAg) test result. Because of elevated liver enzymes and lack of anti-HBs following vaccination, further serologic testing was performed. At presentation, the patient was asymptomatic. Physical examination findings were unremarkable. This patient's elevated transaminase levels and birth in a country with high HBV prevalence prompted serum HBsAg testing. A false-positive HBsAg test result is unlikely, particularly in the context of the positive IgG anti-HBc and hepatitis B e antibody (anti- HBe) test results. The patient's negative IgM anti-HBc and HBeAg test results, in addition to transaminase levels being below a value that was 2 times the upper limit of "normal" values, supported the diagnosis of chronic inactive HBV infection, characterized by little or no HBVreplication, minimal or no liver inflammation, normal liver enzyme serum levels, absence of HBeAg, presence of anti-HBe, and undetectable or low levels of serumHBVDNA. Resolution of HBV infection is characterized by a negative HBsAg test result with positive anti-HBs and IgG anti-HBc test results and therefore was unlikely in this patient. The patient was informed of her chronic hepatitis B diagnosis and the need for regular monitoring, at least annually, of serum HBV DNA and alanine transaminase levels to assess viral replication and candidacy for HBV treatment. Liver ultrasonography and elastography findings did not show fibrosis or focal masses.  Additional supportive information: This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and time to onset were unknown. This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Allergic reaction; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Allergy to plants (to trees).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. Medically Significant      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were provided.  Patient experienced allergic reaction immediately within 20 minutes. She was taken to the hospital and stayed there for 4 to 5 hours. Patient did not take the second dose as her doctor said not to take the second vaccine as she got an allergic reaction. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Went to ER and was admitted on April 25, 2022, C-Diff diagnosis, Bowel Infection, discharged on April 27,2022. CT of chest done in ER. Still see doctor for IBS.
still contracting Covid 19 virus/ tested positive; still contracting Covid 19 virus/ tested positive; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "still contracting Covid 19 virus/ tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She tested positive on Tuesday morning and took 3 tests to confirm;  Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  Additional information: Main symptom reported was scratchy/sore throat. States it is a light case.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Lump on my upper right arm at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the right arm on 31Mar2021 at 11:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and sulfa (sulfonamide) allergy. The patient received unspecified medications within two weeks of the vaccination. The patient previously received codeine and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 03Apr2021 at 11:00, the patient experienced a lump on her upper right arm at injection site. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event lump on the upper right arm at injection site. The clinical outcome of the event lump on upper right arm at injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 76 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) till Jul2022 at citrate free and second regimen since 2022 (ongoing) (Lot number: 1162590) at citrate free, all subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "covid-19" related to BNT162b2.  Clinical information: In Jul2022, the patient experienced COVID. Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 Vaccine (Tozinameran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of COVID was not provided. Change History On 25Aug2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE)  and Covid-19 cannot be ruled out.
PAIN, NUMBNESS  AND PARTIAL PARALYSIS OF COMPLETE LEFT SIDE,  INCLUDING ARM, LEG, AND FACE.
For the first injection I experienced adverse reaction starting about 2.5-3 hours after injection.  Symptoms started with some imbalance, confusion, and numbness in left ear.  As the night progressed the numbness in my ear resulted in losing hearing in that ear due to my inner ear being numb.  I experienced vertigo symptoms, headache, fever, chills, achiness, and fatigue.  Hearing returned after two days.  Other symptoms subsided after 3 full days.  For second injection I broke out in hives (chest, trunk, arms, neck, face), itching, confusion, elevated heart rate, and fatigue after 1.5 hours post vaccination.  I took Benadryl after my school nurse tended to me.  Symptoms progressively increased through the night.  I experienced severe muscle pain, fever, chills, headache, spinal pain, and nausea.  These symptoms were severe throughout the night and the next day.  After a shower later in the afternoon the day following the shot, I broke out in hives again and blisters formed where my hives had been the day before as well as severe itching all over my trunk and hands.  I took benadryl again and attended a telehealth visit to describe my symptoms and he confirmed an allergic reaction.  Other symptoms subsided after taking benadryl all evening and tylenol.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PROQUAD (dose, route and lot # not reported) post supported excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The patient was initially admitted to a telemetry floor bed, placed on supplemental oxygen, treatment was initiated for acute on chronic respiratory failure, It was noted that the patient had been treated for COVID in the recent past. initially, it was thought that the patient would remain stable on 2 L, which was a in increased from what was recommended upon his recent discharge, 2 L, patient was noted to have pancytopenia, not a. new finding, heparin was discontinued once platelets drop below 50. On 11/21-22, the patient's oxygen rate had to be increased of 7 L. It was suspected that the patient had developed pulmonary edema, volume overload. An echocardiogram was obtained. which did not show significant systolic or diastolic dysfunction, nor did it show significant valvular abnormalities. The patient was given diuretics intermittently, out this did not improve his respiratory status. Over The next several days, the patient's oxygen requirements increased, and he was  placed on BiPAP. Cultures ordered, and the patient was placed on empiric antibiotics. No organisms were identified. The patient was continued to receive empiric antibiotics. After a few days, the patient's respiratory status required nearly continuous BiPAP use. After discussions with the patient, he agreed to the recommendation to change code status to DNR. The patient continued to require BIPAP continuously, For a couple days, he was able to tolerated discontinuation just Jong enough to take a little bit of fluid and food by mouth.  Patient was transitioned to comfort care.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a mild case of Shingles after the 1st dose of Shingrix. No other information was provided by the patient. The reporter had previously contacted GlaxoSmithKline response center, however, no duplicate case was found. The patient's healthcare professional would contact medical information.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2), administration date 08Mar2022 (Lot number: FK9894) as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Heart Issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacture: Unknown, Caller reports her husband has received all of the COVID-19 vaccines.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia"; MALAISE (non-serious), outcome "unknown", described as "did not feel to good". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: he had COVID-19 as well. Clinical course: The reporter reports her husband has received all the COVID-19 vaccines which she and her husband received together, and he had COVID-19 as well. She reports that she received the COVID-19 vaccine booster dose on 08Mar2022. Caller states her husband is 6'2" and her husband is 2 of her. The reporter states her husband is bigger than herself. The reporter states her husband's heart issues was the whole reason behind getting the COVID-19 vaccines. Caller states all of this is trial and error and no one will know unless she calls. The reporter states her husband is like 3 years younger than her. The information regarding, Product strength, count size dispensed and sample of the product available to be returned is not applicable. If packaging sealed and intact is not provided on call. No follow-up attempts are possible. No further information is expected.
Patient fainted and vomited within 15 minutes of vaccination.  No treatment needed.  Patient released to home with parent.
elevated lump on the injection site; itchy; arm site hard; arm site bright red swollen; injection site heat /  hot area around the injection site; injection site knot; injection site redness / 2 x 1 inch, red (less intense); injection site soreness; back pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 LEVOTHYROXINE SODIUM (SYNTHROID), LEVETIRACETAM, PANTOPRAZOLE, SPIRONOLACTONE, LACOSAMIDE (VIMPAT) and BIOTIN for an unknown indication, CYANOCOBALAMIN (VITAMIN B-12), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), ZOLPIDEM TARTRATE (AMBIEN) and CALCIUM.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain). On an unknown date, the patient experienced VACCINATION SITE MASS (elevated lump on the injection site), PRURITUS (itchy), VACCINATION SITE INDURATION (arm site hard) and VACCINATION SITE SWELLING (arm site bright red swollen). On 03-Mar-2021, VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain) had resolved. At the time of the report, VACCINATION SITE MASS (elevated lump on the injection site), PRURITUS (itchy), VACCINATION SITE INDURATION (arm site hard) and VACCINATION SITE SWELLING (arm site bright red swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant products include estriol cream, extra strength Acetaminophen.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Significant FU / extra events added On 03-May-2021: Follow up was received on 03 may 2021 included The left arm site was hot, hard, bright red swollen and they all resolved with a darkened spot on skin.
At injection site red swollen and fever in arm. Strarted about a week after shot. Not real bad or severe. Now just kind of itches.
Employee given a flu shot at 1030 AM on 11/13/06. She was staying for observation about 15 minutes. I began to feel tingly and flush. Checked B/P and it was 180/88. Employee stated she didn't feel well. Rash noted on arms. Continued to feel sick and was given Benadryl 50mg PO now.  B/P at 1040 AM 148/70 and at 1045 shot up to 180/90. Discharged morning has to check and O2 at 2 hours given. No complaints of difficulty breathing noted. BP at 1115 shot up to 200/100 and employee transported via ambulance to hospital. Employee given Decadron IV. Continue to have reaction on 11/14/06 and went back to doctor. She was given Decadron IV, Medrol dose pack, Zyrtec and Benadryl PRN and advised to stay home for 5 days. Diagnosis: anaphylaxis sustained reaction from flu shot.
Arm was super sore; shots were painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was super sore) and pain (Verbatim: shots were painful). The outcome of the pain in arm and pain were not reported.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got Shingles vaccine several years ago, early 50's.  The reporter stated that arm was super sore, she thought her hubs felt a little sick.  The patient further stated that shingles shots were painful after a few hours but she was sure better than shingles. The follow up would not possible as no contact details were available.
Patient reports left arm pain without swelling or redness. She states that she did not have severe pain in the left arm in the 4 days after vaccination.  She states that she has pain when she lifts her arm above her head. She states that she cannot use ibuprofen or naproxen due to an allergy but has been using Voltaren gel with no relief. I recommended that patient consult her physician for an evaluation. Patient has an appointment scheduled for 01/25/2021. I spoke with  patient again on 01/18/2021 and she reports that her arm is feeling a bit better and she is able to move it more. She did report that she had tried to use Tylenol to help with the pain and also took Percocet once a day and that has alleviated the pain. I recommended that patient go to her upcoming appointment to have her arm evaluated and I will follow up with her after her appointment.
Extreme dizziness, nausea, muscle weakness and pain, chills, headache, backache,  Couldn't sit up - collapsed and fell off bed, difficult walking even with help  Arm pain began a few hours after, symptoms above started around 10pm day of vacinnation Tuesday, July 27 dizziness and nausea continued but not as extreme. headache, weakness and tiredness remained. Slept most of day  Wednesday, July 28  only tiredness and fogginess remain
Pt was 34 weeks pregnant, gave Arexvy vaccine instead of Abrysbo vaccine
Brain fog started 1 hr after vaccine. Peaked at 1 week. Still don't feel back to "my normal".  More depressed and irritable. Difficulty concentrating. Very frustrating in work and personal life. I wish brain fog and other potential mood or mental side-effects were tracked better. My Mom and husband had similar reactions. We can't be the only o es affected this way.
Pt came very close to passing out was in and out of conscious thought/communication. Felt like she was "not here" & was very hot. EMS checked her vitals, BG = Fine.