chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Therapy non-responder  This case was reported by a nurse and described the occurrence of not responding to therapy in a 52 year-old female subjects who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  The subject's medical history included non-smoker and non-drinker.  The subject's concurrent conditions and concurrent medications were not reported.  On 12 October 1992, the subject received the third dose of hepatitis B vaccine (dosing was not specified). The subject received the second dose on approximately 45 days after vaccination with the first dose of hepatitis B vaccine, a hepatitis B surface antibody titer was negative. A fourth dose of hepatitis B vaccine was given on 02 May 1997. On 05 May 2006, approximately nine years after the fourth dose of hepatitis B vaccine, a hepatitis B surface antibody titer was also negative.  The nurse considered the event to possibly be related to vaccination with hepatitis B vaccine.
noticed difficulty breathing and extreme pain on inhalation. went to the emergency room and was diagnosed with pleurisy
mother reports that he developed chest pain, tightness and SOB on 6/5/21.  He will see his Pediatrician on 6/16/21.  He was supposed to have 2nd covid dose on 6/10/21 but has been postponed until doctors appt.
Shingles; other zoster-related conditions; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 19-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about 21-AUG-20106 the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for the long-term prevention of shingles and zoster related conditions. Subsequently, to patient's Zoster Vaccine Live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zoster-related conditions. Then, on an unknown date, the patient was hospitalized due to the event .As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries including but not limited to cost for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. At the reporting time, the outcome of herpes zoster and zoster related conditions was not provided. The reporter considered the event herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
MUSCLE TIGHTNESS, CRAMPING FROM JAW DOWN TO BREAST (ON LEFT SIDE ONLY), SWEATING. BEGAN APPROXIMATELY 15 MINUTES POST-VACCINATION AND LAST FOR 4-5 MINUTES. PATIENT SAYS SHE HAS THIS REACTION ON OCCASION, UNRELATED TO VACCINES.
Itchy rash developed over entire body 2 1/2 hours after receiving flu immunization.  Pt. took 50 mg Benadryl with no effect.  Continued taking 50-75mg Benadryl every 4-6 hours with relief but rash kept recurring after 4-6 hours.  Patient was treated with prednisone dosepak.  It got worse the following day, and she was given more prednisone but it caused stomach pain.  Five days after receiving the shot, she went to the ER and was given cortisone IV with very little improvement.  Was seen by allergist who increased prednisone to 40mg x 5 days and taper off.  8 days after shot, patient feeling better but still symptomatic.
On 9-17-2021 I experienced difficulty breathing and made an appointment with my primary care physician, Dr.  He scheduled me or a pulmonary exam which I took and everything appeared normal.  The next day he scheduled me for an EKG and the results of that were abnormal.  He referred me to a cardiac specialist, Dr. who ordered an Echocardiogram, the results of which showed an ejection fraction of 15%. He scheduled me two days later for a heart cauterization.  The results, as described by Dr. was damage due to a series of small heart attacks, and irregular heart beat.  He ordered a heart defibrillator which I am wearing all the time now for the next 3 months.
Liver injury following SARS-CoV-2 vaccination/ Acute Liver injury; This is a literature report.  A 37- year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered" described as "Liver injury following SARS-CoV-2 vaccination/ Acute Liver injury." The patient underwent the following laboratory tests and procedures: ALT (alanine aminotransferase): greater than 5000 IU/l; ALP (blood alkaline phosphatase): 144 IU/l; blood bilirubin: 2.8 mg/dl; INR (international normalised ratio): 5.5; Autoimmune serologies: negative; COVID-19 test (SARS-CoV-2 test): negative; and viral serologies: negative. Therapeutic measures were not taken as a result of liver injury. The patient received NAC infusion treatment.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is too limited to make a meaningful medical assessment of the case. However, based on the available information in the case provided, the causal association between the reported event Liver injury and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship post vaccination. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
pt recv vax & devel large localized rxn w/itchiness, was referred to family MD;
Physician reports pt irritable, crying, skin warm to touch post vaccine. Per physician pt recovered.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid. After receiving SHINGRIX, the patient experienced large swelling at injection site that was warm to touch. This case has been linked with the case US2018182676, reported by same reporter.
This spontaneous report as received from a healthcare student refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. Route, dose, dose number and lot number were not reported. On an unknown date the patient received ZOSTAVAX while he had an active case of shingles. No adverse symptoms were reported. Action taken regarding to the use of ZOSTAVAX was not reported. The outcome of patient received ZOSTAVAX while he had an active case of shingles and no adverse symptoms were unknown. Reporter causality assessment was not reported. Additional information has been requested.
She got after the vaccination low grade fever; she was feeling tired; the skin on her face and back warm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age of vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the vaccination, on an unspecified date, the patient experienced low grade fever, she was feeling tired and also got the skin on her face and back warm. The patient wanted to know if the weight was factor for the dosage of the vaccine. She was worried she might get too much of the vaccine since she stated that she was very reactive to medications. The patient asked if there was a study being done for the Pfizer-BioNTech COVID-19 Vaccine in children less than 16 years of age and if the same volume (0.3 ml) was administered to children. The patient wanted to know what would happen if she does not get the second dose and whether one dose will be efficacious. The patient wanted to know if she could get the second dose of the vaccine after 21 days and it would be better in order to have less side effects. The patient wanted to know what would be the advise to those patients that got a severe allergic reaction to the first dose of the vaccine. The patient asked if she could cut the second dose in half due to her size. She wanted to get two doses of half dose each time for the second. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd vax on 21SEP92 & on 30SEP92 exp sharp pain p/eating yogurt; pain was so severe that had to leave work & see MD; had hepatomegaly, fatigue & inc SGOT & SGPT; had very sharp pains bet 1OCT92 & 12OCT92; inc SGOT, SGPT, alk Phosphatase
Approximately 30 minutes after receiving injection, patient began to c/o itching to (B)UE, chest, and neck. Visible hives to (L) forearm. Denies further symptoms. Benadryl 25mg po. Patient declined further treatment.
This case was reported by a nurse via other manufacturer and described the occurrence of drug allergy in a female patient who received Influenza vaccine. Concurrent medical conditions included drug allergy (allergy to : metformin, lithium, flu shot, trazodone, lisinopril, EFFECOR, ABILIFY and TRILEPTAL). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving influenza vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to influenza vaccine.
Systemic: Fainting / Unresponsive-Mild, Additional Details: faint for 5 seconds then recover saying fear of needles
Patient felt like he was going to "go down", he has a history of vasovagal response.  Patient has a second vasovagal and EMS was contacted. Patient then stated he had been standing for the last 5 hours during a swim meet and did not take his Norvasc that was to be taken daily.
Palpitations; Burning sensation; felt Faint; Headache; Fatigue; Pain at the injection site; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 07-Nov-2023, the patient experienced PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pain). On 11-Nov-2023, PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.  Within 20 minutes of receiving Spikevax, the patient had a mild headache and felt somewhat faint. Within 6 hours, she had fatigue and pain at the injection site. At approximately 22 hours after the injection, she experienced heart palpitations that continued for approximately 11 hours more. At approximately 30 hours after injection, the patient also felt a burning sensation in her feet and intense joint pain that lasted about 6 hours. Fatigue continued for approximately 72 hours total.   It was unknown if the patient experienced any additional symptoms or events.
104.2 fever taken at 2:15 a.m. on 4/20; 1 tsp Motrin immediately administered; drove to emergency room; 1 dose of Tylenol given at 3:00 a.m.; fever reduced to 100.8 by 5:30 a.m of same day; highest subsequent fever recorded 101.1 at 9:30 a.m. on 4/21;  fever continued on and off for several days.  Finally ending on 4/27:  Speech appears to have been adversely affected.  He speech was more articulate before the vaccine.  He no longer say words he said very clearly before vaccine.
I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.; I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) and MYALGIA (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 0205L20A and 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM, PROBIOTICS NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), HYOSCYAMINE, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), TRIAMTERENE, ATENOLOL, CALCIUM, LISINOPRIL and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) and MYALGIA (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.). At the time of the report, GAIT DISTURBANCE (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) and MYALGIA (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided
Fine papular rash on trunk, upper extremities, face itching developed within 8 hours of receiving vaccines. 2-22-07 Patient's mother contacted. Rash cleared after 2 days. No other symptoms noted.
expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received via registered nurse. GMI number: 01570546.  This case involves 73 years old male patient to whom expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination; MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Prophylactic vaccination; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Prophylactic vaccination.   On 11-Apr-2023, the patient was administered expired first dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection at dose 0.5ml once (powder lot: UJ633AA, expiry date: 30-Jan-2023) via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) at same day latency.  It was reported that Caller confirmed that an expired dose of ACTHIB was administered to a patient. The diluent was within the correct date, but the powder portion had expired 30JAN2023. Caller would like to know how to proceed. This is reported as a medication error due to the inappropriate administration of an expired product to a patient.    Action taken: Not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event expired product administered.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache after first vaccine; Rashes after first vaccine; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 11263), via an unspecified route of administration on the left arm on 01May2021 at 14:15 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history included known allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient took other medications like food supplement (unspecified) within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On unspecified date in May2021, the patient experienced headache for one day after first vaccine, and rashes after first vaccine. The outcome of the events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
lt arm & leg tonic-clonic sz;pt was staring & not verbally responsive;occurred @ 630AM on 10MAY98;pt had fever 102.1;sz lasted 8 minutes;911 called;hosp from 10MAY98 to 13MAY98;pt also devel 5 maculopapular to maculovesicular spots;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 12-DEC-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Breakthrough with lesions. Temp of 101 on 06/25/04 treated with Tylenol. More lesions formed over the next two days around mouth- in mouth, on tongue, neck and arm. Saw Dr 6/28-Benadryl and Tylenol and Ibuprofen
myocarditis following COVID-19 mRNA vaccination; This is a literature report for the following literature source: "Increased Interleukin 18-Dependent Immune Responses Are Associated with Myopericarditis after COVID-19 mRNA Vaccination", Front Immunol, 2022; Vol:13, pgs:851620.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, 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: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis following COVID-19 mRNA vaccination". The patient underwent the following laboratory tests and procedures: Biopsy heart: higher interleukin levels; Interleukin level: higher.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available
Dizziness, Myalgia, Rash, UrticariaPruritus, NauseaVoiting, abdominal pain Narrative:
High fever of 106.1 on 11/9/23 morning.  Evaluation in the ER.  High CRP. Swelling to the Left arm on 11/20/23 Evaluation at office on 11/10/23 with repeat CBC & CRP.  Rocephin given.  Elevated CRP & WBC. Evaluation at office on 11/11/23 with repeat CBC & CRP.  Rocephin given.  Keflex started for cellulitis.
Patient stated the day after her vaccination she experienced a rash at the injection site and down her arm. She felt feverish and had a headache. She stated about 10 days later she had some tightening and a scratchy feeling in her thought as if her air way was closing. She states she was not having trouble breathing. Patient is unsure if the symptoms that occurred 10 days later were due to her vaccine or the trial drug she is on.
Patient was administered the wrong amount of vaccine in the route it was given. Patient recieved 0.1ML Sub-Q. Patient was re-dosed immediately with the proper amount for the proper route.