chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician, via a GSK representative, and described the occurrence of hepatitis B positive in a child subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included elevated liver enzymes and sexually transmitted disease. On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (details unknown). At an unknown time after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy ("no immunity/no protection"). The physician reported that four subject's, all children from the same family, were vaccinated with the hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are now older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 3 of 4 (see case IDs A0938693A, A0939314A, A0939316A for details of the other reports).
Patient received the second dose of the covid vaccine on 01/06/2021.   c/o  of fever, chills, hot flashes (face), numbness of the Left buttock, soreness of Left breast, dizziness, headache few hours after the injection.    She is concerned about the numbness of the Left buttock and sore Left breast. The injection site was on the Left arm.
COVID 19; COVID 19; interchange of vaccines products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. Concomitant medication(s) in 2 weeks included: CHOLESTROL, start date: Sep2022, stop date: Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Sep2022, outcome "unknown", described as "interchange of vaccines products"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 (start date: Sep2022, Stop date: Oct2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bronchitis; Tested Positive for Covid-19; A spontaneous report was received from a consumer concerning a male patient of unspecified age who was administered Moderna's COVID-19 vaccine and experienced bronchitis and tested positive for COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025520A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.    On 30-JAN-2021, the patient experienced bronchitis and tested positive for COVID-19. He was prescribed azithromycin, methylpred and benzonatate. He reports no other side effects.  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events of bronchitis and tested positive for COVID-19 was unknown.; Reporter's Comments: Based on the available information the Moderna's COVID-19 vaccine does not contain a virus, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.
Fever induced seizure during her sleep time, moaning eyes rolling back strange still arm & leg movements, i am not sure of time course as it was scary for me to witness, I called the nurse careline to ask what to do & what may have caused it.
3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first temp 102. took two Tylenol and temp went down.  8Pm I was flush and my temp was 105.5, 5minutes later 106. PCP called and advised my wife to take me to the ER and took two more Tylenol. Arrived at ER Temp was down 100.2
Received Pfizer COVID vaccine on Wed night 1/31/21 at 5:50pm. I had no prior recent illnesses prior to getting the shot. About 24 hours later, developed fevers/chills, body aches, headaches, and fatigue, and a notable pain in the front of neck -- felt like tender thyroid. Temp was 100.3F on Thursday night 1/14. Took ibuprofen and went to bed. Next day felt fine, went to work, but symptoms returned on Friday night without fever. Symptoms persisted through the weekend without fever until Sunday AM 1/17/21 at 3:40am, I woke up with a temp of 101.7F. Went to get tested for COVID on Sunday 1/17/21 and Tuesday 1/19/21. Both times were negative (both rapid and PCR). Remained febrile on Monday and Tuesday AM. Went to urgent care on Monday 1/18/21 and was negative for flu, but provider observed the thyroid was tender. TSH was checked on 1/18/21 and was abnormal, 0.027 and FT4 was 3.20. Had virtual appt with PCP on 1/19/21, and she ordered more blood tests to evaluate the hyperthyroidism. On 1/21, repeat TSH was 0.014, and FT4 and T3 were both high. Inflammatory markers were elevated, liver function tests were mildly elevated, but thyroid antibodies were all negative. Over the course of the week after getting the shot, I experienced tachycardia, palpitations, fatigue, and shortness of breath and dyspnea on exertion with simple tasks like walking up a flight of stairs or getting up from the couch to walk to the kitchen. PCP ordered an echocardiogram to evaluate the dyspnea on exertion, but it was normal. I had radioactive iodine uptake thyroid scan performed on 2/3 and 2/4, and it was notable for markedly low 24-hour uptake, consistent with Hashimoto's thyroiditis, or other types of thyroiditis. As of 2/5/21, I am feeling significantly better from the past 3 weeks, and the hyperthyroid symptoms have improved and flu-like symptoms have resolved. Due to possible relation to the vaccine, I have delayed the 21-day booster shot to 23 days, and plan to get it this afternoon 2/5/21.
Rash on arms, hands, chest and upper back; Rash was red, itchy; Rash was red, itchy; pustules and painful; pustules on arms, hands and chest; Pustules on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PUSTULAR (pustules on arms, hands and chest), PUSTULE (Pustules on chest), RASH (Rash on arms, hands, chest and upper back), RASH PRURITIC (Rash was red, itchy) and RASH ERYTHEMATOUS (Rash was red, itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Crohn's disease since 04-Mar-2014.   On 29-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-Mar-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 30-Jan-2021, the patient experienced RASH PUSTULAR (pustules on arms, hands and chest) and PUSTULE (Pustules on chest). On 03-Feb-2021, the patient experienced RASH (Rash on arms, hands, chest and upper back). 03-Feb-2021, the patient experienced RASH PRURITIC (Rash was red, itchy), RASH ERYTHEMATOUS (Rash was red, itchy) and PUSTULE (pustules and painful).   The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency; PREDNISOLONE for Adverse event, at an unspecified dose and frequency and ADALIMUMAB (HUMIRA) (subcutaneous) ongoing from 06-Jun-2014 for Crohn's disease, at a dose of 40 milligram per week.   At the time of the report, RASH PUSTULAR (pustules on arms, hands and chest), PUSTULE (Pustules on chest), RASH (Rash on arms, hands, chest and upper back), RASH PRURITIC (Rash was red, itchy), RASH ERYTHEMATOUS (Rash was red, itchy) and PUSTULE (pustules and painful) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: New events added. Concomitant drug information updated. Dose #2 information updated.
Coughing blood; Sore arm; Itchiness; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (Coughing blood), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at injection site). On 18-Apr-2021, the patient experienced HAEMOPTYSIS (Coughing blood). At the time of the report, HAEMOPTYSIS (Coughing blood), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.
Pt was given GARDASIL vaccine upon checkout Pt fainted. Lost consciousness for ~ 5 sec. Fell and hit head on floor. Sent to ER for CT scan, IV.
Tightness of chest, pulse rate jumping from 42 to 80 to 39 to 88 etc.   EKG had ST elevation of about 1 mm in lead aVR  with diffuse ST depression in multiple other leads with about  1mm and downward sloping.  Does not meet criteria for ST elevation MI but is concerning for ischemia.    Catherization did not show blockage.
In the middle the night around 2 AM, I realized that a lot of my joints and muscles hurt. My elbow and finger joints on right arm. My neck and lower back had muscle pain. When I rose the next morning I found I had a low-grade fever. I had extreme fatigue, pressure in my head and at some points I felt like I was listing to the left when walking. Much better 24 hours later, only the neck and lower back still twinging.
1/20/21 vaccinated; 5 days later nausea, vomiting, slight headache following.
Given on shoulder Hurt right away Could not lift as far as shoulder Trying to get out of clothing was difficult
I have a pea sized, pliable bump on my bicep. It was painful now it has not been painful anymore. This bump is still here.
Fatigue; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: unknown, Age at vaccination was 48 years) via an unspecified route of administration, administered in Right arm on 16Feb2021 12:45 PM as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: unknown, Age at vaccination was 48 years) via an unspecified route of administration, administered in Left arm on 28Jan2021 8.00 AM as dose 1, single for covid-19 immunization. Past drug event includes naproxen sodium due to which patient experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. On 17Feb2021 10:00 am the patient experienced, Fatigue, chills and body aches. The patient did not receive any treatment for the events. Outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
This spontaneous report was received from a registered nurse regarding unspecified number of patients whose demographics were unknown. The pertinent medical histories and concurrent conditions of patients were unknown. On an unknown date in SEP-2015 unspecified number of patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (lot # K016966, expiry date 10-MAY-2017) through unknown route. Concomitant medications were not reported. No adverse events were reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
itchiness at the area of the injection; soreness at the area of the injection; red bumps (mosquito bite like) at the area of the injection; red bumps (mosquito bite like) at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE PAIN (soreness at the area of the injection), VACCINATION SITE ERYTHEMA (red bumps (mosquito bite like) at the area of the injection) and VACCINATION SITE MASS (red bumps (mosquito bite like) at the area of the injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE PAIN (soreness at the area of the injection), VACCINATION SITE ERYTHEMA (red bumps (mosquito bite like) at the area of the injection) and VACCINATION SITE MASS (red bumps (mosquito bite like) at the area of the injection). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE PAIN (soreness at the area of the injection), VACCINATION SITE ERYTHEMA (red bumps (mosquito bite like) at the area of the injection) and VACCINATION SITE MASS (red bumps (mosquito bite like) at the area of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was allergic to many unspecified medications where she will break out in hives.  No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
AFTER RECEIVING VACCINES HE HAD AN ELEVATED TEMP OF 100.6, SWOLLEN EYELIDS, DYSPNEA, WHEEZING BILATERALLY AT THE BASES. URTICARIA.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 41st of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
Pt recvd vax 20MAY92 & on 22MAY had tonic clonic generalized seizure, eyes rolling & twitching; pt now on Phenobarb;
Erythema, edema and pain at the injection site starting 24 hr after receiving injection.  Area of edema, redness measures 7 inches in diameter.
Had both shots, still got them 2 years later/suspected vaccination failure; Still got them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK receipt date: 17-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots of the vaccine and still got them 2 years later. The patient would not wish this was his/her worst enemy. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
From initial information received on 09May05 from a healthcare professional regarding an adverse event occurring, it was reported that a 13 year old male pt received a dose of YF Vax, lot number UE500AA, administered SC in the left arm on 06May05 at 11:45AM. At 2:00PM on 06May05 the pt experienced shortness of breath. He visited the ER and was treated with Benadryl, epinephrine and Solumedrol. He was admitted for observation at another hospital due to the unavailability of beds at the first hospital. At the time of this report it is unk if the pt recovered from these events.
I came down with epstine Barr virus that left me bed ridden for 3 months; This is a spontaneous report from a contactable Consumer (Patient).  A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in right arm on 27May2021 at 14:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Patient's medical history was none. Concomitant medications in two weeks were none. Patient had no Known allergies. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in right arm on 27Apr2021 at 14:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. Facility type vaccine administered was hospital. Reporter stated that on 01Jun2021 at 12:00 am after receiving the vaccine, he came down with epstine Barr virus that left him bed ridden for 3 months. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient underwent lab test and procedures which included on 07Jun2021 PCR (Nasal Swab) result was Negative. Patient did not receive any treatment for the adverse event. Outcome of the event was resolving.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
01/31/22 inpatient Physical Rehabilitation for "recurrent mechanical falls". PMHx of "coronary artery disease"
left arm which is her injection arm, she had COVID arm; hives which jumped all over her body; rash feeling; redness in 2 by 2 inch; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AL21A, 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Fatty liver, Penicillin allergy and Iodine contrast media allergy (radioactive iodine contrast).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch). At the time of the report, VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-555542 (Patient Link).