chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the first vaccine he suffered a massive brain bleed.  Then in the nursing home he contracted Covid-19 and was in Hospital Heart Transplant unit for 6 days.  After 4 or 5 days back in the nursing home he contacted Covid-2 pneumonia.  His balance is off he has memory loss and a lot more.
3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following 2 weeks, strong pain in arm muscle that travelling under arm into lymph nodes. Approximately 30 days after injection experienced a mild heart attack and unexplained pericarditis.  Symptoms at onset were major pressure in chest and elevated blood pressure 210/99.  Prescribed blood pressure medication, blood thinners and 4 does of  indomethacin for pericarditis
Sore arms, both right and left. Nausea Swollen lymph node in armpit with general pain and tenderness, left side of body.
No adverse event has occurred - patient was given Moderna at age 17 and 9 months old.
2? red circle at injection site and firm to touch. Minor itchiness. So far for about 24 hours
about 16 days p/vax had onset of muscle weakness involving lower extremities;had flaccidness of lower extremities w/hyperreflexia;MRI x 2 suggested transverse myelitis;viral cult pending;has slowly been resolving since onset;
Today I just feel bad; I have pain in my hip and back; I have pain in my hip and back; I had like heart palpitation; I was trembling; I couldn''t lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (Lot number: FF2587, Expiration Date: 31Dec2021) at the age of 80 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension; AMLODIPINE; LISINOPRIL.  The following information was reported: PALPITATIONS (non-serious) with onset 01Oct2021, outcome "unknown", described as "I had like heart palpitation"; TREMOR (non-serious) with onset 01Oct2021, outcome "unknown", described as "I was trembling"; MOVEMENT DISORDER (non-serious) with onset 01Oct2021, outcome "unknown", described as "I couldn''t lay down"; FEELING ABNORMAL (non-serious) with onset 02Oct2021, outcome "unknown", described as "Today I just feel bad"; BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 02Oct2021, outcome "unknown" and all described as "I have pain in my hip and back". Therapeutic measures were taken as a result of palpitations, tremor, movement disorder, feeling abnormal, back pain, arthralgia.  Additional Context: Concern: Consumer stated, she was just concern about side effect she was having last night she was trembling like (voice not clear) together and she had like heart palpitation that's what she call it. She couldn't lay down. She had to you know kind of sit and then up and today she just feel bad and she have pain in my hip and back and she was wondering was that side effect from, she got her on 15Sep2021. she got my COVID Pfizer (Covid-19 Vaccine), 15Sep. Treatment: Consumer stated, she only took a painkiller. Acetaminophen. Dose: Consumer stated, she just took one, 500 milligrams.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 16-year-old male patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included Meningitis ACWY vaccine (potential MENVEO)for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose and Meningitis ACWY vaccine (potential MENVEO) at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season and Meningitis ACWY vaccine (potential MENVEO), the patient experienced fatigue, headache and joint pain. On an unknown date, the outcome of the fatigue, headache and joint pain were unknown. It was unknown if the reporter considered the fatigue, headache and joint pain to be related to Influenza vaccine Quadrivalent 2018-2019 season and Meningitis ACWY vaccine (potential MENVEO). Additional details were reported as follows: This case was reported by the patient's mother. The age at vaccination was not reported but, it could be 15 or 16 years. The patient received unknown manufacturer's meningitis vaccine and a flu shot at the same time. The reporter did not remember any of the manufacturer name. No other details or timelines were known. The reporter was distraught because the representative could not provide medical advice on how to treat the symptoms.
Patient 's blood pressure was 160/105, hyperventilation, flushing, finger tingling
Abscess; Crohn's disease; Device issue; This is a solicited report based on the information received by Pfizer from agency (Manufacturer Control No: 21K-163-4081454-00).   Solicited report from by a contactable 24-year-old female patient with events of might have Crohn's instead of ulcerative colitis due to abscesses and non-serious might have Crohn's instead of ulcerative colitis due to abscesses and pen misfire with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced might have Crohn's instead of ulcerative colitis due to abscesses and pen misfire. Pfizer biontech COVID-19 vaccine (Tozinameran) was also considered suspect. The patient was in hospital for abscesses. She thought that she might have Crohn's instead of ulcerative colitis due to abscesses. She had pen misfire. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 23May2021, patient received 1st dose COVID-19 vaccine manufactured by Pfizer. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event(s) of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset and pen misfire was not provided. Agency's opinion is that there is no reasonable possibility that the events of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset, might have Crohn's instead of ulcerative colitis due to abscesses unknown onset and pen misfire are related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Reported events of Abscess and Crohn's' disease are most likely intercurrent conditions and unrelated to BNT162B2 vaccine. Pen misfire was related to co-suspect medication Humira (Adalimumab). Case will be reassessed upon receipt of additional information.
Patient reports being unusually tired x 2 days after vaccine. Reports pain initially at injection site that moves to various other areas on her body. Extreme weakness in upper extremities.
On 03/28/2021 my fingers, feet, and ankles swelled like if it was arthritis.  I could barely walk because of that. I could not even open a milk carton with my fingers. I saw my PCP and she referred me to a rheumatologist. They did blood work and my inflammatory markers were elevated. I had an appointment on 06/01/2021 with my orthopedic doctor because he injects my knees for arthritis every 4 months. He injected me with a steroid and it all went away. I was feeling better. I got a shingles shot and the symptoms came back. The rheumatoid doctor is starting me on a new medication and it seems to be working.
Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose: 5 / Moderna, Dose: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2021 as dose 1, single (Lot number: 026B21A), on 01May2021 as dose 2, single (Lot number: 002C21A), on 29Dec2021 as dose 3 (booster), single (Lot number: 041J21A) and on 19Jul2022 as dose 4 (booster), single (Lot number: 051B22A) for covid-19 immunisation. The patient's relevant medical history included: "Bladder cancer" (unspecified if ongoing); "Known allergies: Codiene" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2022, outcome "not recovered", described as "Pfizer, Dose: 5 / Moderna, Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication in 2weeks. Patient received Paxlovid as Covid-19 treatment from 06Jul2023 to 11Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Having fever; Having chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Having fever) and CHILLS (Having chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Having fever) and CHILLS (Having chills). At the time of the report, PYREXIA (Having fever) and CHILLS (Having chills) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
(1) Face muscle, left side,  along  the lower jaw, feels swollen, about 3 inch diameter circle.  No swelling visible  from outside. It is not num, feels like num.  Has been that way for last five days, no improvement. No pain,   (2) Minor rash, about two inches diameter, middle of the lower back. Has lasted more than 5 days now.
Fever in a 4 month old female who was inadvertently vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed for prophylaxis.  Patients medical history included cold and sinus infection. On 12/19/2005 the patient inadvertently received a dose of Boostrix rather than the intended 1st dose of diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined.  Bootrix is recommended for immunizing individuals 10 through 18 years of age.  On 12/19/2005, the subject also received injections of 7-valent pneumococcal conjugate vaccine.  Approximately one day later, on 12/20/2005, the patient experienced a fever of 101 degrees.  The fever resolved on 12/21/2005.  The nurse considered the events to possibly be related to vaccination with Boostrix.  The nurse also reported that, the fever could have been from the vaccinations or from the cold and sinus infection.
Rash on extremities (red, raised, itchy) as well as small hard pustule-like hard bumps on left fingers and palm
This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015), the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose, route of administration, lot# and expiry date were not reported). No improperly stored doses of oral, ROTATEQ were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age. Concurrent condition or medical history was unknown. On an unknown date the patients were vaccinated with doses of incorrect stored ZOSTAVAX (dose, route and lot# were unknown). No adverse effects were reported. This is one of several reports received from the same reporter (1505USA005209 and 1505USA005210). Additional information has been requested.
60 min erythema. Pain and swelling. Tdap given on 4/24/2013 at 1030 am. Swelling noted on 4/24/13 at 1700. Area noted worse on 4/26/13 in AM (R) deltoid.
deep vein thrombosis in leg; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4369015-00.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Manufacturer: Pfizer Biontech Covid-19 Vaccine, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer Biontech Covid-19 Vaccine, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "deep vein thrombosis in leg". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of deep vein thrombosis. The patient was treated with Xarelto. Patient was on was on blood thinner. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of DEEP VEIN THROMBOSIS IN LEG with HUMIRA(ADALIMUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of "deep vein thrombosis in leg" with the suspect product(s) BNT162b2 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event DEEP VEIN THROMBOSIS and the suspect drug BNT162B2.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Patient found unresponsive in home, attempted CPR and provided epi x 3 in transport to ED.  ACLS continued at the ER, but RSC unable to be achieved. Death pronounced at 0925 AM
possibility some doses were administered, were already expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 18-Nov-2022 Reporter's comment: The pharmacist reported that a box of bexsero expired doses had some activated syringes. Once he found that box, he reported that exists the possibility that some doses were administered in spite they were already expired.  The reporter did not had information about potential patients. The reporter did not consent to follow-up. Additional supportive information: The patients received an expired dose of Bexsero, which led to expired vaccine used. The case kept valid as master case based upon the reported possibility of administration of doses.
This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 53-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 6 months and 1 day prior to the 2nd dose of SHINGRIX). On 9th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), injection site pain, injection site bruising, muscle pain, tiredness and injection site swelling. On an unknown date, the outcome of the cellulitis, injection site pain, muscle pain, tiredness and injection site swelling were recovered/resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the cellulitis, injection site pain, injection site bruising, muscle pain, tiredness and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: After a dose of SHINGRIX the patient had swelling and bruising at the injection site. It was painful, like he was hit in the arm by a bat, and he had some cellulitis going down his arm. He also experienced more general muscle pain and tiredness, but not enough to stop him from going to work. The patient was fine now.
Two hours after receiving the vaccine, pt began having eye swelling, a rash on upper portion of body and itching.
localized erythema warmth & swelling to Lt  thigh that was 4-5 cm in diameter. treatment - benadryl PO & topical, zyrtec, tylenol. Ibu outcome - continuing to monitor
Cellulitis at vaccination site.  Occurred 03/02/2005.  Started on veclex 2 times per day for 7 days.
Facial/neck swelling. Face and neck reddened. Sensation of something caught in throat. Itching to back and chest.
se llenó de alergia / full on allergy; se marea / gets dizzy; El.labio del paciente está bien reventado, y las orejas parece que le hubieran reventado / lip is well busted, and his ears look as if he had been blused; tiene hinchada su cara, su cuello y su cabeza y parte de las espalda como si le hubieran picado hormigas / swollen face, neck and head and part of the back as if they had been stung by ants; ears look as if he had been busted; lip is well busted; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (se llenó de alergia / full on allergy), DIZZINESS (se marea / gets dizzy), SWELLING (El.labio del paciente está bien reventado, y las orejas parece que le hubieran reventado / lip is well busted, and his ears look as if he had been blused), SWELLING FACE (tiene hinchada su cara, su cuello y su cabeza y parte de las espalda como si le hubieran picado hormigas / swollen face, neck and head and part of the back as if they had been stung by ants) and SKIN ABRASION (ears look as if he had been busted) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HYPERSENSITIVITY (se llenó de alergia / full on allergy), DIZZINESS (se marea / gets dizzy), SWELLING (El.labio del paciente está bien reventado, y las orejas parece que le hubieran reventado / lip is well busted, and his ears look as if he had been blused), SWELLING FACE (tiene hinchada su cara, su cuello y su cabeza y parte de las espalda como si le hubieran picado hormigas / swollen face, neck and head and part of the back as if they had been stung by ants), SKIN ABRASION (ears look as if he had been busted) and CHAPPED LIPS (lip is well busted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at a dose of 20 mg. At the time of the report, HYPERSENSITIVITY (se llenó de alergia / full on allergy), DIZZINESS (se marea / gets dizzy), SWELLING (El.labio del paciente está bien reventado, y las orejas parece que le hubieran reventado / lip is well busted, and his ears look as if he had been blused), SWELLING FACE (tiene hinchada su cara, su cuello y su cabeza y parte de las espalda como si le hubieran picado hormigas / swollen face, neck and head and part of the back as if they had been stung by ants), SKIN ABRASION (ears look as if he had been busted) and CHAPPED LIPS (lip is well busted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SARS-CoV-2 RNA Resp Ql NAA+probe~SARS-CoV-2, qPCR performed on 7/20/21. Test came back positive. Case investigation interview with patient has not been performed as of the time of this note.
Mother called to report pt woke up 4-22-10 8 AM with "pain" to eyes and both legs felt like lead and fatigue. Reviewed VIS. Advised mother to take pt to see healthcare provider this AM. Will call her back 4/27/10.
Her throat hurts a little bit and her stomach hurts a little bit.; Her throat hurts a little bit and her stomach hurts a little bit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "Her throat hurts a little bit and her stomach hurts a little bit.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.