chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NEUROENDOCRIME TUMOR; PAIN IN EXTREMITY; This spontaneous report received from a patient concerned a 64 years old male. The patient's weight, height, and medical history were not reported. The patient received Ibrutinib (tablet, oral, batch number: 1140389) 420 mg, every 1 day, from SEP-2020, for chronic lymphocytic leukemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported), start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced neuroendocrime tumor, and pain in extremity. Laboratory data (dates unspecified) included: PET scan (NR: not provided) which showed Neuro endocrine tumor. Treatment medications (dates unspecified) included: lanreotide to suppress the growth in every 28 days of tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ibrutinib was not changed. The patient was recovering from pain in extremity, and the outcome of neuroendocrime tumor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-Neuroendocrine tumor. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
pregnancy with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnancy with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date is 03-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UT7682KA and expiry date: unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of pregnancy with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient had no adverse event. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken : not applicable.  Outcome: Unknown  Additionally, at time of reporting, the pregnancy was still ongoing.
Arm was swollen ,gigantic, humongous like the incredible hulk,; Can put their hand around it.; Cold and sweating; Couldn't sleep; Felt sick; Pain in their entire body; Headache; Fever; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen ,gigantic, humongous like the incredible hulk,), MOVEMENT DISORDER (Can put their hand around it.), NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep) and MALAISE (Felt sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004f21a and 078cz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep), MALAISE (Felt sick), PAIN (Pain in their entire body), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm was hurting). On 11-Sep-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen  ,gigantic, humongous like the incredible hulk,) and MOVEMENT DISORDER (Can put their hand around it.). The patient was treated with NAPROXEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 11-Sep-2021, NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep), MALAISE (Felt sick), PAIN (Pain in their entire body), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm was hurting) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm was swollen  ,gigantic, humongous like the incredible hulk,) had not resolved and MOVEMENT DISORDER (Can put their hand around it.) outcome was unknown.      Concomitant product use was not provided by the reporter. it was reported Paitent arm was still gigantic.   This case was linked to MOD-2021-295327 (Patient Link).
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 14-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1906USA011674:
light headed, dizziness, slight nauseous, warm feeling, then chills, throat feels strange  Water and  crackers given, felt better after water, crackers
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site lump, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site lump, injection site erythema and injection site itching were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site lump, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The reporter did not consent to follow up.
did not experience any symptoms; inadvertently administered one dose of each of varivax and proquad; This spontaneous report was received from a registered nurse refers to a 12 month old patient. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 20-NOV-2019, the patient was inadvertently vaccinated with one dose each of varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S006018 with an expiry date of 27-FEB-2021 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) of lot# S008569 with an expiry date of 16-SEP-2021 both for prophylaxis (strength, dose, anatomical location and route of administration was unknown for both the suspects) (inappropriate schedule of product administration). The patient did not experience any symptoms (no adverse event). The outcome of inappropriate schedule of product administration was unknown. No product quality complaint (PQC) was involved with this report.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information were provided. No treatment medication were provided. Vaccine was refrigerated on 07-May-2021.
had developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number T79D7, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown 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 believes he received 1st dose of Shingrix and experienced shingles.
This spontaneous report was received from a medical assistant who reported that on an unknown date, improperly stored doses of PEDVAXHIB, (lot #s M036056, expiry date 18-MAY-2019 and L042258, expiry date 18-AUG-2018) had been administered to unspecified patients. The numbers of doses were unspecified. There was a previous temperature excursion for the vaccines of 47°F to 77°F for 45 minutes. Then, the vaccines had other temperature excursions of 47°F to 77°F for 4 hours. No data logger involved. No adverse effects were reported. This is one of three reports from the same reporter source, (linked to MARRS # 1706USA008963 and 1706USA009319). Additional information has been requested. Sender's Comments: US-009507513-1706USA008963: US-009507513-1706USA009318.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 11th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced rash and joint pain. On an unknown date, the outcome of the rash and joint pain were recovering/resolving. It was unknown if the reporter considered the rash and joint pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a rash down her arm and really sore joints. The healthcare professional did not know the onset but patient informed her of this on Saturday 13th October 2018.  It was getting better. The healthcare professional stated that would informed the patient to call the agency as well to report this.
LUMPS COME UP, LAST LUMP WAS BEHIND THE RIGHT EAR; KNOTS UNDER SKIN; ITCHING; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: calamine, and hydrocortisone. On 21-JUL-2021, the subject experienced itching. On 21-JUL-2021, the subject experienced knots under skin. On an unspecified date, the subject experienced lumps come up, last lump was behind the right ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, and knots under skin, and the outcome of lumps come up, last lump was behind the right ear was not reported. This report was non-serious.
Streaking red rash and low grade fever x 24 hours; pain to higher degree than expected
CDC reports: 4 mo infant developed local rxn consisting of swelling, & crying for 2 hrs following immunization, was pale & "moved in slow motion" at home, seen at ER; Dx crying due to pain.
I got my hep A shot approx 1100 hrs and at approx 1400 hrs my body began to ache like I had the flu. At approx 2130 hrs I began to break out in hives and then approx 1 1/2 hrs later I went to the ER.
I had mild flu symptoms after the first shot. I was down for a couple days.  The second shot was way worse.  I am on day 6 and still have a lot of pain in my upper arm. I was absolutely down for three days with flu like symptoms, fever, bodyaches, severe sweating, increased heart rate and nausea. Tylenol and Advil did not help at all. I was just incredibly sick for over three days. Better today, but my upper arm is still hot to the touch and quite sore.
a weird feeling; a fever of 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (a weird feeling) and PYREXIA (a fever of 102 degrees) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B214) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (a weird feeling) and PYREXIA (a fever of 102 degrees). At the time of the report, FEELING ABNORMAL (a weird feeling) and PYREXIA (a fever of 102 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature (36-37 degree Celsius): 38 degree Celsius (High) 102 F.     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.   Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR : AE outcome
Late 3/4 afternoon I had an itchy arm. It is red and rashy with a bump in the middle but it is NOT on the injection site. it looks like a teardrop shape down my arm about an inch from my elbow. I put Benadryl cream on it last night and hoped it would go away over night but it has not.
Swelling under my left arm pit the size of a lemon  assumed lymph node; Pfizer:Dose Number: 1 Batch/Lot No: .03/  Moderna Dose Number: 2 Batch/Lot No: 65081186-1221; Pfizer:Dose Number: 1 Batch/Lot No: .03/  Moderna Dose Number: 2 Batch/Lot No: 65081186-1221; Pfizer:Dose Number: 1 Batch/Lot No: .03/  Moderna Dose Number: 2 Batch/Lot No: 65081186-1221; This is a spontaneous report from a contactable Other Health Professional(patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 05Nov2021 13:00(at the age of 57-years-old) (Batch/Lot Number: EA6780) as single dose for covid-19 immunisation in Pharmacy or Drug Store. The patient was not pregnant. The patient was not pregnant at time of vaccination. Medical history included psoriasis from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no Known allergies.Concomitant medications included vitamin d, fish oil and vitamin c (ASCORBIC ACID) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unspecified date(Batch/Lot Number: 03) as single dose for covid-19 immunisation and Moderna as dose 2 via an unspecified route of administration on unspecified date(Batch/Lot Number: 65081186-1221) as single dose for covid-19 immunisation and experienced Interchange of vaccine products. The patient experienced swelling under my left arm pit the size of a lemon assumed lymph node on 07Nov2021, pfizer: dose number: 1 batch/lot no: .03/ moderna dose number: 2 batch/lot no: 65081186-1221 on an unspecified date. No treatment received for the event. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
developed pneumonia; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from contactable nurse, the patient.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported.  On 26Dec2020, the patient tested positive for COVID-19 and subsequently developed pneumonia on an unknown date. Due to this, the patient did not get her second dose which was scheduled on 12Jan2021 as she was still ill. The clinical outcomes of COVID-19 and subsequently developed pneumonia were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Patient had received two immunizations (Bexsero and Menactra) and passed out about 30 seconds after both immunizations were given. Patient fell off the exam table due to passing out and endured a laceration to the right side of his bottom lip due to the impact of the fall and the braces that that patient has. The provider was in the next room down when this occurred and quickly came to assist with the patient. The patient's vitals were taken several times and the provider did neurological checks as well. The patient stated to feel nauseous again and started to get tremors throughout his body. Provide states was neurologically intact,. When patient attempted to sit up became lightheaded and dizzy twice. Due to the patient not bouncing back quickly and declining in his state of health the provider decided to transport to ER.
Patient has been experiencing constant muscle pain in the left arm for the last 7 days since vaccination was received. Pt has stated she has trouble moving arm backwards. Will be seeking or scheduling appointment with her doctor.
ACUTE PULMONARY EMBOLISM 4/6/2022 CANCER METASTATIC TO UNSPECIFIED LN  ACUTE PULMONARY EMBOLISM 4/6/2022 COLORECTAL CANCER
Ears started ringing loud on the 4th day still ringing today when hot second dose.
Seizures - onset probably about 3/13.  First seen for this 3/20 or 3/21. Seizure Disorder - initially diagnosed 3/20 - observed at daycare probably around 3/12 - In retrospect may have been as early as 3/5. So far 3 hospitalizations
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative via Pfizer, Inc. concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: minocycline allergy. On an unspecified date, the patient previously vaccinated with elasomeran (Moderna vaccine) (Dose Number in Series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, vaccine administered at left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with elasomeran (Dose Number in Series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (Dose Number in Series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered at left arm on 07-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included cannabidiol (CBD oil) for unknown indication, magnesium for unknown indication, menaquinone-7 (K2) for unknown indication, vitamin d nos for unknown indication, zinc for unknown indication and X (drug name unspecified) for unknown indication.  On an unspecified date, the patient experienced confirmed covid-19 infection. On 07-JUL-2022, the patient tested positive for coronavirus disease (COVID-19) test hence confirmed clinical vaccine failure. On the same day the patient started treatment with Paxlovid. The last dose of Paxlovid was administered on 12-JUL-2022 for the treatment of COVID-19. On 13-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 18-JUL-2022, the symptoms returned. On 19-JUL-2022, Laboratory data included: COVID-19 virus test Positive (Dose Number in Series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and the action taken for paxlovid was drug withdrawn on 12-JUL-2022. The outcome of the confirmed clinical vaccine failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000243918.; Sender's Comments: V0: 20220752325- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Client states had "flu-like" symptoms 24 hrs after immunizations of H1N1 and PNEUMOVAX.  Had temp of 101 F, achy, sore (L) arm near armpit, not at site of injection.  Feels "fine" today, with quarter-sized red spot under (L) arm.  Encouraged to speak to own physician.  F/U 1/8/10 "Red spot" (L) underarm improved, no further problems.