chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse reported that a 20 years old patient received PROQUAD.; No additional AEs; This spontaneous report was received from the nurse, regarding to a patient of 20-year-old of unknown gender. The patient's pertinent medical history, current conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On an unknown date, at the age of 20 years-old (Product administered to patient of inappropriate age), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not reported).
Vaccine was given as a booster dose.  Client had had 2 Pfizer doses on 4/10/21 and 5/10/21.
"puking violently"; severe reaction to the injections; CAPTURING THE STORY   This is a non-interventional study report.  A 58 year-old female patient received bnt162b2 (COMIRNATY), on Aug2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation; talimogene laherparepvec (TALIMOGENE LAHERPAREPVEC/ (T-VEC)) (Batch/Lot number: unknown). Relevant medical history included: "Melanoma", start date: Jan2015 (ongoing), notes: Surgery - Feb2015, Subsequent radiation therapy, pembrolizumab (KEYTRUDA), binimetinib (MEKTOVI), encorafenib (BRAFTOVI) 2015-2020, T-VEC - 2021. The patient's concomitant medications were unknown. The following information was reported: VOMITING (hospitalization) with onset Aug2021, outcome "recovered" (Aug2021), described as ""puking violently""; INJECTION RELATED REACTION (hospitalization) with onset Aug2021. During an interview about the patient's experiences before and throughout the COVID-19 pandemic, patient described receiving T-VEC injections in early 2021 (12 injections between Jan 2021 and April 2021) without serious side effects. Patient then received notification that the injections had effectively treated the existing tumors. However, in early August 2021 patient was notified that a new tumor was present, and would need to receive additional T-VEC injections. Patient then came down with COVID-19 in early August 2021 and had to postpone treatment. Patient's doctor then advised patient to receive the COVID-19 vaccine (patient was previously unvaccinated), which patient did so approximately 2 weeks after recovering from COVID-19. Patient then returned to received T-VEC injections approximately 10 days after receiving the first dose of the Pfizer COVID-19 vaccine, and had a severe reaction to the injections, including "puking violently" that required hospitalization. Patient's oncologist attempted T-VEC injections two additional times after that, and patient had a similar reaction each time. Additionally, approximately 13 new tumors had formed following receiving the COVID-19 vaccine. Patient attributes both the reactions and growth of new tumors to receiving the Pfizer COVID-19 vaccine. The action taken for study drug BNT162B2 was not applicable, while for talimogene laherparepvec was unknown. The outcome of events were recovered on Aug2021.  The investigator considered there was not a reasonable possibility that the events "puking violently" and "severe reaction to the injections" was related to bnt162b2. The causality assessment for interacting product talimogene laherparepvec was not provided.; Sender's Comments: Based on the current available information, a causal association between the suspect product BNT162B2 and the reported events vomiting, injection related reaction were considered as unrelated.
patients that after he got moderna booster shot, he experienced lymphadenopathy. he says there is swelling on various lymph nodes on his body, gained over 5 pounds of water weight. he says the swelling has not gone down at all. I told him he needs to talk to his doctor or see urgent care.
FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
STROKE; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. 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 next month after vaccination, the patient experienced stroke, and was in a wheel chair, probably will be rest of life. As per the patient, "I got the J & J vaccine and had stroke the next month. Still in a wheel chair and probably will be rest of my life. Cannot believe that do not have to compensate us for this". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221217904- Stroke.  The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.
Headache; Fever temperature of 99.3 F; exhaustion; swollen lymph nodes; tenderness under armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes), AXILLARY PAIN (tenderness under armpit), HEADACHE (Headache), PYREXIA (Fever temperature of 99.3 F) and FATIGUE (exhaustion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and AXILLARY PAIN (tenderness under armpit). On 12-Jan-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever temperature of 99.3 F) and FATIGUE (exhaustion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) was resolving and AXILLARY PAIN (tenderness under armpit), HEADACHE (Headache), PYREXIA (Fever temperature of 99.3 F) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included vitamins and Birth control; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
they accidentally administered FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE with no reported adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/ non health care professional via Agency (reference number 00824877).  This case involves a 66-year-old male patient who was by mistakenly given dose of suspect and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 21-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7336LA and expire vaccine: 21-Oct-2022) (Frequency Once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "Nurse practitioner asks what the proper next steps would be; asks if the patient should still receive FLUZONE HIGH DOSE in addition to the FLUZONE QUADRIVALENT that was already administered."  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Thursday evening was extreme fatigue and mild body aches. Friday 2/11/22: Severe fatigue - inability to carry out normal daily tasks, slept for 13 hours straight, husband had to leave work early to pick our kids up from daycare because I couldn?t.  Stiffness and pain in whole left arm, armpit, muscle between collarbone and breast - can?t turn the steering wheel with my left arm when I drive Severe muscle and bone pain in my whole bodymade it very hard to move.  Headache, nausea, no appetite, diarrhea, sharp lower abdominal pains, pain in right upper abdomen, fever 102 Woke up at 1am confused, nauseous, and extremely thirsty Saturday 2/12/22 (current symptoms) moderate body aches, moderate fatigue, mild nausea and decreased appetite, stiffness and soreness in left arm are the same as they were Friday
Couldn't even lift arm; Pain (shooting into jaw line a couple of days ago); Heaviness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heaviness), LIMB DISCOMFORT (Couldn't even lift arm) and PAIN (Pain (shooting into jaw line a couple of days ago)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LIMB DISCOMFORT (Heaviness) and PAIN (Pain (shooting into jaw line a couple of days ago)). On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Couldn't even lift arm). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (Heaviness), LIMB DISCOMFORT (Couldn't even lift arm) and PAIN (Pain (shooting into jaw line a couple of days ago)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the patient. The patient stated that she had several Chinese herbs and turmeric.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: follow up added
Pt. states the symptoms started bilateral leg tingling and numbness. Patient has history of cardiovascular issues. She states she takes 325mg of Aspirin daily and also has multiple stents.
large saddle PE with large clot burden and scattered pulmonary emboli throughout all lobes.
About six weeks after the second Moderna COVID vaccine, I started experiencing thirst, more frequent urination and noted some weight loss. This continued and then by end of April 2021, I started experiencing other symptoms including white flakes in urine, cramps in calves, and dry mouth. I sought medical care for these odd symptoms and despite having normal blood glucose at annual physicals, including in July 2020, my blood glucose run on 6/10/21 was 379. I do not have any history of diabetes nor is it in my family history, parents, siblings, grandparents and aunts/uncles on both sides. I have been started on glucose monitoring and insulin as of 6/18 with my primary care physician. I have a follow up with an endocri
Light-headed-ness, headache, mild nausea, increased heart rate with a sudden onset within 5 hours after vaccination. Instructed to contact Primary Care Physician the next morning (07-OCT-2020). Informed that no testing was necessary at this time and to call 911 if symptoms became worse.
Chills, fatigue, body aches, red scratchy eyes. Improved the next day.
Severe Muscle pain; excruciating pain at his left hand side; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe Muscle pain) and PAIN IN EXTREMITY (excruciating pain at his left hand side) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Severe Muscle pain). 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain at his left hand side). At the time of the report, MYALGIA (Severe Muscle pain) and PAIN IN EXTREMITY (excruciating pain at his left hand side) outcome was unknown.
This spontaneous report as received from a Medical Assistant via a Company Representative refers to a 20 year old male patient with type I Diabetes. On 17-AUG-2012, the patient was vaccinated intramuscularly (IM) with a dose of PNEUMOVAX23 (Lot #, and dose not reported). Concomitant medications were not reported. On 20-AUG-2012, while on PNEUMOVAX23, the patient had a seizure. The patient sought Medical Attention; he was admitted to an unspecified hospital (date unknown) for an unspecified length of time. Patients outcome was reported as recovered (stop date not reported). The relatedness between the event and PNEUMOVAX23 was unknown. Additional information has been requested.
He experienced an extremely high fever (103.9 °F); This is a spontaneous report from a contactable consumer (patient's wife). A 65-years-male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not reported), via an unspecified route of administration on 21Apr2021 (at the age of 65-years-old) as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient experienced an extremely high fever (103.9 °F). Treatment received on same day at night (21:00) acetaminophen (TYLENOL) and the fever has not dropped so much. Today he had a fever of 101.7 °F and now it's at 101 °F. Reporter would like to know if she could be able to give patient ADVIL instead of acetaminophen or alternate between both. The outcome of event was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from an unknown source concerning an 11-year-old white female with no pre-existing allergies, birth defects or medical conditions, who on an unspecified date in December 1995, was vaccinated with a second dose of Varivax. There was no illness at the time of vaccination. There was no concomitant medication. On 14-MAY-2006 the patient developed a mild case of chickenpox. It was noted that she contracted them from her father who had shingles. She had a couple dozen spots on her face, back and stomach that were not very itchy. It was unspecified if the patient sought medical attention. No outcome was reported. Additional information has been requested.
01-18 began at night (5 hours post vaccination) with pain in the arm, moderate intensity (he could not tolerate moving or lifting it) acetaminophen treatment 13ml every 4 hours. This event currently continues with mild intensity 01-20 starts at 10am, fever starts 38c treatment acetaminophen ends 01-21 persists with pain, weakness and headache.
This vaccine was given after BUD. Parent did not report any adverse  reaction after receiving this vaccine.
Patient expressed anxiety.  Had same symptoms with flue vaccine in 10/2020.  Left arm injection site no redness, warmth.  Patient expressed both parents recently passed away and expressed increased anxiety.    Pt walked to the car, steady and stable.  Pt will take tylenol as prescribed, rest, and hydrate.    Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs.  Pt denied HTN.   Vitals: At 13:25, 160/82.  1 minute after 99  At 13:45, 160/82, 98HR,  99% spo2.
Systemic Lupus; Weird; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Systemic Lupus"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Weird". The events "systemic lupus" and "weird" required physician office visit.  Clinical course: The reporter stated that very soon after having Comirnaty, the patient started having very weird, generalized symptoms. The reporter referred the patient to a Rheumatologist and the patient was diagnosed with Systemic Lupus. The caller was asking about other patients that may have been reported possibly having an autoimmune type of flare when the caller connected the reporter to medical. Caller is unaware of any other medications, medical conditions, labs, testing, or treatments for the patient relevant to these events. At that time, the caller did not think about it being an adverse event because the reporter wasn't even sure that it was an adverse event related to Comirnaty.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Systemic lupus erythematosus and the suspect drug BNT162b2 (COMIRNATY) cannot be excluded. 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.
Headache, Myalgia, chills Narrative:  employee states: the night of the second injection experienced chills, headache, joint and muscle aches
Vaccine adjuvant without active component; Received vaccine adjuvant without active component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Shingrix. On 20-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: Received vaccine adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter reported that the patient received Shingrix vaccine adjuvant without active component. The reporter did consent to follow up. The reporter gave by error Shingrix adjuvant portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case had been linked with US2023058298 and US2023AMR058824 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023058298:Same reporter/Other patient US-GSK-US2023AMR058824:Same reporter/Batch case
4 days after shot started to feel slurred speech, fatigue, 'sleepy', bilateral drooping of eyelids and right sided jaw/dental pain.  13 days after shot (11/17/21) had admission for CHF/volume overload and new onset Atrial fibrillation.  She had another hospitalization 12/14/21 where she was found to be in heart failure with volume overload and pleural effusions were noted.  She had another hospitalization for acute dizziness and a fall 1/31/22.
Covid like symptoms - full body chills, full body soreness especially in the chest and neck areas, headache,  general malaise and lethargy, extreme pain at injection site - so severe that it woke me up from sleep.
IPOL vaccine was given to a patient after the expiration date with no reported adverse event; Initial information received on 11-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who reported IPV (VERO) [IPOL] vaccine was given to a patient after the expiration date 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 Hepatitis B Vaccine for Prophylactic vaccination (immunization).  On 11-Aug-2023, the patient received a dose 0.5 ml of suspect IPV (VERO) Suspension for injection lot U1C571M expiry date: 17-JUN-2023 via intramuscular route in unknown administration site for immunization.  On 11-Aug-2023  ipol vaccine was given to a patient after the expiration date with no reported adverse event (expired product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event ipol vaccine was given to a patient after the expiration date with no reported adverse event.  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.