chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HSV2 outbreak; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex (HSV2) and was ongoing at the time of this report. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 15Apr2021, a day after receiving the vaccine, the patient experienced HSV2 (Herpes simplex virus-2) outbreak. The patient had gone almost a year without an outbreak. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event HSV2 outbreak was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
9AUg94 pt devel fever 102-103, nausea, malaise; had febrile sz on 10AUG94; was taken by ambulance to hosp & had 3 more szs; fever persisted; was hospitalized x 9 days;encephalitis r/o; pt cont to be on Tegretol
MCV4 was administered in R deltoid and patient was fine. Hep B #3 was administed in Left deltoid and right after that immunization the patient started complaining of feeling sick to his stomach. He began sweating profusely and cool compresses applied. The parent was notified and on way to the school. The student stated that this happened the last time he received a vaccine. The student became very weak and lethargic. He would spit in the trashcan every so often. Parent arrived and stated that this had never happened before. Ambulance was called. Student's O2 Sat was 98-99% and heartrate was 75-80 a minute through out. Blood Pressure was 97/78. Student began to respond to mother and student stood up to walk out. Ambulance was cancelled per parents request. Student was instructed to sit down and escorted out to mom's vehicle via wheelchair. Student was still complaining of his stomach hurting when he left. He was going to the urgent care center in town and family is foreign speaking only--our translator went with family. Student never had rash, hives or any difficulty breathing.
This study case was received from the investigator in a trial on 14 August 2013. A 23-year-old male subject was found to have unspecified disease of pericardium 13 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 21 May 2013 and 20 days after receiving a dose of TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported) on 14 May 2013. Relevant laboratory data included abnormal troponin I at 00.70 and a normal ECG and echocardiogram on 03 June 2013. Treatments were not reported. Past medical history included chest pain, abnormal ECG (electrocardiogram), dizziness/fainting spells, shortness of breath, and eczema. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
anaphylaxis; This is a spontaneous report from a contactable other healthcare professional on behalf of a physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced anaphylaxis after the administration of meningococcal group b rlp2086 on an unspecified date. Outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
flare up on left forearm-lesions; injection site warmth; tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of skin lesion in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced skin lesion, pain in arm and touch sensitivity increased. The patient was treated with acyclovir. On an unknown date, the outcome of the skin lesion was recovered/resolved and the outcome of the pain in arm and touch sensitivity increased were unknown.   It was unknown if the reporter considered the skin lesion, pain in arm and touch sensitivity increased to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who himself was a nurse. The age at vaccination was not reported but the age could be 63 or 64 years. In 2018 a year ago from the date of reporting, the patient received 1st dose of Shingrix in the right arm. A week or two later, there was a flare up on left forearm- lesions, sensitive to touch and painful. The reporter would like to know if he could receive the 2nd dose or could restart the series based off of the flare up. The reporter consented to follow up. This case had been linked to the case US2019142355, reported for the dose 2 of the same patient.
arm pain after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain after previous doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Drug allergy, Cancer (Started 25 to 30 years ago), Blood pressure abnormal and High cholesterol.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain after previous doses). At the time of the report, VACCINATION SITE PAIN (arm pain after previous doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unknown blood pressure and high cholesterol medication.  No treatment medication reported.   This case was linked to MOD-2022-559342, MOD-2022-559589, MOD-2022-559608 (Patient Link).
Inflammation and sores on  back of tongue and inner lip.; Inflammation and sores on back of tongue and inner lip.; Inflammation and sores on back of tongue and inner lip.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 25Feb2021 at 13:45 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included polycythemia vera, shellfish allergy, allergy to legumes (raw peas) and allergy to nuts (some nuts). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydroxycarbamide (HYDROXYUREA) and warfarin (MANUFACTURER UNKNOWN); both taken for unspecified indications on unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 25Feb2021 at 15:15, the patient experienced inflammation and sores on back of tongue and inner lip. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with triamcinolone acetonide (MANUFACTURER UNKNOWN) dental paste. The clinical outcome of the events inflammation and sores on back of tongue and inner lip was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Vaccine had expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) 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.   This case was linked to MOD-2021-015145, MOD-2021-075375, MOD-2021-075452, MOD-2021-075507 (Patient Link).
1/17/17 pt returned to our office complaining of sore left arm above elbow.  Left arm, mid area between elbow and shoulder,  with redness noted, a little warm to touch.pt states that arm had been unusually sore, but soreness did not start, nor did redness, until at least 2-3 days post injection.
Sore at injection site, hoarse, red itchy eyes, cough, aches, headache, fatigue.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 63 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 (dose number in series 1) (suspension for injection, route of admin, and batch number not reported) dose was not reported,1 total, therapy start date was not reported for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total, administered on 15-DEC-2021 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-DEC-2021, the patient experienced administration of expired vaccine (dose number in series 2) and no other adverse events reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211235069.
Dose one was given without diluent being added to vial.  0.3 ml dose given.  Patient waited for 30 minutes at vaccination site without any signs and symptoms developing.
Breakthrough case admission after 3 vaccines Moderna 2/19/21 Lot# 023M20A;  MOderna 3/19/21 Lot# 002B21A;  Moderna 11/2/21 Lot# 077C21B
Pt. had dizziness upon receiving vaccine and then developed a rash on right torso 30 minutes after vaccination.
Muscle, joint pain.  The worst is the pain in my lymph nodes.  I had nodes removed for cancer screening in the location of the pain.  this is day three of the painful lymph nodes.
This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot # R003293, expiration date 31-JUL-2019 for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute PROQUAD was properly stored. No adverse effects were reported. The vaccine was exposed to temperature excursion between minus 14 degree Celsius (C) and minus 10 degree C (average minus 12 degree C) for a time frame of 25.5 hours without previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter (MARRS # 1902USA006189). Sender's Comments: US-009507513-1902USA006189.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was was receiving palliative care for pancreatic cancer that was diagnosed in 9/2019. Patient presented to medical center on 3/8/21 with pneumonia and fluid around heart/abdomen requiring paracentesis and later passed away on 3/17/21.
Left arm pain - below injection site to hand - 24 hours after inj. fever - 100 degrees - sore throat, right ear ache. 48 hours after inj.
Fever 103, diarrhea, ROM, dx ear inf. 9/3/08. Tylenol, Motrin, Cefzil.
The day after he received the Booster ( had taken Moderna for his other vaccines and Booster No,1) he spiked a fever to 105, shaking chills, fatigue, generalized malaise.  He ended needing to be hospitalized for one day because of elevated liver function tests,  hepatosplenomegaly, pneumonia and other abnormal lab results.
right ear pain that radiated down the right side of her neck/ diagnosed with otitis media; irreversible pulpitis with symptomatic apical periodontitis which required a root canal; irreversible pulpitis with symptomatic apical periodontitis which required a root canal; she continued to experience severe pain after the root canal and was diagnosed with trigeminal neuralgia; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or around 27-OCT-2016, she was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered right ear pain that radiated down the right side of her neck and was diagnosed with otitis media. On an unknown date, shortly after, she was diagnosed with irreversible pulpitis with symptomatic apical periodontitis which required a root canal. She continued to experience severe pain after the root canal and was diagnosed with trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination, she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
Approx 12 hours after immunization pt spiked fever to 103 followed by seizure of 3-4 min.
Premature ventricular contractions very frequently (less than 1 min apart). Began on 10/1/21 at 6pm and continued until 10/2/21 all day. Fewer on 10/3/21 and 10/4/21. Disappeared by 10/5/21.
Employee described symptoms of nausea, vomiting, diaphoretic, and sensation of burning of tongue.
Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thrombocytopenia.  Clinical Presentation and Course: 1 week after receiving Janssen COVID19 vaccination, patient developed gradually worsening headache. On March 17th, patient presented to Hospital with dry heaving, sudden worsening of headache and  L sided weakness.  Evaluation with head CT revealed a large R temporoparietal intraparenchymal hemorrhage with 1.3cm midline shift.  She ended up getting intubated for worsening mental status. On evaluation at arrival in Medical Center, she was noted to have extensor posturing.  Repeat imaging revealed worsening midline shift to 1.6cm.  CTA showed cortical vein thrombosis involving the right transverse and sigmoid sigmoid sinus with tentorial herniation. Patient developed brain herniation and brain death was pronounced on March 18th, 2021.
The first I was sick for 2 days with fever; Fever; Flu-type symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EW0167) via unknown route of administration on unspecified date as dose 1 single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that after first I was sick for 2 days with fever. The first one was fever and like a Flu-type symptoms. I was like in bed for 2 days. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Joint pain, fatigue, antibiotics and pain medication were prescribed. I still have the pain and fatigue.
Admitted to hospital on 6/26/22-6/30/22. Presented to the ED with c/o shaking.  Diagnosed with tremors, covid, elevated troponin, and UTI. Had visual hallucinations. Confirmed alcohol withdrawal and acute psychosis during hospitalization. Consulted social work, neurology, cardiology, and psychiatry during admission
Information has been received from a health professional concerning a female pt who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, within a few days of vaccination, the pt experienced a varicella rash over the entire body. It was described as a disseminated rash with several lesions, some vesicular in nature. No prescription drug treatment was needed for the experience and there was no hospitalization. The pt recovered. Additional info has been requested.
My ears started ringing about a week after the first dose. They have not stopped. First dose was 3/9/21, second dose was 3/30/2021 Lot #EP6955.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PROGESTERONE from 23-Jan-2021 to an unknown date for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Dec-2020 and the estimated date of delivery was 03-Oct-2021. On 02-Mar-2021, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 02-Mar-2021, PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of pregnancy for mRNA-1273,  with no associated AEs. Patient will continue to be contacted for further monitoring of AE's during the pregnancy.