chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gardasil was administered subcutaneously, not intramuscularly, as the person who did the injection in the hospital did not pay attention; This spontaneous report was received from a patient of unknown age and gender referring to themselves. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), subcutaneously, for prophylaxis (formulation, dose, lot number and expiration date were not reported), rather than intramuscularly, as the person who did the injection in the hospital did not pay attention. The reporter wanted to know if this mistake prevented the efficiency of the vaccine and if the dose should de repeated.
Pt tested positive for COVID ON 8/25/22  at home; discovered unresponsive at her home on 8/27/22; pt deceased; Medical Examiner stated COD:  COVID 19 viral infection
This spontaneous report has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were not reported), lot# M037533 with expiration date 31-MAY-2018, for prophylaxis. The vaccines were exposed to temperature excursion of 9 degrees Celsius to 25 degrees Celsius for 2 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA000379: US-009507513-1707USA012435:
Shot administer on the 5/14/07. Fever of 104 on 5/22/07 - fever remained through 5/24/07 (dropping to 101). Onset of generalized rash on 5/24/07 through present. Rash is all over body & itchy. Rash & fever have inhibited sleeping pretty drastically.
Initial report was received from a consumer on 19 October 2012. A 64-year-old female patient had received an intramuscular injection of FLUZONE High-Dose, lot number U4497AA, in the right arm on 17 September 2012. Six hours later on 17 September 2012, the patient experienced hearing loss in her right ear. She was seen the next day and her ear was irrigated but the hearing loss continued. The patient was seen on 26 September 2012 for complaints of vertigo. The patient was seen by an ear nose and throat (ENT) doctor on 12 October 2012 and diagnosed with bilateral hearing loss with right greater than left. An MRI of brain was scheduled to rule out tumor. The patient had a "follow-up for asthma" at the time of vaccination. The patient had a history of asthma, deep vein thrombosis (DVT), hypertension, rheumatoid arthritis, rhinitis, osteoarthritis, endometriosis and bladder hypertonicity. The patient had allergies to sulfa and penicillin. The patient's outcome was not recovered. Documents held by sender: None.
Moderna vaccine was given to a 16 year old patient. No adverse event reported. Patient's primary physician to be contacted regarding incident and consulted on decision to continue series.
81 y.o. male admitted 1/10/2022 with PMHx significant for HTN, HLD, diastolic heart failure, CKD III (baseline 1.2-1.3), CVA, seizure disorder, BPH, alzheimer's dementia who presented from SNF with increasing hypoxia and COVID positive. The history was obtained from the patient's wife via telephone as patient not able to provide much information with his underlying dementia. She notes he was moved to long term care Monday and tested positive on Tuesday 1/4/22. She is not sure why he was tested, other than for intake into the new facility. On Tuesday he was moved to a different facility. She notes that he apparently developed worsening hypoxia. Nursing home information sheets note he was hypoxic into the 80's on 4L of oxygen.  He is s/p Moderna vaccine x2. Wife states she was trying to get him boosted but he has not received it yet.
shortness of breath; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported a side effect on the COVID-19 vaccine. On an unspecified date, she experienced shortness of breath within 24 hours and asked if it was an expected side effect or if she should consult her healthcare provider (HCP). The patient considered the event as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt called office to report possible reaction following Immunization. Pt came in for evaluation by provider, complaining of "severe" pain at injection site. Reported chills/fever, tunnel vision, difficulty focusing vision. Pt advised that symptoms likely caused by robust response to PNEUMOVAX. Pt symptoms had improved by time of office visit. Pt was advised to call with any recurring symptoms.
Extremely tired for most of the afternoon/evening, sore arm for the rest of the day and into March 29th, high fever, as high as 101.9 starting around 10 PM and ending on March 29th  after taking medicine, nausea during the morning of March 29th and lasted until about 9 AM
I don?t know if this is explicitly related to the vaccine, but I have been diagnosed with DVT in a femoral vein in my right leg as of 4/22/2022, when a doctor at an Urgent Care called Urgent Care found a blood clot in my femoral vein in my right leg. This is unusual because I am only 21, don?t have a history of blood clots, don?t smoke, haven?t flown on a plane in years, and am very active. I just wanted to put this in to notify that a young person that has gotten this vaccine is experiencing this.
8/30 - Pt showed a red, raised area at injection site about 3 inches in diameter - not painful or itchy, but said she had a headache and wheezy stomach. 8/31 - Became 8 inches, skin leathery, woke up w/sore joints.
Stroke; Blockage/Clogged two arteries; Not normal electrocardiogram/Abnormal nuclear stress test; Low energy; COVID; COVID; 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-163-4396809-00 (AbbVie).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown), on 28Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159670), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID"; ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "Low energy"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered", described as "Stroke"; ARTERIAL OCCLUSIVE DISEASE (medically significant), outcome "not recovered", described as "Blockage/Clogged two arteries"; STRESS ECHOCARDIOGRAM ABNORMAL (non-serious), outcome "not recovered", described as "Not normal electrocardiogram/Abnormal nuclear stress test". The patient underwent the following laboratory tests and procedures: Cardiac stress test: Abnormal, notes: Nuclear stress test; Electrocardiogram: Not normal. The action taken for adalimumab was unknown.  AbbVie's opinion is that the events of stroke, blockage/clogged two arteries and not normal  electrocardiogram/abnormal nuclear stress test are not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of COVID with sequela and low energy are related to Humira(Adalimumab).    The reporter's assessment of the causal relationship of "stroke", "blockage/clogged two arteries", "low energy" and "not normal electrocardiogram/abnormal nuclear stress test" 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. The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.   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.
suffered a syncopal episode after being administered COVID-19 Pfizer vaccine #1 dose at the conference room downstairs at our clinic. Prescriber came and upon arrival, patient was alert and oriented x 3 laying on the ground.  Blood pressure was initially elevated but decreased towards the end of visit.  The rest of his vital signs were normal.  His lungs were clear to auscultation bilaterally and his heart was regular rate and rhythm. EKG was normal. Patient reports he has had previous syncopal episode when having blood drawn.  Patient likely suffered an episode of vasovagal response syncope.  Patient was sat upright and sat on a chair for 15 minutes prior to discharge.  He has no more syncopal episodes after that and felt back to baseline prior to discharge
Had ?Moderna arm? after both doses. Less than a month after my second dose, I was diagnosed with wet macular degeneration.
This spontaneous report as received from a nurse practitioner referring to a 13 year old female patient. The patient pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-OCT-2017, at 13 year-old,  the patient was prescribed and vaccinated with PROQUAD for prophylaxis (strength, dose, route, Lot # and expiration date were not reported). Only FDA approved per 12 "s". No prescription drug treatment was required for the experience and the patient was fine without symptoms ("Sx"). No adverse effects were reported.
Patient admitted as inpatient on 7/17 due to hyponatremia. Patient was tested for COVID-19 and was positive on 7/13.
Within an hour or two of shot I experienced redness, swelling, burning in face on side of shot, hives, hands swelled, arm swelled, itching.  Later I developed some congestion & body aches.  On 12/03/07 still have body aches & slight itchiness with just a little congestion.  No visible hives or swelling.  Also on 12/03/07, I felt "funny".  Somewhat scatterbrained like my thoughts were not as cohesive as normal.  I felt something was not right.
I have experienced swelling in both ankles and feet. There is pain in the left inner ankle but not the right. It hurts to touch and with movement, but I can twist/move it freely. There has been no injury to neither foot/ankle. The swelling reduces with rest and elevation but has not gone completely away since it began.
I had the shingles shot twice. I had the shingles; shingles; muscle disease; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and muscle disorder. On an unknown date, the outcome of the vaccination failure, shingles and muscle disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and muscle disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles shot twice and had terrible shingles around her left mid waist. The reporter stated that the comment by GlaxoSmithKline was interesting for her because she had a muscle disease.  The reporter wondered if the shingles vaccine messed with her muscles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
chills, fever, anorexia (lost #12 ),, severe low back pain, weakness....unable to get out of bed for 4 days
Entire deltoid where I received the injection is red, itchy, and is suffering from dry peeling skin. I still went for my second dose since I read about covid arm and they still recommend getting a second dose. I received my second dose on 2/23/21. The symptoms are persisting and have increased.
legs completely paralyzed/could not move legs; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (legs completely paralyzed/could not move legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and Pneumonia (a mild case). Concurrent medical conditions included Adrenoleukodystrophy (Defined as long fatty acids attacking myeloid sheath, damaging it similar to what happens in sclerosis. It is a long progression disease and patient walks around with a walker.).    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced MONOPLEGIA (legs completely paralyzed/could not move legs) (seriousness criterion medically significant). On 30-Oct-2021, MONOPLEGIA (legs completely paralyzed/could not move legs) had resolved.            No concomitant medication provided.  The day after booster dose patient could not move legs, these were completely paralyzed. Arms were fine. Symptoms lasted until 30-Oct-2021 morning.  Booster dose was given in right dominant arm.  No treatment information provided.  Company Comment: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Monoplegia. The event occurred on the day after the third dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-370698, MOD-2021-370528 (Patient Link).; Sender's Comments: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Monoplegia. The event occurred on the day after the third dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The pt developed fever of 101.5 deg. F., headache, lethargic, vomiting on 05/08/2002. By 05/10/2002, the pt had swollen, warm, welt on right deltoid. Saw doctor on 05/08/2002, ruled out all other medical problems.
I walked in to received my first dose of the Moderna Covid19 vaccine at approx 12:20pm 1/7/21. The RN who was giving me my injection palpated the top of my shoulder and NOT my acromian process and administered the injection closer to the top of my shoulder, the vaccine did initially hurt more than a typical vaccine would when it was being administered but i thought that might have been normal. Approximately 1hr after receiving the vaccine my left shoulder joint started to have this pinching sensation in the anterior joint when I would raise my arm forward. The pain got progressively worse throughout the day with significantly decreased range of motion in that shoulder and significant pain in my shoulder joint. The pain was so bad it actually kept me from sleeping that night. I never had any muscular pain or any other symptoms beside the joint pain, which was alarming since it should have been administered into the muscle. I believe the vaccine my have been incorrectly injected into the shoulder joint or potentially a smaller muscle in the shoulder. The pain and decrease ROM is preventing me from doing most of my regular day to day activities. Today 1/9/21 has been a full 48hrs after receiving the vaccine and the joint pain has not gotten any better and my range of motion is still significantly decreased, which would prevent me from performing my tasks as an RN.
Headache; Sore Arm; Chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.
Trouble breathing 20 min after shot given, wheezing and tightness in throat and lungs. Took 3 puffs of Proair inhaler helped with breathing. Extreme fatigue, to the point it was hard to move. Deep dry cough started on 03/31/2021.
Nurse administered an empty syringe to a patient as an IM injection. The patient was supposed to receive a second dose of the COVID-19 Moderna vaccine but when the nurse administered the dose, the syringe was empty. The patient was brought back to actually receive the vaccine once the mistake was realized.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035510,  expiration date 13-MAY-2017, oral (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50 degrees Fahrenheit for 1 hour 18 minutes. Data logger was involved. There was also previous excursion of 60 degrees Fahrenheit for 7 hours. Additional information has been requested.
Narrative: Admission Date Oct 8,2021 Discharge Date: Oct 9,2021 Condition of patient at discharge: Stable Disposition of Patient at Discharge: Home Primary Diagnosis during Admission/Treatment: COVID-19 86yo patient with history of Afib (not on anticoagulation), alcohol and smoking history, and dementia who presented to the Emergency Room with nausea and vomiting. Patient noted acute onset nausea and vomiting on day of admission. He did not note any abdominal pain. He also noted fatigue, SOB, and cough with new production as well. Endorsed subjective fevers and chills. In the Emergency Department, the patient was afebrile with HR 110, RR in 30s, and BP 189/116. Reported hypoxia requiring 2L O2. CXR with pulmonary infiltrate on L midlung and COPD. Labs notable for WBC 11.62 and COVID positive despite being fully vaccinated w/ Pfizer vaccine for Covid-19 on 2/2/2021 and 2/23/2021. UA with 250 LE and WBC 51-100. After he was admitted to the hospital, the patient was stable on Room Air, received INV-CASIRIVIMAB/IMDEVIMAB INJ product, and was stable for discharge the following day.
Initial onset at 130 PM: Dr. reported to me that patient's mom had called reporting a reaction to the flu shot. Patient has hives all over their body. Dr. advised mom to treat with Benadryl and to take patient to PCP's office. Patient was not reported to have any signs of respiratory distress. I called mom who stated that he was seen by his pcp and that the Benadryl was effective. Mom states PCP has not advised any other treatment of reaction. Mom states patient gets flu shot every year and that this is the first time the patient has had a reaction. Mom understands to call back if she has any other questions or concerns. Continued symptoms reported at 330P: 2013/09/12 15:42: Called mom, she stated they were in the PCP office when he was given the Benadryl and the hives did get better. They have now returned and they are cover more of his body. Mom stated they are on the way to ER. Told mom that if she can she may want to call her PCP to make them aware. Mom verbalized understanding. Patient presented at ED at: 1612: Treatment there: Treatments Rendered: prednisolone oral soln: Orapred 35 mg po stat; ranitidine oral syrup: Zantac 35 mg po stat; hydroxyzine hcl: Atarax 9 mg po stat.  Prescriptions Written: prednisolone sodium phosphate 25 mg/5 mL (5 mg/mL) Oral Soln;Dispense: 35 milliliters; Refills: 0; Substitution: YesPrescription Type: Standard epinephrine 0.15 mg/0.15 mL (1:1,000) IM Pen Injector (Also Known As Adrenaclick); Dispense: 2 injectors; Refills: 0; Substitution: Yes Special Instructions: inject into lateral thigh if difficulty breathing, syncope/hypotension, altered mental status, profuse diarrhea/abdominal pain. Prescription Type: Standard diphenhydramine 12.5 mg/5 mL Elixir; Dispense: 240 milliliters; Refills: 0; Substitution: Yes Prescription Type: Standard hydroxyzine 10 mg/5 mL (5 mL) Syrup; Dispense: 75 milliliters; Refills: 0; Substitution: Yes. Prescription Type: Standard famotidine 40 mg/5 mL Oral Susp (Also Known As Pepcid); Dispense: 30 milliliters; Refills: 0; Substitution: Yes. Prescription Type: Standard. Please followup with the below contact(s):  Please followup with your primary care provider in: 1-2 days. Discharged at 17:56 on 9/12.