chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient contracted COVID after being fully vaccinated.  No booster. Loss of taste, loss of smell, congestion, cough, headache, body aches, fatigue.
Pt received one dose of rotavirus for his scheduled 4 month vaccination.  After administration of the vaccine, patient vomited immediately after entire dose.  Pt was immediately given another dose of rotavirus.  Pt did not exhibit any adverse effects at time of administration.  Mom aware of second dose given.
Shoulder pain; Extreme pain in arm; During administration the needle did not go in perpendicularly; This is a spontaneous case, initially received from other health professional via Med Communication (reference number: SEQ19-04449) on 11-Oct-2019, concerning a 27-year-old, male patient.   The patient's relevant medical history and concomitant medications were not reported.  On 26-Sep-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261204 and expiration date: 26-Jun-2020] for influenza prophylaxis. It was reported that during administration, the needle did not go perpendicularly into arm (explicitly coded as Product administration error').  On 01-Oct-2019, the patient experienced extreme pain in the arm and shoulder pain.  On 09-Oct-2019, the patient visited his physician, and was advised to visit orthopaedist, and to rest from heavy activity and lifting. The patient used Tylenol (paracetamol), administered via oral route and Voltaren (diclofenac), administered topically, as a corrective treatment for shoulder pain, and was also advised to use ice.  On an unknown date in Oct-2019, within two weeks from vaccination, the events of pain in arm and shoulder pain were resolved.  The case was assessed as non-serious.  The reporter did not provide a causality assessment.  Follow up received from other health professional via Med Communication (reference number: SEQ19-05528) on 24-Oct-2019: Stop date for the events pain in arm and shoulder pain was provided and the outcome was changed from not resolved to resolved. The narrative was amended accordingly.  Company comment: The patient experienced musculoskeletal pain and pain in extremity after product administration error with the suspect drug Flucelvax Quadrivalent. No medical history, diagnostic findings or concomitant medications were reported. Reported events were likely result of administration error, and as such are considered unlikely related to the vaccine as a suspect product (defaulted to Related causality in the safety database). Product administration error is assessed as not related per company conventions.; Sender's Comments: The patient experienced musculoskeletal pain and pain in extremity after product administration error with the suspect drug Flucelvax Quadrivalent. No medical history, diagnostic findings or concomitant medications were reported. Reported events were likely result of administration error, and as such are considered unlikely related to the vaccine as a suspect product (defaulted to Related causality in the safety database). Product administration error is assessed as not related per company conventions.
Information has been received from a registered nurse concerning an 18 year old Caucasian male patient who on 09/01/00 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Ten minutes post-vaccination, the patient developed a painful upper arm and "severe cold sweats". It was noted that 10 minutes after the patient was vaccinated, he had to "pull over and get out of his car due to orange spots before his eyes. He laid down on the grass. The patient also complained of lethargy, muscle weakness, heart pounding, and feeling not with it. The patient recovered30 minutes post-onset. The patient denied rash, itching, shortness of breath, dyspnea, or fainting. Unspecified medical attention was sought.
believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.; 102 degree temperature all night; chills all night.; small red circle about the size of a 50 cent piece after her second dose.; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.), PYREXIA (102 degree temperature all night), CHILLS (chills all night.) and VACCINATION SITE ERYTHEMA (small red circle about the size of a 50 cent piece after her second dose.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (102 degree temperature all night), CHILLS (chills all night.) and VACCINATION SITE ERYTHEMA (small red circle about the size of a 50 cent piece after her second dose.). On an unknown date, the patient experienced POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.). At the time of the report, POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.), PYREXIA (102 degree temperature all night), CHILLS (chills all night.) and VACCINATION SITE ERYTHEMA (small red circle about the size of a 50 cent piece after her second dose.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree.         No treatment medication were provided.   This case was linked to MOD-2022-648146, MOD-2022-648281.
Extreme dizziness occurred immediately after the injection. As the dizziness increased my heart started pounding as hard as it could. I began to taste blood in the back of my throat when swallowing saliva. Dizziness kept increasing until the point the I nearly fainted. Breathing became extremely labored. I felt feelings of impending doom. I thought we were going to have to call an ambulance. It felt like I was dying. The episode lasted about 5 minutes, and was the worse 5 minutes of my entire life. Overnight I had the worst chills I have ever experienced. I also had a fever, but the chills were awful and worse than the fever. The next day I was experiencing tachycardia with a pulse of 120 bpm, my normal is around 60 bpm; I was also experiencing heart palpitations and skipped heart beats (I have never felt this before). On the third day I was mostly feeling weak, but still experiencing tachycardia and skipping heart beats/palpitations. By the fourth day I felt somewhat more normal again.
first 48 hours fatigue, nausea, headache Day #9 post vaccine rash on Left upper arm and upper chest Day #18 rash on Right arm
2 days after receiving the Shingrix vaccination, I experienced a sudden onset of visual changes of my right eye including flashing light, black floater, and visual distortion. I contacted Dr. who instructed me to contact an eye specialist. I contacted and was examined by Dr. who diagnosed me with acute vitreous detachment. No treatment was prescribed. After doing some research, I discovered optical adverse reactions related to the Shringrix vaccination that were similar with what I had experienced and presented my concerns to both Doctors, who both stated they did not believe the event was related to the vaccination but were not able to provide me with documented evidence to support their conclusion. Although my symptoms have improved, I still have a black floater and a mild visual distortion. I am unwilling to receive the second vaccination as I am concerned that the event would repeat itself and result in a worse outcome.
Was due Hepatitis A, MMR, Varicella - was given Hepatitis A, Varicella, MMRV. Notified mother and told of incident and symptoms to watch for.
ON 10/30/17 HE SOUGHT TREATMENT AT URGENT CARE FOR RIGHT ARM PAIN. HE WAS SENT TO THE HOSPITAL AND ADMITTED. HE WAS DISCHARGED ON 11/1/17.
Narrative:  81 yo M with PMH significant for CKD 3a, RCC s/p L nephrectomy (2016) with hepatic dome mass, psoas mass, and mesenteric nodule, COPD, OSA, and hypothyroidism who was admitted for COVID PNA s/p Pfizer (02/21), initially on 4L NC but with worsening dyspnea and increased spO2 requirements was transferred to ICU 8/11 for higher level of care. Patient was initially placed on HFNC for oxygenation support, but decompensated despite steroid, dexamethasone. Patient eventually was fully BIPAP bound starting 8/22. On 8/27, patient was no longer able to maintain oxygenation >85% despite maximal BIPAP support. We discussed with the family that intubation at this point would just result in further suffering, and that patient is very unlikely to recover from overwhelming COVID PNA. Family decided to withdraw care and patient was placed on comfort care. He passed on 11:02 PM 8/27.
Patient received MENACTRA vaccine at 0940 in the right deltoid and was directed to waiting area for check-out. Patient and mother notified clerical staff at 1000 of possible reaction. Patient immediately taken into clinic room. Patient complained of feeling hot and itchy. Patient noted to have small areas of redness to upper right chest. Nickel sized hives to the back of both earlobes.  No airway obstruction, no dificulty breathing. Call made to Dr. medical director who advised 25mg oral Diphenhydramine and observe patient x1 hour. 25 mg oral diphenhydramine administered at 1015 patient improved rapidly with hives resolving at 1100. Pt released at 1115 with referral to PMD for futher evaluation.
The day after the vaccine I had a 101 fever. The next day it went down a little. By that weekend I had like chicken pox on my arms, chest and shoulder area. It was just itchy but did not bother me much. I also have a huge lymph node on the back of my neck. I was not able to move my neck it was too painful. I saw a NP, in  another area. She prescribed flexeril which really helped. I took it a couple times and the swelling went down.
DIARRHEA; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 06:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 20-MAR-2021 16:00, the subject experienced diarrhea. On 20-MAR-2021 16:00, the subject experienced chills. On 20-MAR-2021 16:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and diarrhea was not reported. This report was non-serious.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender who received the first two doses of GARDASIL injection administered intramuscularly in the gluteal muscle. The first dose of GARDASIL (administered intramuscularly in the gluteal muscle) was administered on 26-JUL-2013 (lot #, expiry date, dose unknown), the second dose of GARDASIL (administered intramuscularly in the gluteal muscle) was administered 26-AUG-2013 (lot #, expiry date, dose unknown) and the third dose of GARDASIL (administered intramuscularly in the deltoid muscle) was administered on 13-JAN-2014 (lot #, expiry date, dose unknown). No adverse event reported. Additional information is not expected.
Information has been received from a physician via a company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and route were not known). On an unknown date, after receiving the vaccine the patient fainted. Additional information has been requested.
Patient presents to the site for her COVID vaccine. She completed her questionnaire to receive the vaccine and it was determined that she was eligible. She denies any contraindications at this time. She received her vaccine @ 9:40 am and was seated in the vaccine waiting area. She alerted the nurse that she was beginning to feel dizzy around 9:45 am. At that time this NP was alerted and arrived to patient side. The patient was complaining of dizziness, tingling and swelling to the left side of her face, but denies any trouble breathing or swallowing. She was helped to the floor and laid supine and the first set of vitals were obtained. EMS on scene and they hooked her to their EKG machine which obtained the blood pressure and normal sinus rhythm was noted during the entirety of the episode. Monitored patient in supine position until 9:57 am, then she sat up. She reports that she is diabetic and did not eat this morning, so finger stick was obtained which resulted at 105, orange juice was given to patient upon her request. At 10:03 25 mg of benadryl was given due to patient still complaining of facial tingling. Patient's husband was called at that time. She refused to be transported to hospital by EMS. At 10:16 am patient was up to chair and still complaining of facial tingling, but denies shortness of breath or difficulty swallowing. Husband arrived at 10:25 am and transported the patient by private vehicle to the emergency room.
After the 1st shot, I started getting a couple of blisters on my leg, near my collar bone and on my back. Only 3 of them. They were small little blisters, but they itched terribly; After the 1st shot, I started getting a couple of blisters on my leg, near my collar bone and on my back. Only 3 of them. They were small little blisters, but they itched terribly.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  After the first shot, patient started to getting a couple of blisters on leg, near collar bone and on back. Among them, 3 small little blisters, itched terribly. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is the 2nd vaccine for the patient. She was not given another lot# for  this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 17-MAR-2016 the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) (with lot # and expiration date K002920 and 26-FEB-2016, respectively) (dose and route of administration were not provided). Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Still have small tender spot at injection site (<dime sized). Still experiencing intermittent tenderness in lymph node in lateral pectoral area - both symptoms started at same time - the day after the booster shot and have continued to diminish over time.
She already received the first and second dose of the Pfizer COVID 19 and she will be having her eye surgery; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer received the first and second dose of the Pfizer COVID 19 Vaccine and she will be having her eye surgery next Wednesday. The outcome of event was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date in February 2014 the patients were vaccinated with RECOMBIVAX HB (lot number and frequency unknown) (dosing regimen and frequency unknown) which had been improperly stored. No concomitant medications were reported. No adverse events were reported. The action taken with RECOMBIVAX HB was unknown. No product quality issue was reported. This case is related to case 1403USA008198 and 1403USA008197 via same reporter link. Additional information has been requested.
headache, fever 101, body aches, chills, nausea, wheezing and coughing
This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010180: US-009507513-1806USA010176: US-009507513-1806USA010181: US-009507513-1806USA010171: US-009507513-1806USA010173: US-009507513-1806USA010175.
No adverse event occured. Patient received first pfizer on 4/18/21 and completed sec dose on 5/20/21 as Pharmacy. Upon reviewing patient profile on immunization registry, 3 additional doses were recorded at unknown places 5/26/21, 7/12/21 and 8/16/21 were recorded.
Received a Zostavax shot on 8/22/06, shingles rash appeared on 8/30/06.  10/26/06 Requested by FDA to contact reporter to clarify which vaccine given. 10/27/06 T/C to reporter/provider to request missing info.  Letter faxed to PCP to request medical records/ss 10/27/06 Received medical records from PCP which reveal that patient was new patient at this MD & he received Zotavax per the vax records.  However, the MD note indicates a different lot number.  T/C to PCP to confirm which vax lot number is correct as record is unclear.  T/C to manufacturer to inquire what lot number for which vax.  Stated lot number on report is for Gardisil & that lot number in MD records is correct for Zostavax.  Notified FDA of same./ss
Feeling lightheadedness and High Blood Pressure even after 10 days of 2nd dose; Feeling lightheadedness and High Blood Pressure even after 10 days of 2nd dose; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 06May2021 08:30 (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 15Apr2021 08:30 (at the age of 36-year-old) as dose 1, single for covid-19 immunisation and experienced hypertension. On an unspecified date in 2021, the patient experienced feeling lightheadedness and high blood pressure even after 10 days of 2nd dose. The patient underwent lab tests and procedures which included blood pressure measurement: 140/94 on 17May2021; Today my BP is around 140/94. The outcome of the events were not recovered.   Device Date : 17May2021  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
Guillaine Barre; barely walk; barely walk has to walk with a cane; After getting the flu shot that went downhill; Condition worsened; has to walk with a cane and very weak; Initial information received on 21-Mar-2023 regarding an unsolicited valid serious case received from a patient.  This case involves an unknown age male patient who had guillaine barre, barely walk, barely walk has to walk with a cane, after getting the flu shot that went downhill, condition worsened and very weak after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date in Oct-2021, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (With unknown formulation, strength, route, lot number, expiration and at unknown administration site) for prophylactic vaccination (immunization).  On an unknown date, patient developed guillaume barre (guillain-barre syndrome) barely walk (gait disturbance), barely walk has to walk with a cane (walking aid user), after getting the flu shot that went downhill (depressed mood), condition worsened (condition aggravated) and has to walk with a cane and very weak (asthenia) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine  Relevant laboratory test results included: Lumbar puncture - On an unknown date: [it stated that he had GBS (guillain-barre syndrome)]  Action taken: not applicable.  Caller states that he is having an intravenous procedure to help in form of treatment.  At time of reporting, the outcome was Unknown for all events.   Seriousness criteria: hospitalized and medically significant for guillain-barre syndrome.; Sender's Comments: Sanofi company comment dated 23-Mar-2023: This case involves an unknown age male patient who had guillaine barre, barely walk, barely walk has to walk with a cane, after getting the flu shot that went downhill, condition worsened and very weak after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based on information provided, the role of an suspect vaccine cannot be assessed.