chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my arm so messed up and I threw up for 24 hrs, I did get the super flu shot; Initial information received on 29-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult patient with an unknown demographics whose arm so messed up and he/she threw up for 24 hours, did get the super flu shot (injection site reaction), while he/she received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) patient stated that his/her arm so messed up and patient threw up for 24 hours, did get the super flu shot (injection site reaction).  Details of laboratory data were not reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
This spontaneous report as received from a nurse concerning to a 12 month old patient, of an unknown gender. Medical history and concurrent conditions were not reported. On 21-JUL-2014, the patient was vaccinated with the fourth dose of liquid PEDVAXHIB (lot number and expiration date were not reported), 0.5ml, intramuscular. Co-suspect and concomitant therapies were not reported. The nurse reported that on 21-JUL-2014, a 12 month old patient inadvertently received a fourth dose of PEDVAXHIB. No adverse effects reported. Additional information has been requested.
on 3-11-2021 pt presented to PCP  and reported onset around the last week of February 2021. PCP directed pt to ED  for urgent evaluation     pt was hospitalized  x 2 day, treated and sent home on Eliquis.
Fluarix vaccine given to patient under the age of 18.  Lot # afluaa147 exp 8/4/06.
I did not have an adverse reaction to the vaccine. On 11/19/2022, I had blood in stool and severe cramps. I went to an urgent care, and they did some blood work and referred me to a gastroenterologist. I am scheduled for a colonoscopy on 12/19/2022.
Patient called the clinic today to report a serious reaction to vaccines she received here. I phoned her at 1:00 and she related the following to me: She was seen 8/10/07 in the International Travel Clinic and received the following vaccines: IPV, Yellow Fever and Typhoid (VI). On 8/16/07 she broke out with whole body hives. She went to her PMD and received Prednisone, Benadryl and Tagamet. That evening she had hives again and her tongue started swelling, she went to the ED and received the same meds. 8/17/07 in the evening she returned to the ED with hives and the back of her throat swollen. She was treated with same meds. On 8/18/07 she again returned to the ED with hives and the back of her throat swollen and was treated with the same meds. On 8/20/07 she saw her PMD who said to continue the regime and added Decadron. Her doctor said it was the most severe reactions he had ever seen. He said to call the Public Health Clinic. She has not had any blood work done. Every day she continues to have hives, no strength and cannot work. The patient said that she has never been allergic to anything until this past July when she broke out in a rash to Levaquin four days after starting it. She has had Hep B vaccine in the past with no reaction and received Hep A vaccine 8/8/07 at her PMD. I spoke to a doctor today and filled him in on the situation. He said it is being handled appropriately.
Diarrhea; This is a spontaneous report from a contactable health professional (reported for herself). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 (07:30 AM) at single dose for Covid-19 immunization. The patient's medical history included psoriatic arthritis, seizure disorder, and allergy to latex. Concomitant medication included esomeprazole sodium (NEXIUM). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea on 15Jan2021 (06:00 AM). There was no treatment received for the adverse event. The outcome of event was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Daptacel and IPV administered on left left on 6/23/04. There was an immediate reaction with erythema & the development of a wheal in from of doctor.
Shoulder pain post AVA notes that this started at same time had anthrax shot, notes they injected him rather high and feels that triggered it. Difficulty with putting on jacket and other motions involving overhead movements   Symptoms: PAIN IN LEFT ARM(M79602).
Headache; dizziness which has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and DIZZINESS (dizziness which has gotten worse) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache) and DIZZINESS (dizziness which has gotten worse). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) and DIZZINESS (dizziness which has gotten worse) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant Medication was available.   This case was linked to US-MODERNATX, INC.-MOD-2021-060838 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060838:Mother
Mom stated child had a rash to both arms and has complaining of itching.  Subjective data.  Mom stated child had a fever.  Mom called children's healthcare nurse line and was instructed to give child children's BENADRYL.
Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery from 04-Mar-2021 to March 2021. Concurrent medical conditions included Osteoporosis. Concomitant products included ROMOSOZUMAB (EVENITY [ROMOSOZUMAB]) for Osteoporosis.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Due for second dose of Moderna Covid-19 vaccine on 04March2021, but did not received) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11 Mar 2021, the patient  stated  that she was due for second dose of Moderna COVID- 19 vaccine on 04 Mar 2021, but did not received as she was having surgery that day and her health care provider advised her to not take the vaccine due to possible side effects.  Treatment medication was not provided by the reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 ( Lot # 012M20A) with no associated AEs.
Patient stated she felt a burning sensation in her chest radiating to her throat that lasted less than a minutes. Radiated to her back, no SOB. Came on about 15 minutes after vaccine and lasted less than a minute. Evaluated by MD, EKG done.
Patient reported feeling lightheaded and dizzy a few minutes after receiving the vaccine.  Medical staff monitored the patient's vital signs, BP was 120/70 and ten minutes later, on discharge, was 130/78.  Patient reported those BP values were normal for him. Staff also offered him gatorade and he drank it.  Patient recovered and was discharged at 9:30 AM.
Pt is a 57 y.o. female with hx episodic svt, on no meds, presented after 4 hrs of tachycardia and chest discomfort, given 6mg then 12 mg adenosine by EMTs which worked in the field. Arrived here, trop is 0.21, CTA chest neg for PE, labs otherwise ok, DR consulted with another Dr, thought it was ok to go home on low dose metop, but patient has continued chest discomfort and was afraid to go home, was decided to admit for serial trop. Dr will see in am.   No cardiac risk factors; nonsmoker, brother has svt and had successful ablation, no fam hx CAD. Drinks up to 3 glasses wine per night. Office worker. EKG now nsr without ischemic changes.  Hospital Course by Problem:  #Paroxsymal SVT: No recurrence of sxs following adenosine administered by EMTs. Associated mild troponin elevation as below to 0.41 likely due to persistent tachycardia. EKG NSR w/o ischemic changes. Admitted and started on metop 25 mg XL nightly without recurrence. Cardiology consulted. Echo showed no WMAs or valvular issues, with preserved LVEF (although E/A flow reversal suggestive of possible diastolic dysfunction). Pt stable to discharge 3/16 with outpatient cardiology follow-up.  - discharge on metop XL 25 mg nightly - referred to follow up w/ Dr (info added to AVS) w/ TOC cardiology. Since she is a patient, she may elect to seek a referral through her PCP.   #Elevated troponin: Trop peak 0.4. No ischemic changes on EKG. Suspect due to prolonged tachycardia. Also possible mild pericarditis as below. No WMAs seen on echo. Outpatient stress test recommended by cardiology. - outpatient follow up with Dr for stress test  #Small pericardial effusion, ?mild pericarditis: Small effusion seen on echo. Given associated mild chest discomfort, query possible pericarditis. Unclear if this triggered SVT or vice versa. Hemodynamically stable w/ no evidence of tamponade physiology on echo and only mild symptoms. - given small size and mild sxs, no anti-inflammatories rx'd - pt given return precautions and advised of signs/symptoms that should prompt her to reach out to PCP or cardiologist
Diagnosed with "dry eyes" by Optometrist; Felt "Something in left eye and right eye; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OCULAR DISCOMFORT (Felt "Something in left eye and right eye) and DRY EYE (Diagnosed with "dry eyes" by Optometrist) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced OCULAR DISCOMFORT (Felt "Something in left eye and right eye). On 16-Feb-2021, the patient experienced DRY EYE (Diagnosed with "dry eyes" by Optometrist). At the time of the report, OCULAR DISCOMFORT (Felt "Something in left eye and right eye) and DRY EYE (Diagnosed with "dry eyes" by Optometrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included medications for high blood pressure.  Treatment medication included no tears eye drops.
This spontaneous report was received from a registered nurse concerning multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque forming units (PFU) lot # M030140, expiration date: 18-AUG-2017, as prophylaxis. (Dose and route of administration were not reported), which experienced a temperature excursion of max 9 Fahrenheit degrees for 1 hour and 21 minutes. A previous temperature excursion was reported of max 12.8 Fahrenheit degrees for 4 hours and 2 minutes. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports from the same source (MARRS linked report 1612USA008766). Additional information has been requested. Sender's Comments: US-009507513-1612USA008766.
reaction/faint grey dot; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 3-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (For tolerance of 1st dose of Pediarix ,refer case US2022AMR148962), Prevnar with an associated reaction of skin discolouration and Actihib with an associated reaction of skin discolouration.   On 17th August 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 2 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:US2022AMR148962   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. Additional Supportive Information: This case is linked to the case US2022AMR148961, US2022AMR148919, US2022AMR149560 and US2022AMR149561 reported by the same reporter. It was unknown if the reporter considered the depigmentation spot to be related to Prevnar and Acthib.; Sender's Comments:  GSK-US2022AMR148919:same reporter GSK-US2022AMR149560:same reporter GSK-US2022AMR149561:same reporter GSK-US2022AMR148961:same reporter
Late noc of 12MAR92 felt warm, t102 by MN, ran sl fever on 13MAR92 (not measured); was very quiet-sitting on moms lap & then by 530PM t103 ax; slept poorly, t101 on 14MAR, mom noticed spots behind ears & top of head;
Pt. called to report: Rec'd flu vaccination on 10/22/08. Approximately 4 hrs after vaccination had difficulty breathing, self-medicated with one Benadryl capsule, symptons subsided in approximately 20 minutes and did not return.
Severe facial pain developed over the week post-vaccination. Dentist cleared patient. UC diagnosed Bell?s palsy or trigeminal neuralgia six days post vaccination. Prescribed prednisone and gave a toradol shot. Primary care doc saw patient the following day, confirmed trigeminal neuralgia diagnosis, referred to neurologist and prescribed gabapentin.
Pfizer Covid-19 vaccine treatment under Emergency Use Authorization(EUA): 71 yo female was administered the Pfizer vaccine. During post vaccine monitoring, the patient's entire chest and face were bright read. She had red sponts on her upper chest and shoulders. She reported feeling very hot, but denied any itching, shortness of breath, chest tightness, or itchiness in her throat. Benadryl 50 mg was administered IM into left deltoid. Patient reported allergies to bee stings and IV dye. Vitals were stable. EMS was called and took patient to the hospital per protocol
Bells palsy seen by MD several times during course of illness; referred to neurologist; slow recovery; had similar episode 10 yr ago on opposite side of face, same time of year;
Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine until about 6 hours later. At that point, I started to get very dizzy and lightheaded. Every time I opened my eyes, everything was spinning. This lasted four about 3-4 hours. I kept breaking out into sweats. I had a horrible headache for about 4 days straight. I am still continuing to having headaches. I am still having hot flashes and dizziness episodes at times that go away after about a few minutes. Two days ago, I stated to developing swelling in my hands with achy joints which has not gone away.
Patient called on Monday 2/8 complaining of flu like symptoms, Advised   to take acetaminophen, drink plenty of fluids and rest. Called him back Tues 2/9 said he spoke to his nurse and was going to the hospital. Didn't describe symptoms before he hung up.
Case number PHEH2014US000526 is an initial spontaneous report received from a nurse on 03 Jan 2014: This report refers to an 11-year-old male child. He was given only MenCYW-135 liquid component of MENVEO (batch number: M13012 and expiry date: Sep 2014) intramuscularly on 31 Dec 2013. No adverse event was reported following this administration error.
This spontaneous report was received from a registered nurse refers to an adult 15 year old female patient. On 16-DEC-2014 the patient was vaccinated with VAQTA (dosing regimen unspecified). No concomitant therapy was reported. On 16-DEC-2014 the patient inadvertently received adult doses of VAQTA, instead of pediatric doses. Nurse reports that the two patients are sisters. No adverse effect reported and there was no product quality complaint involved. The outcome of inadvertently received adult doses of VAQTA was unknown. This case is linked to: 1412USA009309 (same reporter). Additional information has been requested.
pt recv vax & immed devel arm numbness & tingling;pt devel low grade fever of 101 & an inj site rxn,characterized by golf ball size lump;the lump was very red & hot to touch;tx DPH
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "vit d deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: plus antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies.  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 available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013120A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021). On 16-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021) had resolved.            No concomitant medication information was reported.  No treatment medication information was reported.   This case was linked to MOD-2021-385844 (Patient Link).
Awakened about 14 hrs later by alarm on I watch with pulse at 105.  Continued to go up to 123. My blood pressure which is VERY well controlled (often almost low) was 173/94. Very scarey. I was able to reach pharmacist who told me this ?seems to be happening to some? and Google said 20% have had ?what seems to be trasitory high BP and rapid pulse.? She told me not to exert, drink fluids. At 11:40 it was still high (for me) at 138/73 pulse 74.  I noticed both my doctor and local doctor.  I am reluctant to have now recommended 2nd booster (this was 1st booster) and wondering what to do. Pharmacist said maybe try another -like pfsizer???
Patient requested Moderna booster. Patient stated that 2 previous doses were recieved in another location. Patient's ID was verified, consent form filled out  and signed by patient attesting to being elgible to receive vaccine. No record was found in system. Patient was administered vaccine, monitored for 15 minutes and then left clinic. When patients information was updated in system, it was discovered that patient had recieved a Pfizer vaccine, same day, at a local pharmacy. Attempts were made to contact to patient via phone (no address given). Patient did not answer; voice message left asking patient to return phone call. After numerous unsucessful attempts,  patient was reached and a follow-up was conducted via phone. Patient admitted to getting a second dose at pharmacy after leaving our clinic. Patient stated that they had no reaction to either vaccine and did not experience any complications from either vaccine.
Patient was given vaccine for 5-11 yrs instead of 6 months -4yrs vaccine.  Physician was notified and discussed with parents what to look for related to side effects.
02-21-08 received Varicella and flu vaccine in left arm.  Patient noted swelling and skin warm within 24 hours.  No other symptoms.  2-25-08 saw doctor to follow up on swelling.
It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 2/8/00. Reportedly, the pt experienced a vasovagal reaction, post vax. BP-120/60, P-52, R-16. Resolution of symptoms after elevation of legs, ammonia ampule inhalant and ingestion of orange juice. The pt completely recovered from this experience.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's drug reactions/allergies, concurrent conditions and historical conditions were not provided. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). The patient's concomitant medications were not provided. On an unknown date the "patient had an unspecified titer drawn which resulted low" (antibody test negative). The outcome of the event was unknown. The causality assessment was not provided. No further information was provided. Additional information is not expected since the pharmacist declined to provide any further information.