chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received TYPHOID, YELLOW FEVER, and POLIO at 325 PM. At 330, pt became unresponsive and began falling to one side of the chair with rigid extremities and eyes rolled back in his head and tongue protruded. After approximately 3 minutes, pt's color began to come back and pt was responsive and helped into room 1 and on exam table with feet elevated. BP 84/56, pulse faint. After another 5 min, BP 108/70, pulse strong and 80. Pt color returned and pt able to sit up and stated he felt much better. Pt stated this happened to him when blood was taken once. Pt left ambulatory with help with his mom and siblings.
8/6/08 - Mom described as red rash on bilat legs, arms, back, chest, underarms red circles (rash) no drainage. Mom used zinc oxide and cleared within few days; 8/11/08 - Onset of fever - Mom administered Tylenol and fever subsided within two hours; 8/12/08 - child persists with cough
HYPERACTIVITY (ADHD-LIKE); BURNING PAIN IN HAND AND UNDERARM; SWELLING IN ARM AND HAND; NERVE PAIN; INFLAMING NEUROPATHY; INFLAMMATION OF HANDS AND FINGERS; DIZZINESS; ARM PAIN; CHILLS BUT NO FEVER; NAUSEA; GENERAL TIRED; MUSCLE ACHE; 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: 1085031, expiry: UNKNOWN) dose was not reported, administered on left deltoid on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hyperactivity (adhd-like). On MAR-2021, the subject experienced burning pain in hand and underarm. On MAR-2021, the subject experienced swelling in arm and hand. On MAR-2021, the subject experienced nerve pain. On MAR-2021, the subject experienced inflaming neuropathy. On MAR-2021, the subject experienced inflammation of hands and fingers. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced arm pain. On MAR-2021, the subject experienced chills but no fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced general tired. On MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, hyperactivity (adhd-like), burning pain in hand and underarm, nausea, muscle ache, general tired, chills but no fever, swelling in arm and hand, nerve pain, inflammation of hands and fingers, inflaming neuropathy and dizziness was not reported. This report was non-serious.
Pt with increased pain, redness and fever following injection, and developed cellulitis L deltoid.
Pt had 2 episodes of brief febrile seizures beginning early am on 11/8/13, quickly resolving. Temp 102.7 while in ED. Pt discharged with DIASTAT script 10mg to use if needed following further seizure activity. Follow up appointment to be scheduled with Pedi Neuro.
This case involves a patient (unknown age and gender) who received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (extra dose administered) instead of PNEUMOCOCCAL VACCINE (wrong product administered). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient received two doses of suspect INFLUENZA QUADRIVAL A-B VACCINE, and the extra one was given instead of PNEUMOCOCCAL VACCINE, (lot number and expiry date not reported) each via unknown route in an unknown administration site for prophylactic vaccination respectively on an unknown date. It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (same day latency). It was reported "Nurse says that patient was given two doses of the Flu vaccine. Patient was doses recently with FLUZONE Quad. The nurse is requesting that information be electronic mailed to her to help her reassure the patient that she does not need to worry or if there are any concerns. She would like to know if something is needed to be done for the patient since this happened. Patient was doses recently with FLUZONE Quad" The nurse states that the patient received another Fluzone Quadrivalent vaccine instead of a pneumonia vaccine and they had already received a flu vaccine for this year. She states that it must have happened at another location because there is no documentation at their clinic. She was asked for additional adverse event (AE) information and she states that the hospital will be back in touch with her if additional information is needed. This is all the information she provided at the time of her call." At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.
Nine days after receiving injection a broad red patch appeared at or near the injection site.  Treated with anti biotic--mostly gone in one week
This spontaneous report was received from a pharmacist concerning an 80 year old female patient who on an unknown date, several years ago was vaccinated with a dose of PNEUMOVAX23, (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient had experienced a severe allergic reaction; her injection arm was swelled up down to her elbow. No treatment information was reported. At the time of the report, the patient's outcome was not provided. Additional information has been requested.
0530 am began feeling ill, pt reports passing out twice, nausea, vomiting, sweating and "chemical smelling urine". The patient reports this lasted about 10 hours and by 3:30 she felt fine again.
n/a. pt just became 12 yo about 2 month ago but received pediatric dose.
Information has been received from a registered nurse concerning a 15 month old female who on 29-SEP-2005 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Four days later, on 03-OCT-2005, the patient experienced a seizure without fever. No further information was provided. A product quality complaint was not involved. Upon internal review, seizure was determined to be an other important medical event (OMIC). No further information is available. Other business partner numbers included E200600013.
Received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number L32MF, expiry date 31-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020) and Shingrix (2nd dose received in 2021).   On 21-JUN-2023, the patient received the 3rd dose of Shingrix. On 21-JUN-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter reported that by mistakenly patient received third dose of Shingrix vaccine. The reporter stated that after reviewing patient records he realized that patient already received two doses of Shingrix vaccine. The reporter asked for safety information. The reporter did consent to follow up. The patient received extra dose of Shingrix vaccine in error, which led to extra dose administered.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 patient's symptoms improved after Moderna vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine).    Concomitant medications were not reported.  Reporter stated she had been administering the 65+ bivalent dose to her patients who have symptoms of "long-haul COVID" (non-indicated use of vaccine) and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reaction reported. Treatment medications were not reported.  This case contains information for patient 7 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Patient received 1st dose of vaccine and sat in the post- vaccination area. Pt lost consciousness and and slumped to floor off chair.  RN and RN responded to patient. Pt was conscious and responsive to verbal stimuli. Pt reports he became sweaty and dizzy and then passed out. Pt denies any pain or urgent medical issues. After incident pt reports to passing out once before due to getting blood drawn.  Pt stable and responsive after post vaccination area clearance.  Patient denies blood thinners. No deformities noted upon physical exam.
Next day full body red rash, 103-104 degree fever, deep body aches, skin sensitivity, joint pain, headache, brain fog,lasted 4 days,  One week later period started with large chicken-egg sized blood clots, heavy flow lasted 2 days longer than typical period for me. Second cycle after vaccine started 4.22.21 with same very large clots, intense cramping and bloating
Event occurred after 2nd dose, Patient was diagnosed with Covid-19, Tylenol, and classified as Inpatient.
Hives all over body that started on my face, neck andshoulders and spread down my body over; Get irritated; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included basal cell skin cancer and was going through radiation treatments at the time of reporting. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient experienced hives all over body that started on face, neck and shoulders and spread down the body over the next few days, they were not extremely itchy but those in close contact with hair or tight clothing to get irritated. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives which included treatment with diphenhydramine (BENADRYL), cimetidine (TAGAMET) and cortisone (MANUFACTURER UNKNOWN) cream. The clinical outcomes of hives all over body and got irritated were not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Generalized sunburn like red rash all over the body 4 hours after the vaccines. Got better after 50mg of Benadryl.
Tongue felt numb -- "Like he burned his tongue"  Tingly sensation.  At 6 p.m. on 3/19/2021 his tongue still feels the same.  No swelling in his tongue.  Denies other symptoms
Fever 102; very fatigued; Headache; left arm pain; increased nasal congestion; This is a spontaneous report from a contactable consumer (Patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Formulation: Solution for injection via an unspecified route of administration in the left arm on 17Feb2021 09:00 (Batch/Lot Number: EN 5318) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM; famotidine (PEPCID [FAMOTIDINE]); beclometasone dipropionate (QNASL); magnesium (MG [MAGNESIUM]); amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS); ergocalciferol (VIT D). The patient previously took BNT162b2 for covid-19 immunisation, anaprox and experienced drug hypersensitivity. On 17Feb2021 17:00 patient experienced fever 102, very fatigued, headache, left arm pain, increased nasal congestion. Patient perform lab tests which included body temperature: 102. The patient not tested for COVID-19 prior to vaccination and post vaccination. The patient did not receive treatment. The outcome of the events was not recovered.
Patient presented to Health Department to receive a Pfizer Bi-Valent booster vaccine. Patient was inadvertently administered a Pfizer Mono-Valent vaccine.
Burning to the touch sensation in leftleg. From upper groin to bottom of feet; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 01:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease. Concomitant medications included thiamazole (METHIMAZOLE) for an unknown indication and from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 04:00, the patient experienced burning to touch sensation in left leg, from upper groin to bottom of feet. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event burning sensation in left leg from upper groin to bottom of feet was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
PATIENT HAS RED RAISED RASH ABOUT 3 INCHES IN DIAMETER AT INJECTION SITE AS WELL AS LATERALLY ACROSS THE CHEST - TREATED WITH BENEDRYL ORAL - RASH STILL THERE AFTER 4 DAYS BUT NO FURTHER AE.
Patient went for morning jog on 06/04/2018 (2 days after injection). She experienced SOB, and fast heart rate which never happened before.
sx progressed from local react to systemic-local swelling, redness, tenderness, feverish, fatigue, aching, flu-like sx; seen by MD 5DEC94 prescribed Keflex 220mg; 1 qid x 5 days; Depro 600 1-2 bid for swelling;
This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (dose and route were not reported) lot # M032650 and expiry date: 31-MAR-2019, lot # L037554 and expiry date: 25-DEC-2017 for prophylaxis. The call was because of a data logger. There were no adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007517: US-009507513-1612USA001375: US-009507513-1612USA007518.
complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6207), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 08:30 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient started throwing up, fever, complete body went paralyzed and lost vision all it the ER on 05Apr2021 13:00. The events were resulted in emergency room /department or urgent care. There is some treatment (saline and ondansetron) for the events. The patient did not have covid prior vaccination, did not test covid post vaccination. The patient received Covid test post vaccination via Nasal Swab on 05Apr2021, covid test result was negative. There is no known allergies, no other medical history, no other vaccine in four week, no other medications in two weeks. The outcome of the events was resloving.
felt a "swoosh" "something odd" Narrative: B/P 132/85 HR 68
Extreme muscle cramps/ pain, fatigue, SOB.  Blood loss hemoglobin critical
09/01/22 presents to ED for "shortness of breath". PMHx of "CAD, GERD, hypertension, diabetes, peripheral artery disease, abdominal aortic aneurysm"
pt recv vax 04FEB93 & exp pain that radiated down arm; 6FEB93 pt devel swelling @ inj site & exp discomfort down arm; a couple days later devel 1/2" by 1/2" sl red raised bump, warm feeling, discomfort that radiated down arm;
administered to 4 month old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The practice lead stated that a 4 month old patient inadvertently was administered Kinrix in left thigh, which led to inappropriate age at vaccine administration. The reporter inquired how to proceed. The reporter consented to follow up.
Low grade fever, fatigue & muscle + joint pain - symptoms started the day after he received the vaccine.
cough- extremely painful, fever, nasal congestion, loss of taste, headache, body aches. starting on 10/22/21. Received Pfizer 3rd dose on 10/21/21
seizure, fall, hit his face, LOC; traumatic injury of head, facial trauma, seizure.
7/7 - about 9am or 10 am in morning, his face on the right side began to droop.    He felt as though he may be having stroke, as known from prior event.  Yet, he drove himself to the ER.  A stroke event was ruled out.  He was diagnosed with Bell's Palsy syndrome with numbness and paralysis on the right side of his face.   Treatment include high dose steroid Prednisone for 5 days.  Adjustment with increase in this blood pressure medication, as his blood pressure was running in the 210s/110s. (extremely high).   Prior to this event - pt traveled under the false security that he was okay to mingle since he had been vaccinated.    (Currently, the place he traveled to is showing a COVID surge).   Now today on 7/22 -patient still is suffering from the Bell's Palsy side effect.  Slowly he is regaining feelings and very slight movement of his face.
Very dizzy immediately, first day was very dizzy and almost fainted, very tired second day I had a rash on my arms and was still very exhausted and had high fever, also tight chest and coughing third day I was still exhausted and had a mental health episode of severe depression and suicidal thoughts, which I do have depression sometimes, but not LIKE THIS. It was very scary. Day 4 I am more myself currently, but unsure of how things will go from here.
Is a side effect of the shingles vaccine a rash?; This case was reported by a consumer via (Shingrix GSK and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced rash. The patient enquired if the rash was a side effect of shingles vaccine. Follow-up would not be possible as no contact details available.