chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin rash like hives; felt very itchy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 05Nov2021 16:30 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 09Nov2021 01:00, outcome "not recovered", described as "Skin rash like hives"; PRURITUS (non-serious) with onset 09Nov2021 01:00, outcome "not recovered", described as "felt very itchy". The events "skin rash like hives" and "felt very itchy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, pruritus.  Additional information: Is pregnant: No. Adverse event: Skin rash like hives suddenly happened on the back in the middle night of day 3 post immunization. On the following days of day 4/5/6/7skin rash like hives happened again after warm shower. The kid felt very itchy. He never has allergy history or hives before. Today is day 7 post immunization. Will keep monitoring on it. Adverse events start date: 09Nov2021. Adverse events start time 01:00. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment ae: Yes. If patient recovered: Not recovered. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medical history: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient submitted a written statement stating after she received a PNEUMOVAX and ADACEL on 06/06/14, she developed a fever in the evening that lasted 24 hrs. On 06/07/14 evening patient developed upper abdominal pain and body aches. On 06/08/14 patient stated s/sx resolved.
Pt complained of not being able to shut her eye completely, stated that when she was eating that everything tasted funny, and then when she smiled, one half of her face didn't move. On 11/25/12, my daughter was taken to the Emergency Room to find out what happened, lab work drawn, and CT of the head was performed as well. After 3 hours in the ER, diagnosed with Bells palsy, and then followed up with her doctor on 11/26/2012, which also confirmed Bells Palsy.
Patient received immunizations on 9/18/07. 9/18/07 in evening has increase fussiness/emesis, 9/19/07 - was stooling normally with, intermittent emesis. Stool at 9/20/07, then no stool x 24 hours, then smell heme +, not grossly bloody stools. Admitted 9/21/07 with ileus, NBNB emesis, (see attached).  10/17/07-discharge summary included with report for DOS 9/21-9/23/07- DC DX: Possible viral GI infection.  Two day history of poor po intake and vomiting as well as 1 day history of decreased stooling. Premature 27 weeks. Stool positive for trace occult blood. Previous hospitalization 9/14/07 with DX ALTE related to choking on medication. Mutlichannel study showed mild immature respiratory pattern with periodic breathing.  10/17/07-vac rec received no changes required.
Swollen, (raised), warm area  and redness on site of injection even after 7 days from administration. She can hardly move her arm.
Systemic: RHABDOMYLOSIS-Medium, Additional Details: AFTER RECEIVING THE VACCINE PATIENT HAD MUSCLE WEAKNESS AND FELL DOWN. PATIENT WAS TAKEN TO DOCTOR AND DIAGNOSED WITH RHABDOMYLOSIS
redness at the injection site; arm was sore initially; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Oct2021 15:00 (Lot number: FF8635) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "pain" (unspecified if ongoing); "osteoporosis", start date: 1999 (ongoing); "constipation" (unspecified if ongoing); "Hypothyroidism", start date: 1976 (ongoing); "Spinal stenosis" (ongoing); "spine curvature" (ongoing); "2 back surgeries", start date: 2014 (unspecified if ongoing); "Thyroidectomy", start date: 1993 (unspecified if ongoing); "Pain-Back" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ACETAMINOPHEN;HYDROCODONE taken for pain, back pain (ongoing); ALENDRONATE SODIUM taken for osteoporosis (ongoing); SENNA PLUS [DOCUSATE SODIUM;SENNOSIDE A+B] taken for constipation (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: 12:00 PM, Anatomical site of Injection: Right Arm, Rout of administration: intramuscular, Batch/Lot number: EJ1685 PFIZER, Dose: 1st, Time (24hr): 01:00 PM), administration date: 15Jan2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "had no issue"; Bnt162b2 (DOSE 2, SINGLE, Time: 12:00 PM, Anatomical site of Injection: Right Arm, Rout of administration: intramuscular, Batch/Lot number: EN5318 Biotech Pfizer, Dose: 2nd, Time (24hr): Approx. 12:30 PM), administration date: 05Feb2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "had no issue"; Flu vaccine, for Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 19Oct2021, outcome "recovered" (2021), described as "redness at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 19Oct2021, outcome "recovered" (2021), described as "arm was sore initially". Therapeutic measures were not taken as a result of vaccination site erythema. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Caller states she has put ice on the effected area. No prior vaccinations within 4 Weeks.  Follow-up attempts are completed. No further information is expected.
Case number PHEH2014US003629 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 71-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose of 0.5ml on 08 Jan 2014. No adverse event was reported following  this administration error (inappropriate age at vaccine administration).
I26.99 - Pulmonary embolism  SHORTNESS OF BREATH ABNORMAL LAB
Narrative:  A 71yo male with PMH of coronary Bypass surgery, Chronic Periodontitis, Coronary Artery Disease, Hypertension, Hyperlipidemia and Adult Hydrocele Received Janssen Covid - 19 vaccine 0.5ml In the right Deltoid per policy and protocol, on March 20, 2021 No ADR was reported Per Physicians April 14, 2021 documentation, the patient was hospitalized for SOB and under Hospice Care @ Hospice Patient passed away on April of 2021 cause of death not specified
body aches. Widespread hives started to form roughly 36 hours after vaccination. Located over torso, neck, elbows, and groin area.
(RD) redness, edema, fever, neck pain, body aches. Tx with KEFLEX.
"Symptoms began on same day as vaccination. Symptoms were identical to when I actually had the COVID infection in January-2021. No energy, hot and cold chills, headaches, arm ache, etc., all of which lasted 5-7 days.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 18-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
blackout episode (temporary loss of vision) while attempting to rise  Extreme pain and feeling of pressure/bursting all over body; extreme sensitivity when any area of the body was touched (including scalp, legs, etc) Fatigue, weakness and inability to get out of bed or sit without aid for roughly 24 hours  O2 dropped to 92 per pulse oximeter at home Swollen,  painful lymph node under armpit 2 days after vaccine  Gasping for breath (although no coughing or sneezing) Nausea Drinking a lot, extreme thirst but very little urination
very sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (very sick). At the time of the report, VACCINATION COMPLICATION (very sick) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Tiredness, loss of appetite, coughing, nausea, Arm ache, excessive thirst, some sweating. NO high temperature.
Flushing, pruritis   Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse.   Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed.   Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
Systemic: Fainting / Unresponsive-Medium, Additional Details: PATIENT FAINTED WHILE WAITING IN STORE AFTER VACCINATION. PATIENT DISCLOSED A PHOBIA OF NEEDLES AFTER FAINTING AND ATTRIBUTED RECTION TO THIS PHOBIA. PATIENT IS BEING EVALUATED BY PARAMEDICS.
Pt. was observed leaning to right side with eyes closed for 5 seconds.  Then open eyes and had no recollection of what had happened.  Pt. states he is feeling fine denies and SOB of chest pain.
This spontaneous report as received from a registered nurse refers to unspecified number of unspecified patients. On unknown dates the unspecified number of unspecified patients were vaccinated with RECOMBIVAX HB INJ 10. There were unspecified extensions of the intervals between doses. These unspecified patients had negative titers for hepatitis B after completion of the RECOMBIVAX HB series. Outcome of the event was unknown. Additional information has been requested.
Admission Date: 8/28/2023 Discharge Date: Aug 29, 2023 Discharge Disposition:  home health care svc  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Febrile illness [R50.9] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 83 y.o. male with a history of CAD, HTN, HLD, diet controlled DM II, tobacco use, OSA, and CKD III who presents to the ED at the insistence of family members due to worsening generalized weakness.  The patient insists he has been feeling overall ?fine? he has been weaker and not eating very much.  He had a fall on Friday 8/25, characterized as slipping out of bed, landing on his knees without loss of consciousness or acute injury.     In the ER, patient was febrile to 102 F, but not tachycardic or hypoxic. BP borderline low but asymptomatic. Labs showed mild hyponatremia, na 133, Cr 1.35 (slightly above baseline), gluc 250, no leukocytosis, normal lactic. Initially concern for sepsis so blood cultures obtained and pt received 2L fluid bolus and zosyn IV empirically. Fever improved with tylenol. COVID test returned positive. CXR showed no acute findings but small asymmetric nodular opacity LUL possibly infectious vs malignancy. Due to generalized weakness in COVID-19, he was placed in observation with internal medicine for further evaluation and treatment.   The patient remained on room air during his hospitalization.  It was discussed with him the CT findings and he chose to follow up with primary care doctor for repeat CT scan of the thorax to monitor the lung mass.  PT/OT did evaluate the patient and recommended home assist with home health care and PT/OT.  Patient was doing well overall therefore he was discharged in a stable condition.
Sweating, chills, fever, joint pain, muscle aches, nausea, difficulty eating, around 2am almost collapsed and had tight throat
Back pain and itchiness surfaced approx 5 days after vaccination.   Consulted doctor 1 week after vaccination and confirmed shingles.
Menactra was ordered and to be given, patient given Trumenba in error.  No reaction noted.
persistent inconsolable crying/uncontrollable crying; Initial information was received on 21-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 4 months old female patient who experienced persistent inconsolable crying/uncontrollable crying while receiving vaccine DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious persistent inconsolable crying/uncontrollable crying (crying) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (persistent inconsolable crying/uncontrollable crying).  At time of reporting, the outcome was Unknown for the event persistent inconsolable crying/uncontrollable crying.
He started having Encephalitis such as hallucinations, anxiety, stop talking , screaming ,   lost his mind, weird movements . I took him to many doctor, but no one can help him . Until I took him to a neurologist that can provided him a treatment .
This spontaneous report as received from a nurse via company representative refers to a 19 year old patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 25-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 and second dose of GARDASIL 9 was vaccinated on 05-JAN-2016 (dosing details were not reported). On 10-JUN-2016 the patient received third dose of GARDASIL (interchange of vaccine products and inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Pt received his 2nd Pfizer vaccination too early.   No known adverse reactions.  1st Pfizer vaccine: 04/02/2021 2nd Pfizer vaccine: 04/16/2021
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/15/2023  -  RECURRENCE OF SAME SYMPTOMS
No additional AEs reported/No adverse side effects have been reported; Medical Assistant reported that an improperly stored dose of MMR-II was administered to a patient on 8/22/2022. Caller stated no adverse side effects have been reported from the patient. No additional AEs reported. No PQCs reported.         ?    Na; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-AUG-2022, the patient was vaccinated witha a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U022985, expiration date 22-JUL-2023, albumin status has been verified as recombinant human albumin (rHA), 0.5 mL, subcutaneously (anatomical location was not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of -12.3 degrees Celsius (C) for 1 hour (LLT:  Product storage error temperature too low). There were no previous temperature excursions reported. No adverse event was reported.
My left arm and back, injection site, has been hurting since first dose.; My left arm and back, injection site, has been hurting since first dose.; My left arm and back, injection site, has been hurting since first dose.; it was even painful to sleep on and sore to movement; This is a spontaneous report from a contactable other hcp (Nurse) reported for herself. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via intramuscular, administered in Arm Left on 23Dec2020 10:00 (at the age of 41-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. No known allergies. Concomitant or other medications in two weeks included none. No other vaccine in four weeks. The patient experienced left arm and back, injection site, had been hurting since first dose, it was even painful to sleep on and sore to movement on 23Dec2020. AE resulted in none of the above (details unspecified). No covid prior vaccination and covid was tested post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 09Feb2021. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient recieved his 1st COVID19Vaccine at Approximately 750pm on 9/10/21. The patient began feeling Dizzy approximately 5 minutes after receiving the vaccine. His BP was taken and was 71/43 pulse 51. We contact EMS at 8:04pm. The patient was slowly improving When EMS Arrived
Father called 2-3-2020 - reported rapid HR - 188 Bilateral thighs - rash/welts/swelling above + below injection sights
1) Rash on chest, arms and legs and face. 2) Tingling in hands. 3) Slight sore throat.
Patient came in for a first dose and received a Bivalent Booster vaccine.  Pfizer has been notified. According to CDC guidelines with Pfizer Bivalent no repeat dose is necessary. Patient should return for the second dose  with the monovalent Pfizer
5 minutes, post vax, the pt developed a rash to her torso (front and back). Her BP was increased at 170/90 and pulse increased at 120. Her lungs were clear and she denied shortness of breath. No pharyngeal edema noted. Her vital signs returned to baseline after 15 minutes. Observed for 45 minutes.
fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (she is allergic to eggs).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-533282, MOD-2022-533290 (Patient Link).
given expired PENTACEL vaccine to a child with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received by a health professional via call center.  This case involves a child of unknown demographics who was given expired Pentacel with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (form, strength: unknown; lot UJ4168A and expiry date: 12-Mar-2022) via unknown route in unknown administration site as prophylaxis.  On an unknown date (Latency: unknown), Nurse had given expired Pentacel vaccine to a child with no reported adverse event (expired product administered).  Action taken: Not applicable.  Event outcome: Unknown   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 guidelines. 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.
Low spo2 needing oxygen at night with Cpap.  Word salad can not complete a sentence without needing to search for words, extreme weight gain. Now allergic to most foods no dairy, gluten, or pork, only grass fed beef, chicken and fish. No sugars or GMOs the list is extensive now allergic to Almonds, legumes,  never allergic to any foods prior.  Brain fog.
serum sickness;fever;achiness/arthralgia;giant urticaria;tx w/Claritin & motrin;
Received dose #1 at 6:30pm in the evening. No immediate noticeable side effects. Went to sleep around midnight then woke up around 4:00am with severe upper left arm soreness. Did not take any medications or use any heat or ice to help with the pain because I didn't want to interfere with the vaccine effectiveness.
BODY AND NECK GOING ALL THE WAY DOWN TO HER FEET; COULDN'T SLEEP AND WAS TOSSING AND TURNING ALL NIGHT; 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body and neck pain going all the way down to her feet. On 06-APR-2021, the subject experienced couldn't sleep and was tossing and turning all night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body and neck pain going all the way down to her feet, and couldn't sleep and was tossing and turning all night. This report was non-serious.