chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Saturday, November 20, 2021 client received her Pfizer Covid-19 vaccine booster (LOT #: FF8841) at 1:33 PM in her left deltoid. During assessment questions, client stated she had no know allergies and takes no medications. Client to be observed for 15 minutes after vaccination. At approximately 1:46 PM, while in Observation Area, client stated to EMT she was experiencing "tingliness or tickleness" in her left palmar surface for less than 5 minutes only with no pain or any other symptoms. Client denied SOB. Client was brought to sit in anti-gravity chair, offered water and vitals started. Lead RN offered 50 mg oral solution Benadryl and EMS to which the patient denied. At 1:45 PM: BP 124/88, HR 69, O2 sat 98%, RR 20, skin warm and dry. At 1:52 PM, client states she was a bit anxious to get the vaccine. EMT educated client to seek medical treatment if symptoms persist and signs and symptoms of adverse reactions. At 1:57 PM, client stated the tickleness sensation was "better" and "less." No further interventions needed. At 1:58 PM, client left vaccination site with a steady gait and her husband drove her home.
given twice in 3 mos; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: This case was reported by the registered nurse. The age at vaccination was not reported. The patient received Menveo vaccine twice in 3 months, which led to shortening of vaccination schedule. The formulation, dose, frequency, lot, start/stop date and the duration dates were not known. The reporter did not agree to follow up.
fever; chills; This is a spontaneous report from a non-contactable consumer (Patient). A non-pregnant adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunization. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration, as dose 1, single for COVID-19 immunization. It was unknown if the patient received other vaccine in four weeks and unknown if patient was diagnosed with Covid prior vaccination. On an unspecified date in Feb2021 (after second dose), patient experienced fever and chills. It was unknown if the patient received treatment for the events. It was unknown if patient was diagnosed with Covid post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
25 days after GARDASIL #3 developed syncopal episodes- recurrent, over course of 6 mos. Neuro and cardio work- ups WNL.  1/22/09 MR received from PCP including multiple neurology and cardiology consults from 8/07-1/13/09. OV 2/4/08 for recurrent sinusitis since 9/2007. HPV#3 given.  Returned 3/3/08 with c/o H/As and dizziness as well as 1 fainting episode over past few days. Tx with abx for sinusitis and vasovagal syncope discussed. Pt fainted after blood draw in office with continued fuzzy vision and inability to get up. Unresponsive x 45 minutes.To ER. Received IVF which caused swelling. Still feeling unwell with photophobia, H/A, lightheadedness and neck soreness. No memory of ambulance ride. Still c/o H/A 3/6/08.  Somewhat better 3/14/08 with exception of exhaustion.  Several more episodes of H/A, fainting, chest ache with racing heart, stomachaches. Episode 9/17/08 face red, extremities grey with tonic-clonic movements of extremities and eyes rolling back. Unresponsive x 45 minutes. Referred to Neuro and Cardiology.  Neuro consult 4/14/08 and 9/25/08 with normal exams. DX: Syncope. Panic attacks. Vasovagal syncope. Cardiolgy consult 10/2/08 for eval of syncope with shock-like, stabbing chest pain which self resolved. Subsequent episode with heart racing and difficulty breathing. No dx mde. Improved by 1/13/09.
sore throat 3NOV93; abdo cramps 4NVO93; SOB 5NOV93;
No further adverse events; Caller is HBP reporting on behalf of HCP an administered dose of expired MMR II. Caller reports no history of prior excursions on products. No additional details provided. No further adverse events/no product quality complaints.; This spontaneous report has been received from office manager and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 25-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (rHA) (M-M-R II) 1 dose, lot #T020656, expiration date: 16-JUN-2022, as prophylaxis (strength, vaccination scheme and route of administration were not provided) beyond the expiration date (Expired product administered). The was stated that no prior excursions occurred, and no further adverse event was reported.
Some "injection site soreness"; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CAD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: Hypertension (controlled with Losartan and metoprolol); "Asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Losartan for Hypertension; Metoprolol for Hypertension. Vaccination history included: Bnt162b2 (dose 1 via intramuscular), administration date: 05Mar2021, when the patient was 72 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "Some "injection site soreness"". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: It was unknown if patient had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & devel  rheumatoid arthritis; lab tests evaluated antihbs neg;
Pt presented on 6/8/21 with epigastric pain radiating to her back, nausea, bloating and chest pressure. Abd US on that day showed gallbladder wall thickening, LFTs: elevated AST/ALT/APhos. Pain worsened so on 6/10 she went to Hospital ER. CT Abd: thick gallbladder, ascitis, pericardial effusion. Echo: large pericardial effusion with signs of tamponade. Pt underwent emergency pericardiocenthesis obtaining 2 L clear fluid. Inital cytology and complete AI w/u was non contributory. After 3 days in ICU with serial echos showing stable trace pericardial effusion pt was discharged home on colchicine. Repeat echo 7/21: reaccumulation of pericardial effusion, pt required pericardial window.
pt recvd vax; exp fatigue; general malaise, lt arm wakness & dec sensation; progressing to lt leg; hx of ha; oth areas, dec sensations; currently pt under tx;
Patient received an expired Janssen Covid 19 Vaccine. Vaccine was punctured on 6/3/21 and was left in the refrigerator, which was later used on 6/5/21
Per patient's wife, patient has been hospitalized due to Guillain-Barre syndrome.
I received my first dose of the Moderna COVIDI19 vaccine on 12/29/2020 not knowing I was pregnant.  I took a home pregnancy test the week of 1/3/2021, which came back positive.  On 1/17/2021, I started having some spotting and saw my OBGYN on 1/18/2021.  My OBGYN did a transvaginal ultrasound and estimated I was about 5 weeks pregnant.  I went for bloodwork prescribed by my OBGYN on 1/18 and 1/20 to measure my HcG levels.  By 1/20-1/21 the bleeding became heavy and my HcG levels dropped.  I had a follow up appointment with my OBGYN on 2/3/2021 where they performed another transvaginal ultrasound and more bloodwork to confirm that I had miscarried.
Noted 3/21 am to have swollen red left leg. Not bothering pt on exam. 2 1/2cm diameter erythema, indurated nodule, non-tender.
Woke up Sat. morn and could not comprehend/function, think of words or put a sentence.  I was taken to the ER @ hosp. and admitted where I was then released on the following Mon. afternoo
muscle pain called PCP who recommended taking Tylenol  Advised to continue with PCP recommendation of using Tylenol. If sx's progress see PCP.
Nursing 12 month old developed swollen lymph nodes in his groin; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Nursing 12 month old developed swollen lymph nodes in his groin) and PYREXIA (Fever) in a 12-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L207) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included Exposure during breast feeding.    On 01-Feb-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Feb-2021, the infant was diagnosed with LYMPHADENOPATHY (Nursing 12 month old developed swollen lymph nodes in his groin) and PYREXIA (Fever). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The infant was treated with PARACETAMOL (TYLENOL) on 02-Feb-2021 for Fever, at an unspecified dose and frequency. On 04-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, LYMPHADENOPATHY (Nursing 12 month old developed swollen lymph nodes in his groin) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 102.7 (High) Fever lasted for 12 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Patient was given Tylenol twice within 12 hours& it got resolved on 04Feb2021. Patient was taken to pediatrician who ruled out flu & streptococcal  infection.  No concomitant medication information provided.
Headache Narrative: ha 1 wk after vaccine h/o migraine treated as migraine.
t104.4 10 days p/vax; minor rash (few bumps) chest & 1 leg; resolved w/in 2 days w/o residual problems; was reported to pt's MD;
COVID+ 1/15/2023.  Vaccination status - moderna x3 + pfizer x1 BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/15/2023 Discharge Date: Jan 19, 2023   Active Hospital Problems   Diagnosis Date Noted POA ? History of COVID-19 01/16/2023 Yes ? AKI (acute kidney injury) 01/16/2023 Yes ? Paroxysmal atrial fibrillation 01/16/2023 Yes ? History of stroke 01/16/2023 Yes ? OSA (obstructive sleep apnea) 03/22/2016 Yes ? HTN (hypertension) 04/09/2013 Yes ? Unspecified hypothyroidism 04/09/2013 Yes ? Stage 3b chronic kidney disease 04/09/2013 Yes  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Altered mental state [R41.82] Weakness [R53.1] Acute cystitis without hematuria [N30.00] Right sided weakness [R53.1]   HOSPITAL COURSE: 89-year-old admitted on 1/15 with findings of altered mental status and transient stroke-like symptoms including right-sided facial weakness and evidence of previous stroke.  Evaluation emergency room showed abnormal urine with large amount of leukocytes, and the patient reported some dysuria.  Patient was placed on ceftriaxone and cultures subsequently were positive for Proteus sensitive to all.  Patient received 3 days of ceftriaxone which was then discontinued.  Neurology was consulted and recommended brain MRI.  The patient had previously undergone MRI procedures and had difficulty with general anesthesia so the family was reluctant to repeat an MRI with general anesthesia.  After extensive discussion with Neurology it was recommended that the patient consider therapeutic anticoagulation because of past history of stroke, recent episode of COVID, and known atrial fibrillation.  Previously it was felt that the patient had to high fall risk to warrant therapeutic anticoagulation.  After additional discussion and evaluation by Physical therapy it was felt that therapeutic anticoagulation would be reasonable to pursue.  The patient's neurologic symptoms resolved.  At the time of admission the patient was also noted to have acute kidney injury on top of CKD.  This was treated with IV fluid rehydration and discontinuation of the patient's lisinopril.  Patient's initial creatinine was 2.29, his creatinine improved to 1.9 on 1/17.  Patient's baseline creatinine is between 1.3 and 1.4.  The patient was started on Eliquis 2.5 mg 2 times a day on 01/17.  If his renal function continues to improve the Eliquis dosage may need to be increased. Patient also noted to have bradycardia with afib with heart rate in 40s at times not on rate control medication without significant symptoms occasional report of dizziness with mobility and amlodipine further decreased . Family had previously decided against pace maker and decision not to send with heart monitor as they would not want intervention.  Patient was discharged in improved condition on 1/19.
This spontaneous report was received from a nurse referring to a 13 year old male patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 10-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot # N023828 with expiration date 25-JUN-2020, for prophylaxis. It was stated that immediately following vaccination, the patient experienced abdominal pain and nausea. Additionally, the patient vomited (vomiting). No treatment was given for the events and no laboratory diagnostic test was performed. It was reported that later on the same date, the patient recovered from the events. The causality assessment between the events and GARDASIL 9 was not provided.
No adverse event; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient. Products were administered 2/13/2023.       ?    Names of vaccines involved (including lot/exp) PEDVAX HIB W021182 2/27/2025; ROTATEQ W02; This spontaneous report was received from a nurse and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 13-FEB-2023, the patient was vaccinated with an improper storage doses of with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W021182, expiration date: 27-FEB-2025 (upon internal validation was determined to be a valid number), administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W026135, expiration date: 31-JAN-2024 (upon internal validation was determined to be a valid number), administered for prophylaxis (strength, and route of administration were not provided). The vaccines were storage at temperature above 9 degrees centigrade (13.25 C) with a time frame of 2 hours 32 minutes and 0 seconds. There was no information about previous temperature excursion (incorrect product storage). No additional adverse events.
Approximately 24 hours after vaccine given, pt developed flu-like symptoms with fever, chills, headache, aches and rash. Rash was local at injection site about 6cm, red, hot welt and also hives on back, chest and arms. Seen 11/03 and treated with Zyrtec and Medrol dose pak.
Patient passed out/fainted approx 5 minutes after vaccination; Layed patient  on floor on back with ice back behind neck; patient regained conciousness and maintained verbal conversation til rescue arrived. Refused transport to hospital.
Petechia, Ecchymosis and immune thrombocytopenia; This literature-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       Concurrent medical conditions included Immune thrombocytopenia.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) to be possibly related.    Concomitant medications were not reported Treatment medications were not reported.  Company Comment: This case concerns a 34-year-old male patient with a relevant medical history of Immune thrombocytopenia, who experienced the unexpected serious event/AESI of Immune thrombocytopenia aggravated after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the dose of mRNA- 1273 vaccine, dose number unknown. Clinical manifestations included petechiae and ecchymoses. The rechallenge is not applicable since only information about the first dose was disclosed. Underlying immune thrombocytopenia remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report; Sender's Comments: This case concerns a 34-year-old male patient with a relevant medical history of Immune thrombocytopenia, who experienced the unexpected serious event/AESI of Immune thrombocytopenia aggravated after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the dose of mRNA- 1273 vaccine, dose number unknown. Clinical manifestations included petechiae and ecchymoses. The rechallenge is not applicable since only information about the first dose was disclosed. Underlying immune thrombocytopenia remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
Fever, chills, headache, dry cough, left calf pain, tremor in left thumb
muscle aches and pains; headache; chills; feel as if I am on fire.I just took my temperature and I am running a fever of 100.4; soreness at the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the site), MYALGIA (muscle aches and pains), HEADACHE (headache), CHILLS (chills) and PYREXIA (feel as if I am on fire.I just took my temperature and I am running a fever of 100.4) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced INJECTION SITE PAIN (soreness at the site). On an unknown date, the patient experienced MYALGIA (muscle aches and pains), HEADACHE (headache), CHILLS (chills) and PYREXIA (feel as if I am on fire.I just took my temperature and I am running a fever of 100.4). At the time of the report, INJECTION SITE PAIN (soreness at the site), MYALGIA (muscle aches and pains), HEADACHE (headache), CHILLS (chills) and PYREXIA (feel as if I am on fire.I just took my temperature and I am running a fever of 100.4) outcome was unknown.            Concomitant information were not provided by the reporter. Treatment information were not reporter.   Reporter did not allow further contact
On July 30, 2019, patient was seen at Pediatrics for the first dose of three HPV.  On July 31, 2019, we noticed a raised, red, slightly itchy rash (hives)  in patient's armpits and around his neck.  We took photographs.  The next morning August 1,  the rash had spread to his front and side torso, and on both of his legs.  We quickly scheduled a same-day appointment with Dr. for the late afternoon.  By the time of the appointment with Dr., however, the rash had almost completely disappeared.  My husband, who brought patient to the appointment, showed our photographs to Dr., who advised that patient not continue with the HPV vaccine series.  Patient stated that he was not in any distress during the course of the rash, only slight itching.  After August 1, the rash did not recur.
Improperly stored administered vaccine; This spontaneous report was received from a physician referring to a patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.      On 23-DEC-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number T040207, expiration date 18-JUL-2022; dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.  The vaccine was exposed to a temperature of 27.4 degree Celsius (C), for a time frame of 52 hours and 30 minutes. There were no previous temperature excursions.