chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom reports at approximately 2PM, child began screaming. This lasted approximately 2 hours. Mom also reports she got pale. Denies fever. Doing ok today (12/12/02). 12/16/02 Doing well but mom feels she sleeps more.
itchiness on the injection site; area became swollen; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at injection site), INJECTION SITE PRURITUS (itchiness on the injection site) and INJECTION SITE SWELLING (area became swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness at injection site). On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness on the injection site) and INJECTION SITE SWELLING (area became swollen). On 08-Feb-2021, INJECTION SITE PAIN (soreness at injection site) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchiness on the injection site) and INJECTION SITE SWELLING (area became swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Approximately 5 minutes after vaccine administration,  pt. C/O tiredness, weakness/fatigued,  slow loss of vision.  He was guided to a flat surface in a supine position with legs elevated , Slow deep breaths were encounter,  ice pack applied at the back of his neck.  Vitals included 90/60, 68,  @18, 98% RA. Pt. Was alert and oriented  x4.  At 11:44 am, second vitals were, 110/70, 57, 26, t=98.2, @ 98%RA. Vision was restored back tk normal with minimal dizziness.  At 11:44, all symptoms  had subsided as per pt. report.  Pt. did mmot experience any falls or trauma while at the clinic. At
Information has been received from a registered nurse, concerning a 15 year old female patient, who on 22-AUG-2007 was vaccinated IM, with the first dose, 0.5ml, GARDASIL (Lot #658556/1060U).  There was no concomitant medication.  Following the vaccination, the patient experienced dizziness, began to sweat, and complained of arm and abdominal pain.  The patient was instructed to lie down flat for 30 minutes, and blood pressure was monitored and found to be within normal limits (value not specified).  No treatment was required, and the patient recovered from the events on the same day.  Additional information has been requested.
About 3 days after the first vaccination I started to notice a  slight humming or buzzing in my ears at night.  Mostly noticeable when I go to bed not enough after the first shot to keep me from sleeping so didn't think much of it.  After the second shot it is  more noticeable even during the day.  Not so much to be disabling but I do notice it and I have never had this happen before.  I had normal side affects for first and second shots otherwise, sore arm, some fatigue and slight chills more so after the second shot as it these symptoms lingered for almost a week but nothing too severe and those are gone now but the humming/buzzing noise is still there in the background. Is there something I can do to help alleviate this or will it go away on its own?
Sore arm at injection site; aching across my back (from waist to neck); chills; headache; no energy to get up out of bed; no energy to get up out of bed; some coughing; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholestrol" (unspecified if ongoing), notes: other medical history: High Cholestrol; "low thkyroid" (unspecified if ongoing), notes: other medical history: low thkyroid; "acidic stomach" (unspecified if ongoing), notes: other medical history: acidic stomach. Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; PROTONIX [OMEPRAZOLE]. Past drug history included: Pseudoephedine for loss of breath, reaction(s): "Known Allergies: pseudoephedine", notes: known allergies: pseudoephedine-loss of breath. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 09Mar2021, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: not listed, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 11Feb2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "Sore arm at injection site"; BACK PAIN (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "aching across my back (from waist to neck)"; CHILLS (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering"; HEADACHE (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering"; LETHARGY (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "lethargic"; ASTHENIA (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Jun2022 at 01:00, outcome "recovering" and all described as "no energy to get up out of bed"; COUGH (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "some coughing". Therapeutic measures were taken as a result of vaccination site pain, back pain, chills, headache, asthenia, loss of personal independence in daily activities, cough, lethargy.  Reported Event: Sore arm at injection site, aching across her back (from waist to neck), chills, headache, no energy to get up out of bed, some coughing and lethargic. Consumer did not have any of these effects when she got other Booster Shots. Consumer took withheld Brand Pain Relief pill before bed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 15Jun2022.  No follow-up attempts are possible. No further information is expected.
A few hours after having the 2nd vaccine I suffered from really bad cold chills and fatigue.  I stayed in the bed most of the evening hours just trying to keep warm.  Later that night, approximately 4 a.m. I asked my husband to assist me to the bathroom.  I fainted and collapsed in the bathroom while being assisted by husband, who tried to hold me as I fell.  He and my mom were able to revive me after a few minutes. using cold wet towels.  Husband drove me to hospital ER due to lingering dizziness, and pain in my legs and feet.  Diagnoses were ankle sprain, foot sprain, knee sprain, side effects of vaccination, and syncope.  A walker was delivered to my home to assist with mobility.  Toes on left foot remain sore.
Right upper thigh red and swollen--seen by nurse on 05/23/2002. On 05/24/02, patient returns to clinic with hot, swollen itching right upper thigh (8cmx5cm) reaction. Prognosis for possible abscess.
she broke out in hives from her left shoulder to her left wrist; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 12-AUG-2023, 2 days after receiving Shingrix, the patient experienced hives (Verbatim: she broke out in hives from her left shoulder to her left wrist).  On 14-AUG-2023, the outcome of the hives was resolved (duration 2 days).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 The patient reported that she received the Shingrix vaccine about 1 and ½ weeks ago in her left arm.  The patient states that 2 days later she broke out in hives from her left shoulder to her left wrist and the hives cleared up in 2 days.  The reporter did not consent to follow-up.
REPORTS HE AWOKE ON 3 APR 2022 at 0600 AND BEGAN EXPERIENCING NAUSEA, DIZZINESS, VOMITING WITH BLOOD, CHILLS, DIAPHORESIS, AND HEADACHE. PT REPORTS HIS HEART WOULD INTERMITTENTLY BEAT "FAST" WITH PALPITATIONS IN 3 SECOND EPISODES. "Patient nontoxic-appearing no acute distress. Vital signs remarkable for tachycardia. EKG unremarkable other than sinus tachycardia. Patient with some presyncopal symptoms. Troponin undetectable lowering suspicion for ACS. D-dimer elevated; however, CT PE negative. BNP not elevated point-of-care ultrasound at bedside demonstrates grossly normal EF without pericardial effusion. Labs are   unremarkable otherwise. Despite pain medication and 2 L IV fluids patient remains persistently tachycardic in the 130s. He has no signs of toxidrorne or history of substance use. Unclear etiology. Patient does report mild improvement symptoms. Given persistence of tachycardia with unclear etiology discussed case with hospitalist who accepts patient for observation." 3 April 2022, 0745  1000 ML saline IV, 0838  ondansetron 4mg/2 mL injection, 0906  iopamidol 76% injection 100 mL, 0948  1000 mL saline IV, 1157  acetaminophen tablet 1000 mg, 1158  ketorolac injection 10 mg, Discharge Medications: Diphenhydramine 25mg, 7 capsules, Every 6 hours as needed. Ondansetron 4mg, 10 tablets, Every 6 hours as needed. Pantoprazole 40mg, 7 tablets, 1 tablet PO for 7 days. Predisone 20mg, 5 tablets, 1 tablet PO for 5 days. Cetirizine 5mg, 30 tablets, 1 tablet PO as needed. Ipratropium bromide 21mcg spray, 1mL, 2 sprays in each nostril 3 times daily.
It's been less than 24 hours since the shot but the reaction is shaping up to be the same.  Sore throat, trouble swallowing this morning, left cheek feels tingly, headache.  All reactions that I had after the first dose that eventually led to extreme pain when trying to open my mouth on the left side.  It felt like my jaw was locked at a certain point, preventing me from opening it wide enough to yawn without being in terrible pain.
Immediate throat tingliness; Numbness in chest, neck, and lower face; Immediate throat swelling; Numbness in vaccine arm; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration in Arm Right on 17Mar2021 (at the age of 26 years old) as a single dose for covid-19 immunisation. Medical history was not reported. It was unknown if patient had any known allergies. Patient previously received first dose of BNT162B2 via an unspecified route of administration in Arm Right on an unspecified date (Lot Number: EN6198) as a single dose for covid-19 immunisation. Concomitant medication included spironolactone. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced immediate throat tingliness/swelling, numbness in vaccine arm, chest, neck, and lower face on 17Mar2021 09:15, still lasting through today (20Mar2021). Patient received Epipen and steroid as treatment for events. Event caused emergency room/department or urgent care. The outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Arm was a little more sore; Little swelling (arm); Small lump at injection; Tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid.  A 67-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the right arm, on 18Mar2021 at 09:40 (Batch/Lot Number: EN6204), at the age of 67 years old, as 2nd single dose, for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. Medical history included, lymphoma, ongoing type 2 diabetes mellitus, ongoing muscle spasticity, ongoing acidreflux/gastrooesophageal reflux disease (GERD), edema, and ongoing high blood pressure. Concomitant medications included ongoing insulin glargine (LANTUS) for type 2 diabetes mellitus, ongoing metformin for type 2 diabetes mellitus, ongoing baclofen for muscle spasticity, ongoing pantoprazole for acid reflux/GERD, furosemide for oedema, ongoing lisinopril for high blood pressure, ongoing metoprolol for high blood pressure, ongoing apixaban (ELIQUIS) as blood thinner, ongoing calcium/ colecalciferol (CALCIUM PLUS VITAMIN D), ongoing unspecified multivitamins, and ongoing paracetamol (TYLENOL extra strength, not taken a day before shots and a day after shots). It was also reported that insulin glargine, metformin, baclofen, pantoprazole, furosemide, lisinopril, metoprolol, and apixaban were also given to prevent congestive heart failure (as reported). Past drug history included intramuscular administration in the right arm of the 1st dose of BNT162b2 (Batch/Lot Number: EN6201), on 27Feb2021 at 09:50 AM, at the age of 66 years old. On 18Mar2021 the patient performed a blood test for a CT Scan done on 23Mar2021 due to lymphoma surveillance. After the administration of the 2nd dose of BNT162b2, on 18Mar2021, the patient's arm was a little more sore with respect to the first shot, and additionally it had a little swelling with a small lump at injection. The patient additionally described tiredness and feeling unwell. The events were reported as non-serious, and no treatment was needed. The patient recovered within approximately 4 days.  No follow-up attempts are possible; no further information expected.
increased postpartum bleeding; This is a spontaneous report from a non-contactable consumer (patient).   A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 14Apr2021, at the age of 30-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included mental disorder, Clotting disorder and allergy to amoxicillin.  The patient gave a birth 9 days before 1st vaccine dose. The patient previously took first dose of bnt162b2 for covid-19 immunisation on 24Mar2021.  The patient experienced increased postpartum bleeding on Apr2021 with outcome of recovered with sequelae.  The patient underwent lab test included sars-cov-2 test via nasal swab: negative on 20Oct2021. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Severe stabbing chest and back pain radiating to the left axilla. Diagnosed with atypical pericarditis with diffuse ST elevation on EKG but no effusion or pericardial thickening on echo/MRI. Treated with ongoing Colchicine and complete resolution of pain. Spent the night under ER observation. Missed 4 days of work.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # M039914, expiration date of 26-SEP-2018 or M045392, expiration date of 14-NOV-2018 or M045401, expiration date of 14-NOV-2018; strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
There was not an adverse event for this patient.  It was a vaccine error for administration.  The patient was to receive a Kinrix but received in error a Boostrix.  Patient as the same time received a Fluarix  and a IPV at the same time.
Red, warm, swollen (R) upper arm. Fever, chills, body ache and pain. Adverse event documented 1 day after received injection. Now same sx with limited arm motion - strength.
SLUGGISHNESS; HEAVINESS; PAIN; CHILLS; FEVER; HEADACHES; TIREDNESS; SWEATING; DROWSY; WALKING AROUND LIKE FOG; DID NOT REMEMBER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included normal headache. The patient was previously treated with paracetamol for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced walking around like fog. On MAR-2021, the subject experienced did not remember. On 21-MAR-2021, the subject experienced sweating. On 21-MAR-2021, the subject experienced drowsy. On 21-MAR-2021, the subject experienced sluggishness. On 21-MAR-2021, the subject experienced heaviness. On 21-MAR-2021, the subject experienced pain. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headaches. On 21-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, drowsy, pain, chills, and fever on 22-MAR-2021, and walking around like fog, sluggishness, heaviness, did not remember, headaches, and tiredness on MAR-2021. This report was non-serious.
Started immediately the next day with high pitch buzzing  in my ears which I have never suffered from before it has happened every day since receiving my second vaccination. I reported it to the doctor and hoped it would resolved on its own and it has not.
I have typed in GREAT DETAIL the events only to have your stupid system erase ALL of my work!!!
ANTEROSEPTAL INFARCTION; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a 59 year old of an unspecified sex, race and ethnicity. Initial information was processed along with additional information received on 21-DEC-2022. The patient's height, and weight were not reported. The patient was always fit and exercised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 6 decade old. No concomitant medications were reported. On an unspecified date, 2 years after vaccination the EKG (electrocardiogram) picked up an inverted T wave and experienced anteroseptal infarction, and the patient had suspected covid-19 infection. It was reported that "Took 1 J&J covid vaccine...now 2 years later my EKG picked up an inverted T wave...Anteroseptal Infarction at 59 Y.O.. always fit and excercised. They lied to us...your god given immune system is far better than a toxic non effective vaccine developed in 9 months...no long term safety testing. J&J and Pfizer and Moderna...I'll never take any vaccine ever again as long as i am breathing. My god given immune system works...haven't been sick again with covid since having the alpha strain. BTW...this virus was man made...it did not cross over from a bat virus". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of anteroseptal infarction was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be this customer preference case has been assessed and does not represent a product quality complaint. The disposition and root cause determination were documented properly based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20221244833-anteroseptal infarction. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Bad headache, it was worst yesterday. It started lightening up this morning. I started breathing real bad, then I have this cough and I started coughing real bad. I start trying to breathe real fast. I started coughing hard and couldn't stop.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY CHRONIC HYPOXEMIC RESPIRATORY FAILURE
contracted Covid 19; contracted Covid 19; This is a spontaneous report received from non-contactable reporter (Other HCP) via a Pfizer sales representative.  A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Oct2021, outcome "unknown" and all described as "contracted Covid 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient received second dose of Pfizer's Covid 19 vaccine in Jul and contracted Covid 19 in Oct requiring admission to ICU (Intensive care units), with Covid PNA (peptide nucleic acid) and requiring high flow O2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The patient received the first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) and got COVID-19.  Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
Diarrhea, 16 BM in less than 24 hours. Everyday since then till now Nov. 14 2009 have been at least 5 diarrhea  Episodes a day. Had a fever one the first day. Treatment for diarrhea has been Pedialyte. Also has cause a very bad Diaper rash. Patient still eating and drinking. Using cloth diapers to help with the rash. If not better by Monday (11/23/09) will take to docter again.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 22-MAR-2013, the patient received improperly stored  (Oka/Merck) VARIVAX dose 2, from lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received form the same reporter. Additional information has been requested.