chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very Dizzy; Exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 13:15 (Lot number: EN6208) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypophosphatasia", start date: Apr2018 (unspecified if ongoing), notes: rare genetic disease; was born with this but was diagnosed in the spring; "slipped and fell" (unspecified if ongoing), notes: couple of days before Covid shot, was starting to feel better and was up and about stuff; "I hit my head in the back" (unspecified if ongoing), notes: couple of days before Covid shot, was starting to feel better and was up and about stuff; "mild concussion" (unspecified if ongoing), notes: recuperating; couple of days before Covid shot, was starting to feel better & was up & about stuff; "allergic reaction to the treatment for my rare disease" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL taken for drug hypersensitivity; STRENSIQ taken for hypophosphatasia. The following information was reported: DIZZINESS (non-serious) with onset 19Mar2021 08:30, outcome "not recovered", described as "Very Dizzy"; FATIGUE (non-serious) with onset 19Mar2021 08:30, outcome "not recovered", described as "Exhausted". Therapeutic measures were not taken as a result of dizziness, fatigue. Additional information: When probed if the events were worsened, improved or persisting, consumer stated, "It's worsened I would say, I would have said persisting maybe couple of days ago and it's really honestly getting worst.". Date for the second vaccination was due on "08Apr.".  No follow-up attempts are possible. No further information is expected.
psoriasis; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EW0153 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 14May2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included; psoriasis from 2010 to an unknown date Patient's Medical History: PSORIASIS IN 2010. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. There were no concomitant medications.The patient previously took bnt162b2 for covid-19 immunization, Humira ac for psoriasis and experienced discomfort. On May2021 the patient experienced psoriasis. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Administration error - trivalent influenza vaccine was requested and high dose influenza was administered instead.  No adverse effects experience by patient.
the patient had an episode of pericarditis 10 days after the initial second dose; This is a spontaneous report received from a contactable reporter(s) (Physician) from information team for a sponsored program (159558).  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "the patient had an episode of pericarditis 10 days after the initial second dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pericarditis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
I basically felt like I was run over by a truck, had chills, fever, body aches, swelling, random, pain, open soars started on my left arm and my back really deep, a severe headache and I was really lethargic, and I had diarrhea ended up with a cough, short of breath and hard to breathe.
Headache, Tachycardia, facial and tongue swelling Narrative: seen in urgent care 1/17/21 - prescribed steroid pak and epipen. Took Steroid pak, symptoms resolved on 1/18/2021. Called 911 on evening of 1/15, EKG done and normal, tachycardia had resolved. Not taken to hospital.  Other Relevant History:
Felt warm to touch 1-2 hours later. That night 103-104 degrees F with chills - asking what's hallucinations Children's TYLENOL & MOTRIN not helping stomach. Swelling of arm - Thursday c/o arm dead- purple streaks above elbow, was seen by Dr. Still has swollen arm.
A non-serious spontaneous report of felt feverish, cough, sore throat and exhausted was received from a mother/consumer concerning her four-year-old daughter, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. In 2009, the patient received first dose and on 18-Dec-2009, the patient received second dose of H1N1, Intranasal for an unknown indication. The patient felt feverish, had cough, sore throat and exhausted. The patient had same symptoms after first dose. The outcome of felt feverish, cough, sore throat and exhauseted was not resolved.
Pains/aches; Liver was enlarged; Chills; Low grade fever; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains/aches), HEPATOMEGALY (Liver was enlarged), COUGH (Dry cough), CHILLS (Chills) and PYREXIA (Low grade fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal) (Acid reflux). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (oesophageal), PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure management, HYDROCHLOROTHIAZIDE (HCTZ) for Diuretic therapy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Dry cough). On an unknown date, the patient experienced PAIN (Pains/aches), HEPATOMEGALY (Liver was enlarged), CHILLS (Chills) and PYREXIA (Low grade fever). In March 2021, COUGH (Dry cough) had resolved. At the time of the report, PAIN (Pains/aches), HEPATOMEGALY (Liver was enlarged), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) A month after the second dose patient had an x ray that showed her liver was enlarged. Not sure if that was a side effect from the vaccine.         Patient medical history includes Blood pressure, diuretic. Patient did not take anything for the side effects.  The patient reports chills, aches, pains, low grade fever, within an hour developed dry cough for 36 hours and then disappeared 2 days after.
MUSCLE CRAMPING, FATIGUE, DIARRHEA, NAUSEA Narrative: NO FEVER; SYMPTOMS LASTED THRU 1/28/21
Complex febrile seizure 8 days after vax. Pt unconscious for 7 hrs after seizure & in hosp overnight 24 hrs. Diagnosed w/ ear infect & temp over 104 when arrived at hosp. Pt slightly groggy & not herself prior to siezure.
pain in the injection site; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in the injection site on an unspecified date. It was reported that on an unspecified date (reported as Saturday), he felt pain in the injection site that apparently was gone for one day, and then on Sunday it came back and continued to be felt with growing in intensity through Monday and Tuesday. Patient was also asking if NSAID medications could reduce the efficacy of the Pfizer's COVID-19 vaccine building up antibodies. The outcome event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CICLOSPORIN (RESTASIS), VITAMINS NOS and METOPROLOL for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported stated that patient took Acupressure therapy as treatment.    This case was linked to MOD-2021-380501, MOD-2021-380502 (Patient Link).
Pt brought in by dad-> the following morning seizing; pt with tonic clonic seizure - lasting 10 min, paramedics called, pt came out of seizure, but per mom seized again in ER - getting transferred to hospital.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 52-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No treatment medications were reported.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 18-DEC-2013, the patient was vaccinated with first dose of VARIVAX lot # H018451 which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
58 yo female s/p Pfizer COVID19 vaccination: dose 1 on 3/2 and dose 2 on 3/23. PMH of alpha-1 antitrypsin deficiency s/p bilateral lung transplant on mycophenolate, tacrolimus, and prednisone 5 mg daily, atrial fibrillation, HTN, HLD, and recent diagnosis of COVID-19 infection on 9/8 who presents to the ED for evaluation of ongoing fever. She received monoclonal AB infusion on 9/9 prior to admission, but had ongoing fevers, myalgias and headache. ID recommended initiation of Remdesivir. She desaturated with exertion and was also started on Decadron. She completed 4 days of Remdesivir prior to discharge. She was doing well without hypoxemia, fevers or myalgias, therefore, discharged prior to completion of... the fifth dose of Remdesivir. She was discharged to home on 9/14 in stable conditions.
No additional AE; expired vaccine was administered to a patient; This spontaneous report has been received from a nurse referring to a patient of unspecified age and gender. Information regarding medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was not provided.   On 05-JUL-2022 the patient was administered an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, and anatomical site of vaccination were not reported; lot number T008151 has been verified to be valid, expiration date reported and established as 21-JUN-2022) (expired product administered).  It was reported that the vaccine was stored according to prescribing information through the date of administration. No additional adverse event was reported (no adverse event).
The 1st admission to ER on 12/29/01 with a sudden onset of psychosis, 2 weeks after MMR vaccine. She was treated with Xanax 0.25mg. Upon admission to hospital, she exhibited acute confusion/psychosis state. Onset of all the symptoms from 12/29/01 to 1/10/02 include, HA, blurred vision, lack of sleep and food, itching, hallucinations, disorganized, fever, fatigue and hand and leg movement. Treated with diazepam and lorazepam.
Headache, rash swollen arm. Numbness and stiffness. Vomiting
Lost eyesight in one of her eyes; She developed severe headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), via an unspecified route of adminiatration, on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "Lost eyesight in one of her eyes"; HEADACHE (non-serious), outcome "unknown", described as "She developed severe headache". Additional information: The patient cannot perform her doctor duties and was out of the profession.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
he received his booster dose; he received his booster dose; constant fatigue/ tired all day; This is a spontaneous report from a contactable consumer (patient himself). A 63-years-old male patient received BNT162B2 (COMIRNATY mRNA vaccine, formulation: Solution for injection, Lot Number: ec3181, Expiry Date was not reported), via an unspecified route of administration, administered in Arm Left on 14Aug2021 as dose 3 (booster), single for COVID-19 immunisation (Age at Vaccination was 63 years). The patient medical history was not reported. The patient concomitant medications included Avostatin (medications received within 2 weeks of vaccination). No known allergies were reported. It was reported that, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19, Prior to vaccination and has been tested for COVID-19 Since the vaccination. The patient previously received BNT162B2 (COMIRNATY mRNA vaccine, formulation: Solution for injection, Lot Number: ec9269), via an unspecified route of administration, administered in Arm Left on 17Feb2021 as dose 2, single (Age at Vaccination was 63 years) and received BNT162B2 (COMIRNATY mRNA vaccine, formulation: Solution for injection, Lot Number: ec9262), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for COVID-19 immunisation. On 14Aug2021, the patient received his booster dose. On an unspecified date in Aug2021, the patient experienced constant fatigue/ tired all day ever morning even after a full night's sleep (sleeps 8 to 9 hours). The patient has visited physician office as result of events, and they said it is unexplained fatigue on their end. There was no prolonged hospitalization, and no therapeutic measures were taken as a result of events. The patient underwent lab tests and procedures which included blood test: okay/ nothing is abnormal, COVID test: Nasal Swab: unknown result on an unspecified date in 2021 (Post vaccination). The outcome of the event constant fatigue/ tired all day was not recovered.    Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician refers to an approximately 10 week old female patient with no drug reactions or allergies. Pertinent medical history was none. On 15-FEB-2013, the patient was vaccinated with a dose of 2 milliliter (ml) ROTATEQ, oral (lot number was reported as 0577AE, expiry date 28-OCT-2013) orally. Other suspect therapies included LIQUID PEDVAXHIB, DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE and PREVNAR 13 reported as pneumo 13 (manufacturer unknown) which were administered on 15-FEB-2013. On 22-FEB-2013, the patient developed symptoms of intussusception (vomiting, blood stool). The patient sought medical attention. The physician stated that the patient was hospitalized, on approximately on an unknown date in February 2013(reported as this past week) and the patient was diagnosed with intussusception on 24-FEB-2013. The patient was treated with air enema to reduced the intussusception. The physician stated that had the intussusceptions not been detected, it could have been life threatening. The patient was doing well and was hopefully going home on 26-FEB-2013. At the time of this report, the event was resolving. The lot# 0577AE is verified as a valid lot# for ROTATEQ, oral. Additional information has been requested.
Pt recv vax on 9/8/97; on 9/9/97 pt exp flat, red rash on trunk & body w/ pruritus; tx=Benadryl.
Pt became diaphoretic, vasovagal reaction loss of site for less than a minute occurring 10 minutes after vaccination administered in waiting room, nausea, SOB. BP 100/62, Pulse 77 4 minutes  reading. EMS called Paramedics arrived pt examined and reported at 19 minutes after  to be stable conscious with slight dizziness. Pt was initially placed on exam table supine with legs elevated.
Information has been received from a nurse referring to a 16 week old patient of unknown gender. On 28-JAN-2015, the patient was vaccinated with the first dose of ROTATEQ 2 ml, (strength, lot number and expiry date were not reported) orally (inappropriate schedule of vaccine administered). The nurse stated that patient data was not presently available to answer all questions. No adverse effects reported. Additional information has been requested.
sensitive to cold air; couldn't dress herself or open a bottle of water; fatigue; joints began to hurt in bilateral hands; wave of pain down her shoulders and down her body; This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (sensitive to cold air), MALAISE (couldn't dress herself or open a bottle of water), FATIGUE (fatigue), ARTHRALGIA (joints began to hurt in bilateral hands) and MYALGIA (wave of pain down her shoulders and down her body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TEMPERATURE INTOLERANCE (sensitive to cold air), MALAISE (couldn't dress herself or open a bottle of water), FATIGUE (fatigue), ARTHRALGIA (joints began to hurt in bilateral hands) and MYALGIA (wave of pain down her shoulders and down her body). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, TEMPERATURE INTOLERANCE (sensitive to cold air), MALAISE (couldn't dress herself or open a bottle of water), FATIGUE (fatigue), ARTHRALGIA (joints began to hurt in bilateral hands) and MYALGIA (wave of pain down her shoulders and down her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient had a compromised immune system.
MMR was administered on 03/03/2020 and pt. was seen on 03/18/20 with c/o fever and rash x 4 days. Pt. was advised to go home and quarantine.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 31st March 2018, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. She had a headache the next day on 31st March 2018 and her arm was sore for a few days.
Information has been received from a consumer via a company employee, referring to her 17 year old daughter. Information of concomitant therapy, pertinent medical history and current condition was unknown. On 11-AUG-2018, the patient was administered her first dose of GARDASIL 9 (strength, frequency, route, lot# and expiration date unknown) for prophylaxis(reported as vaccination) at an unspecified medical walk in clinic. On August 2018, 24-36 hours post vaccination, the patient experienced aches, pain, muscle weakness, fatigue, diarrhea and nausea lasting until 13-AUG-2018(reported as yesterday and today). The outcome of the events was unknown. The causality assessment between the events and GARDASIL 9 was not provided.
Pt recv vax on 10/15/97; on same day pt exp chills, nausea, vomiting, malaise &circumoral paresthesia, confusion, rash began at vax site to spread over body
Severe burning in both upper arms, fever 102 f, extreme body aches, head ache, diarrhea.     Sames issues the 2nd vaccine including vomiting and being bed ridden. It has taken months to feet better.  Still not 100 percent.  Have joint pain and heavy legs at times still. Had COIVD-19 5-21-21 and had pneumonia