chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; UPSET STOMACH; CHILLS; FEVER; 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: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 104. On 29-APR-2021, the subject experienced vomiting. On 29-APR-2021, the subject experienced upset stomach. On 29-APR-2021, the subject experienced chills. Laboratory data included: Fever (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, vomiting and upset stomach was not reported. This report was non-serious.
7/27/21 ? Approx. 3:30pm Patient received his Tdap and his Meningococcal conjugate MCV4 shots. He reported the 2nd one hurt which was the Tdap.   7/27/21 ? Approx. 10pm Complained of his arm hurting bad. Site was hard and red. Took 2 Tylenol before bed.  7/28/21 ? Approx. 3am Woke up and was shivering in his legs and felt cold. Said he had a horrible headache and his arm was super sore. Leg shivering continued off and on for about 30 minutes. We went to go downstairs to get a bucket because he said his stomach hurt (his normal sign for vomiting). He felt like his legs were weak while walking downstairs. He vomited once. He wrapped up in a blanket and was sitting on a chair. I checked his pulse ox several times over the next 30 minutes. His oxygen levels were between 95-99 and heart rate was between 120-135. His legs began to shiver worse. We were debating to take him to the ER so I went to get a change of clothes. When I came downstairs he had stopped shivering. Oxygen levels were down in the 90?s we decided to see how it would go for the next hour. Still complaining of a headache.  - Approx. 6am Vomit/Dry heaved. Felt cold so put on a hoodie but was not shivering. Complaining of a headache around both temples and the top of his head. Ate a handful of goldfish. Gave 1 Tylenol for pain.  - Approx. 8am Vomited/Dry heaved. Complained of headache. Had him lay down to nap. Called Facility to report symptoms and see if he needed to be seen or just monitored. Pulse ox in the 90?s for both.  - 11am Facility called back. Thinking it is a strong immune reaction to the shots. Monitor symptoms. Should continue to get better, but if any changes or worsening of symptoms call them for him to be seen. Continuing to have a headache. Gave 1 Motrin. Pulse ox 93/98. - 1:30pm Pulse ox in the 93/98. Still having a headache. Gave 1 Tylenol. - 9pm Still having a headache and chills and feeling really tired and lethargic. Arm was still sore, hard and red at injection site. Pulse ox 96/99. Gave 1 Motrin.  7/29/21 8:30am Complaining of a sore arm and headache. Gave 1 Motrin. - 11am Feeling better, still had a sore arm. - 5pm Just a sore arm. Injection site is still hard but redness has become slightly pink. All other symptoms have gone away.
Pt stated she fetl tingling all over then tongue tingling.. laid her down.. stated dry mouth.. gave water...pt waited in office for 30 minutes... Began to leave feeling better, then returned complaining of tightening in chest...  EKG normal.. Oxygen normal... sent to ER with son as driver
Information has been received from a Medical Assistant (M.A.) concerning a 25 year old female patient with a history of high fever after receiving the tetanus toxoid years ago who on 13-FEB-2007 was vaccinated IM in the Left arm with a first dose of Gardasil lot #655618/0186U. Years ago the patient developed swelling, redness and itching of left arm after the first injection and went to the Emergency Room (E.R.) and she was provided antibiotics. On an unspecified date, patient was vaccinated in Right arm with a second dose of Gardasil lot #657617/0384U. She developed swelling, redness and itching of right arm after the second injection and went to see her primary physician. The physician administered antibiotics and felt that event was Cellulitis without a cut causing the event. Patient had high fever after receiving the tetanus toxoid years ago. The patient recovered from the events. Additional information has been requested.
pt recv vax DEC96 & mid JAN97 pt had complete heart block;pt was described as asymptomatic but bradycardic;had a cold @ time that bradycardia was detected;
Sore, scratchy throat; Sore, scratchy throat; Runny nose; Diarrhea; Loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 16:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "migraine headaches" (unspecified if ongoing). Concomitant medication(s) included: AIMOVIG; HUMALOG; LOSARTAN POTASSIUM. The following information was reported: OROPHARYNGEAL PAIN (non-serious), THROAT IRRITATION (non-serious), outcome "unknown" and all described as "Sore, scratchy throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Loss of appetite". Therapeutic measures were not taken as a result of oropharyngeal pain, throat irritation, rhinorrhoea, diarrhoea, decreased appetite.  Additional information: Patient took other medications in two weeks which included Zos (as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 at 15:00 as dose 1, single (Lot number: EW0150), in right arm, on 21Apr2021 at 11:00 as dose 2, single (Lot number: ER8729), in right arm and on 27Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FJ8762), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; ASPIRIN [ACETYLSALICYLIC ACID]. Other medication in 2 weeks product included Covidalal and MultiVitamins. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2022) Negative; (24Oct2022) Positive. The patient received Paxlovid as COVID 19 Treatment from 16Oct2022 to 20Oct2022.
Approx. 1 week post vaccination pt states he experienced itching sensations in (L) & (R) hands, occasional swelling of fingers. Sx are intermittent.
14 hours after got chilled to the bones& lasted about 4 hours, had on clothes & a hoodie & 2 blankets.; Also had a headache which lasted about 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: cw0151) via an unspecified route of administration in the left arm on 13Apr2021 at 18:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, hyperthyroidism, sulfonamide allergy (Bactrum allergy). Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), meloxicam (MOBIC), losartan potassium (COZAAR), molixcan (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6206) via an unspecified route of administration in the left arm on 18Mar2021 at 19:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 10:00, the patient experienced chilled to the bones and lasted about 4 hours, had on clothes and a hoodie and 2 blankets. Also had a headache which lasted about 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chilled to the bones, headache was recovering.  No follow-up attempts are needed. No further information is expected.
D-dimer is mildly elevated  - 0.64 lower Abdomen pain - moderate, lightheadedness since 7th day of vaccine (04/16)
Night sweats x 3 weeks, on-going, negative work up; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ELD140), via an unspecified route of administration in right arm on 22Dec2020 16:00 at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history included depression. No known allergies. No Covid prior vaccination.  Concomitant medications included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN).  The patient experienced night sweats x 3 weeks, on-going, negative work up (non-serious) on 24Dec2020.  AE resulted in ''Doctor or other healthcare professional office/clinic visit''. No treatment received for the event. Patient was not pregnant. Patient not received other vaccine in four weeks. The patient underwent lab tests and procedures which included nasal swab: negative on 07Jan2021.  The outcome of the event was reported as recovered/resolved with sequel.
Given 2 month immunizations on 10/6/2014. Developed sudden onset of groin swelling, redness on 10/23/14. Hospitalized 10-23-24/14 - diagnostic laparoscopy with I&D of Rt groin abscess.
Information has been received from a healthcare student concerning herself with no pertinent medical history and no drug reactions/allergies who in March 2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL. There was no concomitant medication. On the same day the patient developed a "high fever", chills, a cold sore and arm pain at the injection site. About five days after receiving the first dose of GARDASIL the patient recovered. The patient had sought medical attention, phone call. There were no lab diagnostic tests performed. The patient received her second dose of GARDASIL in June 2009 with no adverse experience. Additional information has been requested.
Fever 24-36 hours after immunization given. Tmax 101.5 Also night otitis media
Patient became dizzy and hot. Assisted patient with water and placed him in shock position. Patient rapidly improved.
Rashes and hives all over body, very itchy scalp, and burning in the stomach area.
3/28: period-like bleeding (I have a Mirena IUD and have not had any bleeding since 7/20, prior to its insertion 8/20) *wondering if the vaccine has any impact on birth control efficacy 3/29: woke up having a panic attack (only happened one other time in my life, fall 2019)
sore arm; headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown, PYREXIA (fever) was resolving and CHILLS (chills) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported
I developed enlarged lymph nodes in left axilla. I also periodcally have a skin rash around the left 1st toe where skin peels off, I was told by a VAERS MD that this is not uncommon. I also have developed plantar warts on my left foot. I have reported this to Manufacturer of vaccine.
Pt screened to wait for 15 mins and when asked if he was feeling okay to leave, reported fatigue and tightness in throat. Father reported hx of asthma. I evaluated him and determined reaction to be anxiety-induced. HEENT and Pulm exams normal. I encouraged hydration, and calmed pt down with casual conversation and held for 40 mins
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 15:24, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Hair has become very dry and brittle and continues to break and fall out much more rapidly than ever.
SHORTNESS OF BREATH (SOB); SHALLOW BREATHING; SOME COUGHING; SINUS CONGESTION; WHEEZING; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. Non-company suspect drugs included: interferon beta-1a (injection, route of admin, and batch number were not reported) dose and frequency were not reported from 19-AUG-2021 for drug used for unknown indication. No concomitant medications were reported. On 20-AUG-2021, the patient experienced shortness of breath (sob). On 20-AUG-2021, the patient experienced shallow breathing. On 20-AUG-2021, the patient experienced some coughing. On 20-AUG-2021, the patient experienced sinus congestion. On 20-AUG-2021, the patient experienced wheezing. On 20-AUG-2021, the patient experienced massive headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (sob), shallow breathing, massive headache, some coughing, sinus congestion, and wheezing. This report was non-serious.
Person reported fever of 101 for 4 days, URI with cough.  Cough started to get better, then got worse. After 1 wk, started with dizzy, and unable to control her lower extremeties and almost fell down a flight of stairs. 8/24/06 had difficulty reading.  9/26/06 Received incomplete medical records from hospital.  Patient remains a current inpatient.  8/28-9/5/06 admit --Thoracic consult of 8/29/06 reveals patient had been admitted on 8/27 for neuro symptoms & right side weakness & was found to have multiple left side brain mets lesions on MRI.  Underwent resection of brain mets on 8/30/06. A left throacentesis was done to improve resp status.  1/18/07 Received medical records from hospital which reveal patient readmitted to hospital. 8/28-9/5/06 admit for right sided weakness & lightheadedness. Neuro consult & rad oncology consult revealed probable mets to brain.  Pulm consult done due to left pleural effusion & thoracentesis was done 8/29.  Had brain surgery done 8/30.  Had right facial droop s/p surgery.  Improved & was transferred to rehab at outlying hospital. 9/15-9/27/06 Readmit from rehab --Worsening right side paralysis, N/V & hypoxia.  Was doing well & had regained some strength but on 9/11 developed nausea & declined rapidly clinically over next 4 days.  Now had headaches & complete right side paralysis, N/V.  During hospitalization developed + c diff which was treated & continued on oral antibiotics upon transfer back to rehab hospital.  Hospice was recommended but declined although patient consented to DNR. 11/16-11/22/06  Readmit from rehab with  N/V & failure to thrive & recurrent c diff.  Had restarted chemo on 11/14.  Improved with hydration & supportive care.
Nausea, throwing up, aching body, fever, chills Lasted approximately 20 hours
To ED at 4:49 pm. C/O difficulty swallowing, "itchy" tongue, lips feel funny, short of breath, chest tight. Medical tx with BENADRYL 50 mg IV. VSS lung without wheezes or rales. Heart reg rate and rhythm. D/C after reaction subsided. Did not drive herself home.
Very faint varicella rash, 5 spots max low grade fever, all occurring 4-5 days after vaccine. As stated, vaccine was administered at a location not a part of our practice.
Moderate left arm pain; Mild left arm swelling; Moderate muscle aches; Chills; Mild headache; Moderate Fatigue; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 12Mar2021 11:30 (Lot number: EN6203) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; LANSOPRAZOLE. Vaccination history included: Bnt162b2 (Lot number=EL3247, administration date=17Feb2021, administration time=11:30 AM, vaccine location=Left arm, dose number=1), administration date: 17Feb2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate left arm pain"; PERIPHERAL SWELLING (non-serious) with onset 13Mar2021, outcome "recovering", described as "Mild left arm swelling"; MYALGIA (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate muscle aches"; CHILLS (non-serious) with onset 13Mar2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovering", described as "Mild headache"; FATIGUE (non-serious) with onset 13Mar2021, outcome "recovering", described as "Moderate Fatigue". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, myalgia, chills, headache, fatigue.  No follow-up attempts are possible. No further information is expected.
Subsequent to receiving vax, the pt experienced an injection site rash. The most recent information received reports the condition of the pt as unknown.
Narrative:  72yo patient with cancer diagnosis of right thigh dedifferentiated myxoid liposarcoma in hospice died on 11/20/21. Pt had received covid vaccines on 2/4/21 & 3/10/21. This death is not related to vaccines.
Two years later January 2023 they both received dose 2 of Shingrix.; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose around October 2020.).   In JAN-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Two years later January 2023 they both received dose 2 of Shingrix.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 01-MAR-2023 The patient received Shingrix dose 1 around October 2020 and after two years later in January 2023 the patient received dose 2 of Shingrix. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. The reporter did not want to provided any additional information. The reporter did not consent to follow up. This case is linked with US2023033410, reported by same reporter.; Sender's Comments:  US-GSK-US2023033410:Same reporter
77 y/o M w/ PMH CHF and AV replacement 2016 presenting for SOB for 1 week. Pt states SOB has been progressive since his recent discharge from Medical center. Pt had been admitted 2-3 weeks ago for a CAP and was told he was positive for covid. Pt isn't sure if he received treatment inpt for covid.
Information has been received from a physician concerning an "about 15 year old female patient" who in approximately February 2008, "about a year and a half ago", was vaccinated with a 0.5 mL dose of GARDASIL intramuscularly. It was reported that after having been given GARDASIL, "about a year and a half", "the patient had a quarter sized indentation at the injection that appeared right after the vaccine was administered". The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Began with extreme fatigue on Wednesday, on Thursday became nauseous with multiple incidents,  Friday a fever developed going into the evening,  fever and sweats through the night, fever seemed to break about 3:30am Saturday morning
MUSCULOSKELETAL DISORDER (RIGHT HAND STILL BOTHERING); This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced musculoskeletal disorder (right hand still bothering). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of musculoskeletal disorder (right hand still bothering) was not reported. This report was non-serious.