chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in his arm after the shot; Inappropriate schedule of vaccine administered; This spontaneous report was received from a patient mother on behalf of her son who was a 16-year-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were reported as none.  The patient was on a three-dose regimen of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 25-MAR-2022, the patient was vaccined with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in his arm for the benefits (prophylaxis) (strength, dose, lot # and expiry date were not provided, unknown if intramuscular). On 21-JUN-2022 later than two months (inappropriate schedule of product administration), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in his arm for the benefits (prophylaxis) (strength, dose, lot # and expiry date were not provided, unknown if intramuscular). The patient also received the vaccine with meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) in his arm (strength, formulation, dose, lot #, expiry date, indication and route of administration were not provided). The patient experienced pain in his arm after the second shot on 21-JUN-2022. The patient had not sought medical attention, received the treatment or performed any lab diagnostics/studies. The outcome of vaccination site pain was reported as recovered (recovery date was an unknown date in 2022).   The reporter did not know if the pain was from hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (causality with vaccine site pain was considered as unknown).
Soreness at injection site and general fatigue.; Soreness at injection site and general fatigue.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Soreness at injection site and general fatigue.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gastroparesis; abdominal pain; administration date: 09May2021/dose number: 1/vaccine date: 09May2021/dose number: 2; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09May2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included allergy. There were no concomitant medications.  The patient experienced gastroparesis on 18Jun2021 21:00 with outcome of not recovered, administration date: 09May2021/dose number: 1/vaccine date: 09May2021/dose number: 2 on 09May2021, abdominal pain 3 weeks after second shot on 18Jun2021 21:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included computerised tomogram: unknown results, endoscopy upper gastrointestinal tract: unknown results, ultrasound scan: unknown results.  Therapeutic measures were taken as a result of gastroparesis and abdominal pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left shoulder, upper arm swollen, redness hot to touch, dx with allergic local vs cellulitis. Treatment with Benadryl and Motrin.
21NOV96 pt presented to clinic to show an area on upper posterior arm which was sunken c/o burning in the area;MD told pt needed to have steroid inj in the area;also told problem was directly r/t MMR vax;
Headache, stomach indigestion,  aches and chills, fever (101F), insomnia.
Right thigh red and swollen 6 1/2cm X 5cm around injection site. Warm to touch. Treated with Benadryl and Orapred 1 tsp po QD.
Headache, fever, nausea with onset between 12-24 hours after vaccine administration and duration of about 7-8 days.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown demographics. Information on medical history, concurrent condition, concomitant medication and drug allergies/reactions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency and route of administration were unknown) lot # N005274, expiration date: 03-APR-2018) for prophylaxis. No adverse event reported. Temperature Excursion details were as follows: Temperature and Time frame: Between 32 degree Fahrenheit (F) to 35°F for 8 Hours and between 47 F to 77 F for 9 hours. Previous temperature excursion included 32°F to 35°F for 9 Hours. The call was because of a data logger. No Product Quality Complaint (PQC) was involved. The outcome of incorrect product storage and no adverse event were unknown. No additional information was provided. This case is cross-referenced with 1706USA011420, 1707USA001306, 1707USA001304 and 1707USA001307 (same reporter). Additional information has been requested.
local-redness,warmth,pain,induration 3x3cm,pruritus;systemic- pruritis,vertigo,aching,malaise,nausea
Left thigh cellulitis 4 day post vaccination administered. Treated with Augmentin & Rocephin
Body Aches, temps ranging from 101-103.7, sensation of skin burning, rash , smelling scent of amonia, severe cough, muscle spasms, very winded, very fatigued. Breathing became very difficult so I went to the ER at 3:00am on Saturday morning. After running a covid test (negative) I had a chest x-ray which showed that I now had pneumonia.  Home with multiple medications until Monday morning. Back into the ER, unable to catch breath. Chest pain. Another covid test done as well as a flu test and both were negative. Pneumonia showed to be a bit worse. Multiple blood tests run and one showed possibility of a blood clot in lungs or heart. CT scan showed there was not a clot.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Allergy".  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID infection". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
developed sensations of heat from head to toe initially. in the evening developed twitching in limbs and numbness in the face for about 2 weeks. the third week developed tendonitis in feet with pain shooting up wards of left leg calf and arm
Reporter states that approx 10% of the Tetramune recipients (receiving no concomitant vaccines) are developing inject site swelling & fever to 102 w/in 7-10 days p/vax; sx resolved w/in 2wks; treated w/APAP;
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included two previous pregnancies resulting in normal births of two full-term infants with no defects.  Prior to becoming pregnant the subject had not been using contraception.  On 7 September 2011 at 12:00 the subject received a booster dose of Boostrix (o.5 unknown units, intramuscular, left arm), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 28 weeks gestation at the time of vaccination.  Date of last menstrual period was 25 January 2011 and estimated delivery date was 27 November 2011.  Prenatal testing including ultrasounds on 11 April 2011 and 20 June 2011, and maternal serum alpha-fetoprotein on 10 June 2011, had revealed no evidence of a defect.   Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound tests on 11 April 2011 and 20 June 2011 revealed no evidence of a defect. Maternal serum alpha-fetoprotein on 10 June 2011 revealed no evidence of a defect.
TEMP 101.6, VOMITING, HEADACHE, CHILLS/MUSCLE ACHES
1FEB95 began running a low grade fever, 100-101; suspected teething gave APAP; on 7FEB95, t103, dx w/encephalitis pt found paralyzed lt side to MD, ER per life flight; SPEC showed dec activity in lt frontal lobe; devel rash; no ctrl over
Vomiting and diarrhea and general body aches and malaise lasting 24 hrs.
Visually observed patient looked faint for approximately 5 seconds Patient was reclined on cot, given juice & crackers, BP checked 1st 110/70  BP was weak Patient was observed for 30 minutes, patient verbally reported he was feel much better Left the facility with his father & told to go get food & water
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 04-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Red rash began to cover entire torso,arms,legs,neck. Rash was bumpy, itchy. Fever. Child had general sick feeling, cough. After 2 weeks the rash had turned flat, remained irritated and covering body. Fever, sickness was gone but rash still agitated child terribly, he felt "on fire" at some times. Doctor visit, Doc. called a consult, they determined it was "the worse eczema they have ever seen" (I think that is incorrect) this "rash" persisted almost 2 months and the child still suffers with mild rash and itching on arms/legs.
Patient is a 85 y.o. female patient of, MD with history of CAD, CKD 3, DM 2, GERD, hyperlipidemia, CHF, hypertension, PVD, OSA presented on 3/31/2023 with hip fracture.  Found to have COVID with hypoxia.  Treated with Decadron and remdesivir, clinically improved, saturating well on room air for the last 24 hours, feels comfortable going home instead of rehab   Right hip FNS implant failure S/p right hip removal of hardware and hemiarthroplasty Continue postop care as per Ortho Continue PT OT   Acute respiratory failure with hypoxia Covid-19 Virus Infection Date of onset of symptoms: Asymptomatic Symptoms present on admission: Asymptomatic Date of covid positive test: 4/2/2023 Vaccination status: vaccinated Imaging: Chest x-ray 4/4/2023no abnormality Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Decadron and remdesivir 4/4/2023-4/5/23 Consultants following: None Anticipated special isolation end date: 4/11/2023   Acute on chronic HFpEF CAD s/p CABG and stent to RCA PVD Responding well to IV Lasix Switch back to home dose of Lasix 40 mg p.o. twice daily  Echo 8/2022 LVEF 60% Continue asa, statin, lasix, imdur, metoprolol, nifedipine, Entresto   Orthostatic hypotensionresolved Blood pressure dropped on 4/2, 4/3 after working with physical therapy Responded well to IV fluid bolus Clinically improving, feels comfortable going home Continue nifedipine and metoprolol with holding parameters     DM2 A1c 7.4 SSI Diabetic diet   CKD3b Scr 1.62 Baseline range from 1.4-1.6 Monitor renal function Encourage p.o. hydration, holding Lasix, Entresto    Acute on chronic anemia Anemia of chronic kidney disease worsened secondary to blood loss associated from surgery Hemoglobin 8.9<9.0<10.1 Continue to monitor   Chronic afib Rate controlled Asa, plavix   OSA CPAP ordered
Muscle and joint pain, headache, fever, nausea. Drop in blood pressure, near syncope. Bloodwork showed slighly reduced magnesium level. Magnesium administered via IV.  Blood pressure remained lower than usual for a few days and is now back to normal. Oxygen saturation was also in the low 90%s.
Rash below injection site and on legs.   Mouth Blisters Vaginal Blisters Persisted for 2 weeks
patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have; patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have) and HAIR GROWTH ABNORMAL (patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HAIR GROWTH ABNORMAL (patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.). On 30-Aug-2021, the patient experienced ALOPECIA (patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have). At the time of the report, ALOPECIA (patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have) and HAIR GROWTH ABNORMAL (patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.) outcome was unknown.            No concomitant medication was provided.  Patient received the vaccine in her left arm shoulder deltoid muscle.  Patient reported that, patient hair started to fall out after the second dose of the Moderna Covid-19 vaccine.  The hair on leg before the vaccine the patient had to shave her legs each day. After the vaccine the patient has to shave her legs every 3 days.  Patient tried using shampoo and conditioner with biotene and minerals to try and promote hair growth.   This case was linked to MOD-2022-558287 (Patient Link).
10-5-10 had flu shot - felt odd sensation left face later that day - next day could see left cheek twitch - continues to  have intermittent twitch - subtle tingling left fingers.
High fever 24 hours after shots. Seen in Emergency Room and MD office x 2. Diagnosed bronchiolitis. RSV +. CXR -.
Information has been received from a registered nurse referring to an unspecified number of patients. Sometime in the month of February 2015, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K016425, expiration date: 26-MAR-2016, dose and route were not reported). No symptoms were reported. The nurse did not have patients' identification information available at the time of reporting. This is one of several reports from the same reporter. Additional information has been requested.
Child had inconsolable crying & fussing for >5 hrs after medication was given. Fever to 101 x 3 days & "lump" on leg (at injecttion site) x 1 wk.
Severe migraine lasting till the next morning of April 2nd.   No fever  and site of injection was extremely sore painful to touch but the migraine was very extreme
When the Flumist was administered into left nostril his nose bleed and soaked one tissue and then quick bleeding.
Hospitalized for COVID-19 Reported per Pfizer COVID-19 Vaccine EUA
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 2:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 2:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 34.08 for dose administered on 02-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit at 09:00 AM, 29 degrees at 10:00 AM, 32 degrees at 11:00 AM, 33 degrees at 12:00 PM and 35 degrees at 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
after her tdap vaccine on 5/22/24 she had a sore arm for 5 days which was almost completely resolved. On 6/3/22 she had her pfizer covid booster and again developed a sore arm. this improved but she has a mild 3/10 continued pain with palpation and certain stretches. no numbness, tingling, or swelling.
This spontaneous report was received from a 53-year-old female patient regarding herself with no pertinent medical history and too many allergic reactions that could not be documented. On 10-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) in her right arm, dose and route not reported. Concomitant medications included LITHIUM, SEROQUEL, OMEPRAZOLE, ATENOLOL and ZENPEP. On 11-NOV-2012, next day after vaccination, the patient started to feel the pain, heat and inflammation at the site of injection. She then noticed a red patch and since doubled in size to the size of a baseball. She contacted her health care professional and was told to take an antihistamine and ALEVEL for the pain. Patient also stated she felt a pulling sensation when she stretched out her right arm all the way under her arm pit and the lymph nodes. No rash visible, patient said it was just a red patch on her right arm. No lab studies were performed. Outcome of the reported event was unknown. Additional information has been requested.
Developed diffuse, maculopapular rash fever 108.  Pt previously never vaccinated
pt recv vax 17DEC96  1015AM & 230PM had 4 episodes of jerking legs 5-6x & straightening out back;alert whole time & no fever;had recv APAP a/vax;seen in ER;
Patient received FLUARIX flu vaccination administered by rph today. pt reported a metallic taste in the mouth 15 minutes after administration. Patient had similar event following a flu vaccination a few years ago.
BODY ACHE; HEADACHE; 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, intramuscular) 0.5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with Covid-19 vaccine AD26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of body ache and headache was not reported. This report was non-serious.
Vaccine administered after use by date. Efficacy study done by Moderna and vaccine dose deemed effective, no re-vaccination needed. Moderna Case ID Unknown.
Patient is a 76 y.o. male PMHx severe dementia who presented from his  memory care unit  on 7/20/2023 with CC cough, dyspnea. Found to have acute hypoxic respiratory failure secondary to COVID-19 pneumonia with possible superimposed bacterial pneumonia. After GOC discussion we have transitioned to comfort focused care. Comfort care medications ordered.  Hospice was consulted. Per family request, the patient was transferred to another facility on 7/24 evening.
Right arm is red and swollen, patient not bothered by left. Advised cool compresses.
approx 4 hrs p/shots started having brief 2-5 sec flurries of seizures, clonic w/back arching & posturing;