chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; DIARRHEA; SICKNESS; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. 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: 201A21A, expiry: UNKNOWN) dose was not reported, frequency one total, administered at right arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced vomiting, diarrhea that would not stop hence she had to go to the emergency room where she received an IV. The patient also had severe headache that lasted for several days and fever. The patient said the diarrhea stopped after getting the IV and she was pretty sick until last Saturday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea on 07-APR-2021, and severe headache, and fever on APR-2021, and the outcome of sickness was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: 20210432019-covid-19 vaccine ad26.cov2.s-vomiting, diarrhea. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Redness present to LD - (start 10/3/18), no treatment, no swelling.
Tested positive for Covid-19 on 5/15/22 - home antigen, and on 5/16/22 by PCR. First symptoms appeared 5/12/22.
Various ache and pains, decreased energy level, until finally dxed with SLE after a bout of extreme pain and lethargy.60 day follow-up dated 09/28/00 provided a change in age, and the pt has had a bilateral knee replacement. The pt is still on pain medications. Annual Follow-up states the pt has osteoarthritis and rheumatoid arthritis. The pt also always has joint pain.
Warm touch, some swelling Lt leg PCV-13. 7 1/2 X 6 cm.  Lt leg red indurated swollen.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-OCT-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2016, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Hospitalized initially and COVID Pos on 7.15-7/22/201, sent to rehab then readmitted with abnormal renal function, elevated WBCs and dyspnea.
Received Vax 9.10.21 at 4:30pm. Immediately I felt pain/heaviness in my arm. Slight nauseous  Within an hour, the forehead started tingling and gradually moved across the entire face and into the neck. Started flushing with water  and started walking and moving my face and lips constantly. a cooling sensation began on both sides of my kidney area- from middle of back down to hips. shortly after my ears started plugging.  Had a video dr visit around 7:00pm- was told as long as its on both sides of body, that she thought it was an inflammatory response to the vaccine. Told me to take ibuprofen and tylenol at the same time, then alternate them through the weekend, to eat a healthy meal and drink lots of water.  face tingling subsided later that evening. Had extreme hot and cold flashes along with extreme body aches in joints and muscles. Eating and drinking were no problem.  Saturday late afternoon to late evening was the worst for body aches. Very difficult to move or do anything. My left arm was extremely sore to the point that I couldn't touch or move it. Sunday morning I woke up and my entire left arm was tingling. Extremely tired and body aches were pretty high. Hot and cold flashes were slightly better. Around 3:00 in the afternoon, the whole left side of my face started going numb. Took my blood pressure which was 170s-/high 80/low 90. After 30-45 minutes, I decided to get checked out at ED as the tingling was severe only on my left arm and left face.  A Cat scan confirmed no sign of stroke. Tingling lasted until Monday late morning and afternoon.  Monday-Deep chest/back pain only on the left side.  Extreme exhaustion and body aches. Hard to do much of anything.  Tuesday aches were mostly gone along - had some mild hot and cold flashes, extremely fatigued, and slight headache all day. No relief from ibuprofen or nurtec. Wednesday tried walking with patient- Very difficult, extreme hot flashes and very exhausted. Mild headache persisted all of wednesday. Thursday- pain in both hips, low energy, arm still feels heavy, but pain is gone to touch and can move without pain.all other symptoms gone. Friday- woke up feeling normal again
The next day I had joint aches, fever (100.6), tiredness, sleepiness and no appetite.  It lasted one full day.
20 mins p/vax felt hot flash, itching, tightness & burning of neck & face; pt seen in ER; rash on face & upper chest; given DPH;
She is in fact experiencing skin irritations on her face; It's around my cheek bones and itches and burns; It's around my cheek bones and itches and burns; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 03Mar2021 as 1st dose single and on 24Mar2021 received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she was in fact experiencing skin irritations on her face, it's around her cheek bones and itches and burns on an unspecified date. It was reported that patient had received both doses of the Pfizer COVID-19 vaccine on 03Mar2021 (first dose) and on 24Mar2021 (second dose) and she was asking if anyone who was given the vaccine had reported skin irritations on the face. She mentioned that she was in fact experiencing skin irritations on her face though, she thought it could also be due to the hairspray that was directly sprayed on the left side of her face and about one or two days later she got this. Therapeutic measures were taken as a result of events. The patient was given Allegra and they wanted to put her on a dose pack steroid. The outcome of events was unknown.  Information about batch/lot number is requested.
heart palpitations; itching all over the body; cannot walk very long, and legs are shaky.; short of breath; Athma exacerbations; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS (heart palpitations) and PRURITUS (itching all over the body) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastric bypass. Concurrent medical conditions included Asthma.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant) and ASTHMA (Athma exacerbations). On an unknown date, the patient experienced PALPITATIONS (heart palpitations) (seriousness criterion medically significant), PRURITUS (itching all over the body) (seriousness criterion medically significant) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.). At the time of the report, DYSPNOEA (short of breath) and ASTHMA (Athma exacerbations) had not resolved and PALPITATIONS (heart palpitations), PRURITUS (itching all over the body) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.) 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.   No concomitant medication information was provided.  The patients treatment medication information included oxygen treatment, Benadryl, and prednisone.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Additional Information Was received. Updated the reporters information and added events(Palpitations , Pruritus, Gait Disturbance); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pain in the arm; 1 cm diameter redness at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (1 cm diameter redness at the injection site) and MYALGIA (pain in the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U1081282) 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (1 cm diameter redness at the injection site) and MYALGIA (pain in the arm). At the time of the report, VACCINATION SITE ERYTHEMA (1 cm diameter redness at the injection site) and MYALGIA (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medications reported. no treatment details reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
She just had extremely tired; Sore arm; Patient inadvertently received her third dose last 17Dec2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Dec2021 (Lot number: FK5618) at the age of 7 years as dose 3 (booster) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, LOT# for 1st dose FK5127., Anatomical location: right arm), administration date: 19Nov2021, for Covid-19 immunization; Bnt162b2 (DOSE 2, LOT# for 2nd dose FL0007, Anatomical location: Left arm), administration date: 15Dec2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Patient inadvertently received her third dose last 17Dec2021."; FATIGUE (non-serious), outcome "unknown", described as "She just had extremely tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of inappropriate schedule of product administration, fatigue, pain in extremity. Additional information: The reporter asked for her daughter (Patient) who received the pediatric Pfizer-BioNTech COVID-19 Vaccine second dose then third dose right away. She mentioned that, Patient took her first dose at the local elementary school on 19Nov2021. Patient's second dose was supposed to be given by 10Dec2021 but there was a storm so it was cancelled. Caller mentioned that, Patient's second dose was administered 15Dec2021.The clinic had another vaccination program, and the Patient inadvertently received her third dose last 17Dec2021. It was only found out after the Patient cried that she already got the 2nd dose. Caller confirmed all 3 doses are the pediatric dose, and asked if there was any information for this? Caller mentioned they moved from (city) to (City) in October, and was unsure if insurance would still cover the expenses of the HCP. Asked for financial assistance information. The caller asked about information about who took the 2nd dose of the covid-19 vaccine and got the 3rd dose after 2 days. The patient was not having Other Products, no Patient History. Investigation Assessment: Unknown. No follow-up attempts are possible. No further information is expected.
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient called MD when rash developed and was advised to take Benadryl and call us to report the rash.
The patient's wife reported that her husband's left arm is red, swollen and painful at the injection site. She was instructed to place an ice pack on affected area and have her husband take acetaminophen for the discomfort. I followed up with the patient 12 hours later and the patient's wife stated that most of the discomfort had subsided but the injection site was still red and swollen. I recommended that her husband take BENADRYL to help bring down the swelling and continue with cold compress.
No additional adverse events; a 12 month old  patient received a dose of M-M-R II on 07/12/2021 that had a labeled expiry of 6/17/2021; This spontaneous report was received from a medical assistant, referring to a 12 months old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 12-JUL-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (M-M-R II) 0.5 ml, lot# S018595, expiration date 17-JUN-2021, for prophylaxis (strength, route, frequency were not reported). No additional adverse events reported. There were not known temperature excursions.
Tdap. Thursday 3 wks ago 6/27. Sore Evening Ibuprofen taken. Hard to raise arm up and lower back down hurts. Area itself feels weak, going on since Ibuprofen seems to help then wears off. Has not applied ice, Can bring arm over head but hurts. Called NP instructed to tell client continue with Ibuprofen apply ice if no improvement. Seek medical attention.
Pt had about a half hr limp, unresponsive episode @ home, no fever but weak & tachycardia; Seen in ER w/sleepiness & over next hour was usual happy self;
Pt with itchy throat, flushing, sweaty palms 15 minutes after 2nd vaccine; pt requested to be taken to Urgent Care for evaluation of symptoms
Arm pain; Upset stomach; Nausea; Body aches; Fever; Insomnia; Shaking; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 at 13:00(at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 13:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On 30Apr2021 at 01:00 the patient experienced arm pain, upset stomach, nausea, body aches, fever, insomnia and shaking. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events arm pain, upset stomach, nausea, body aches, fever, insomnia and shaking were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
all over achiness; hypersensitivity; she didn't "feel right."; tenderness; Flushed; skin sensitive; Chills; Inappropriate schedule of vaccine administered; This spontaneous report was received from a registered nurse via a field representative and an office nurse referring to a 25 years old female patient. The patient had no pertinent medical history and no concomitant medications. Information about drug reactions/ allergies was not provided. The patient did not get a flu shot and did not start any new medications.  On 24-APR-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R024264 with expiration date 29-OCT-2019; dose was not reported) intramuscularly in the left deltoid for prophylaxis. On 27-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R009614 with expiration date 30-NOV-2020; dose was not reported) intramuscular in the right deltoid for prophylaxis. On 08-OCT-2020 around 10:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S010729 with expiration date 01-DEC-2021, a dose) intramuscularly in the left deltoid for prophylaxis (reported as cervical cancer prevention) (inappropriate schedule of vaccine administered).  On 09-OCT-2020 around 14:00, the patient presented back to the practice with all over achiness, tenderness and hypersensitivity, and she didn't feel right. On the same day, the patient experienced skin sensitive, chills and flushed. The patient did not experience rash or fever in this situation. The patient had taken actions for events of all over achiness, skin sensitive, chills and flushed. It was unknow if treatment was given for other events. On 10-OCT-2020 (reported in 24 hours), the events of all over achiness, skin sensitive, chills and flushed was recovered. The outcome of other events was unknown. The office nurse considered the events of all over achiness, skin sensitive, chills and flushed was related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The causality between other events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for return/evaluation. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Registered Nurse; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from an office manager concerning a 14 year old female patient. The patient's concurrent conditions included celiac disease and asthma. The patient's medical history included adenopathy. There were no drug reactions and allergies. On 19-OCT-2016, the patient was vaccinated with an unspecified dose of GARDASIL 9 (lot number M028323 with an expiration date of 26-SEP-2018) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. On the same date, after being administered GARDASIL 9, the patient experienced syncope. The patient sought medical attention and was seen by a physician, no treatment was given for the event and no laboratory studies were performed. The office manager stated that the patient recovered from the syncope in less than a minute on 19-OCT-2016. No product quality complaint was involved. The relatedness between the event and therapy with GARDASIL 9 was not reported. Additional information has been requested.
1st dose, fever body ache chills, sinus congestion & pain, headache  for 4 days  2nd dose severe body aches, chills , fever, sinus congestion & pain, headache and nausea. 24 hours, couldn?t get out of bed.  and less severe for 2 additional days.
Patient received YF vaccine on 4/17/14. He reported redness at injection site starting on 4/22/14 and becoming more warm, tender, swollen and red over the past two days. He now reports rash is about 2 1/2 in. in diameter. He also reports low-grade fever and fatigue.
Headache, flushed cheeks, feeling feverish, slight sore throat.  I am using Tylenol and increasing fluids.
Blotchy, erythematous rash on trunk and extremities. Treated with Benadryl 1/2 tsp q 4 hours, prn.
HOSPITAL COURSE: This is a 78 y.o. female with a history of asthma, COPD, BOOP d/t XRT, GERD, breast cancer, HTN, HLD, hypothyroidism, neuropathy, chronic pain syndrome on chronic opiate agonist (Belbuca), OSA, depression and anxiety, recent COVID-19 infection diagnosed 1/3/22 who presented with ongoing weakness, hoarse voice since her Covid infection earlier this month and N/V/D.    Nausea, vomiting, diarrhea Long-haul Covid, possible failure to thrive Clinically seems to have failure to thrive course after COVID-19 infection 1/3/2022 with pre-existing cognitive impairments, chronic pain syndrome, depression/anxiety and frailty. Initially it was reported as N/V/D since her Covid diagnosis although patient reports it started suddenly shortly before admission.  Treated conservatively with supportive cares, IVFs, antiemetics prn and slow diet advancement as she tolerated . Possible viral gastroenteritis.  N/V/D resolved quickly after arrival and she was tolerating a regular diet. C.diff nor enterics were ever collected because diarrhea resolved upon admission.  There were no acute Covid issues during her hospitalization.  Recommended ongoing advancement of her diet as she tolerates and f/u with PCP.     Hypokalemia Likely d/t GI losses, poor oral intake. Replaced during stay.   GERD History of upper GI bleed, gastric ulcers 12/2021 Continue PTA omeprazole 40 mg twice daily. Closely monitored for hematemesis, melena - neither of which occurred. Hgb 10.8 -- > 9 suspected primarily dilutional as 9-10 range is where her Hgb was previously. Ongoing f/u with PCP.   COPD, non-O2 dependent Continued home inhalers: Advair discus, albuterol HFA, DuoNeb, albuterol neb Was not using properly; RT completed education on inhaler use   HTN: BPs controlled, intermittently elevated HLD Continued PTA losartan, Lasix, metoprolol and rosuvastatin   Anxiety/depression Chronic pain syndrome Chronic opiate agonist therapy, Belbuca PTA meds: Tizanidine, gabapentin, sertraline, Belbuca continued   Hypothyroidism Continued levothyroxine    History of breast cancer No acute concerns