chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body ache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No treatment information was provided.  Patient wanted to know if she can take Tylenol.
Pt had no adverse event but second dose of  vaccine was given at 18 days instead of 28 days.
Patient received Pfizer COVID vaccine on 3/17/21 (lot # EN6208), 4/13/21 (lot # ER8731), and 11/19/21 (lot # FH8028). Patient admitted to our inpatient facility on 3/14/22 for septic shock due to perforated viscus, stercoral colitis with stool contamination in the abdomen (s/p ex lab sigmoid colectomy, colostomy on 3/14), acute kidney injury, and acute respiratory failure with hypercarbia and hypoxia. COVID status was negative on admission 3/14/22, but turned positive on 3/17/22, 3/18/22, and 3/21/22. Patient was intubated from 3/14 to 3/16 and is developing COVID pneumonia. Patient was in CCU from 3/14-3/19 and still admitted in our med/surg unit from 3/19 until today (3/22).
Fever, body aches, generalized numbness, especially around ears, neck and torso.
Child developed swelling entire L arm and hand, L side of face. Some itching am after vaccination. No hives or rash. No breathing problems. By time pt seen on 9/26/02 swelling still present but significantly improved. Treated with Benadryl, cool packs. Improving-too soon to say if completely resolved.
Pt is 36 year old female. Shortly after receiving pfizer vaccine pt reported dizziness and slight tightness of the throat. Lungs clear to auscultation. BP and HR within normal limits 118/72, HR 64. No known allergies. Pt is stable after relaxation techniques were implemented.
Itching, red, hive like rash on neck approx 90 minutes after injection, insidious onset
Fainting, feeling of coldness and weakness. Same reaction on 02/12/2009 but vaccine was given with other four.
l had Shingles twice. I had the Vaccination, the last ones after Vaccination / Suspect vaccination failure; l had Shingles twice; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had once before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced shingles twice. The patient had the last shingles after vaccination and he/she stated that they were awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Redness, swelling, warm to touch.  Outer margin of induration is 50 centimeter, inner margin is 32 centimeter in diameter.  Tender to touch as well.
PATIENT STARTED HAVING NUMBNESS DOWN HER RIGHT ARM.  SHE WAITED ABOUT 30 MINUTES TO MAKE SURE SHE DIDN'T HAVE ANY FURTHER SYMPTOMS.  I CHECKED IN WITH HER THROUGHOUT THE DAY AND IT HAD MOSTLY RESOLVED BY THE END OF THE DAY.  UNABLE TO FIND OUT IF IT IS FULLY RESOLVED.
pt recvd vax; fever of 101 w/ N & V, w/in 24 hrs;
Fluarix administered in <6 months old; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a infant patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comments: Physician reported that a patient who was younger than 6 months old received a Fluarix dose. The reporter had consented to follow-up. Additional supportive information: The patient who had received Fluarix Tetra was younger than 3 years which had led to inappropriate age at vaccine administration.
Friend of mine mother is in the hospital for the same thing severe nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (Friend of mine mother is in the hospital for the same thing severe nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified. Concurrent medical conditions included Diabetes and Kidney disorder.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced NAUSEA (Friend of mine mother is in the hospital for the same thing severe nausea) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 06-Apr-2021 due to NAUSEA. At the time of the report, NAUSEA (Friend of mine mother is in the hospital for the same thing severe nausea) outcome was unknown.            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.   This case was linked to MOD21-079111 (E2B Linked Report).; 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. MOD21-079111:original case
Rapid heartbeat; Blood pressure dropped; It was even in the 80 over 50; This is a spontaneous report from a contactable Nurse (patient). An 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Left upper arm on 23Jun2021 (at the age of 81-years-old) (Batch/Lot Number: EW0180) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient did not receive any prior vaccination (within 4 weeks). The patient reported that she had it on the 23rd and that evening, she started experiencing very rapid heartbeat and then her blood pressure dropped, it took almost two weeks to bring her blood pressure, where it was even in the 80 over 50. When asked about treatment received, patient stated that no, she had to do it herself, her son is quadriplegic (further clarification unknown) and she couldn't leave him by himself. Patient stated causality, "Yes." (not clarified further by appropriately paraphrasing events, hence causality tab left unchecked). Outcome of the event rapid heartbeat was unknown, blood pressure dropped was recovered in Jul2021.  Information about Lot/batch number has been requested.
Left deltoid injection site was sore 2 days afterward. When patient puts weight on left arm, she doesn't feel it at first, then it hurts. Discomfort experienced when putting arm back. No external sign of problem.
Severe arm pain radiating to his hand with extension contraction of his wrist-unable to passively or actively straighten or move the wrist. Approximately 20 min before resolution and then experienced mild discomfort in the muscle at area of injection.
Pt. complained of "flu-like" symptoms that began 24 hours after 2nd HBV given 03-22-2004.  Symptoms persisted for 24 hours, and resolved spontaneoulsly without incident.  Patient did not take his temperature at the time of symptoms.  No complaints of these symptoms after the 1st HBV given on 02/23/2004.
This patient was diagnosed with Kawasaki syndrome on 6/4/07 at hospital 7/5/07-ER report received from facility for DOS 6/2/07-DX:Fever and acute viral syndrome. Presented with fever, upper respiratory infection a cough. Temp 102. Pulse 183, when fever defervesced heart rate came down to 132. CXR normal. Urine cath showed no signs of infection. Negative leukocytes and nitrites. 7/5/07-ER report received from facility for DOS 6/2/07-DX:Fever and acute viral syndrome. Presented with fever, upper respiratory infection a cough. Temp 102. Pulse 183, when fever defervesced heart rate came down to 132.  7/17/07-records received for DOS 6/11-6/20/07-DC DX: IVIG Kawasaki Syndrome. Previous admitted from 6/4-6/8 for Kawasaki disease at which time presented with rash and fever. Treated with IVIG. Two days prior to this admission developed fever and decrease in appetite. Macular rash on lower extremities.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Psoraisis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 15Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Jul2022 to 17Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201032788 Same patient, different product and event;
I21.4 - NSTEMI (non-ST elevated myocardial infarction)
At 17:46 in ER, post-ictal; temperature 102.6F; pulse 163. Dx'd with febrile seizure. Mother witnessed seizure driving child home from daycare at 17:30.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. In approximately 2015 (reported as "on unspecified dates since 08-JUL-2015"), the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, lot # K016131, expiration date 23-SEP-2016 (dose, route of administration were not reported). Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
30 minutes after receiving GARDASIL vaccine Pt. developed dyspnea, dysphagia, stabbing, sharp pain (R) arm and hip, neck pain. Dx: Allergic reaction. Bronchospasm.
Patient reported feeling hot and dizzy brought to the EMS room for observation. Doctor at bedside. patient denies chest pain shortness of breath or nausea. Vitals taken, blood sugar 103. Patient given some apple juice and discharged in no distress @ 8:50am.
Left arm swelling and erythema onset day 1 after vaccinations. Day 2 left arm diffuse swelling & erythema 100mm x 100mm from deltoid proximally involving elbow. Left mid arm circumference 198mm. Right mid arm circumference 176mm. Left elbow circumference 193mm. Mild arm pain. Axillary pain day 1 post vaccination only. Left shoulder and elbow functional. Drowsy Day 1 - napped 3 hours. Mild decreased appetite. Arm swelling finally resolved 02 May 2005.
Within 20 - 30 minutes of getting the shot my face below my eyes went tingly to numb.  Then my throat became tight and swallowing felt different.  About 30 minutes after the onset the symptoms started to subside.  Then the around 3:30 pm extreme fatigue set in and I could not stay awake.  I slept for 4.5 hours and went back to sleep a short time later all night.    0n 5/18/21 my tongue swelled, my throat hurt and the inside of my mouth and in random spot ached.  The swelling went away in about 40 minutes and the sore mouth went away but the sore throat lingered most of the day.  I was fatigued again  On 5/19/21 I had fatigue again and my eyes hurt, event behind my eyes.
Pt was inadvertantly vaccinated at 15 yrs of age.  Appt. made by mother and mother was vaccinated at the same time.   No adverse reaction after the vaccination other than a sore arm.  Pt. has no medical conditions, but mother is high risk.
RESTLESS, DIAPHORETIC, HYPERTENSION, SOB, VOICE CHANGE, ITCHING, CHEST AND THROAT DISCOMFORT. LIPS PUFFY, LEFT SIDE OF FACE PUFFY, TONGUE FELT SWOLLEN,SEVERE HEADACHE,  SENT TO EMERGNACY ROOM CRITICAL CARE FOR TREATMENT.  tx: CARDIAC MONITORING, FLUIDS, PPI, STERIODS, ANTIHISTAMINES. f/u WITH ALLERGIST AND PMD. . CARRY EPI PEN, LIQUID BENADRL, CONTINUE MEDICATION GIVEN IN THE ER.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some times to get the VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 01-OCT-2014, the patient was vaccinated with a dose of VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
6 hrs p/vax, woke up screaming, was hot & vomited-became pale-hospitalized;
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
PCR testing for SARS-CoV-2 that was positive 16 days after the third vaccine/ Breakthrough infection after three doses of COVID-19 mRNA vaccine; PCR testing for SARS-CoV-2 that was positive 16 days after the third vaccine/ Breakthrough infection after three doses of COVID-19 mRNA vaccine; This is a literature report.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 25Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "seropositive rheumatoid arthritis" (unspecified if ongoing), notes: 14 years duration; "hypertension" (unspecified if ongoing); "hyperlipidaemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "obstructive sleep apnoea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Certolizumab pegol for rheumatoid arthritis, notes: 200mg SC every other week; Gabapentin for obstructive sleep apnoea; Olmesartan/hydrochlorothiazide for obstructive sleep apnoea; Rosuvastatin for obstructive sleep apnoea; Finasteride. The following information was reported: VACCINATION FAILURE (medically significant), 16 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), 16 days after the suspect product(s) administration, outcome "recovered" and all described as "PCR testing for SARS-CoV-2 that was positive 16 days after the third vaccine/ Breakthrough infection after three doses of COVID-19 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Body mass index: (10Sep2021) 35.6, notes: Units kg/m2; SARS-CoV-2 test: (10Sep2021) Postive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
I received my 5th  Moderna Bivalent COVID-19 vaccine on 10/19/2022. My cold symptoms started on 01/01/2023 in the morning at 8:00am. I  had a runny nose, congestions, cough, chest congestions,  mucus, and difficulty breathing. I went to urgent care at night at 7:30pm  on 01/03/2023. They advised me to take Mucinex, Nyquil, Dayquil, Tylenol, and Sudafed.  I had this cold almost for more than 2 and 1/2 weeks. It's almost gone.
Diarrhea; So Tired; Chills; Nausea; Headache; Achy from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Achy from head to toe) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Achy from head to toe). On 16-Feb-2021, the patient experienced DIARRHEA (Diarrhea) and FATIGUE (So Tired). On 15-Feb-2021, CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Achy from head to toe) had resolved. At the time of the report, DIARRHEA (Diarrhea) and FATIGUE (So Tired) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Tired, feel sick all over, headache. Injection site pain, swelling, very bruised
PATIENT GOT 1ST DOSE ON 4/17/2021 , AND PATIENT START HAVING A PALPITATION THAT INCREASED AND HE HAD TO BE ADMITTED NEXT DAY ON 4/18/2021. TO THE HOSPITAL AND HE IS IN REHAB NOW (PER WIFE) .
pt devel macular type rash 2 days p/MMR vax which was not accompanied by temp & was not followed by MD
patient reported to pharmacy on  3/22/22 with area of redness, swelling, erythemia area approximately 4 to 5 inches lower from injection site. area was approximately one inch in height and 3 to 4 inches in length.  it was separate from injection site.  advised to watch, take benadryl and use cool compress, and to follow up with md if needed.  on 3/23/22 she presented at an urgent care center at the advice of the md.  they gave her rxs for zyrtec and benadryl for possible allergic reaction and she was given rx for cephalexin in case of cellulitis, which she did not take.  she called approximately 4 days later to let me know she didn't need the antibiotic and that the zyrtec and benadryl helped, as it was likely an allergic reaction.
Missed 2nd Dose, more than 36 days have past since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose, more than 36 days have past since first dose) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose, more than 36 days have past since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose, more than 36 days have past since first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided
Papular - vesicular lesions on scalp, face, torso, extremities. Treatment include use of BENADRYL, calamine, oatmeal baths; no school until lesions are dried out.
Headache, diarrhea, temperature, ringing in ears, burning pain in joints, severe soreness at shot site in  left arm, naseua. Took over the counter ibuprofen to no avail.  Soaked in bathtub to diminsh fever.
Had a fever with seizure, >10 minutes. Brought to ER by EMS. Had CT and MRI of head showing cerebellar ectopia, 3 day stay in PICU, EEG unremarkable, followed by neurosurgery and neurology and infectious disease. Had CBC, CMP, stool for enteric pathogens.
Developed cluster of vesicles on left anterior thigh  on 6/13/10. Very itchy. No fever. Now crusted on exam 6/15/10.