chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's friend) reported for patient (reporter's friend) of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The consumer states he had a friend who got the Pfizer vaccine and "the second dose almost killed him." No additional details provided as this comment was made in passing conversation. The outcome of the event was unknown. Information about Lot/batch number is requested.
Had both shots. Two years later got internal shingles/ Suspected vaccination failure; internal shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had internal shingles (no rash) twice).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and 2 years 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 was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles shots after first time of having shingles. Two years later got internal shingles again but not hardly as bad or last as long. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
flu like systems . Brain fog . After 2 days severe brain fog . Hard time Remembering lasted about 3 days .
Patient hospitalized due to breakthrough covid-19 infection from 7/28/21 to 8/4/21. Patient completed the Pfizer vaccine series in March.  Below information is copied from patient progress note (8/3/21): Patient is a 77 y.o. female with a history of CKD, diabetes mellitus, CVA without residual deficits and hypertension the presented to the emergency department with complaints generalized weakness, productive cough, malaise, decreased appetite, loss of taste and smell. COVID-19 positive.   Acute hypoxemic respiratory failure due to COVID-19 -Stable tolerating NC -COVID 19 order set initiated -Cardiac and SpO2 monitoring -Dexamethasone 6 milligram p.o. daily times 10 days -Trend markers -ProBNP 524 -TTE WNL -Awaiting home o2, possible DC if O2 deliver    Hypernatremia -Start D5W -Oral intake    AKI over CKD -Improving -Continue to monitor -Avoid nephrotoxic agents  -Hold spironolactone -Strict I/O -Nephrology consulted    Insulin-dependent diabetes mellitus -Improving, steroid induce -Follow accucheks -Endoconsulted -Continue insulni per endo recs -Hold glipizide for now   Pancytopenia  -likely secondary to acute infection with COVID-19 -Monitor   Hypertension - home antihypertensives: Amlodipine 10 mg PO daily, Metoprolol 25 mg PO BID, Spironolcatone 50 mg BID  -Continue amlodipine and metoprolol -Hold spironolactone with possible acute on chronic kidney injury
I lost a lot of blood on the 11/07/2021 after having sexual intercourse this has never happened before
Pt was given a Pfizer booster vaccine sooner than  the recommended time of 5month. 2nd dose was administered on 11/7/21. Pt made an appt. online for a booster dose for 1/10/2022. Vaccine was administered
Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination.   Information on the lot/batch number has been requested.
A report was received from a health care professional on 11/24/03 concerning a 60 year old female vaccinee who inadvertently received expired Fluvirin on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin. The vaccinee had not experienced any adverse effects as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reactions following vaccination with expired Fluvirin. No follow up pending, all information received.
10/17/21-71 yr/o male who presents to the ED c/o chest pain component.  Tested positive on 10/2/2021.  The patient says he developed low abdominal pain that started yesterday has been constant and worsened today.  He said it started making him concerned and he started having some chest pain.  He thinks it was related to anxiety.  He did not have any shortness of breath nausea or vomiting or sweats with it.  He said he has had a large operation but he does not know what it was.  He said it was done for ulcers.  It sounds like he may have had a vagotomy antrectomy but he did not recognize those names of.  He tested positive for Covid near the first of the month and has Regeneron treatment. No known CAD. Discharge on 10/19/21: HPI:  (see admission H&P for full details) 71 yr/o male with past medical history of BPH who presented to ED with complaints of right-sided lower abdominal pain found to have severe hydronephrosis.    Hospital Course:    Severe hydronephrosis -CT abdomen/pelvis with severe hydronephrosis of the right renal collecting system, circumferential urinary bladder wall thickening related to chronic outlet obstruction  -sp cystoscopy and stent placement -Continue pain control per urology    Chest discomfort -HEART score 2 -ACS ruled out: EKG without acute ischemic changes, troponin negative -symptoms resolved without intervention  BPH -Continue Flomax     Anorectal bleeding, mild blood loss anemia -Differential includes hemorrhoids versus diverticuli versus other -last colonoscopy 2015 with Dr, normal with few diverticulum -seen by general surgery 4/2021 for anemia and FOBT + with decision to observe  -Gastroenterology consulted, outpatient follow-up with Dr. for EGD, SBCE and colonoscopy    COVID-19 positive -Asymptomatic, no oxygen requirement
Headache, nausea, shortness of breath, lung pain then fell asleep. Continued to have a headache and nausea
Itching rash and redness started on right hand move to wrist top of hand then under right eye cheek then neck, chest , back then went to Dr. told me to use the cream she prescribed   Triamcinolone using the rash has spread to some parts of both legs and breast still using medicine  on legs and breast area
Day of, 2 hrs after headache began , by eve. Muscle soreness, remained intermittently.  Day after same headache less, muscle soreness increased, tired. Next day still muscle soreness, tired, redness swelling rash at site spreading down half of upper arm. Following day, today, decreased soreness , less tired, redness spread to back side of arm also, less redness heat and soreness at site.
Small redness on the arm; Little Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish) 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 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 08-Jun-2021, the patient experienced ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish). At the time of the report, ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
NOTE: FLUMIST DEMONSTRATION BLANK - PHARMACIST TESTED FLUMIST DEMONSTRATION BLANK BY SELF ADMINISTERING IN NOSE. IMMEDIATELY COMPLAINED OF BURNING SENSATION IN NOSE.; A spontaneous report has been received from a pharmacist. The report concerns a male patient (age not provided).    No medical history was reported.    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route, on an unknown date.    No malfunction has been reported for FLUMIST.    On an unknown date, the patient experienced note: flumist demonstration blank - pharmacist tested flumist demonstration blank by self administering in nose. immediately complained of burning sensation in nose. (preferred term: Nasal discomfort).    Treatment with Flumist was not changed.    The patient recovered from the event on an unspecified date.    The event was considered non-serious.    The reporter considered  that there was a reasonable possibility of a causal relationship between Flumist and the following event: Note: flumist demonstration blank - pharmacist tested flumist demonstration blank by self administering in nose. immediately complained of burning sensation in nose.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
This spontaneous report was received from a healthcare professional refers to a 59 years old male patient with diabetes, hypertension and the patient did not remember if he had chickenpox in the past none drug reaction/allergies. The pharmacist reported that the patient on 28-JUN-2012, received ZOSTAVAX lot 671140/1266AA exp date 05-NOV-2012, vial, 0.65 ml subcutaneously to prevent shingles. No other co-suspects were reported. Concomitant therapies included unspecified medications for high blood pressure and diabetes. The pharmacist also reported that on 01-JUL-2012, 3 days after vaccination, the patient who received ZOSTAVAX developed red blisters on both of his upper arms and the back of his knees. The pharmacist also reported that recently, the patient started to develop red blisters on his hands and between his fingers. The patient took one dose of BENADRYL 25 mg orally as treatment given for the event, but it caused drowsiness and did not help his symptoms so he did not take any further doses. The patient sought medical attention, the patient's wife stopped by the pharmacy. At the time of report, the patient had not recovered. Laboratory tests were not performed. Reintroducing therapy with ZOSTAVAX was reported as not applicable. Additional information has been requested.
No additional AE details; Patient was administered an expired vaccine; This spontaneous report was received from a medical assistant concerning to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.      On 08-FEB-2021, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (VAQTA) (at the dose of 0.5 ml, route was not reported; lot # S030587, expiration date 06-JAN-2021) for prophylaxis (expired product administered).  No additional adverse event (AE) details were reported (no adverse event).
Moderna Bivalent Booster 0.25mcg was given to patient not 0.5mcg, wrong dose was given to patient.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. Of the patients exposed, 1 patient experienced ENCEPHALITIS, IMMUNIZATION. Of the patients unexposed, 1 patient experienced ENCEPHALITIS, IMMUNIZATION. The exposed patient who experienced ENCEPHALITIS, IMMUNIZATION was in the 19-24 year age range, male. Of the unexposed patient who experienced encephalitis was in the 19-24 year old age group, male.
couldnt sleep all night because of the pain; Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (couldnt sleep all night because of the pain) and VACCINATION SITE PAIN (Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced SLEEP DISORDER (couldnt sleep all night because of the pain) and VACCINATION SITE PAIN (Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore). The patient was treated with IBUPROFEN at a dose of UNK dosage form and ACETAMINOPHEN at a dose of UNK dosage form. At the time of the report, SLEEP DISORDER (couldnt sleep all night because of the pain) outcome was unknown and VACCINATION SITE PAIN (Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore) was resolving.            No concomitant medications reported.     This case was linked to MOD-2021-042928 (Patient Link).
I believe we vaccinated an individual after the beyond use date of the vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and serum sickness. On an unknown date, the outcome of the erythema of extremities and serum sickness were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and serum sickness to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced arm erythema and what he described it as "serum sickness" for a week. The healthcare professional was inquiring if it was safe for the patient to received the 2nd dose of SHINGRIX vaccine. The patient was not immunosuppressed. Information was provided to the healthcare professional from the FAQs (were there more local reactions seen with the second dose than with the first dose) and he was alss informed that the call would be transferred over to medical information as he was not happy with the response. The healthcare professional was in a rush and very adamant about speaking to someone further about his inquiry and therefore he was not probe any further.
Extreme weakness and tiredness, chills, headache  Sleeping 12hrs at night, (usually sleep 7hrs a night) body feels weak and needing to continually lay down  - I?m very active and usually paddle board 5-10 miles on the weekends - had the vaccine on Tues and today is Sat and extremely weak still.  Couldn?t work for 1.5 days
had arthritis in these areas; The pain interrupted his sleep; pain in his left hip, left arm, left lower back, feet and left shoulder; right arm/shoulder felt like bursitis; This is a spontaneous report from a contactable consumer (patient himself). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in right arm on an unspecified date (age at vaccination: 74 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was hypertension, blood cholesterol and arthritis.Concomitant medication included lisinopril taken for hypertension for over 10 years and was ongoing; simvastatin taken for blood cholesterol for over 10 years and was ongoing; famotidine taken for reflux from 2019 and ongoing. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 and the patient experienced low grade "flu", body aches and was sleeping a lot. On an unknown date, the patient experienced had arthritis in these areas, the pain interrupted his sleep. On an unknown date in Mar2021, the patient's right arm/shoulder felt like bursitis, pain in his left hip, left arm, left lower back, feet and left shoulder. It felt bad and achy. The event of arthritis was determined to be medically significant. His doctor had information where it could areas prone to arthritis. This started a couple days after getting the second dose. The patient took Aleve as treatment for the adverse events. If he did anything like driving the tractor and turning it became aggravated. He has been going to physical therapy for arthritis and was not had any problems in over 10 years. His doctor prescribed him steroids. He will see the doctor next Monday for a routine check-up. The adverse events did not require a visit to emergency room or physician's office. The patient did not receive any prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. The outcome of arthritis and sleep disorder was unknown; outcome of other events was not recovered.  Information on lot/batch number has been requested.
reports blood sugars have been higher than normal.  Usually morning blood sugar is 120 and it has been 160 since the day of vaccination.  Rash on head has flared up and is more painful and hot than normal.  Pain at injection site.  No fever no rash on arm or near site of vaccination.
On 12/10 at around 0800 child had a 30 second tonic-clonic episode w/ eyes rolling back and afterwards was sleepy/drowsy. Paramedics were called and brought child to ER where she was crying and appropriate. Temp 38 degrees rectal, NL blood sugar. No other labs/tests. D/C home.
Having issue raising his hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Having issue raising his hand) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Having issue raising his hand). At the time of the report, PAIN IN EXTREMITY (Having issue raising his hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No additional symptoms; Patient was administered one dose of improperly stored VARIVAX; Patient was administered one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-FEB-2020, the patient was vaccinated with one improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX), lot # S025612 expiring on 18-AUG-2021, for prophylaxis (dose, route and site of administration were not reported).    The administered dose of the vaccine experienced a temperature excursion of -14°C to -10°C for 2 hours and a temperature excursion of -9°C to -8°C for 6 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Large, red bulge near the injection site about 2 inches; Large, red bulge near the injection site about 2 inches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site erythema and injection site mass. On an unknown date, the outcome of the injection site erythema and injection site mass were unknown.   It was unknown if the reporter considered the injection site erythema and injection site mass to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Bexsero and developed a large, red bulge near the injection site, about 2 inches. No other information was reported. The reporter consented to follow up. This case has been linked with US2020AMR039749, reported by same reporter.
patient was experiencing low grade fever 99.5 F and all over body aches and joint pain. She said she had trouble breathing in the evening while asleep but she was better when I spoke with her today and she said she had experienced difficult breathing in the past. Resolved at the moment. She is able to complete day to day tasks/activities. Discussed with her to try acetaminophen for fever, and to inform us of any worsening of reactions and to seek medical care if adverse reactions worsen or do not improve.