chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Pharmacy had discovered pt had received expired per beyond use preparation date of covid vaccine booster dose . Pharmacy called patient to provide clinical discolsure that the COVID dose received was expired. Per Moderna, the dose is still effective and does not need to be repeated, but there is higher risk for infection when administering a preservative-free dose after the recommended beyond use date. Patient reports swelling at the site following administration that has improved. Denies redness and fever. No concerns at this time. Recommended to call PCP with any concerns.
Pt is 31 yo male, s/p full Pfizer COVID vaccination: dose 1 on 3/12 and dose 2 on 4/16. On 8/6, pt denies any new onset of COVID symptoms, but confirms exposure to COVID positive person. COVID PCR results positive on 8/6.
2 weeks after injection my daughter had a two day (Tues/Wed) fever of 103. Alternating Motrin/Tylenol did not work. She did not want to eat like normal on these days. On the 3rd day (Thurs) our sleep trained daughter refused to go to bed longer. After hours of doing everything to make her comfortable, she woke up screaming and it did not stop for hours. Extremely uncomfortable and very very hard to console. She refuse to lay down and all the things that would have worked before, did not. She was restless, couldn?t stay in one position, and I had never heard this type of cry before. She had a total of 2 hours of sleep combined the whole night. It lasted from 7PM-11AM. Around then I noticed a body rash on the trunk of her body and went to the pediatrician office.
FATIGUE; CHILLS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4383471-00.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown".  Additional information: It was also reported that it was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Patient had second dose on 27Mar2021. Causality as per reporter for event chills and fatigue was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt took BP after 15 observation period and BP was high 147. Did not inform staff, drove home and when arrived husband noticed her lips were blue and she also had chest tightness some time after. Patient did not seek medical attention and did not consult the pharmacy reported during 2nd shot consultation.
Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As these were new symptoms and were a week and a half out from the vaccine. Went and was tested for COVID-19 and received a negative test. Missed 3 days of work. No one else in my house hold had any symptoms. No one else in the house hold has been vaccinated.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. Health Professional reported that they administered expired FLUMIST. The outcome of the event of administered expired FLUMIST is unknown. The report was considered to be non-serious.
Within 12 hrs pt had an exquisitely painful (L) arm. Couldn't sleep it was so painful. There were 2 welts along with 3" diameter red area around site. Improved after 24-36 hrs, gone after 3 days. Nausea started 24 hours after injection lasted 2-3 days. Diarrhea started 12-14 hrs after the nausea.
Erythema multiforme that started a few days after given first COVID vaccine.  Only skin involvement of hands and elbows.  No oral involvement.  Prescribed clobetasol cream and a few days of prednisone 40mg x 3 days.  Resolving.
I was in my backyard one afternoon I felt pain in my back I thought it was a bee or something that stung me, I didn't pay much attention to it and to bed that night. I wasn't feeling 100 percent the next morning into that night. I had my wife check my back and she noticed little bumps and rash all over, it was very red and painful. The next day after that I went to urgent care and I was told I had shingles. I was prescribed medicine to take for 7 days and the doctor told me to go to my PCP and follow up to see how the shingles were doing I took the medicine. I followed up with my PCP 1 week later and she prescribed me more medicine and pain medicine for my right hand. After I started taking the medicine I didn't work for a whole week because it was really bad. I have severe pain in my right hand, it's a little swollen but it has severe burning pain in my right hand, its 9/12 out of 10 pain.
Patient complained of body ache including abdominal pain, stating he "did not want to go through that again" and was refusing the 2nd Zoster Recombinant vaccine. He indicated the abdominal pain was pretty bad and "I am not taking any chances". Abdominal pain lasted about 48 hours.
This case was reported by a pharmacist and described the occurrence of injection site pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain at injection site for 4 days (included the day of vaccination) which did not interfere with his daily activities. The reporter agreed to follow up from GlaxoSmithKline.
This spontaneous report as received from a healthcare worker (Master of Science in Nursing) refers to his 17 year old son who is the patient. Reporter stated that the patient got 2 doses of GARDASIL (dates were not reported), dose, route of administration, lot numbers and expiration dates were not provided. Reporter stated that pharmacist told them the series needed to be restarted, since the third dose would be late. The patient has restarted the series, and now (dates unspecified) has received 2 additional doses of GARDASIL, dose, route of administration, lot numbers and expiration dates were not provided. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected, because the reporter did not wish to be contacted.
Immunity Titer Low After Series; Initial Report Received on 14-Feb-2023  A registered nurse reported that a patient (age, gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and his/her immunity was still low after the 2-dose series.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On unknown dates, the patient received the first and second dose of HEPLISAV-B vaccine (details not provided).   On an unknown date after completing a 2-dose regimen of HEPLISAV-B, the patient's I"mmunity titer was still low after the series."  No further information as provided. Additional information was requested.   Company Comment: The company assessed the event as non-serious. The case is not immunologically confirmed as the dosing interval, titer and time to titer were not specified.; Sender's Comments: The company assessed the event as non-serious. The case is not immunologically confirmed as the dosing interval, titer and time to titer were not specified.
Tested Positive for Covid-19 on 4-1-2021. She was having cold/allergy type symptoms.
25 days post vax the pt was taken to ER after an episode of change in mental status associated with apnea and cyanosis. The pt was noted to be febrile by his mother. and given Tylenol and a tepid bath. Pt suddenly slumped over forward and had jerky motions of his hand. His mother didn't hear him breathing and he appeared to be blue around the lips. In certainly less than one minute he was breathing again and regained consciousness and normal mental status fairly quickly. By the time the Medics got there he was breathing and alert. The pt has a PMH of high fevers, but never febrile seizures. There has been an upper respiratory infection symptoms within the last few days. The pt has not been tugging on his ears and has not been vomiting or diarrhea or any type of rash. The pt currently takes no medications other than Tylenol and has no known drug allergies. Physical exam revealed temperature of 105.1 rectal, pulse 160 respirations 44, SA02 200% on room air. The tympanic membranes are pearly bilaterally. Mucous membranes are moist. Lungs are clear to auscultation. Heart is regular rate and rhythm. Abdomen is soft, nontender, normal active bowel sounds. The pt was given ibuprofen. CBC, cath urinalysis with mandatory culture, blood culture X1 were obtained to evaluate fever in a child without focus. Urinalysis was nitrate negative, 8 WBCs, 12 epithelial cells, 8 bacteria. This was felt to be a contaminated specimen. White blood cell count was 10.1, hemoglobin 13.1, hematocrit 38.4, platelets 326, there were 5 bands. Febrile seizure. The pt was reexamined several time in the ER from a mental status standpoint. He was constantly awake, alert and using all force equally, his neck was supple, there was always a spontaneous smile, he was very social. He was seen walking with grandma in the ER. The pt was given Rocephin 500 mg IM. A repeat temperature prior to discharge was 101.7. The parents were given febrile seizure instructions and instructed to give the pt Tylenol 4.6 ml and/or Motrin.
Pt recv vax on 1/21/99; 2.5 hr post vax pt exp 2 min tonic/ clonic seizure, fever (100.5), cough, rhinitis; dx=febrile seizure
red raised fluid filled blister, felt damp to the touch.; remaining circle mark; felt damp to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ENALAPRIL MALEATE; METFORMIN; MULTI VIT. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: SKIN DISCOMFORT (non-serious) with onset 08May2022, outcome "recovered", described as "felt damp to the touch"; BLOOD BLISTER (non-serious) with onset 08May2022, outcome "recovered", described as "red raised fluid filled blister, felt damp to the touch."; RASH (non-serious) with onset 08May2022, outcome "recovered", described as "remaining circle mark". The events "red raised fluid filled blister, felt damp to the touch.", "remaining circle mark" and "felt damp to the touch" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood blister, rash, skin discomfort.  Additional information: Red raised fluid filled blister, felt damp to the touch. Lasted close to 2 weeks. Remaining circle mark lasted over 4 weeks. No other vaccine in four weeks. No covid prior vaccination and also no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
covid test (nasal swab PCR): positive; covid test (nasal swab PCR): positive; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 02Feb2021 14:15 (Batch/Lot Number: EL3248) as single dose, and dose 1 intramuscular, administered in arm left on Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. On 09Apr2021, the patient had stuffy nose that worsened with cough and fatigue. On 10Apr2021, patient underwent covid test (nasal swab PCR): positive. Outcome of the events was recovering. Patient was not diagnosed with covid prior to vaccination.; Sender's Comments: Based on the information currently available, vaccination failure of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.
The patient became increasingly fussy on 8/8/2016. This progressed to lethargy on 8/9/16 with bilious emesis and a dark stool. He was admitted on 8/10/16 to the hospital with a RUQ intussusception that was reduced by air contrast enema.
Patient developed chest pain with onset 05/08/21, 3 days after receiving his second Pfizer COVID-19 vaccination (Lot EW0167) on 05/06/21; he had previously received his first Pfizer COVID-19 vaccination (Lot EW0170) on 04/15/21.  Pain continued until presentation at Hospital on 05/11/21, where testing indicated possible myocarditis (see below).  Symptom resolved under observation without specific treatment.
Developed pain and weakness in left shoulder. Seen for evaluation on 10/9/09 and clinically appeared to have rotator cuff tendonitis involving the supraspinatus and teres. Had complaint of weakness in the arm but could not confirm on testing as exam limited by pain.
Patient felt dizzy after receiving vaccine . Mom  said she fainted. We had paramedic come to assess.
Day after vaccine given had swelling, area around vaccine puncture (size of baseball, warm to touch and knot felt).
Tingling in hands and feet, started estimated 2-3 weeks after receiving the vaccine. Still there, as of today 7/22. But has not gotten worse nor have I experience muscle weakness or other symptoms.
"Covid vaccine arm":. Red rash, painful/sore arm, itching, warm arm, slightly swollen under rash
The day after receiving 1st dose, he had nausea.; he had dizziness; He couldn't eat or drink anything; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (The day after receiving 1st dose, he had nausea.), DIZZINESS (he had dizziness) and DECREASED APPETITE (He couldn't eat or drink anything) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Mar-2021, the patient experienced NAUSEA (The day after receiving 1st dose, he had nausea.), DIZZINESS (he had dizziness) and DECREASED APPETITE (He couldn't eat or drink anything). At the time of the report, NAUSEA (The day after receiving 1st dose, he had nausea.), DIZZINESS (he had dizziness) and DECREASED APPETITE (He couldn't eat or drink anything) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a pharmacist concerning an 8-year-old patient who was vaccinated with a dose of Varivax. Subsequently the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint. No other information was known. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a patient with no known history of chickenpox or prior varicella virus vaccination who was exposed to 2 friends who were vaccinated with varicella virus vaccine live and subsequently developed lesions. On 08/26/2000, the patient developed "a maculopapular rash, with some vesicles. The patient had 18 lesions, reported as itchy." The nurse thought the patient may have some scabbed lesions remaining. The patient also experienced general malaise and irritability. Three additional patients had similar experiences following exposure to varicella virus vaccine live. Follow up information indicated that a specimen has been sent for PCR analysis and the results were negative for varicella zoster virus. Additional information has been requested.
I tested positive for covid-19 on November 3, 2021 at I experienced sneezing, clogged ears, and hearing loss those are the only three symptoms that I experienced.
This spontaneous report as received from a pharmacist refers to a currently 72 years old female patient with hypertension, arthritis and high cholesterol. The patient has no drug reactions or allergies. The patient was vaccinated was 0.65 ml ZOSTAVAX (lot number 672478/1603AA, expire date 13-JAN-2012) subcutaneously on 27-JUN-2012. No other co-suspects were reported. Concomitant medications included MOBIC, CRESTOR, potassium chloride - USP, furosemide, lisinopril, generic bisoprolol fumarate, ZIAC and tramadol hydrochloride. On unknown date the patient who received ZOSTAVAX had developed a rash on both legs. The patient described as a "shaving" type of rash. The patient was starting to develop a rash on both arms as well at the time of report. No treatment was given for adverse event and no laboratory diagnostics studies were performed. The patient was not recovered by the time of report. The patient had visited the pharmacy for medical attention. Additional information has been requested.
Fluttering; This case was reported by a consumer via call center representative and described the occurrence of heart fluttering in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced heart fluttering (serious criteria GSK medically significant). On an unknown date, the outcome of the heart fluttering was recovering/resolving.   It was unknown if the reporter considered the heart fluttering to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix and had fluttering. On an unknown date in 2020, the patient had Electrocardiogram, Echocardiogram, Electrocardiogram ambulatory test and result showed cardiac flutter. The reporter did not consented for follow up.      Lab Comments: On an unknown date in 2020, the patient had Electrocardiogram, Echocardiogram, Electrocardiogram ambulatory test and result showed cardiac flutter.
Pt recv vax on 1/6/99; on 1/12/99 pt exp nausea, diarrhea & flu-like sx, fever x 3 day
Info has been received from an RN concerning a 33 month old female who on 6/2/04 was vaccinated with a dose of varicella virus vaccine live (lot 645169/0348N). On 11/30/05, the pt experienced breakthrough chickenpox. Unspecified medical attention was sought. The RN reported that the case was mild, less than 50 lesions. Subsequently, the pt recovered from breakthrough chickenpox on an unspecified date. No product quality complaint was involved. Follow-up info from an RN was received on 2/16/06 and indicated that she was unable to find "SR#" and that no further info was available. Additional info is not expected.
After my second vaccine, immediately after, I felt nausea. I have had nausea ever since; I am taking Phenergan. I had a big bruise on my left breast (where my breast cancer was) a few days after. I had an OBGYN appointment around 01/24/21 and they found lymph nodes and wanted to do a mammogram to make sure the cancer hadn't come back. I had the mammogram done and no cancer. I asked them to remove my breast. They told to wait 6 months to see if the bruising goes away and because the vaccine is new. After the 6 months I am going to go back to my oncologist. The bruising has not gotten worse but has not gone away either.
Had flu shot Monday 9/19/16 at her work. In evening at home noticed shot area had redness and rash and sore to touch. Called us 2 days later at office to report to us and tell us it was getting better. Recommended ice, ADVIL and BENADRYL and tell her physician.
Half-dollar size swelling and itching at injection site. Accompanied with fever at injection site noticed about 3 hours after vaccine administered. Treated with Allegra 180mg PO QD for 7 days prescribed by PMD.
First night complete exhaustion chills and diarrhea for four days Impaired eyesight  Pain in the region of left kidney
Patient came into the pharmacy today and showed me the vaccination site. Was a 3" x 3" inflamed site that looked slightly ulcerated. She said it was a slight bruise on 10/9, progressed to current status fairly rapidly.
During COVID vaccine observation period patient reported dizziness and light headness, no hives or rash noted.  No SOB reported and no wheezing heard.  Vitals checked WNL.   Pt given juice and educated on reaction and reassurance provided.  Pt offered and declines ED assessment.
Trouble thinking; Trouble talking; Whole body rash; A spontaneous report was received from a consumer concerning a 68 year-old, female patient, COVID-19 vaccine (mRNA-1273) received the first Moderna COVID-19 vaccine (mRNA-1273) on 02 Feb 2021. Patient stated after first Moderna vaccine she had a rash on day 9, Patient stated she received her second Moderna vaccine on 01 Mar 2021 and on day 12 she had a whole body rash.  The patient's medical history, as provided by the reporter, immunocompromised . Concomitant medications reported included Antidepressant, Topamax, Zocor. Treatment received include Acterma Prednisone  on 02 Feb 2021. Patient stated after first Moderna vaccine she had a rash on day 9, all around the injection site down arm above elbow. Patient stated she received her second Moderna vaccine on 01 Mar 2021 and on day 12 she had a whole body rash. Patient stated she visited her doctor on 15 Mar 2021. Patient stated healthcare professional (HCP) prescribed acterma and prednisone.  Patient stated she is immunocompromised. Patient stated the only clear part on her body is the sole of her feet and eyes and arm at the injection site.  Action taken with mRNA-1273 in response to the events was not applicable.  The events, trouble thinking, trouble talking, rash all around injection site, immunocompromised were not resolved.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product onset of the event including evidence of re-challenge and excluding any other etiology, a causal relationship with the event cannot be excluded. Rash is consistent with  the product safety profile.
After my booster shot, shot #3, I was diagnosed with a breakthrough COVID positive test. My symptoms were:  Vomiting on and off for about 12 hours Diarrhea for 3-4 hours Headache for a few days Fatigue for a few weeks
Narrative:  76 yo male patient with diagnosis of end stage chronic kidney disease in full care by home hospice died at home with hospice on 10/1/21. Pt had received covid vaccines on 1/21/21 & 2/19/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.