chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Other demographics were not reported. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date the patient developed shingles after the vaccination with ZOSTAVAX reported as "developed shingles afterwards a couple of years ago". The outcome of patient developed shingles was unknown. Additional information has been requested.
I just do not feel good; I was kind of feeling weak and now I am feeling even worse; Shortness of breath; Mental fatigue; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included had knee replacement surgery on 08Mar2021 and was kind of feeling weak. The patient's concomitant medications were not reported. The patient went on Wednesday to get the Pfizer vaccine and just did not feel good. The patient had knee replacement surgery on 08Mar2021 and was kind of feeling weak before getting the shot and now was feeling even worse. The patient had shortness of breath and mental fatigue. The patient had headache that would not go away, patient had chills. The outcome of events feeling weak before getting the shot and now was feeling even worse and headache was not recovered; other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
FELT THE NEEDLE ONLY; WORRY; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with pneumococcal vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-MAR-2021 13:10 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced worry. On 14-MAR-2021, the subject experienced felt the needle only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt the needle only and worry was not reported. This report was non-serious.
blood sugar was high; This case was reported by a consumer and described the occurrence of blood sugar increased in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date.). Concurrent medical conditions included diabetes.   On 1st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st December 2020, less than a day after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the spouse of the patient. The patient was vaccinated with 2nd dose of Shingrix  a day before reporting. Caller reported last night her husband's blood sugar was high and this still ongoing at this time.  Caller reported her husband was put on an insulin pump in the past couple of weeks and before last night his blood sugars had been steady and stable. The reporter diid not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR240756:same reporter
Injection site is swollen, red and hot and very itchy.; Injection site is swollen, red and hot and very itchy.; Injection site is swollen, red and hot and very itchy.; Other Vaccine on Same date product: Flu; Other Vaccine on Same date product: Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Oct2023, outcome "unknown" and all described as "Other Vaccine on Same date product: Flu"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 05Oct2023, outcome "not recovered" and all described as "Injection site is swollen, red and hot and very itchy.". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse concerning a 25 years old female patient who on an unknown date was vaccinated with a dose of GARDASIL, intramuscular (lot # 16288A, expiration date on 21-JUN-2014). On 24-FEB-2012, the patient suffered from an upset stomach after receiving the GARDASIL. At the time of the report, the event outcome was unknown. The relatedness for the event was unknown for GARDASIL. Additional information has been requested.
Itchy rash on chest, back, arms and neck about 24 hours after Zostavax vaccination.  Medrol Dosepak started within 24 hours on onset of symptoms.  Symptoms resolved upon completion of dosepak.
lymphedema: stiff neck, nearly 0 degrees ROM, neck spasms and pain mainly on Left side, severe headache that felt like clenching of the back of my skull, couldn't open mouth more than 25%, trouble swallowing, sometimes choking;  swelling lumpiness and pain to the touch  of Right lower breast, face, clavicle area and neck; hoarse voice.  Starting 4-7 shot of Toradol, Naproxen, cyclobenzaprine, 4-9 stopped Naproxen started Prednisone 20mg for 7 days. I was incapacitated for 2 1/2 weeks, I'm still getting spasms Left side of neck if I try to move my head to far, still don't have full ROM.
Weal immediately formed at site of injection. Patient also bled from site of injection requiring cotton ball affixed in place with bandage. Had patient sit in chair for further observation. Patient started to have redness on skin expand from site of injection. Patient started to itch at injection site. About 3-4 minutes patient was itching left arm and top of head. Pharmacist administered 2 x 25mg diphenhydramine tablets at that time. Pharmacist continued to observe patient and repeatedly asked if there was any itching in throat or trouble swallowing. Patient indicated that she started to itch in throat and could feel it start to swell. Pharmacist at that time administered in left leg mid-line of femur, epinephrine auto-injector 0.3mg and had 911 called. Patient started to feel the effects of the 2x25mg diphenhydramine, drowsiness and reduction of weal/redness at injection site. Also at the same time, patient did begin to feel the effects of the epinephrine, ie jitterness and no futher swelling in throat.  Paramedics came and transported patient to hospital.
Subsequent to receiving one dose of varicella virus vaccine live in the spring of 1999, the pt developed chickenpox. She sought unspecified medical attention.
Had Tonic Clonic seizure witnessed by nurse and doctor immediately after vaccine administration (Td). Seizure lasted less than 1 minute. Patient with no PMH, no meds. No prior history of seizure as per patient.
Intense pain in left middle finger, unable to bend or use for 12 hours. Pain gradually subsided and full use restored but some residual pain remains.
2/22/2021 (6 days after vaccine) developed shingles of R L4/L5 dermatome
became worse, she could not speak, the right part of the limbs did not move/diagnosed a stroke; coma; evening of the same day she was gone; low blood pressure; ill; confused in conversation; This is a spontaneous report from a contactable consumer. A 97-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Aug2021 the patient was vaccinated. After 2 hours, when they were returning home, the patient became ill (she began to react unusually to events, confused in conversation, slowed down her speech). After 10 we arrived home, the situation did not change, being scared, the reporter immediately called an ambulance. The doctor said that this was a normal phenomenon after vaccination, and because of low blood pressure, he gave an injection that increases blood pressure, recommended sleeping and resting. The reporter did not calm down on this and called the doctor who did the vaccination, she repeated the same thing that everything would pass in 2-3 days, and that this condition fully complies with the recommendations. The doctor and reporter called several times during 22Aug2021 and 23Aug2021, she assured they that she had called the COVID center, and they said the same thing - a normal reaction of the body. At about 8.30 am on 24Aug2021, the patient became worse, she could not speak, the right part of the limbs did not move, an ambulance was immediately called, the doctor diagnosed a stroke, then took her to the specialized hospital. As a result, she was in a coma (24Aug2021) until 31Aug2021, and in the evening of the same day she was gone. The patient died on 31Aug2021. It was not reported if an autopsy was performed. The outcome of events was not reported.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: evening of the same day she was gone
Dizziness, Palpitations, weakness, flushed, paresthesia of hands Narrative:  tachycardic in ER and hypokalemic  Other Relevant History:
A non-serious, spontaneous report of fever of 100 degrees F, sneezing, achy muscles, coughing and diarrhea has been received from a 36-year-old mother who experienced the events subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 18-Sep-2009 at the pediatrician's office where she takes her children. On 22-Sep-2009, the patient developed several side effects which she believed were related to FLUMIST. These included fever of 100 degrees F for the last 24 hours, sneezing, achy muscles, coughing and diarrhea. On 23-Sep-2009, she treated the fever which has risen to 101 degrees F with acetaminophen. The outcome of the adverse events is unknown.
Patient had two syncope events after vaccine administration lasting approximately 5-10 seconds. He was monitored continuously. EMS were called and checked blood pressure, blood glucose, and did an EKG -all values were normal. Additionally, patient remained being monitored for 30 minutes until picked up by family member.  Patient recovered from adverse events.
Anaphylaxis to Moderna Spikevax 2023-2024 vaccination. She had difficult breathing as her throat and chest swelled up 5 mins post vaccination. Gave her 1 dose of generic Epipen 0.3mg IM and she instantly felt better and could breathe. Called 911 for medical assessment. Her viatls were good on assessment by paramedics at 2.57pm
Had hives before vaccination. Day after the vaccination, left arm was swollen (the size of a grapefruit), red, hurt. Also had fever; took Tylenol. Went to bed because had bad joint aches (shoulders, knees, hip). After 6 hours fever resolved; next day felt tired but OK. Went to allergist because hives continued, by then felt ok with vaccine adverse events.
Approximately 1 hour after 1st vaccine the arm vaccine was administered began to throb and ache, couldn't move it without extreme pain.  Fever began approximately 2 hours after 1st vaccine, my temperature went up to 102.5°F at it's highest.  Before fever started my head began to feel very strange, like I was motion sick, very dizzy and lightheaded, also felt I might pass out.  Then the headache started, I've suffered from migraines in the past and this headache was just as bad as my worst migraine. As soon as fever began so did the muscle pain and soreness and stiffness and bone and joint pains.  Took Tylenol, when that did nothing to provide enough relief for me to sleep, I tried Motrin which I still got little relief.  This went on for 7-8 days, each day I would feel slightly better than day before.  After 2nd vaccine approximately 3-4 hours after I had another fever, around 101.5°. Muscles have been sore and painful since then.
Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic; Flu like symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, ABDOMINAL PAIN UPPER (Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 antibody test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up was received in that  patient stated that she did not experience any AE from her second dose  the person she spoke to misunderstood that these symptoms were related to something else entirely and not the vaccine that patient  had 3 days later.
Expired vaccine. No temperature excursion occurred. Moderna determined the vial "maintained the activity necessary to  protect against the SARS CoV-2 virus at the time of administration." No adverse reactions reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist. A female patient over 70 years of age experienced redness at the injection site. The redness was described as about 6 inches across. The patient also experienced pain at the injection site and swelling. The patient denied permission to contact their physician. The pharmacist did not wish to proceed with a safety report.
COVID-19 Break Through Case: On 11/07/2021 I got my 1st booster shot. My adverse event started on 05/03/2022 around 3-4PM. I had flu like symptoms. I had headache, fever, I had cough on the 05/05/2022. On 05/04/2022 I did a COVID-19 home test where I tested positive. I called tele heath doctor and spoke with her. She told me to rest and to drink plenty of fluid. Basically I treat this like a common flu. I still have cough but am getting better.
Monday after, I thought I had a spider bite under my right breast that wrapped around to my back and I went to doctor they diagnosed me with Shingles.
Two days after immunization, patient developed pruritic erythematous papules on the trunk that subsequently generalized to the upper and lower extremities.  Remained afebrile with no associated symptoms. COVID testing was negative. Biopsy showed :  Right lower abdomen, punch of skin:  Vacuolar interface change with perivascular lymphocytes and a few eosinophils.  See note.  Note: This mid to upper dermal predominantly perivascular infiltrate also reveals a few scattered interstitial inflammatory cells. On balance, the findings are suggestive of an adverse drug reaction (including vaccination) or viral exanthem.
Patient is under 5 years of age and vaccinated with the Pfizer Pediatric vaccine
1 1/2 hrs. after receiving flu shot, client reports a mild headache which gradually increased into excruciating pain. Client also began to chill heavily. Headaches and chills continued for 10-11 hours.
About 20 min after my arm started burning - like someone was holding a match to it. And that stopped. And then I got a shooting pain up from neck to ear; shortness of breath; lips were tingling and mouth was going numb (like a was getting Novocain) and I got a headache and then I got an earache too; I started to feel itchy - all within a short time. I was given Benadryl. It was enough to get my home. I took another Benadryl and I was okay from all my symptoms except the itching (like I was in an ant next) that itching lasted for three days even with taking Benadryl.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received FLUARIX QUADRIVALENT. In September 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related FLUARIX QUADRIVALENT. Additional details received as follows: The case was one of the 7 cases reported for adverse events experienced by the 7 patients vaccinated with FLUARIX QUADRIVALENT, at the same facility. This case was regarding the patient who experienced more than usual redness and swelling at injection site. The cases reported for the other 6 patients were US2015137455 and US2015137458 (anaphylactic shock), and US2015137462, US2015137463, US2015137464 (redness and swelling at injection site) and US2015137460 (full body rash). There were many employees were vaccinated at the same facility with the FLUARIX QUADRIVALENT, among them 7 patients experienced events.
3" x 5" increasing in size reddened & raised area on left upper deltoid.
sore arm for about 3 days; real tired for about a week too; Initial information received on 19-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 65 years old male patient who experienced sore arm for about 3 days and real tired for about a week too while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, and family history were not provided.    On an unknown date, the patient received one dosage of suspect influenza vaccine suspension for injection produced by unknown manufacturer (strength, dose, route, batch number and expiry date) in unknown administered site for prophylactic vaccination. Information on batch number is requested.   On an unknown date the patient developed "sore arm for about 3 days" (pain in extremity) and 'real tired for about a week too' (fatigue)  (unknown latency) following the administration of influenza vaccine.   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events (sore arm for about 3 days, real tired for about a week too).  At time of reporting, the outcome was Unknown for the event sore arm for about 3 days and was Unknown for the event real tired for about a week too.
Pain redness rash at injection site, spent next two days (9-19 and 9-20) in bed with nausea, muscle pain, dizziness, shivers, headache, and approximately 36 hours after injection began sharp pain in right ribs that traveled into my right back. Went to my physician on September 26, 2018. They ordered blood test and ultrasound of my right quadrant stomach and gave prescription for acyclovir 800mg. Symptoms persisted for about 10 days. About 4 days after beginning medication I was able to resume some normal activities. Headache and dizziness persisted until about 3 days ago, October 14, 2018, and still have some back pain when lying down.
Gastrointestinal issues; excessive bloating, painful gassiness, trouble passing waste, occasional nausea. Change in digestive issues - previously, was prone to painful diarrhea (possible IBS, was never diagnosed) that occurred in a pattern; it no longer happens (mostly because I've tried to stop eating certain foods but sometimes it would happen anyway). Have had symptoms of trapped gas since teenage years, but those symptoms were negligible. Have attempted changing and severely restricting diet; it does not completely alleviate the discomfort, but it does help (at first thought I'd developed gluten intolerance).  The symptoms came on very suddenly.
no adverse events, patient only received vaccine at a not recommended age, pt was 17yrs old and moderna is recommended at 18 yrs old.
Extreme fatigue 3rd week 9/10. Shortness of breath 1st week in 10/10 followed by muscle aches and cramps by the 2nd week in 10/10 had severe muscle pain arm and leg weakness, dragging right foot, tingling down both arms into fingers, by 4th week extreme all body pain muscles, bones, spasms extreme weakness.