chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness to injection site x 24-48 hours. Decreased vision, had recent eye exam 1.5 weeks prior to vaccine, since vaccine, clarity of vision has decreased.
Received 2nd Pfizer vaccine at 1430, at 2330 developed severe left flank pain with vomiting. Patient febrile on arrival to ER with HR 130's and very hypertensive. Sepsis protocol initiated with CTA abdomen/pelvis ordered which showed Emphysematous Pyelonephritis on the left. Patient with severe sepsis with lactic acid elevated.
Patient developed redness, swelling, and warmth of the right upper arm the day following the vaccination. Patient was given a dose of BENADRYL with no improvement. Followed up in the clinic 48 hours post vaccine with some improvement. No fevers, chills, or URI symptoms present. Right arm without defined area of erythema. Right upper arm and forearm are affected with visible swelling. No pain or itching.
COVID vaccine- not documented which one  Reactions: Syncope d/t "anxiety to needles" per pt, vasovagal response, Myalgia, Nausea, dizziness, lightheadedness, loss of consciousness
Flu shot was given at 11:55am by the nurse left deltoid. I was still sitting in the chair and within 30sec to one min severe nausea come over me which turned into what i would describe as heart palpitations with racing heart rate making it harder to breath. Cool cloth was placed on my neck, nurse who gave the injection reported me appearing bright red. Staff was able to move me to a bed. i was able to tell them that my heart was not feeling well and maybe we should take my blood pressure.  Series of three blood pressures were taken. i usually run 90/60's. 12:10pm bp140/85 P47 O298%.   12:25pm bp144/90 P51.  12:39pm bp156/96  p50 o298.  Started feeling spinning and saturation 71%. 12:44pm asprin given as precaution.  Employee Health was called. Took direction from them and headed to the nearest ER.
Swollen lymph nodes over her shoulder near her neck. Started on the left, and few days later the right side started too.
Patient received Hepatitis B - adult - Lot number BX2X3, GlaxoSmithKline, exp 7/13/19 IM (L) deltoid on 3/7/17. Pt. returned to clinic on 6/19/17 and reported her (L) arm swelled and had hives after injection on 3/7/17.
No adverse effects were reported; patient received an improperly stored ROTATEQ on 11/4/2019 or 11/5/2019. Exact date of administration unknown.; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On approximately November 2019 (reported as "11/4/2019 or 11/5/2019, exact date of administration unknown"), the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004253 with an expiration date in 21-OCT-2020), orally, for prophylaxis (strength, dose and frequency were not provided), that underwent a temperature excursion with a lowest temperature of 1.3 degrees Celsius, during a time frame of two hours and eighteen minutes. No previous temperature excursion was reported, however, it was stated that the digital data logger was involved. No adverse effects were reported.
Progressive pain and swelling and erythema of right lower leg starting 3-4 days after vaccination.
pt c/o lt arm pain 2-3 day p/vax;has been to several different MD since then for same complaint;now under going physical therapy;states lt arm hurts anytime raises arm;pt feels r/t flu shot;states no MD has said flu vax caused arm problems;
Rash; Discoloration; Pain at injection site; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash, injection site discoloration, injection site pain and swelling. On an unknown date, the outcome of the rash, injection site discoloration and injection site pain were unknown and the outcome of the swelling was recovering/resolving.   It was unknown if the reporter considered the rash, injection site discoloration, injection site pain and swelling to be related to Shingrix.  Additional information received were as follows: The pharmacist stated that the patient experienced rash, discoloration at injection site about 2 to 3 inches in size, pain and swelling. The swell had decreased. No further details were provided.
Excessive thirst; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old patient with unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), linum usitatissimum seed oil (flaxseed oil) (MANUFACTURER UNKNOWN) and prenatal vitamins (MANUFACTURER UNKNOWN) used for an unknown indication from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Apr2021, the patient experienced excessive thirst. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event excessive thirst was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Approximately one week after administration of the vaccination I started having severe pain in my testicles. This included swelling, redness, heat and pain. The pain was severe. These symptoms were constant for about 2 months. The symptoms are no longer constant but, they are intermittent now. It will return for several days and then subside only to return again. The pain is about a 7-8 out of 10. I have surgery scheduled for 12/13/2021. I have a varicocele since childhood that has never given me any pain. They are going to repair it in an effort to stop this pain.
While still at store, body felt sluggish & dizzy, went home & had massive diarrhea.  Did not feel right for 4 months.  Ringing in ears has continued to this date.
24 hours following vaccination mother witnessed 5 to 10 second episodes of head and arm trembling and shaking. The mother video recorded the events.  The parent sought treatment at a local emergency room (Hospital) on 06/20/19. Patient was admitted for observation and a neurology consultation.
Injection site began to swell and itch; used calamine lotion. Injection site is still currently sore and has itch. Took Benadryl.
pt stood up and walked out the door, experienced vasovagal syncope ~2 minutes after vaccination while still in clinic waiting room. Pt had not eaten or drank anything all day.  Pt struck head, experienced laceration above right eye, and bleeding to right front tooth, unclear if tooth affected.
No adverse effects reported; one 43 year old patient inadvertently received one dose of PROQUAD; Information has been received from a nurse referring to a 43 year old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided.  On 10-JUL-2019, the patient was inadvertently vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R026720, expiration date 17-MAR-2020, subcutaneous for prophylaxis (strength, dose and frequency were not provided) (Inappropriate age at vaccine administration). Other suspect therapy included sterile diluent(manufacturer unknown). No adverse effects reported. The outcome of the events was unknown. The causality assessment was not reported.
Hives / large red raised rash on left arm near the site  Appeared on 7/4 still there today
This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bloody nose/casing blood for a couple weeks) and VACCINATION COMPLICATION (really bad reaction) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A214) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (bloody nose/casing blood for a couple weeks) and VACCINATION COMPLICATION (really bad reaction). At the time of the report, EPISTAXIS (bloody nose/casing blood for a couple weeks) and VACCINATION COMPLICATION (really bad reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low (Low) her grandmother has low platelets from before..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.   She never went back to get her 2nd dose of the vaccine. She went to a couple ENT doctors, who could not figure out the issue. She received the vaccine in her left arm, the symptoms lasted about a month, and are done.
Red, itchy rash developed around injection site 8 days after Moderna shot #1. Rash was 2 inch x 3 inch. Also 1 day after arm rash developed (day 9 after injection),  I developed a small itchy rash on left foot heel - about the size of a quarter and 2 tiny, itchy red spots on each hand and one spot on right foot small toe & 1 tiny bump on back. Arm rash lasted 5 days ( until 3/23) , heel rash is getting better but still visible and not as itchy. Tiny bumps are not as itchy anymore and have faded some as of today 3/23/21.
Pt recv vax on 1/25/99; on 1/26/99 pt exp unconsolable crying x 2 days; tx=Tylenol & Pedialyte
Large golf ball size swelling at injection site that has gone done but persists today 02/13. Pain at injection site that last about 4-5 days . And slight itching at injection site
cardiovascular stress; fatigue; incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of cardiovascular disorder in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cardiovascular disorder, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the cardiovascular disorder, fatigue and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cardiovascular disorder and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. In 2019, the patient received 1st dose of Shingrix and expected cardiovascular stress and fatigue. The patient had not received his second shot yet, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Fever; Aches; Chills; This is a spontaneous report from a contactable consumer. A 23-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Apr2021 the patient experienced fever, aches and chills. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, aches and chills were recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Narrative "The patient did not have any relevant medical history" updated to "The patient's relevant medical history was not reported".
Off label use; A 42 year old reported that received the first dose of Shingrix; Right arm was pretty sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th June 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced pain in arm and off label use. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the inappropriate age at vaccine administration and off label use were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was received as follows: A 42 year old female received the first dose of Shingrix, which led to inappropriate age at vaccine administration. The pharmacy was refusing the patient to provide the second dose because of her age due to state law. The patient had a prescription from her physician due to her recurrent case of shingles.  She also reported that her right arm was pretty sore for two to three days after the vaccination and then it resolved. The reporter did not consent to follow up.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery in right side, and concurrent conditions included heart issue, cancer, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021 and, on 11-AUG-2021 the patient was exposed to life covid-19 cases and hence on 14-AUG-2021 her doctor ordered her to take titer test (antibody test) to check for protection and the result came out to be negative (confirmed immunological vaccine failure). The patent said that she did not know the type of test that the doctor ordered her to take and what she knew was that they drew blood from her in the doctor's office. The patient said that she feels she was not protected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210834896-covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Arm pain one hour after the shot, but it got worse. It seems that it was swelling; Bone pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm pain one hour after the shot, but it got worse. It seems that it was swelling) and BONE PAIN (Bone pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm pain one hour after the shot, but it got worse. It seems that it was swelling) and BONE PAIN (Bone pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm pain one hour after the shot, but it got worse. It seems that it was swelling) and BONE PAIN (Bone pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 20 (High) 20.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported
Incorrect storage of drug; Product Complaint; nodule at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date 22nd October 2021) for prophylaxis. This case was associated with a product complaint.   On 5th September 2019, the patient received Shingrix (intramuscular) .5 ml. On 5th September 2019, immediately after receiving Shingrix, the patient experienced injection site nodule. On an unknown date, the patient experienced incorrect storage of drug and pharmaceutical product complaint. On an unknown date, the outcome of the injection site nodule was recovering/resolving and the outcome of the incorrect storage of drug and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site nodule to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The pharmacist reported last 7 adjuvants of box appear to be thicker and difficult to withdraw. He noted the one he gave on the day before reporting was of this consistency, without particulate but the patient immediately developed a nodule at the site of injection. The reporter called today to report the difference with the remaining 7 adjuvants. He noted these have a clunkier flow and thick. They had been stored in a fridge that doesn't have a freezer attached, the temps have been at 41 and 42 degrees Fahrenheit, which led to incorrect storage of drug and pharmaceutical product complaint. The reporter also noted a "jelly like" consistency to the adjuvant. He would return the box and remaining vials of adjuvant and powder. The credit of 7 doses to direct GlaxoSmithKline account.  The patient nodule was reducing in size per the pharmacist. The reporter consented to follow up.
Patient received her vaccine at 0710. At 1040, she reported a headache and itching on her face and abdomen. She was evaluated at office by RN. She was given Benadryl 25 mg po at 1100. She is to follow-up with by the RN later this afternoon. Patient voiced understanding.
Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX (strength and anatomical location were not provided) lot # N020852 with expiration date on 31-JUL-2018 for prophylaxis and with a sterile diluent (manufacturer unknown) (lot number and expiration date were not provided). No adverse effects were reported.
09/07/2002 father brought 2 child with right arm swollen. Dr. examined him and sent pt to ER Dx cellulitis. On 09/09/2002 pt came back for f/u with Dr. and right arm is improving. Pt is taking antibiotics given by ER and will be f/u 09/12/2002 with Dr.
Woke 10/23/99 with fever of 103, headache, body aches, dizziness, symptoms lasted until 10/25/99.
very negligible side effects like a headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262, Expiration date: unknown), via an unspecified route of administration, administered in Arm Right on 19Feb2021 13:40 (age at vaccination was 64 years) as dose 1, single for COVID-19 immunization. The patient's medical history included breast cancer female (she is a former breast cancer patient) and mastectomy from an unspecified date in 2009 to an unspecified date in 2009. Concomitant medication included valsartan (DIOVAN) taken for hypertension, levothyroxine sodium (SYNTHROID), mesalamine taken for irritable bowel syndrome and metformin taken for glucose tolerance impaired, start and stop date were not reported. On 19Feb2021, after first dose patient experienced very negligible side effects like a headache. Patient received second dose on 12MAR2021 at 13:45 for COVID-19 immunization. No treatment was received for the adverse event. The outcome of the event was recovered on an unspecified date in2021.  Follow-up attempts completed. No further information expected.