chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt did not show any signs of distress, reactions, or changes in when he arrived. Monitor SXS.
Information has been received from a 17 year old female consumer with no relevant medical history (also reported as healthy) who on 26-JUL-2010 was vaccinated with the third dose of GARDASIL (dose unknown). It was unknown if there were any relevant concomitant medications or any relevant past drug history. The patient reported that after she received the third dose of GARDASIL, on 26-JUL-2010, her "abdomen was feeling a little weird". The patient stated that she was not aware that she was pregnant. The patient's physician was not aware of the event. As of 28-JUL-2010, the patient was still experiencing the event. There was no relevant laboratory data. Additional information has been requested.
Had a fever of nearly 102, became extremely dizzy. Terrible body aches which made her miserable. Couldn't eat felt nausea and got a bad rash. Extreme fatigue where she laid in bed for 2 days, and she stated she also lost 3lbs.
After initial vaccination, I noticed a small rash near the injection site. I also had arm swelling and pain but it went away in about two days. However, one week after the injection I developed a rash on the side of my arm near the injection that is causing pain and swelling. The rash is continuing to grow.
Patient presented with shortness of breathe and fatigue. Patient claimed that their caretaker is unvaccinated and recently was positive for COVID-19.
SWELLING AND REDNESS AT INJECTION SITE. MOM STATES HAD BLISTER.  WHEN CHECKED ON 4/20/19, SWELLING DECREASED AND NO BLISTER NOTED
pt recv flu vax 5min p/vax in lt deltoid;c/o nausea & faintness;nurse w/pt @ side fainted;loss of consciousness & stiffness 3sec & recovery;states has a hx of anxiety attacks;911 called & pt taken to hosp;
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 05-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 28-Aug-2021 The patient died on 28-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. No treatment information was provided.  This report concerns a female patient with no relevant medical history who died (unexpected event) due to an unknown cause. The event occurred after an unknown duration following vaccination with the first dose of mRNA-1273. The rechallenge was assessed as not applicable as the patient passed away. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-327538 (Patient Link).; Sender's Comments: This report concerns a female patient with no relevant medical history who died (unexpected event) due to an unknown cause. The event occurred after an unknown duration following vaccination with the first dose of mRNA-1273. The rechallenge was assessed as not applicable as the patient passed away. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Information has been received from a 53 year old female with no pertinent medical history and no known drug reaction/allergies who on 18-APR-2007 was vaccinated with a single dose of ZOSTER. Concomitant therapy included thyroid medication. On 26-SEP-2008 the patient had broken out in a rash on her abdomen, sides and back. The patient went to her physician and did blood work. She was diagnosed with the shingles. The patient's events persisted. Additional information has been requested.
PT BECAME PALE, WEAK AND DIZZY AFTER ADMINISTERING HPV VACCINE. PT WAS SITTING AT TIME ON INNOCULATION. PT REPORTED FEELING COLD AFTER ADMINISTRATION.
Nervous before vaccine and history of anxiety/asthma. Patient vomited x 1 after injection, experienced dizziness/shaking. BP readings: 163/85, 137/89, and 128/77.  Patient received Benadryl 25 mg, Albuterol x 1, and Epi-Pen. Patient refused to go to ED - got better and left vaccine clinic with friend. Advised to monitor for signs of anaphylaxis for next 12-24 hours.
Pt had a syncopial episode, causing pt to fall down, fracturing his right, lower tibia/ankle. Pt lost consciousness for about 1 minute, was A&O x3 upon regaining consciousness. Pt was caught by the vaccinator, although he still bumped his head on the tile floor.
Information has been received from a physician concerning a 23 year old female with no medical history, who in approximately December 2007, was vaccinated with a third dose of GARDASIL. Concomitant therapy "possibly" included hormonal contraceptives (unspecified). Subsequently, post vaccination the patient experienced mild encephalitis. On 04-FEB-2008 the patient was seen in the office for her symptoms. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review mild encephalitis was considered to be an other important medical event. Additional information has been requested.
They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Patient ID reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 1-Dec-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.  Treatment medication was not provided by the reporter
on 1/27/21 I starting seeing a rash on my face. It has worsened each day since the 27th. I have taken Benadryl 25mg  for 3 days with no relief. I have consulted the Rheumatologist to see if this could be a result of the prednisone and the vaccine together.
Extreme fatigue, headache, lack of appetite, short term memory deficits , insomnia, muscle and joint pain.
small swelling 12 hours after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (small swelling 12 hours after the first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (small swelling 12 hours after the first shot). At the time of the report, SWELLING (small swelling 12 hours after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by reporter. No treatment medication reported by reporter.   Reporter did not allow further contact
locked up my shoulder/pain; 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 received bnt162b2 (BNT162B2), administered in deltoid right, administration date 25Feb2021 (Lot number: EN6198) at the age of 73 years as dose 1, single and administration date 18Mar2021 (Lot number: EN6208) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Problem" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "several glands removed along the breast area" (unspecified if ongoing), notes: because they were enlarged. Concomitant medication(s) included: ELIQUIS; METOPROLOL TARTRATE taken for hypertension; WELLBUTRIN SR taken for depression; LANSOPRAZOLE. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "locked up my shoulder/pain". Therapeutic measures were taken as a result of arthralgia.  Additional information: patient had an adverse reaction to COVID -19 vaccine: it landed on the side where several glands removed along the breast area because they were enlarged, it settled right there in that area and locked up her shoulder and when she got the second one she could not move the arm. She had got to see a chiropractor and go back to her orthopedist to get cortisone shot and a step for physical therapy which she has been doing and she was finally home and she was continuing here at home but it messed me up. Patient cannot lie on her left side and it hurt so much to move it but she was pushing through. She was losing control of her shoulder. Patient had swollen lymph nodes alongside of my breast which were removed, that was before taking the vaccine. She got about 75 percent use that she had to continue with the therapy and make it for function. Patient was told or she may have to have surgery. Treatment: shoulder freeze. Patient went to a chiropractor to break up the calcium deposits cannot use it and she went to the orthopedist to get cortisone injection in shoulder.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021504971 same reporter/drug, different patient/ event
Patient reports arm swelling and pain beginning day vaccine was administered on 4/11/19 in the evening before bedtime. Patient returned to pharmacy on 4/12/19. Swelling observed on upper left arm and patient reported continued pain when lifting her arm. She was advised by the pharmacist to apply ice and to take an over the counter pain medication (Tylenol or Advil) and was instructed to return to the pharmacy if pain and swelling did not improve. Patient returned to pharmacy on 4/13/19 and reported improvement in swelling and pain after ice and Tylenol but that she was still symptomatic. Pharmacist advised to continue to apply ice and take Tylenol and to return/contact MD if no improvement or worsening conditions.
Red, warm, firm lump on right arm measuring at sight of injection.  Lump is raised and itchy.  Largest diameter measured 1 3/4 inches.  Lump appeared several days after injection of vaccine.
11PM 4NOV94 pt brushing teeth & passed out cold on the bathroom floor; periods of dizziness have occurred since then; pt undergoing a series of test & was seen by MD & neurologist;
VACCINE ADMINISTERED OUTSIDE OF THE HOLD TIME FROM PUNCTURED VIAL; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced vaccine administered outside of the hold time from punctured vial. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine administered outside of the hold time from punctured vial was not reported. This report was non-serious.
Blood in urine (gross hematuria) lasting for 4 days. Bright red blood in urine beginning the following afternoon (4pm) and continued bright red for several days. Day 4 was dark red blood in urine. Fatigue continued for 3 days but mild overall. Facial butterfly rash began 36 hours after vaccination and lasted for 24 hours ultimately peeling.
developing shingles/suspected vaccination failure; covid infection; developing shingles post covid infection; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: developing shingles/suspected vaccination failure) (serious criteria GSK medically significant), covid-19 (Verbatim: covid infection) and shingles (Verbatim: developing shingles post covid infection).  The outcome of the vaccination failure was unknown and the outcome of the covid-19 and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, covid-19 and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure, covid-19 and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 5-Oct-2023 The patient self reported that developing shingles post covid infection. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Pt threw up 25 min after receiving the vaccination. The pt c/o headache and vomiting. Pt was observed for an extra 30 min. Vomiting subsided and ot went home in stable condition.
Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulates. Administered Benadryl 50mg PO. symptoms persist after 20min. Called 911, evaluated and transported to Emergency Dept.
Cellulitis of shoulder from deltoid to elbow joint, allergic type, a large local reaction.
Breakthrough case admission after 3 vaccines Moderna 1/31/21 lot# 011L20A;  Moderna 2/28/21 lot# 012L20A;  Moderna 11/2/21 lot# 076C21A
This spontaneous report as received from a physician refers to a 8 week old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-AUG-2017, at 6 weeks of age, the patient was vaccinated with ROTATEQ dose 1, orally (dose, concentration, lot# and expiration date were not reported). On 12-SEP-2017, two weeks after the first vaccination, the patient was vaccinated with second dose of ROTATEQ. The outcome of inappropriate schedule of drug administration was unknown. No Product Quality Complaint (PQC) was reported.
Rash, itchiness, "welting", swelling, redness, warm to touch - worsened for 3 days, swelling decreased on 4th day
Pt recv vax on 9/16/98; on 10/22/98 pt exp halitosis, fever, pox rash over body.
Patient stated feels dizzy today (day after administration). Her MD sent her in a prescription for meclizine to help with dizziness.
Dose administered greater than 12 hours post initial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post initial puncture) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post initial puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided.  The vial was initially stored in the refrigerator on 17-Nov-2021. The vial initially punctured on 17-Nov-2021. The vial had no temperature excursion.
pt recv vax; devel redness, swelling & pain at inject site; resolved p/ some time;
Initial report received from a physician on 18/May/2006. An 18 year old male patient with no pre-existing medical history had received an intramuscular left deltoid injection of MENACTRA, lot number U2050AA, on 15/May/2006. Three days later, the patient was examined by a physician and was experiencing generalized itching and significant spasms of the neck bilaterally. The patient was treated with muscle relaxants and anti inflammatories. At the time of this report the patient had not recovered.
Fever for over 24 hours of 102. Sever muscle pains and headache. Also, sever paid under left armpit.  Random cough started too.
menstrual irregularities x 6 months, heavy bleeding, altered smell x 6 months, new diagnosis of thyroid & adrenal disorder
I received the third Pfizer booster for COVID-19 on 6/10/2022. On 9/14/2022, I began getting a runny nose and scratchy throat. About six hours after the beginning of those symptoms, I developed a severe cough. I would like to mention that I had received the second dose of the JYNNEOS monkeypox/smallpox vaccine on 9/10/2022, and I wonder if it affected my immune system in such a way that it left me vulnerable to a COVID-19 infection. On 9/15/2022, I had slight body aches and chills that lasted for only one day. Aside from that, the coughing continued. I also had both head and chest congestion. The cough was productive and produced a lot of phlegm. The first 3 days were the worst, but after that, I gradually got better. During the first 3 days, my symptoms were about a 9/10 on the severity scale, but on the fourth day and afterwards, the severity had dropped down to about a 5/10. I took iHealth home antigen tests on 9/15/2022 and 9/16/2022 and got a negative result both times. However, when I took another home test on 9/17/2022, I got a positive result. I got positive results when I tested myself every other day afterwards until 9/26/2022, which was the first day I got a negative result. Even though I had a negative result, I still had residual symptoms that included head and chest congestion, which lasted for about 2 weeks afterwards. For about 2 weeks after I got my negative result, I would often feel fine, but then I would momentarily feel kind of weak or not right for a few seconds. A few seconds later, I would get my bearings and feel fine again. At the time of this writing, I feel that I have made a complete recovery from the COVID-19.
So on August 20th my family and I were out, we were out shopping, and I just felt super fatigued like I could barely walk. I got a headache very bad and I told my husband we had to leave immediately. When we got home, my fever was about 101. Through that night I had a migraine fever, chills. On the morning of the 21st of August 2021 I went to the urgent care. I got acetaminophen and something else. Those medicines did not work. I was in so much pain. My head hurt so bad, never anything like it in my life. I was nauseas, Had a fever, all of that. On the 23rd I went back to the urgent care. I got a prescription for the cough I had and sent me home. My symptoms continued. I was vomitting, had the 103 fever and headache and chills. Then on the 28th of Aug the symptoms subsided and I was feeling better. The only thing that is lingering is my fatigue, I am winded after doing small amount of walking and that is the only thing that is left.
Large red approximate size of grapefruit  raised sore at injection site.  Still irritated 72 hours after injection