chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nearly 3 months after the 5th dose had Gastro pain with diarrhea that continued for a month and lost 8 pounds. During that month had a headache that lasted for a week. Went to doctor and after examination doctor thought it was Gastro Intestinal Virus and wanted me to take Imodium and Tylenol. A week or so later I started having crippling back pain and had leg pain that was became extremely painful. Called a Nurse line and was told to go to the Emergency Room fearing a blood clot. At the hospital was given X-rays and an Anti-inflammatory injection, was sent home with Muscle Relaxers. The back pain never got better, but became more painful. Went to my doctor and after examination I was told that it was just lower back pain and was sent home with Prednisone and another Muscle Relaxer. Is currently in Physical Therapy.
On Feb 2, 2000 the pt developed a sterile abscess measuring 1 inch by 1 inch at the injection site. Eventually, the abscess developed fluctuant areas and drained spontaneously. On March 29, 2000, a superficial lesion remained. The patient recovered.
I26.99 ACUTE PULMONARY EMBOLISM 9/7/2022 ACUTE ADULT RESPIRATORY DISTRESS SYNDROME J96.00 ACUTE RESPIRATORY FAILURE 10/22/2022 ACUTE ADULT RESPIRATORY DISTRESS SYNDROME R09.02 HYPOXIA 9/7/2022 ACUTE ADULT RESPIRATORY DISTRESS SYNDROME I26.99 ACUTE PULMONARY EMBOLISM 9/7/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 10/22/2022 ACUTE RESPIRATORY FAILURE R09.02 HYPOXIA 9/7/2022 ACUTE RESPIRATORY FAILURE
Approximately 10 minutes after receiving vaccine patient began to experience some mild discomfort on the left neck (mild "stiff neck"), heavy arm or discomfort, and mild tingling in the fingers.  Initial BP 149/92  HR 91.  Patient clinically stable at 30 minutes post-vaccination.  Neck pain gone 30 minutes post-vaccination; patient only feels pain at injection site.  BP 143/95  HR 86  O2=98%.  Patient released from clinic at 2:22pm.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-MAY-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 24-APR-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 81-years-old female patient started to receive bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection)via an unspecified route of administration from 03Feb2021 to 03Feb2021 at SINGLE DOSE for covid-19 immunisation .Medical history included thrombosis from Feb2020 to an unknown date Verbatim: blood clots.  Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]).  The patient previously took eliquis for thrombosis.  The patient experienced sore arm  on 03Feb2021 and The patient underwent lab tests and procedures which included investigation was unknown results  and Consumer calling about Pfizer COVID-19 vaccine who says she just had a question since she had the first dose of the vaccine yesterday. She says that the first dose went fine, and she had no ill effects at all other than a sore arm, but she didn't know that Ibuprofen shouldn't be taken before getting the vaccine and she takes low dose Aspirin every day. She says yesterday she took her dose of Aspirin, and she doesn't know should if she should continue to take her low dose Aspirin. and Caller took a low dose aspirin before taking the first dose. She is asking if that is okay.   .
Sore arm; very very tired; flu like symptoms; headache; fever (100.2), achy.
4 days after I was walking into my office and I got very dizzy, room was spinning, then my vision blurred. The whole event lasted a few minutes. I went to the ER they ran a bunch of tests and couldn?t find a reason for the event. Not sure if it was the vaccination or something else.
I felt unwell about 6 hours after having the vaccine, around 1-00 on August 31.. That evening I had a slight headache and increasing ear pain in my right ear., feeling a little hot all over. My left arm where the shot was given was swollen and tender. Starting at 8:00 AM on September 2, I started getting a painful, red, bumpy, itchy rash on my buttocks, closest to the anus. Within an hour, the rash spread to the back of my thighs, then to the sides of my thighs.  As the day progressed, the rash moved to my back (flanks only), then to my arms, underside mostly, but also little whitish bumps on my arms with a lot of redness. By 6:00 PM the same day, my ears were hot and itchy.
Information has been received from a consumer concerning his fiancee who on 22-JUN-2009 was vaccinated with the first dose of GARDASIL.  Subsequently, the patient "could not get up" after vaccination.  Then the patient was hospitalized.  At the time of the report, the patient's outcome was unknown.  No further information is available.
Patient developed left lower extremity DVT and subsequent PE. He has no other risk factors for thrombosis. No recent surgeries or immobilizations. No chronic medical conditions. Of note, the patient also developed a Bell's Palsy after the first dose of his Moderna Vaccine which was given on 10/13/2021.
3rd DTp/OPV given on 8APR91 approx 3 hrs later arm examined by PHRN arm had swelling @ inject site, appeared like 1/2 an egg; 0 other sx; Mom instructed to apply ice give DPH; arm examined again erythema-pink color, tenderness & edema;
Rash in chest & back & extremities. Noted on 9/28/11. Rx ATARAX 10mg/5ml 1/2 teaspoon orally 3 times a day.
Initial pain and generalized lethargy with muscle aches lasted 3-4 days. Onset of injection site discomfort, stiffness in muscle red rash started at day 7, worse on day 9. Rash extended approximately 10cm around injection site
Two days later the left arm got red swollen. Felt hot, non tender - went to urgent care. No treatment. Released. (inject site).
After vaccine, minor fever and chills.  About a month later, dizzyness, weakness in arms, inability to walk, felt like was going to faint. Felt bloated, stomach pain, headaches. At one point, had acute broncitis. Felt balance was off, Migraine headaches. Still has broncitis. Has been to the ER and Urgent car several times. Has been to several doctors' appointments and has to go back.
two doses of Shingrix in 2017, diagnosis of shingles November 2021/ suspected Vaccination failure; diagnoses of shingles, November 2021; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (1st outbreak refer link case US2021246376). Previously administered products included Zostavax (received one dose in 2012).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In November 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received two doses of Shingrix in 2017 and the patient had diagnosed shingles. No further details provided. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021246376:1st outbreak
Information has been received from a physician concerning a female (age unknown) was vaccinated with a dose of Gardasil. Subsequently, after receiving the vaccination the patient fainted. The patient sought unspecified medical attention. At the time of the report, the patient had recovered on unspecified therapy. No product quality complaint was involved. Additional information has been requested.
"Coughing and flu like symptoms, SOB for 48 hours"  Narrative:
About 7 pm the night of injection I started having a headache and body aches. The next morning I woke up with a fever, body aches, chills and really bad head ache. I could not seem to fall asleep or get warm. About 11 pm they started to improve. On the morning of the 11th I was back to normal.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received contains patient demographics, vaccine start date and dose details
The patient was vaccinated with the Janssen COVID-19 vaccine on 4/2/21 around 1:30pm. She reported experiencing fatigue and chills like the flu about 6 hours after vaccination, and the same night she experienced a broken blood vessel in her right eye. Her chills and fatigue resolved on Monday, 4/5/21. The residual blood in her eye resolved on Monday, 4/13/21. She notes she has experienced a broken blood vessel in her eye before, possibly caused by wiping off her makeup.
I had my vaccination on 12/21/2020. In 01/2021 I started to have light and skipping menstrual cycles for 3 months. I had spotting and then my menstrual cycle stopped. This was weird because I was very regular up until my vaccination.
Headache; Chill; Fever; Slight joint pain; This is a spontaneous report received from contactable consumer (husband reporting for her wife) via contactable Pfizer Sponsored Patient Assistance Program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 05Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Mar2021 the patient experienced headache, chill, fever and slight joint pain. The outcome of events unknown.  Information on the lot/batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
I was having normal bowl movements until after my 2nd vaccine. A few weeks after vaccination I started to have diarrhea and my feces is small. It's the size of my pinky finger, I do regret getting the vaccine. After the vaccine, I had to stop my daily exercising or any additional activities due to the diarrhea. There is no treatment because he found nothing wrong with my colon, After I eat, I cannot go out for a while. My stool is extremely soft or in the form of diarrhea. It's not getting any better and I feel I don't want to eat because I know I will have to  go to the bathroom, I am extremely upset and I feel uncomfortable going out with my friends, Its embarrassing. I am trying to incorporate more fiber but that has not been effective. I had a colonoscopy of June 1st and there was 1 polyp found but they indicated everything was fine. I went in on December 07, 2021 and had my gynecologist look and my primary care doctor did a CT Scan and it was also normal. I am going to follow up with my gastroenterologist since the diet he has placed me on is not effective.
ADACEL left arm, ENGERIX-B, and PNEUMOVAX (R) arm were given to pt. on 6/30/13. Pt. called 7/1 and said he has chills and fevers. Recommended TYLENOL/MOTRIN for fever and recommended Dr's visit if symptoms worsen. Pt. called back 7/15/13, stated he is being hospitalized for cellulitis due to swelling to his (L) arm.
Two days after received #4 DTAP and #4 HIB, patient mother noted only a generalized body rash.  The child had no fevers, no other signs of illness was eating/drinking well and very active.  On physical exam 07/23/2002, she was noted to have resolving extensive maculo-papular rash on trunk upper extremity, lower extremity and mild on face.  NO other significant findings on patient.
Area of increased redness, swollen, warm to touch. SOB like someone sitting on chest. Area of redness has improved-still pain laying or leaning on it, itchy-mottled. SOB unchange.
PATIENT HAD SORE ARM FOR 2 DAYS, THEN WORSENING NEURAL/MUSCLE PAIN FROM SHOULDER DOWN HAND, COULD POSSIBLY BE BRACHIAL NEURITIS. PATIENT WILL BE SEEING HER PRIMARY CARE PHYSICIAN, WAITING TO HEAR BACK FROM THEM.
Moderna vaccine:   Started with arm pain and a knot in the right arm. The knot lasted for a few weeks and after that, it turned into a hole or a dent in that arm. After over a month, the dent is getting bigger as of the vaccine is eating away at the muscle in my arm. I have not contacted my doctor yet but I will tomorrow.
Information has been received from a medical assistant, concerning a 9 months old patient, who on 30-AUG-2012 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (route, and frequency were not reported). There were not adverse effects reported. Additional information has been requested.
Sudden high heart rate 64-153 taking several minutes to subside, chest pounding; Sudden high heart rate 64-153 taking several minutes to subside, chest pounding; lightheaded; appears to be an episode of SVT; This is a spontaneous report from a contactable other hcp. A 39-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 20Aug2021 13:30 (at the age of 39-years-old) as DOSE 1, SINGLE for covid-19 immunisation at other facility. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included omeprazole (OMEPRAZOLE); loratadine (CLARITINE); montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. The patient previously took Sulfa and experienced allergies. Other vaccine in four weeks included none. No COVID prior vaccination and COVID was not tested post vaccination. The patient experienced sudden high heart rate 64-153 taking several minutes to subside, chest pounding, lightheaded, gradually subsided, appeared to be an episode of SVT on 21Aug2021 21:15. The patient underwent lab tests and procedures which included heart rate: high on an unspecified date. No treatment was received for the events. The event appeared to be an episode of SVT was recovered with sequel on an unspecified date, while the other events were recovering at the time of this report.  Information on the lot/batch number has been requested.
Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
patient states that the evening after receiving the shot (received at about 10:00am), she began to feel sweaty and hot and her face began to swell up, also felt nauseated and some malaise.  She states that she took some acetaminophen.
PT NOTED HAVING A LOT OF PAIN IN HER RIGHT ARM AND FELT "COMMON COLD SYMPTOMS" THE DAY AFTER. NOTED HER HEART RATE AND BP WERE INCREASED, BUT NOTED IT MIGHT HAVE BEEN STRESS AND HER WORKING ALL DAY. SAID NOW SHE FELT BETTER, BUT HER ARM WAS NOW RED AND HOT BUT IT WAS GETTING BETTER. THIS WAS 3 DAYS LATER. RECOMMENDED SHE TAKE AN NSAID/APAP AND USE COLD COMPRESS/ICE FOR PAIN /SWELLING. SAID SHE WOULD CALL IF THINGS DID NOT IMPROVE.
This spontaneous report was received from registered nurse and refers to a female patient of unknown age. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 12-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 (dose route of administration, lot number and expiration date were not reported). On 17-NOV-2016, the patient was supposed to receive her second dose of GARDASIL 9, however according to the chart documentation she received an unspecified influenza vaccine (reported as "flu shot") (dose, route of administration, lot number and expiration date were not reported). The nurse reported that the patient stated she received the second dose of GARDASIL 9. On 09-MAR-2017, the patient received another dose of GARDASIL 9 lot number: M04373, expiration date: 22-JUN-2019 (dose and route of administration were not reported). The reporting nurse was not sure if this was the second or third dose, since there had been a confusion which of the vaccines the patient received on 17-NOV-2017. No adverse events were reported. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Information has been received from a licensed practical nurse (LPN) referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot# L001333, expiration date 13-JAN-2017) (dosage, strength and route unknown). (Temperature: -13 degree Centigrade, time frame: 402 hours 55 minutes. Two previous temperature excursions: -13 degree Centigrade for 24 hours as well as -14 degree Centigrade for 14.5 hours). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for contact.
PATIENT PASSED OUT FOR 15-20 SECONDS.  HE WAS SITTING IN A CHAIR AND NO SECONDARY INJURIES OCCURED. HE CAME BACK AND HAD NO OTHER ISSUES OR PROBLEMS. GAVE HIM SOME WATER AND HE CONFIRMED NO OTHE SYMPTOMS AND HE WAS BREATHING REGULARLY WITHOUT ANY ISSUES. OFFERED TO CALL 911 AND GO TO HOSPITAL. PT. REFUSED AND SAID HE IS DOING FINE.
After the 1st dose she was tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (After the 1st dose she was tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had Covid in March of 2020, loss smell & taste, had a fever, and aches & pains) in March 2020. Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.    On 20-Feb-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 FATIGUE (After the 1st dose she was tired). At the time of the report, FATIGUE (After the 1st dose she was tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-375104, MOD-2021-375073 (Patient Link).
pt recv vax; exp stomach cramps, diarrhea, v, n, HA & fatigue; recovered
No additional AE details; extra dose of VAQTA was administered to a pediatric patient who had already completed the series; This spontaneous report was received from a nurse prescriber and refers to a pediatric patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 24-OCT-2022, the pediatric patient was vaccinated with en extra dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml, lot #W006214, expiration date: 04-MAR-2023, administered for prophylaxis (strength, site, and route of administration were not provided) (extra dose administered). The patient had already completed the series on 27-MAY-2020. No symptomatic side effects reported. No additional adverse events details or product quality complaints were reported (no adverse event).
events are ongoing; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (events are ongoing) 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (events are ongoing). At the time of the report, VACCINATION COMPLICATION (events are ongoing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was injected with Restylane Kysse in the lips. Three months later the patient had a touch up with Restylane Defyne. Five weeks post injection with Defyne, the patient experienced delayed onset nodules to the injection area. Treated with steroids and products dissolved. Concomitant medications was not reported.  Treatment medications was not reported.