chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a patient's friend refers to a 64 years old female patient (110- 120lbs). In approximately 2008 (reported as 3-4 year ago) the patient was vaccinated with a dose of ZOSTAVAX (lot# was noted reported, one injection under the skin). About 3-4 years after was vaccinated with ZOSTAVAX in early January 2012, the patient got shingles. . The patient seemed to get over the shingles in about 4 weeks or so. The patient's friend had no idea what all concomitant medications were, but stated "was alot". The patient was gave some medication for the treatment of the AE but her friend was not sure. The patient was always going to the doctor and sought medical attention so maybe lab diagnostics studies were performed. Additional information is not expected.
Child was getting pfizer vaccine age related and the nurse went to inject patient and patient moved. Approx 0.1cc was inserted. Dr. was notifed and we repeated  full dose without incident.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. Vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
Severe Migraines, Extreme Fatigue, Heart fluttering, Loss of concentration, Tremors, overall extreme malaise
arm started to swell up / approximately 1/2 inch by 2 inches / Now / is about 4 inches by 4 inches/ swollen like a baseball; circular area with 2 red dots; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2021, less than a week after receiving Shingrix, the patient experienced erythema. On 19th January 2021, the patient experienced extensive swelling of vaccinated limb. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema were not recovered/not resolved.   The reporter considered the extensive swelling of vaccinated limb and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received the dose, 2 days ago from date of reporting.  The patient stated that a few hours after receiving the injection, her arm started to swell up.  She reported that the area started off approximately half inch by 2 inches and that overnight the swelling got worse.  Then the area was about 4 inches by 4 inches and was swollen like a baseball (symptoms were not recovered).  It was a circular area with 2 red dots.  The reporter asked how long this could be lasted and information was provided per content frequently asked questions and copy of the PI was offered. The reporter was advised to follow up with her HCP.  She stated that she had been treating it with Tylenol and warm compresses.  The reporter did not consent to follow-up and declined to provide HCP information.
Reported low grade fever, aching fingers, aching neck and hands (unable to make fist), extreme fatigue. Complained flu-like symptoms.
Extreme aching all over, fever up to 101 for 3 days after vaccination on Feb 28. Second reaction on 3/15: minor ashiness, fever up to 101 for 1 day.
Headache, Myalgia, NauseaVomiting, Started with malaise, fatigue, then headache, then later started vomiting; only symptom remaining is body aches Narrative:
pt recvd vax & c/o urticaria; to clinic; tx w/ DPH & meds;
This is a spontaneous report received from a non-contactable consumer. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: unknown, Expiration Date: Unknown), via unspecified route of administration on right arm on 07 Mar 2021 for COVID-19 immunization. The patient medical history was not reported. The patient was allergic to strawberries, latex. The patient's concomitant medications were not reported. Patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination nor tested post vaccination. On 08 Mar 2021 the patient experienced breaking out in big hives, right shoulder, under right arm, left shoulder. Some hives round, some square, some long and thin after 30 hours of vaccination. The outcome of the event was not recovered. Treatment for the event taken by the patient included hydrocortisone cream as self application. No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
SIRVA/ damage to rotator cuff showed with 48 hours and is still causing problems 9 weeks later.
Itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck; Itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 15:00 (Lot number: EN6208) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Peripheral Neuropathy" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing). The patient had not experienced Covid-19 prior vaccination. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Drug hypersensitivity"; Valium, reaction(s): "Drug hypersensitivity". Vaccination history included: Bnt162b2 (First dose (Lot. EN6203), received at 03:00 PM, in the left arm), administration date: 21Feb2021, when the patient was 74 years old, for COVID-19 immunisation. The following information was reported: RASH PRURITIC (medically significant), RASH ERYTHEMATOUS (medically significant) all with onset Jul2021, outcome "not recovered" and all described as "Itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck". The event "itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash pruritic, rash erythematous (Prednisone-one shot then one course oral).  The adverse events were described as following: "itchy, red rash. Appeared first on lower back (late July 2021). Then spread in late August/early September. It started and has continued on left arm, near elbow and spread up and down the arm. Then about a month later it spread to her chest. Mostly right side; then to the back of her neck (at hair line and up into her scalp above the hairline). All rash areas-left arm, chest, and back of her neck have continued to irritate the patient. All areas are still itchy and red except lower back, which has stopped itching". Post the vaccination, the patient has not been tested for COVID-19.   Then, the patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:00 (Lot number: FH8020) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. In mid December, the patient experienced rash, a new area appeared on her lower right leg.
Right thigh 2 puncture marks, lower mark with no immediate surrounding erythema but some induration. No increased heat or tenderness. Some redness a few cm medial to lower injection site with without ragged border without poor demarcation.
Was administered a DPT vaccination at Dr. office.  Within a couple of hours, I had a gran mal seizure.  Mother was RN and witnessed the seizure.  Fell to the floor and was unconscious for about 30 minutes. Mother notified Dr. and he recorded the event.  My son. also had life altering adverse reactions to DPT at 10 months.  He had 3 seizures within a few hours of the DPT vaccination.  He stopped breathing, eyes rolled back in his head, went limp and turned purple in my arms.  Paramedics worked on him for 40 minutes to revive him.  He had a complete neuro workup, EEG with Dr.  I have entered him in VAERS, also.
THE VACCINE ADMINISTERED WAS OUTSIDE OF APPROVED STORAGE & HANDLING INSTRUCTIONS FROM MANUFACTURER. Pfizer does not have data to support vaccine stability.
About 10 days after second dose, I had rash with tiny bumps over my left arm, two legs, lower back, and forehead. I applied lotions and anti-itching lotions. The rash is now quite light after a month. It seems will take a few more weeks for the rash to completely disappear.
Very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Very sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR065996   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received first dose of Shingles vaccine and made him or her very sick. The patient stated that he or she do not usually had bad reactions to the vaccines. The physician advised him or her not to take the second dose. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR065996:Same reporter
your vaccine is hurting people; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (your vaccine is hurting people) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (your vaccine is hurting people). At the time of the report, VACCINATION COMPLICATION (your vaccine is hurting people) outcome was unknown.        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.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
About one hour after H1N1 vaccination patient started to have diarrhea and minor rash on abdomen.  Rash progressed to arms and legs.  Patient sought treatment at ED and placed on prednisone and Benadryl.  Rash spread to palms, soles of feet, and mouth.  Itchy with diarrhea controlled with Immodium.  No fevers, no cough, no abdominal pain.11/9/2009 Ed records for 11/6/2009. patient presents with c/o's rash and diarrhea. Tx: IV steroids and benadryl. DC DX: allergic reaction vs drug reaction vs viral syndrome.
Patient is age 12 Should have received Menveo (meningitis conjugate vaccine) Instead received MenB vaccine, which does not qualify for and should not have been given before age 116
fever, sweating, headache, cough, bloody nose, congestion, fatigue, difficulty eating, muscle weakness, slept for over 24 hours in total two days after vaccine
Pain and swelling started in heels. Then hands and feet different locations on each. No treatment. Ongoing.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that the patient was vaccinated with the first dose of GARDASIL on 20-JUL-2012, with the second dose on 27-DEC-2012 and with the third dose on 18-FEB-2013. NO dosage information or route of administration was reported. No lot numbers or expiration dates were reported. No adverse events were reported. No further information was provided. Additional information has been requested.
24 hr. after administration, Mom reported a bruise at the site with an area of hives adjacent. Child went to baseball practice after injection and could have been injured at that time. Mom declined to bring the boy into the office.
As I was driving my daughter to school at 715am, I got and occular migraine and my field of vision was blocked for about 1/2 hour.  The next day 1/19/2012 I got a debilitating migraine that lasted 5 hours. The next day, 1/20/2012, I got another occular migraine while at dinner with my husband and my field of vision was blocked at approximately 4:45. It lasted 45 minutes and was followed by a migraine. In 2008, I noticed an intolerance to sulfites in that they bring on occular/regular migraines. I requested thimerasol free vaccine and was assured before being asministered that it was thimerasol free. There is neurological impairment/damage involved with getting a flu shot for me because of the sulfites in the vaccine.
Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient (age and gender not reported) who experienced adverse outcome to her shoulder, while patient received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious adverse outcome to her shoulder (musculoskeletal discomfort), following the administration of INFLUENZA VACCINE. Relevant tests were not reported. Final diagnosis was adverse outcome to her shoulder. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as unknown. List of documents held by sender: none.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in freezer, one to two vials were taken out and placed in the fridge each day as needed. No concomitant medications were reported. No treatment was given.
This case was reported by a physician via other manufacturer and described the occurrence of arrhythmia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced arrhythmia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the arrhythmia was fatal. The reported cause of death was arrhythmia. It was unknown if the reporter considered the arrhythmia to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. On an unknown date, the patient experienced pulmonary arrhythmia and passed away. No additional information was provided. Reported Cause(s) of Death: arrhythmia.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 07-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported). The second dose was administered on 10-OCT-2016 (dose, route of administration, lot # and expiry date were not reported). The patient received the third dose on 15-DEC-2016 (dose and route of administration were not reported) lot # M034195, expiry date: 14-APR-2019. No adverse effects were reported. Additional information has been requested.
Within 24 hours, post vax, developed fevers of 102F-105F. 30 hours, post vax, had a brief febrile seizure.
dizziness; fever; chills; pain at injection; ringing in ear (L) and (R); weakness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ear (L) and (R)), ASTHENIA (weakness), DIZZINESS (dizziness), PYREXIA (fever) and CHILLS (chills) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis ((Humira) history-medication stopped 3 weeks prior and 1 week after Moderna injections) since an unknown date. Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced TINNITUS (ringing in ear (L) and (R)), ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (pain at injection). On 11-Feb-2021, the patient experienced DIZZINESS (dizziness). On 11-Feb-2021, ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (pain at injection) outcome was unknown. At the time of the report, TINNITUS (ringing in ear (L) and (R)) and DIZZINESS (dizziness) outcome was unknown.
10/27/21 pt had a positive COVID test in HCF; 11/4/21 to ED with worsening SOB; dx with AHRF secondary to acute COVID pneumonia; given Decadron, ABX, O2 supplementation; DNR/DNI; pt passed away on 11/23/21
Information has been received concerning a patient who on an unspecified date was vaccinated with the second dose of series ROTATEQ, oral. It was reported that the patient from a physician's office received two doses of ROTATEQ and then experienced intussusception. No further information is available at this time of reporting. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
I experienced shingles, pain in my rib cage for several days and a minor rash.
leg hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg hurt). At the time of the report, PAIN IN EXTREMITY (leg hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided by the reporter.   Reporter did not allow further contact
exhaustion by end of the day, that lasted over a week.  Widespread inflammation throughout body/joints.  Increased weight from the inflammation (my diet remained the same), Inflammation lasted just about 2 weeks, then I pee'd out all the fluid in the next 3 days, the weight dropped (diet still the same).
p/vax T103.4, sleepy, lethargic, some localized swelling of thighs;
Pt states that he gets a rash when he gets a temperature. Pt states that the rash usually gets really hot, then the temperature leaves my body and the rash goes away. Usually resolves in 3 days or so.
only first dose was received; exposed by virus (non COVID) after first shot; Could not drive; dizzy; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only first dose was received), VIRAL INFECTION (exposed by virus (non COVID) after first shot), FEELING ABNORMAL (Could not drive), DIZZINESS (dizzy) and VOMITING (throwing up) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL (Could not drive), DIZZINESS (dizzy) and VOMITING (throwing up). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only first dose was received) and VIRAL INFECTION (exposed by virus (non COVID) after first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only first dose was received), VIRAL INFECTION (exposed by virus (non COVID) after first shot), FEELING ABNORMAL (Could not drive), DIZZINESS (dizzy) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications were provided
C/o on 10/21/14 had difficulty breathing and her arm was red, warm and had some swelling. Hx of HTN and asthma. Currently no difficulty breathing but c/o swelling under arm. Advised f/u w/ medical provider.
Client had a syncopial episode approx. 15 min. after injection. Arms and legs become rigid. Very pale. Able to respond. Stated throat felt "funny". Benadryl given per standing order. Condition improved. Vital signs stable. Client able to walk out of clinic unassisted.
PPSV 23 given instead of HPV 9. NO adverse reactions as per discussion with guardian on 11/6/18.
My arms became really sore and jaw started hurting. I also had a tingling feeling throughout my body and the migraine was very intensed. By the April the 12  and 20th  had go to the ER. The symptoms did not sub-sized on the 21st of April.
PAIN IN RIGHT LEG, ACTING LIKE LEG LOCKING UP OR NOT WANTING TO WALK ON IT. GAVE 2 DOSES OF CHILDRENS TYLENOL 6/15/16 AND AT TIME OF REPORT HAS ALREADY GIVEN 2 DOSES.  MOTHER REPORTS THAT CHILD SEEMS TO DO BETTER WITH LEG AFTER TYLENOL ADMINISTRATION.
Patient reportedly passed away on 3-24-21 on the day after the vaccine was given.  We have no further information at our facility regarding the event.