chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ON 08-03-2006 CHILD RECEIVED DTAP/HIB,MMRV, AND PNEUMO CONJUGATE IMMUNIZATIONS.ON 09-07-2006 MOTHER OF CHILD TO HEALTH DEPT. TO REPORT A POSSIBLE REACTION TO IMMUNIZATIONS. MOTHER REPORTS "WITHIN THE WEEK AFTER RECEIVING SHOTS THE CHILD'S HEAD STARTED TILTING TO ONE SIDE, SHE QUIT TALKING WORDS,STOPPED WALKING, CRAWLING, SITTING UP. SHE WAS SLEEPING ALL DAY AND NIGHT,WOULD WAKE UP TO EAT AND THEN BACK TO SLEEP." MOTHER STATES "TOOK CHILD TO THE CHIROPRACTOR ON 08-18-2006 FOR AN ADJUSTMENT DUE TO HER HEAD TILTED TO ONE SIDE AND SAYS CHILD DID IMPROVE AFTER THE ADJUSTMENT FOR A SHORT TIME." THEN ON 08-25-06 MOTHER STATES "TOOK CHILD TO PROVIDER DR. AND MOTHER SAYS SHE WAS TOLD BY DR. "CHILD'S REFLEXES ARE OKAY, SHE COULD HAVE A BROKEN NECK DUE TO THE CHIROPRACTOR'S ADJUSTMENT. TAKE HER TO HOSPITAL." MOTHER REPORTS "CHILD NEVER HAD A FEVER, APPETITE WAS GOOD, URINARY AND BOWEL FUNCTION OKAY. HAD BEEN TEETHING 4-5 TEETH,COULD ALWAYS MOVE HER ARMS." MOTHER SAYS "CHILD HAD A SEIZURE 5-06 DUE TO A HIGH FEVER BUT NONE SINCE." "CHILD WAS HOSPITALIZED ON 08-25-2006 AT HOSPITAL.MOTHER SAYS "WAS TOLD BY PHYSICIAN CHILD HAD LESIONS ON THE BRAIN-CAUSE UNKNOWN.POSSIBLY MAY HAVE BEEN DUE TO IMMUNIZATIONS." MOTHER REPORTS "CHILD UNDERWENT PHYSICAL THERAPY DURING HOSPITALIZATION AND MOTHER PLANS TO ARRANGE FOR CONTINUED PHYSICAL THERAPY. CURRENTLY CHILD CAN'T WALK OR CRAWL. SITS UP FOR A FEW SECONDS BY HERSELF BEFORE FALLING OVER TO ONE SIDE. STANDS WITH HELP FOR A FEW SECONDS ONLY." MOTHER SAYS "CHILD IS STILL NOT PRONOUNCING WORDS ONLY "BABBLING." CHILD IS HOLDING HER HEAD UP AND HAS HEAD CONTROL. PT.DISCHARGED FROM HOSPITALON ON 09-06-2006.PEDIATRIC DISCHARGE ORDERS-HOSPITALIZATION SUMMARY STATES REASON FOR HOSPITALIZATION "ACUTE SEVERE GENERALIZED WEAKNESS" AND DISCHARGE DIAGNOSIS. ACUTE DISSEMINATED ENCEPHALOMYELITIS." HOSPITAL COURSE/SIGNIFICANT FINDING." "PT. HAD A POSITIVE RESPONSE TO IVIG TREATMENT X 2, SHE HAS SHOWN INCREASED STRENGGTH ANDHEAD CONTROL, INCREASED PHONATION, INCREASED ACTIVITY/INTERACTIVITY. REPEAT MRI SHOWED NO CHANGE." FOLLOW-UP APPOINTMENT WITH OU PEDS DR. ON 09-13-2006.  7/20/07 Received hospital medical records which reveal patient experienced acute severe generalized weakness x approx 1 month.  Noted to be floppy on admit w/prominent head lag.  Admitted 8/25-9/5/06.  Tx w/IVIG & progressed well.  D/C to home on tapering steroids.  Readmitted 9/25-9/29/06 for continued generalized weakness & increased irritability.  MRI & LP were repeated.  Received additional IVIG w/minimal improvement. D/C to home w/continued PT. FINAL DX: Acute disseminated encephalomyelitis; possible progressive neurodegenerative disorder.
This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported  and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Dizziness, light headed, prolonged observed in office. Rx Meclizine. Mom claims similar symptoms lasted 1 wk after the 1st Gardasil dose.
This spontaneous report as received from a physician assistant refers to a male patient in his mid-sixties. Within the last two weeks, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). The patient suffered an immediate injection site reaction to red and swollen to the size of goose egg. It was given BENADRYL as a treatment for the adverse effect. The outcome of injection site reaction of red and swollen to the size of goose egg was unknown. The casual relationship was not provided. Additional information has been requested.
Following vaccines, episode of syncope followed by brief seizure 2-3 seconds. Recovered fully without meds.
Achiness especially in back and knees, pain like nerve pain in fingers, nausea, loss of appetite, fatigue, brain fog, diarrhea, low grade fever up to 101.4, trouble sleeping overnight after getting the vaccine the evening before. The symptoms lasted all day on 01/20/2021, the day after I got the vaccine, all better the following day on 01/21/2021.
blood clot right leg in groin area; cyst in left leg behind the knee; Both of her legs started swelling up; muscle spasms in her leg; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0182) via unspecified route of administration in in left upper arm on 09Jun2021 at 11:00am, at patient age of 58-year-old, as a single dose for COVID-19 immunisation. The patient medical history included Covid-19 in Oct2020.  The patient concomitant medications was none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number RA7886) via unspecified route of administration on 19May2021 at 11:00am, at patient age of 58-year-old as a single dose for COVID-19 immunisation and experienced diarrhea. In Jun2021, the patient experienced blood clot right leg in groin area, cyst in left leg behind the knee. This is affecting her health and she has a lot of bills racking up. She had not had any blood clots or anything like this till after the shots. Blood clot and Cyst occurred around the same time. Both of her legs started swelling up. She went to the doctor on 14Jun2021 since both legs were swollen and it would not go away. They did an ultrasound of the vein, a test called HCUS vein extremity was done. She had another test called a DUP scan and one called XTR vein complete. When querying results, she reported that one of the tests found the main clot and then went into check that there was nothing missed. She did not know exactly when the blood clot and cyst started but 14Jun2021 is when it started to take a toll on her body. She knew it did not feel right but did not know why.  She was fine before that. Regarding cyst outcome, she can see and feel it more. Sometimes it gets to where if someone were to put their hands around her leg and squeeze real tight with pressure, it is very odd. As treatment, she was on an acetylsalicylic acid (BABY ASPIRIN). She has an appointment made to see a specialist for medical oncology and hematology. Since the second shot she had muscle spasms in her leg so bad that even when she stood up, she could not get it to stop, it was so painful and never had anything like that before. The events did not require a visit to emergency room, but required a visit to physician office. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
7 hours after injection- extreme fatigue and headache  then  fever by 10 pm.  Fever gone by morning but headache and fatigue lasted 3 days.
I had a sinus infection at the time also. I had congestion and coughing on October 27, 2022. By the next day it was increasing, and I contacted the provider. He prescribed 5 days of ciprofloxacin which caused a little break up but I was still having coughing, congestion and headache with achy joints. Maybe mild fever. On October 29, 2022, I retested, and it was possible. The doctor ordered PAXLOVID and I started PAXLOVID on October 29. In 24 hours, I felt better. The cough lasted for several weeks, and I still have on and off cough from normal allergies as well. The doctor prescribed vibramycin  for the sinus infection as well.
Patient reported swollen arm from shoulder to wrist beginning day after vaccinations .  Patient also states that she had an IV in the same arm 4 days before vaccines, as well.  The arm was very tender and unable to raise arm.  Reported heat and lines down her arm. She reported to an urgent care and was ruled out for blood clots, and was treated for cellulits.
This spontaneous report was received from a nurse refers to 8 anonymous patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. On an unknown date in 2015 (also reported between 01-SEP-2015 and 30-OCT-2015) the patients were vaccinated with improperly stored ROTATEQ (strength, dose, frequency and route were not reported) lot # L013202 with an expiry date of 27-JAN-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Pt walked to observation area, stated to girlfriend that he was feeling dizzy and fell to his the ground on his face. Pt was sitting up and alert when staff arrived to help.
No adverse event; 2nd Bivalent dose; 2nd Bivalent dose (Partial dose) of Moderna COVID-19 vaccine; syringe leaked at time of administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (2nd Bivalent dose), UNDERDOSE (2nd Bivalent dose (Partial dose) of Moderna COVID-19 vaccine), SYRINGE ISSUE (syringe leaked at time of administration) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2023, the patient received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Apr-2023, the patient experienced EXTRA DOSE ADMINISTERED (2nd Bivalent dose), UNDERDOSE (2nd Bivalent dose (Partial dose) of Moderna COVID-19 vaccine) and SYRINGE ISSUE (syringe leaked at time of administration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (2nd Bivalent dose), UNDERDOSE (2nd Bivalent dose (Partial dose) of Moderna COVID-19 vaccine), SYRINGE ISSUE (syringe leaked at time of administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXTRA DOSE ADMINISTERED (2nd Bivalent dose), UNDERDOSE (2nd Bivalent dose (Partial dose) of Moderna COVID-19 vaccine) and SYRINGE ISSUE (syringe leaked at time of administration).    No concomitant medications was reported. No treatment medications was reported.
Tenderness, edema, erythema at injection site which started on 08/01/2012. Patient received vaccine on 07/30/2012.
Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the right arm on 07Jan2021 16:00 at a single dose for COVID-19 immunization. Medical history included depression. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA).  The patient experienced chills, body ache, headache, insomnia on 08Jan2021 02:00. Outcome of the events was not recovered. No treatment was given for the adverse events. The reporter assessed the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information of lot/batch number has been requested.
woke up with low grade fever 99.4,  nausea, headache,  injection site pain (continuously since injection),  chills,  tierdness
2-19-21  by 8pm full body aches and head ache 2-20-19  12am woke to severe chilling and temp 101.3, 6am temp 100.8, 5pm temp 99.9, 9:30 pm temp 99.7,       slept the whole day with continual aches and pains in legs, arms, and back, with a severe headache 2-21-21  6:30am temperature 97.6, improvement in aches, headache gone, slight ache in legs, arms and       back, walking better, feel like getting up and doing something
Bronchitis; felt very very sick; She had the 1st shot on  april. She didn´t get the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), PRODUCT DOSE OMISSION ISSUE (She had the 1st shot on  april. She didn´t get the 2nd dose yet) and ILLNESS (felt very very sick) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She had the 1st shot on  april. She didn´t get the 2nd dose yet). On an unknown date, the patient experienced BRONCHITIS (Bronchitis) and ILLNESS (felt very very sick). At the time of the report, BRONCHITIS (Bronchitis) and ILLNESS (felt very very sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She had the 1st shot on  april. She didn´t get the 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported  Doctor had diagnosed Bronchitis may/may not be related to the vaccine. (both believes was not).
Extreme fatigue/ very tired; Upset stomach; hoarseness; Dry cough; Muscle aches; Tightness in chest; Headache that comes and goes; Feel lousy; A spontaneous report was received from a consumer, concerning  a 76 years adult male patient, who received Moderna COVID-19 Vaccine and experienced 1 dose.  The patient's medical history was not provided.  The concomitant products was not provided.  On  09-Feb-2021,prior to the onset of events,the patient received the first dose of  mRNA-1273(lot number: 031M20A) and route of administration is  intramuscular route for COVID-19 infection prophylaxis.   Patient got vaccine on 9 feb21. Caller said she has Extreme fatigue, Upset stomach, anxiety.  Caller wanted to know, Are these symptoms normal. Symptoms are lingering. She said everyday she wakes up she feel lousy. she has mild symptoms. Every day she has hoarseness, dry cough, muscle aches and is Very tired. She has tightness in chest. She had her first dose 9feb21. She said she had COVID in September and that she had antibodies after the virus. She also had headache that comes and goes. Her concern, about second dose. She has asthma in the past.  Treatment history was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The Outcome of the event(s)  was considered to be not resolved at the time of this report.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 10th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:case
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had pain in her shoulder following dose of SHINGRIX. The pharmacist had no further details regarding the patient or vaccine administration.
She developed recurrence of her atrial fib. Required ED visit. Had TIA symptoms. Stroke eval negative. I will resume evaluation as an outpatient. Having to start her on Eliquis.
Nurse did not swab site of injection before administration. Eyes became irritated and got progressively worse as if had stones in them; left eye had swelling and redness on left corner, right eye also irritated. Washed eyes; had some relief and went to sleep. later on noticed that had swelling on both eyes (bags on eyes) especially top lid of left eye. Puffiness on top and bottom lid reduced. Right now has watery eyes.
Patient tested positive for Covid19 after being vaccinated with the Pfizer vaccine eua 4/1/2021-4/22/2021
Pt became warm and dizzy. Had pt hut her head down on the table, applied ice to her neck. Pt passed out several seconds later, became stiff as I was holding her, then became limp for sev seconds before awakening. Had pt lay down with legs elevated for about 15 min.
on 2/1/07 noticed a hive approx les than 2 inch itching, hot.  On 2/2/07 hive got bigger, 2 inch itchy.  Called hotline #, took to Dr. on Sat 2/3/07 was giving Benedryl - did not relieve symptoms.  Dr. told to watch it, if s/s worsened consult Dr.  By Sun, lighter in color, Monday gone.  02/14/07 PC to RN @ HD location of hie at varicella injection site, left upper arm
Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving Shingles vaccine, the patient was having headache. The patient asked that, what he/she should take for the headache. Additional supportive information: The follow up would not be possible as no contact details were provided.
C/O redness, hardknot and pain started 8/22. Pt also has swelling started on 8/23/02. Apply ice and Advil for discomfort.
This spontaneous report as received from a health care worker refers to a patient of unknown age. The patient's medical history was not reported. On 15-APR-2014 the patient was vaccinated with MMR II (lot # 0649AE, Expiry date: 27-MAR-2014) (Dose:0.5 milliliter (ml) subcutaneously. Concomitant therapy VARIVAX was administered on 15-APR-2014. The patient administered expired dose of MMR II on 15-APR-2014. The outcome of expired dose of MMR II was administered on 15-APR-2014 was unknown. Additional information has been requested.
Rebound of covid symptoms and positive rapid test; Rebound of covid symptoms and positive rapid test; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6199), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound of covid symptoms and positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Negative, notes: positive rapid test on day 10 after being negative on day 6; (23Jun2022) Positive, notes: positive rapid test on day 10 after being negative on day 6. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received no other medication in 2 weeks. Patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient has continued pain in left arm from flu shot. He sleeps on left side and it is so painful that he has trouble sleeping. It hurts him to even lift his arm. Began when shot was administered almost 5 months ago.