chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt tired; This is a spontaneous report from a sponsored program. A contactable nurse (patient) reported that a 34-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She felt tired after getting the first dose of the vaccine on unspecified date. The outcome of the event was unknown.  Information on the lot number has been requested.
second dose recieved after 11 months of first; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of Shingrix in June 2021).   In May 2022, the patient received the 2nd dose of Shingrix. In May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-Jul-2022 Reporter's Comment: The case was reported by the patient. The reporter did not consent to follow up. Additional Supportive information: The patient received second dose of Shingrix after 11 months after receiving first dose, which led to lengthening of vaccination schedule.
Information has been received from a physician concerning a 2 day old female who on 29-MAR-2007 was vaccinated IM in the right leg with a 0.5 mL dose of PEDVAXHIB (OMPC) (lot #653523/0063U).  Concomitant therapy included MMR (MSD) and PREVNAR.  On approximately 29-MAR-2007, after vaccination, the patient developed an injection site reaction described as red, warm, swollen, and a painful knot (size of knot not reported).  On 06-APR-2007, the patient was examined in the physician's office for an unrelated visit, and the injection site reaction was disclosed at that time.  The physician reported that the injection site reaction had resolved by 06-APR-2007, and that the duration of the injection site reaction was unspecified.  A concern regarding the lot was reported.  Additional information has been requested.  This is one of several reports received from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of an agency and was released.
Patient received vaccines around 11:30AM and called later that night stating she now has a fever and "thinks she is coming down with something". She also stated that her arm was sore where she received the vaccines and it felt like "a golf ball" in her arm. We explained that you can't get sick from either vaccine since they are both dead viruses and came to the conclusion with the patient she might have been sick prior to the vaccines being introduced to her system. She stated she was going to put heat on the injection site to help with the discomfort. She was advised to use ice, but denied it stating she doesn't want to use it since she has a fever. Also discussed other remedies to help her treat symptomatically.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with (Oka/Merck) VARIVAX (lot #, expiry date, dose and route not reported. On an unknown date, the patient experienced cellulitis. The outcome of the event was reported as recovering. The patient had contacted the physician's office on unspecified date. This is one of several reports from the same source. Additional information has been requested.
Initially red, swollen right upper arm at injection site. Pain with movement of arm and mild itching. By the next morning (10/5) a red, warm to touch area the size of a tennis ball was present in the upper arm area. The red area was raised with a clear demarcation at the edge of the reddened area (like a ridge). 10/6 area remained red, swollen, warm to touch, and painful. By 7:30 Ronan began to complain of headache, chills and feeling very fatigued. He had a low grade fever as well as the previously listed symptoms.
PARALYZED LEFT SIDE OF THE BODY; DEATH; This spontaneous report received from a health care professional concerned a 29 year old female. Initial information received on 16-APR-2021, processed along with information received via telephone communication on 20-APR-2021. The patient's weight was estimated about 200 pounds (reported as overweight but healthy). The patient's height and medical history were not reported. The patient had a baby in JAN-2021 and had a epidural at the time of birth.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The vaccination site was not reported. No concomitant medications were reported.  The reporter, which is a health care professional, reported that the patient's (the reporter's cousin) death cause could be JANSSEN COVID-19 vaccine. The reporter said that the patient was fine without symptoms for one week after her scheduled vaccine.  As per the reporter, the patient received the JANSSEN COVID-19 vaccine approximately 2 weeks ago (the patient was scheduled and her family assumed she went and received the vaccine). The reporter said that one week after the vaccine date the patient went to get her hair done, and when the patient sat on the chair, she suddenly could not move her left side. Ambulance/emergency room was called and the patient was taken to the hospital. The patient was in the hospital about a week and then passed away. An autopsy was performed but results were pending. The reporter had no details regarding imaging studies or laboratory values (platelet counts, D-dimer or fibrinogen), and does not know anything about the hospital course. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 16-APR-2021, and the outcome of paralyzed left side of the body was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This is a spontaneous report of a 29-year-old female who developed sudden hemiplegia approximately one week after receiving the Janssen COVID-19 vaccine, was hospitalized and died one week later.  The patient had a history of being overweight, and was approximately 3 months post-partum.  No medical history or concomitant medications were reported.  The hospital details and cause of death were not provided.  There are insufficient details to make a meaningful medical assessment at this time. Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I started to feel Sinus Congestion and a headache. The headache lasted for about seven days and nothing relieved it. I tried multiple pain medications. I tested positive on the second day. I took an at home test first and then I got tested at my workplace. I was given the Monoclonal antibodies on day 7. I had already started to feel better by then. I had the Regeneron. My headaches cleared up with a day or two. I lost my sense of taste and smell 5-7 days in and it lasted for about one week. I felt better after two weeks and I just had a little lingering fatigue. It has been three weeks and I am back to normal.
Patient received 2nd dose of Moderna series today 4/16/21. This was an "off Label" use as the patient is 17. CDC recommends if under age patient receives 1st dose Moderna it is appropriate to finish the series.
On 5/08/03, patient left work early, feeling dizzy and "seeing spots". Had trouble sleeping that same night. Began having chest pain at 3AM on 5/09/03 which persisted. "Feels like lungs are cramping". Called Health Department at 11AM. Directed to local ER.
Myalgia, Fever, chills Narrative: employee states: her first vaccine was 12/23/2020 her second was  1/20/2021 on the evening of 1/20/21 she was more tired than normal and woke up  on 1/21/21 with a fever (101.2 F), chills and myalgias. Symptoms lasts about 4  hours and she went into work late. She was still tired and her arm was sore but she was back to normal by 1/22/21
Mother reported to this RN seizure like activity on the night of 9/9/2021.  Vaccine was given on the afternoon of 9/7/2021.  Per mother patient was looking in the mirror at his arm, as arm was sore.  She heard patient fall to the floor and witnessed seizure like activity.  Patient was seen at Hospital and discharged to home same day.  Referral to cardiology and neurology pending.
I have had brain fog, headache and chills since getting the vaccine intermittently. Today, 3/23, I?ve had severe nausea and developed a fever of 100 currently.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 4 week old infant. On 15-NOV-2013, the patient was vaccinated with oral ROTATEQ lot # J003813, expiration date: 10-AUG-2014 (dose and route were not reported). No concomitant medications were reported. The infant was not experiencing any adverse effects at the time of the report. Additional information has been requested.
Received vaccines on 2-10-14. On 2-12-14, "screamed" for 12 hours. Could not be consoled. "Blood curdling cry."
Head feels heavy; Dizziness; Arm is sore to touch; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea). At the time of the report, HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: SYNCOPE-Mild, Systemic: Vomiting-Mild, Additional Details: PT WENT UNCONSCIOUS FOR A FEW SECONDS. VACCINE WAS GIVEN AT 10:24AM. PT REPORTED TO FEELING DIZZY AND LIGHTHEADEDNESS. HE VOMITTED & PALE FACE. PARAMEDIC ASSESSED PT AND RECOMMENDED GOING TO THE HOSPITAL TO GET A COMPLETE EVALUATE TO BE ON THE SAFE SIDE DUE TO LOW BLOOD PRESSURE AND IRREGULAR HEART RATE. PT CALLED BACK AFTER DISCHARGE AT 3:30PM. NO ISSUES. ALL VITALS & TESTS ARE NEGATIVE PER PT. PT WAS DIAGNOSED WITH VASOVAGAL SYNCOPE. NEGATIVE FOR ANAPHYLAXIS.
Patient received Flu and COVID19 vaccines. He informed us he sometimes gets light headed after vaccines. After receiving second vaccine patient started to slump to the side and immunizer called pharmacist over. We got patient to the floor- he was still breathing and had a pulse.  He did not hit his head at all. He then started to convulse/eyes rolled back for less than 10 seconds before becoming fully alert again. Another coworker called 911 during this time.  Patient was able to answer questions/aware of what was going on right away, just continued to feel lightheaded. Paramedics arrived and ensured patient was okay/took vitals. He declined transport and we observed until symptoms resolved.
I immediately felt a "charge" go down my arm to my wrist and my wrist muscles tightened. (My wrist was fractured January 2016, the fracture subseqently "settled" followed by Complex Regional Pain Syndrome (CRPS) to that arm and hand.)  Later in the day, I used KT Tape (kinesiology tape) to help alleviate the wrist discomfort and took ibuprofen for injection site pain.   Some discomfort in my wrist continues. Injection site pain continued for more than two weeks. There continues to be occasional discomfort at the injection site.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 84-year-old male patient who received SHINGRIX. Concomitant products included terazosin. On 3rd May 2018 16:00, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site rash were recovered/resolved. The reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness and swelling at the injection site the day after receiving the vaccine. The patient stated the rash extended for about 5 inches at the injection site. The symptoms lasted for about 5 days and then disappeared. The patient had denied permission to contact their physician.
pt recv 6JUN98 & 12JUN98 pt c/o of muscle aches, joint aches & upper arm sore;
Ear sensitivity, hearing issues; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 at 11:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 07:00, the patient experienced ear sensitivity, hearing issues. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event ear sensitivity, hearing issues was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approx. 30 min after receiving 2nd dose of COVID vaccine pt stated feeling "dizzy and flushed." Pt taken by wheelchair to private observation area and VS assessed by RN. Pt noted to have an elevated BP outside of normal parameters.  Pt aox4, denies any pain, sob, chest pain or difficulty breathing. Pt continued to monitored and assessed by RN over a period of approx. 30 min. and BP remained elevated outside normal parameters.  Pt agreeable to be treated in Emergency Room.  Pt taken by wheelchair to ED by charge nurse and another ED staff member. Pt able to follow commands and able to ambulate on his own to wheelchair. Pt denies any dizziness, blurred vision, nausea, sob, head/chest pain or difficulty breathing.
Client stated she felt "light headed" .  Blood pressure at 12:07 140/102 pulse  81.  Juice offered.  12:20 client stated she felt "fine"  Blood pressure 120/102 pulse 78.   Client was encouraged to rest and contact physician in case of any adverse reactions.  Client left at 12:25pm.
The patient, was injected with Moderna COVID19 vaccine at 17 years old at another facility, Library, as a first dose. The patient did not experience any adverse events after the first dose. The patient came to our pharmacy,  to receive a second dose of Moderna COVID19 vaccine off-label. Permission was obtained by child's parent and physician to give a second dose of Moderna. The second dose was given on May 18th, 2021 at Pharmacy after the expressed approval of the patient's PCP Dr. and patient's father.
A report has been received from a health professional concerning a 13 year old, male patient had been receiving Nasal FLUMIST (INTRANASAL) was administered on 17-Jan-2014. The health professional reported administration of EXPIRED FLUMIST as expiration date of the drug was 13-Jan-2014. FLUMIST (INTRANASAL) was discontinued on 17-Jan-2014. The outcome of the event of EXPIRED FLUMIST QUADRIVALENT ADMINISTERED is unknown. The report was considered to be non-serious by the reporter. Corrected reported on 17-Mar-2014: Case suppressed with the reason of medication error with no adverse event. Corrected report 18-Mar-2014: Corrected report 18-Mar-2014: Form completed date changed to 03-Feb-2014. Initial date received date and date reporting clock start date changed to 03-Feb-2014.
covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (lot number 011A21A) on 20-Mar-2021, Moderna COVID-19 Vaccine (lot number 032M20A) on 17-Apr-2021, Moderna COVID-19 Vaccine (lot number 058H21A and 1st booster) on 05-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Seasonal allergy, Allergy (Allergy for Yellow Jacket) and Allergy to venom (Allergy for Wasp Venom).    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2022,  after starting , the patient experienced COVID-19 (covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test). At the time of the report, COVID-19 (covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2022, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that patient had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines. She coughed twice, had a stuffy nose, and was tired. These are all regular symptoms for her. She was exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test.  No treatment information provided.
The pt experienced swelling of fingers on both hands, fingers had red sore like spots. They itch and were very painful.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with chronic obstructive pulmonary disease. On 22-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot #, expiration date and indication were not provided). Since December 2013, prednisone (manufacturer unknown) was prescribed to the patient for an unspecified reason. On 30-DEC-2013, the patient was prescribed an unspecified dose of prednisone (manufacturer unknown) and an unspecified dose of prednisone  (manufacturer unknown) in January 2014 for an unspecified reason. On 14-FEB-2014, the patient was also prescribed prednisone (manufacturer unknown) 80 mg/day for an unspecified reason. The prescription for prednisone (manufacturer unknown) 80 mg/day had not been filled yet. At the time of the report, the patient's status was not recovered, reported as not improved. Additional information has been requested.
Just a little pain at injection site that lasted a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little pain at injection site that lasted a day) 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.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Just a little pain at injection site that lasted a day). At the time of the report, VACCINATION SITE PAIN (Just a little pain at injection site that lasted a day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) Negative for antibodies.         No concomitant products were reported.  No treatment drugs were reported.   This case was linked to MOD-2021-287857 (Patient Link).
A non-serious, spontaneous report of administration of full dose in one nostril was received from a nurse concerning a female child of unknown age subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 17-Feb-2009 and incorporated into the narrative: No adverse event reported.
headache, body aches, dry cough, fever-highest at 102, fatigue, chills, sinus congestion, nasal congestion,. starting 11/20/21
Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizziness, shortness of breath, nausea, shaking. patient is clammy & pale, a&o x4, lungs clear bil all lobes, pulse normal, cap refill <3, V/S @ 10:20, b/p 140/90, r22, p72, t 99.7, unable to obtain o2 stat via pulse ox r/t pt shaking. Patient states that temp normal runs 96.8. Monitoring pt while obtaining health history. 10:40 V/S t 99.8, b/p 160/74, p113, 02 88% on RA, r 24, o2 placed on pt 15l nonrebreather, o2 91%. 10:50 EMS arrived, pt a&ox4, no change in condition, V/S 100/60, 100% on 15L nonbreather, p90, r22. 10:55 still nausea, 4mg sublingual zofran given.  11:04 pt transferred to stretcher with assisit, a&Ox4, V/s 132/69, p80, 94% o2 on 10l via nasal cannula, r26 co2 33. pt transferred via ambulance, pt request to be taken to hospital.
FEVER 102 FOR 6 DAYS; NAUSEA; HEADACHE; PAIN; SWELLING
Pt developed pins/needles sensation in right hand 10  minutes post-vaccination. wrist to finger tips. Denies pain, numbness. Assessed by RN (denies airways, breathing, swelling problems). Denies hives