chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Follow-up information was received that provided adverse event of pyrexia, vaccination information and recovery status of medication error. Information regarding Prevnar vaccine was received from a nurse regarding a 10 month old male patient who inadvertently received two doses of Prevnar in the same right leg at the same office visit and received two doses of Prevnar in the same right leg at the same office visit on 15 Jun 2006. On the same day, the patient received the third dose of DTap vaccine. On 16 Jun 2006, the child developed a fever of 101.5 degrees Fahrenheit.  Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 15 Jun 2006. Dose regimen was two doses on the same day (intramuscular). Concomitant vaccine included DTap. On 15 Jun 2006, the patient received two doses of Prevnar in the same right leg at the same office visit (incorrect dose administered) (accidental overdose), when the child was supposed to receive only the third dose in the Prevenar series. On 16 Jun 2006, the patient developed a fever of 101.5 degrees Fahrenheit (pyrexia). It was unknown if the patient recovered from the pyrexia. No additional information was available at the time of this report. Follow-up information was received that provided information, concomitnat vaccination information, treatment and recovery status. Information regarding PREVNAR vaccinw was received from a nurese regarding a 10-month-old male patient who  inadvertently received two doses of PREVNAR in the same right leg at the same office visit on 15-Jun-2006. On the same day, the patient received the third dose of INFANRIX (Glaxosmithkline) DTAP. On 16-Jun-2006, the child developed a fever of 101.5 degrees Fahrenheit. On 15-Jun-2006, the patient received two doses of PREVNAR in the same right leg at the same office visit. When the child was supposed to received only the third dose in the PREVNAR series, along with another childhood vaccine. On 16-Jun-2006, the patient developed a fever of 101.5 degrees Fahrenheit. Treatment included TYLENOL. On 21-Jun-2006, the patient recovered from the pyrexia
Not sure if this an adverse event but I was told by my hospital to report this to VAERS.  Patient completed moderna vaccination series (Dose 1: 2/6/21, Dose 2: 3/6/21). Patient now has tested covid positive as of 11/2/21.
Patient is due on 4/28/2022. No said pregnancy complications stated. Patient indicated she she was lightheaded after vaccinated due to not eating in the morning.
Woke 4 am to use bathroom. While using bathroom, got dizzy and nauseaous and broke out in  a full body sweat, then passed out, falling to the floor.
vomiting; This spontaneous case was reported by a physician and describes the occurrence of VOMITING (vomiting) 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.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient did not have vomiting with first 2 Moderna shots.  Concomitant and treatment medication was not reported.
09/26/2022 I had a pain in my back. I went to the urgent care on 09/26/2022. They couldn't find my pulse and told me that I had Ventricular trigemini. I went to the cardiologist on 10/21/2022 he did an EKG. I had a nuclear stress test and I wore a Holter monitor for 3 days. It showed that the irregular heart is still there. They prescribed with metoprolol for once a day. On 06/2022 I took a home test it was positive. My symptoms were mild. We are still trying to figure out the main cause of my irregular heartbeat. It might be from COVID-19 infection but not sure. My cardiologist told me that it would not go away. Hopefully the medication will control it.
About 30 - 40 minutes after my 2nd vaccine, while driving home, I got dizzy enough to stop driving. I pulled over and let my spouse drive. Within an hour the dizziness passed and I felt fine after.
Pins in the top of your head; Flu like symptoms; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pins in the top of your head), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Pins in the top of your head), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, HEAD DISCOMFORT (Pins in the top of your head), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
pregnant woman received Infanrix; pregnant woman received Infanrix / DOB :04-MAR-1992; received Infanrix instead of Boostrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On 12th October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and adult use of a child product. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the inappropriate age at vaccine administration, adult use of a child product and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that a pregnant patient received Infanrix instead of Boostrix, which led to vaccine exposure during pregnancy, inappropriate age at vaccine administration and Adult use of a child product. The reporter consented to follow up by email.
About a day later I noticed some itching in the back of neck and over the course of a few more days, it got worse and I started to see red welts developing on my neck, left shoulder, and left upper side of chest and back.  It was very itchy and starting to get more painful.  Then 10 days later some of the welts turned to scabs while new welts were developing.  Much more pain.  Also, I left shoulder started to increase with pain and was loosing range of motion.    About 5 days into the first shot, I spoke to my primary doctor and originally he said just a reaction to vaccine, use Alegra and that should  take care of it.  I contacted him 10 days into the vaccine and sent him pictures of the welts and he said it's very clear I have the shingles.  While he didn't say the shingles were related to the vaccine, the timing is very suspicious.  I truly believe something happened with the vaccine that caused this.
This was the second dose of a two dose schedule.  I had no adverse events with the first dose.  This dose was received 4 weeks after the first dose.   Initiated with chills about 10 hours after receiving vaccine.  Progressed to low-grade fever, chills, overall aches and pains.  Tired, lack of energy.   Treated with Tylenol, 1000mg Q6 hrs for 24 hrs. Provided some relief.  Symptoms resolved in about 24 hours.    These are all known adverse events for this brand of vaccine.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a nine-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 02-Jan-2011. The patient received the expired FLUMIST on 03-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 11-Mar-2011: The reporter confirmed that there was no late occurrence of adverse events.
Information has been received from a consumer concerning her 19 year old daughter who was vaccinated with all 3 doses of Gardasil. On 05-JAN-2008, after the second dose, the patient experienced mild hives and blotches. After receiving the third dose, the patient had huge red blotches on her face that became dry and warm to the touch. As of 18-JAN-2008, the patient was recovering. Additional information has been requested.
Patient experienced swelling and redness in arm the day following vaccine administration. She went to the ER and the doctor prescribed BENADRYL and an antibiotic (she did not have the name available). Patient is feeling better and taking the medication as prescribed. Doctor diagnosis was cellulite according to the patient.
patient was given 0.3 mL 12+ Bivalent booster and should have been given 0.2mL 5-11 bivant booster
their heartrate increases due to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (their heartrate increases due to the vaccine) 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 HEART RATE INCREASED (their heartrate increases due to the vaccine). At the time of the report, HEART RATE INCREASED (their heartrate increases due to the vaccine) 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 medications were not reported. Heart rate was spike on day 2 and usually subsides by day 6.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CEREBRAL EMBOLISM
PATIENT WAS GIVEN AN EXPIRED DOSE PER POLICY. AFTER SPEAKING WITH PFIZER, THE DOSE HAD A 15 DAY GRACE PERIOD SO WAS STILL WITHIN THE TIME FRAME OF BEING GIVEN AND DOESN'T HAVE TO GET ANOTHER 1ST DOSE.   PATIENT WAS CALLED AND INFORMED BY DR ABOUT THE SITUATION THAT OCCURRED AND MADE SURE NO OTHER QUESTIONS WERE HAD BY THE PATIENT.
May have started experiencing headaches around time of 2nd or 3rd anthrax vaccine, but his headaches did not become severe enough to seek medical evaluation and treatment until 5 January 2008 (within 30 day of receiving 3rd anthrax vaccine).  Neurology first saw patient in May 2008 for evaluation of headaches and diagnosed him with likely migraine vs other h/a syndrome.  Characteristics of headaches include: 1) Two types of headaches: a. Constant, dull headaches, low intensity, occasional gradual increase in intensity.  b. Intermittent, lancinating, throbbing, excruciating headaches primarily affecting left side of head (from occiput ? parietal and temporal areas).  Positive photophobia and anorexia, but no nausea or vomiting.  During the peak of their course, headaches were occurring every 2-3 days.  2) Associated visual changes: Experiences blurred vision and transient partial (left lower field) vision loss in left eye during severe headaches.  (Reports that he has experienced these visual changes in the absence of intense headaches.)  Also on at least 2 occasions, his left pupil was dilated and was painful.  Episodes of visual changes usually do not last for > 30 minutes.  3) Associated tingling in left face, tongue and increased pressure sensation in ears with some of intense headaches.  No focal weakness, visual changes, dysarthria, or dysphasia.  4) No specific triggers identified ( e.g., wine, cheese, chocolate, sleeping changes)  except headaches  are worse with intense heat and with prolonged computer use.  5) Evaluation included negative head CT and ophthalmologic exam, but those records not visible to VHC.  6) Loss of consciousness (LOC) associated with some of intense headaches.  First episode of headache-associated LOC was in June 2008.  At the time, SM was evaluated where they noted motor disturbances (trouble getting things out of pocket) and tingling in hands, but no lightheadedness, dizziness or nausea.  In August 2008, his roommates found SM face down with bilateral arms jerking.  When they turned him over, he made eye contact with them, but was confused for several minutes.  Approximately 10-12 episodes of LOC have been reported,  some associated with bilateral shaking of hands, with duration estimated to be < 5 minutes up to 45 minutes.  Denies associated bowel or bladder incontinence or tongue biting. 7) Medications for headaches have included: VERAPAMIL, ZOMIG 5 mg, INDOCIN, and Naprosyn.
contracted the Delta virus; contracted myocarditis/the myocarditis got really bad; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (contracted myocarditis/the myocarditis got really bad) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 010M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not report any medical history or condition.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced MYOCARDITIS (contracted myocarditis/the myocarditis got really bad) (seriousness criterion medically significant). In July 2021, the patient experienced COVID-19 (contracted the Delta virus). At the time of the report, MYOCARDITIS (contracted myocarditis/the myocarditis got really bad) had resolved and COVID-19 (contracted the Delta virus) outcome was unknown.            Concomitant medication not reported.   She received the second dose in Mar 2021. Immediately after she contracted myocarditis, which she reported to her doctor. At the end of Jul 2021, she contracted the Delta virus, and the myocarditis got really bad. She mentioned during that time she was moving, and she was able to make the move.  Treatment medication not reported. Company comment- This is a spontaneous case concerning a 71-year-old female patient with no medical history reported who experienced the expected and serious (medically significant) event myocarditis immediately after a dose of mRNA-1273 vaccine, given as a second dose of COVID vaccine schedule, was administered. It was reported that immediately after she received the vaccine, she contracted myocarditis. Four months after, she contracted the Delta virus, and the myocarditis got really bad. She mentioned that during that time she was moving, and she was able to make the move. Patient now feels good, and her health is better. No further details were provided for medical review.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
6 month 23 day old male began with c/o diarrhea for 2-3 days, began on 11/11/2012 in middle of night, mixed with blood, associated with abdominal cramping, intermittent.  C/o abdominal pain for 2-3 days started suddenly on Saturday night, not sleeping well due to abdominal pain, cramping draws legs up.  C/o fever 100.5, taking Tylenol.  C/o poor appetite decreased since this morning, did not want to bottle feed this am.  C/o blood in stool mixed with stool dark red in color.  C/o fussy constantly.  Denies: spitting up, vomiting, nausea, sick contacts, abdominal distension, gassy.
Information has been received from a nurse, via a company representative, concerning a 65 year old male, with unknown medical history and unknown drug reaction/allergies, who in late APRIL was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot#650302/1039P).  Concomitant therapy included ezetimibe (+) simvastatin (MSD).  In April 2006, the patient experienced swelling in left arm after receiving the vaccination.  The arm where the patient received the vaccination was red, hard and swollen halfway down his arm.  Unspecified medical attention was sought.  Outcome not reported.  No product quality compliant was involved.  Additional information has been requested.
Big red splotch on arm. Splotch feels very hot and sore to the touch. Also, feeling very hazey and under the weather without specific symptoms
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: other medical history: diabetes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovvid.  Addition al information: Anti-viral details: Paxlovvid: Treatment start date: 28Nov2022, Treatment stop date: 02Dec2022, Indication: Treatment of COVID-19. The patient had no known allergies  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA Symptoms started 12 hours after injection: muscle aches, fever, chills, headache, fatigue, and nausea for roughly 36 hours
Pox lesions > 40 lesions.  Scabbed and pustules / papules.
Havrix adult administered to a 2 y/o; Havrix adult administered to a 2 y/o; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included HAVRIX PEDIATRIC (1st dose received on 25th February 2022).   On 25th August 2022, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-Aug-2022 Reporters comments: The medical assistant reported that the patient was inadvertently administered an adult dose of Havrix. The reporter did not consent to follow-up. Additional Supportive Information: The child patient received an adult dose of Havrix, which led to overdose and adult product administered to child.
Cause of death is believed to be a fatal arrhythmia resulting from advanced old age and aggravated by sepsis due to COVID-19 infection along with gastroenteritis. The death was natural and not unexpected. Tobacco is not believed to have contributed to t
Patient was administered Pfizer Covid-19 vaccination per patient request for 2nd dose but did not have her card with her on receiving the 1st dose at another location (non-Walgreens). On checking she in state registry, patients 1st dose was Moderna
This spontaneous report as received from a pharmacist refers to a 48 year old female patient. The patient had no pertinent medical history or drug allergies/reactions. On 29-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, lot# K007262, expiry date unspecified, dose and route were not provided) in the arm. Concomitant medications were not provided. "The next day", on 30-OCT-2014, the patient experienced fever, nausea, vomiting, soreness and swelling at the injection site. The pharmacist reported that "3 days after" administration, on 01-NOV-2014, the injection arm "got red hot to the touch" and was very inflamed therefore the patient was taken to a hospital and admitted due to myositis of the injection arm and leukocytosis (unspecified white blood cell count (WBC) levels, onset date unspecified, in approximately 2014). The pharmacist reported that the patient was treated with an unspecified intravenous (I. V.) antibiotic and was released on an unspecified date (in approximately November 2014). The pharmacist required lot check for PNEUMOVAX 23 (lot# K007262, expiry date unspecified) to determine if myositis had occurred with other patients who had received doses from this lot#. The outcome of the events was reported as recovering. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.