chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a 6 month old female patient. Approximately on an unknown date in 2006(reported as approximately 7 years ago), the patient was vaccinated with a third dose of ROTATEQ (Lot number, expiry date, route and dose were not reported). Approximately on an unknown date in 2006(reported as approximately 7 years ago), the patient experienced intussusception. It was not clear if there was any hospitalization but they did diagnosis the patient with intussusception. The outcome of intussusception was unknown. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Contracted covid after receiving first vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE TO SARS-COV-2 (Contracted covid after receiving first vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Contracted covid after receiving first vaccine). At the time of the report, EXPOSURE TO SARS-COV-2 (Contracted covid after receiving first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was inadvertently vaccinated with expired M-M-R II, lot # K001997, expiry date 10-FEB-2016 (strength, dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
A report was received from a health care professional on 11/18/02 concerning a group of vaccinees who were inadvertently administered 0.5ml Fluvirin subcutaneously on unreported dates. The reporter has assessed the relationship of the event to the vaccine as unclassifiable.
Hive breakout over inside of thighs and inside of arms; as of this report, hives are still occurring (on face and outside of thighs and arms still) 45 hours from onset.
Pt is being admitted for acute hypoxic respiratory failure secondary to COVID pneumonia.  Patient developed shortness of breath, fever/chills, and cough that started about 5 days ago.  He just returned from a cruise yesterday and reports that he was COVID negative 5 days ago.
Pt developed area approx 4" x 3" at injection site of slight swelling, slightly raised area; area is slightly red, warm, and tender to the touch.
Mother of child reports reaction of fever 105F after 4mo injections. Seen in ER, advised by ER physician to tx with Benadryl/Tylenol Prn. Counseled to return for redness/cont fever or other concerns.
-Tender at injection site. - About 5 and 1/2 hours after injection, had chills and achiness that progressed to trembling; had to put on thermal underwear, then fever. Had to take medicine due to trembling.
pt recv vax 25OCT96 PM by that evening the rt arm was painful & tender by sat noon the rt arm was hot, tender & swollen from the shoulder to below the elbow;pt went to ER on 26OCT96 PM;given IV & then had steroid through the IV & sent
Generalized itching about 90 minutes after receiving injection. I took Benadryl 25 mg PO. Symptoms resolved within an hour.
had stopped my period 6 days prior to 1st dose & 24 hours post-injection: menstrual cycle began'; menstrual cycle began and lasted for 2 weeks. Patient had consistent, normal cycles and had stopped, patient's period 6 days prior to 1st dose; the metallic taste in mouth, lasted for 24 hours; This is a spontaneous report from a contactable consumer (the patient). A 31-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EW0177), via an unspecified route of administration, in the left arm, on 25Jul2021 at 11:00 (at the age of 31-year-old) as dose 1 ,single for COVID-19 immunization. The patient's relevant medical history included bipolar II, ADHD (Attention deficit hyperactivity disorder), general anxiety disorder and relevant past drug history included Oxycodone and Maxalt. The concomitant medications included lamotrigine, bupropion hcl and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (AMPHETAMIN SALTS). On 25Jul2021 at 12:30, 1.5 hours post-injection, patient experienced the metallic taste in mouth, lasted for 24 hours. On 26Jul2021 at 14:00, 24 hours post-injection, menstrual cycle began and lasted for 2 weeks. Patient had consistent, normal cycles and had stopped, patient's period 6 days prior to 1st dose. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the events. Outcome of the event taste metallic was recovered on Jul2021 and outcome of the rest events was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
temperature excursions of vaccine; Product storage error; No adverse event; A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration; 2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT LABEL ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration), EXPIRED PRODUCT ADMINISTERED (2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions of vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:No known allergies.  Concomitant products included PNEUMOCOCCAL VACCINE from 10-Feb-2023 to an unknown date and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) from 10-Feb-2023 to an unknown date for an unknown indication.    On 10-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Feb-2023, the patient experienced PRODUCT LABEL ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration) and EXPIRED PRODUCT ADMINISTERED (2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions of vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL ISSUE (A vial was transported for same day use, was left out at room temp for 6-7 hours, was labelled with the wrong expiration), EXPIRED PRODUCT ADMINISTERED (2 patients received expired doses on 10Feb2023/Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions of vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was initially stored at refrigerator on 09-Jan-2023. vial size was initially 2.5 ml.  Treatment information was not provided.
04/30/2021 CLIENT CALLED STATING HE WAS HAVING FACIAL DROOPING AND SOME SLURRED SPEECH. STATES HIS WIFE NOTICED IT ALSO.  STATES EYES WERE SOMEWHAT BLURRY. DENIES ANY WEAKNESS OR IMMOBILITY ON EITHER SIDE OF BODY. ORIENTED TO NAME PLACE TIME AND DATE. NO DIFFICULTY WITH BALANCE. ALL ACCORDING TO CLIENT. CLIENT RECEIVED 2ND DOSE OF MODERNA ON 04/19/2021. STATES HE DID FINE WITH HIS FIRST DOSE. DUE TO CLIENT'S SELF REPORTED SYMPTOMS DISCUSSED THE IMPORTANCE OF R/O STROKE VERSES BELLS PALSY. ENCOURAGED CLIENT TO GO TO EMERGENCY ROOM NOW IF POSSIBLE. CLIENT STATES HE DOES THINK HE SHOULD AND THAT HIS WIFE WOULD DRIVE HIM.
This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a female patient who received Meningococcal B vaccine for prophylaxis. On 29th June 2018, the patient received the 1st dose of Meningococcal B vaccine. In June 2018, less than a week after receiving Meningococcal B vaccine, the patient experienced mobility decreased, tiredness and sluggishness. On an unknown date, the outcome of the mobility decreased, tiredness and sluggishness were unknown. It was unknown if the reporter considered the mobility decreased, tiredness and sluggishness to be related to Meningococcal B vaccine. Additional details were received as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The reporter asked did anyone have any reaction to the vaccination. A day before reporting, the reporter's daughter received vaccine and could barely lift her arm. The patient was also very tired and sluggish. The patient was not herself.
None - pt administered expired vaccine (8/26/2013). No adverse events experienced. Mtg stated "Satisfactory stability data."
Extreme Chills, Shaking, Racing Pulse, Fever, Projectile Vomiting,  Stomach ache, Headache, Fatigue, Acid Reflux, Wheezing, Explosive Diarrhea, Cough, Mucus, Chest Tightness, Bones Ache, Left Side Pain, Taste Change ( for 1 day everything tasted like onions)
Chest pain since 4 days after vaccination was received. Pain mainly located near center of chest, but is also experienced under ribs and now on the right chest. Pain is not consistent and can come and go. It often feels like a stabbing pain and/or pulsating pain. I also had numbness in my left hand pinky and ring finger followed by sharp pain. I also have headaches that come and go on the left side of my head mainly.
shingles; rash spread down my arm; and was very painful on the surface and extended to deep tissue/ joints; and was very painful on the surface and extended to deep tissue/ joints; arm was sore at the injection site; This is a spontaneous report from a contactable consumer. This contactable Consumer reported events for both doses of Comirnaty for this patient. This is regarding the 2nd dose. A 53-year-old male patient received (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7533) dose 2, administered intramuscular in left deltoid on 08Apr2021 as 2nd dose, single dose for covid-19 immunization. Medical history was not available. Concomitant medications included valacyclovir and gabapentin. Historical vaccine received first dose BNT162B2 (COMIRNATY, Pfizer vaccine, Lot number: EN6204) on 18Mar2021 via intramuscular in right arm/deltoid for Covid-19 immunization and had vaccination site pain. It was reported that, arm was sore at the injection site from the date of the vaccination until the onset of the AE. A rush started forming at the injection site on an unspecified date in 2021. The rash spread down of his Right arm on 12May2021 and was very painful on the surface and extended to deep tissue /joints on an unspecified date in 2021. His physician diagnose shingles on 12May2021 and prescribe antiviral and pain medications. This could be unrelated to the vaccine but he thought they might find it interesting. The outcome of event arm was sore at the injection site was unknown, while with other events was recovering.  No follow ups attempt needed. No further information was available.
BASEBALL SIZE HIVE AT INJECTION SITE. VERY SORE, RED, SWOLLEN. SOME ITCH.
The 1st dose, 5 days later I was diagnosed w/covid. Very Sick  for 2 weeks. Dr. put me on antibiotics and prednisone. Started feeling better 3 or 4 weeks. 2nd shot sick. Did not get out of bed for 2 days. Could barely walk. Very very weeks. Hard time concentrating . Muscles extremely weak. Took about five days to start feeling better. As time goes by my symptoms go up and down. I am however getting weaker and weaker I can barely go up a step my muscles are so weak. I?m trying extra supplements a little more proteins. Vitamins. My weakness is getting worse my muscles are very weak and I have rashes all over my body.
The evening of injection my mouth started to swell. The next morning my lips were extremely swollen. Dr. prescribed ZANTAC and XYZAL which made me very sleepy. By midafternoon I noticed a rash developing on my forearms. By evening I had a pervasive rash covering my forearms and lower legs.  The rash moved to my armpits on day two. I continued to take ZANTAC and XYZAL (at night) with no results other than the swelling in my lips subsided. On day 5 after the injection, I started a course of Methylprednisone which is clearing up the rash. I am currently at the end of day 2 of the prednisone and the rash has considerably subsided.
16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine; 16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included  (Medical history was not provided).    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine). On 17-Mar-2021, WRONG PRODUCT ADMINISTERED (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) had resolved. Not Provided          Treatment information not provided. Concomitant medications were not provided.
Pt recv'd vax in 1986 and subsequently dvlped seizures. No further info is available at this time.
Information has been received from a registered nurse concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently, on an unspecified date, the patient developed difficulty breathing after receiving both the influenza virus vaccine (unspecified) and Pneumovax 23.  It was noted by the reporter that when the patient received the flu vaccine alone (on two separate occasions in two different years), she developed difficulty breathing.  At the time of this report, the patient had recovered.  No product quality complaint was involved.  Additional information has been requested.
Pt felt suddenly weak, chills, headache, nausea.  Unable to function for about 2 hrs and then symptoms suddenly subsided.  No residual symptoms noted.
Swelling at site of injection. Firm 1/2 x 1cm feels like hematoma.
Patient felt very dizzy and thirsty 3 minutes after receiving the vaccine. She drank a small cup of water. She was fainted 3 minutes after drinking water but regained consciousness about 1 minutes but complained that she felt dizzy and warm. I put wet towel on her forehead while she was laying down. Her symptom went away 25 minutes after the immunization. I followed up with her 2 hours after, she said that she was still dizzy and had a headache.
Multisystem inflammatory syndrome. Onset 2/9/22; hospital admission 2/17/22-2/21/22
Patient felt like she was getting a headache or light headed 15mins after vaccinations,  She took all of her daily meds this morning and ate breakfast.  VS at 11:30 were 159/87 P 84 o2sat 98. Had patient sit for 15 more min and gave her water.  Was talking to her and she seemed fine and she reported headache had gone away. Life was very stressful recently.  VS at 11:45 were 176/98 P 82 O2sat 99.  She felt better and felt safe to go home.  She is a healthcare worker and can f/up with PCP re high BP later.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 06-Oct-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. No treatment medications were reported.   This case was linked to MOD-2022-496015 (Patient Link).
fever, myalgia, fatigue, diarrhea, injection arm red, swollen Narrative:  fever 101.7; sx lasted thru 1/28/21
Anaphalactic shock, difficulty breathing, facial swelling, eyelids swelling,  tongue swelling,
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of ROTATEQ orally, lot # M040271, expiration date: 30-APR-2018 and lot # M035455, expiration date: 22-APR-2018. No adverse effects were reported. The vaccines were stored for 2 hours and 30 minutes in the temperature between 9 and 25 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012451: US-009507513-1704USA013231: US-009507513-1704USA013229: US-009507513-1704USA013737.
dizziness; incoherent; loss of balance; All common side effects besides nausea and vomiting; fatigue; injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of INCOHERENT (incoherent), BALANCE DISORDER (loss of balance), ADVERSE EVENT (All common side effects besides nausea and vomiting), VACCINATION SITE PAIN (injection site tenderness) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site tenderness). On 14-Jan-2021, the patient experienced INCOHERENT (incoherent), BALANCE DISORDER (loss of balance), ADVERSE EVENT (All common side effects besides nausea and vomiting) and FATIGUE (fatigue). At the time of the report, INCOHERENT (incoherent), BALANCE DISORDER (loss of balance), ADVERSE EVENT (All common side effects besides nausea and vomiting), VACCINATION SITE PAIN (injection site tenderness) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-008002 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
sick; cannot function; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), ASTHENIA (cannot function) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), ASTHENIA (cannot function) and NAUSEA (nausea). At the time of the report, ILLNESS (sick), ASTHENIA (cannot function) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.