chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy case was reported by a healthcare professional (also the subject) and described the occurrence of a cold in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. Concurrent medications included Prenatal vitamins. The subject had previously received flu shots and had a cold within a few days of getting the previous flu shots (details unknown). On 18 October 2011 the subject received a dose of FLULAVAL (1 ml, unknown, left arm), and experienced overdose and vaccine exposure during her first trimester of pregnancy. The subject received a 1 ml dose of FLULAVAL instead of the indicated dose of 0.5 ml. On 21 October 2011, 3 days after vaccination with FLULAVAL, the subject experienced a cold. The cold lasted 7 days. The gestational age at the time of vaccination was not specified. Date of last menstrual period was not provided. The estimated date of delivery was 12 May 2012. On 28 October 2011, the cold was resolved. At the time of the report, the pregnancy was ongoing. Follow-up information was received via the consumer on 19 December 2011. It was reported that the subject's date of last menstrual period was 06 August 2011. Conception was reported to be normal and the pregnancy involved a single fetus. FLULAVAL was administered intramuscularly to the pregnant subject on 18 October 2011, at 10 weeks gestation. The dose of FLULAVAL administered was actually 0.5 ml as opposed to 1.0 ml reported initially. The subject did not receive an overdose of FLULAVAL. Concurrently and starting prior to conception, the subject received pre-natal vitamins and acetaminophen. The cold experienced by the pregnant subject resolved on 28 October 2011 as previously reported. No additional details were provided. Follow-up information was received via a nurse (office manager) on 22 December 2011 and 03 January 2012. It was reported that the conception was normal. The nurse noted that the subject had not been seen in their clinic regarding the FLULAVAL vaccination. She stated that they do not administer this type of flu vaccine. The facility did not have any further information to provide regarding this issue.
Rapid abdominal weight gain and heavy menstrual bleeding that started on or about 4/4/2022 and continued for several weeks then months on and off.  Saw GYN for annual exam and reported symptoms, underwent multiple diagnostics, Ultrasound, biopsy and MRI, and bloodwork.  MRI showed a very large uterine fibroid that would require abdominal hysterectomy (full incision).  Bloodwork showed high Hemoglobin and Hematocrit which led to a diagnosis of secondary polycythemia, which was subsequently attributed to the large myoma and enlarged myomatous uterus.  I had an abdominal hysterectomy on 9/7/2022, and post op testing showed the polycythemia had resolved after removal of the fibroid, uterus and fallopian tubes.
About an hour (5:30pm est) after receiving the first dose of the Pfizer vaccine on my left arm (taken Saturday, March 6th at around 4:30pm est) I started feeling itchy all over my body (neck, stomach, sides, thighs) and it looked like a rash (very red) showing me signs of an allergic reaction. The same thing happened throughout the day on Sunday (March 7th) and the rash would get better and then worsen so it was very on and off throughout my entire body. On Sunday evening after I took 2 Benadryls the rash got worse on my right arm and a small area of my left arm (bubbly-like features appeared). I went to sleep after taking the Benadryl and when I woke up the next morning it was completely gone. Then on Monday (March 8th) I was fine all day no signs of rashes or itching and then around 5pm I felt a burning sensation on my face and when I looked in the mirror both of my cheeks and a small part of my forehead were extremely red. I then took 2 Benadryls again and went to bed. Today (March 9th) I do not have signs of a rash and have not felt itchy all day.
localized swelling in Left neck and  clavical area. Vaccine given in left arm.  Ibuprofin 800 mg q 8 hours for two days
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # reported as L04884, expiry date 04-FEB-2018 (strength, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several cases received from the same reporter. Lot number L04884 is an invalid lot number for RECOMBIVAX HB. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 18-JUN-2015, the patient was vaccinated with MMR II (lot number, status of rHA, expiration date, dose, route of administration and strength were not reported). Concomitant medication was not reported. The reporter stated that the patient received less than the recommended dosage of the vaccine administered. No adverse effects were reported. Follow up information has been received from the Registered Nurse on 27-AUG-2015, concerning a 12 month old (also reported as 14 month old) female patient, with no known pre-existing allergies, birth defects or medical conditions. On 18-JUN-2015 at 11:30, the patient vaccinated with the first dose of MMR II, (lot number reported as 1003859, no expiration date reported) unknown dose, subcutaneous, in the left thigh. On the same date, the patient was also vaccinated with the first doses of VARIVAX (Lot number reported as 1004654, no expiration date reported) unknown dose, subcutaneous, in the left thigh, and HAVRIX (lot number 4235D) intramuscular in the right thigh (dose not reported). The reporter stated that the syringe of the MMR II vaccine was drawn up in a malfunctioned during the administration of the vaccine, so that most of the dose was sprayed outside the patient. The dose was repeated because the patient did not receive most of the first one. Additional information is not expected as all correspondence was received. General, Patient, Product, Event and Narrative were updated.
multiple unspecified patients were administered a dose of improperly stored GARDASIL 9 or ROTATEQ; No adverse symptoms were reported; This spontaneous report was received from a certified medical assistant reporting about multiple patients of unknown age and gender. Information about the patient's medical istory, concurrent conditions or concomitant medications was not reported.     On unknown dates, the patients were vaccinated with a dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # 1621934 and expiration date 29-JAN-2022 (dose, route of administration, and anatomical location were not reported) for prophylaxis.  The patients were also vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot number: S017631, expiration date: 08-DEC-2020 (dose, and anatomical location were not reported). These vaccines were improperly stored at a temperature above 47-degree Fahrenheit for 3 minutes and a temperature below 36-degree Fahrenheit for 5 minutes. These findings were discovered with a digital data logger and the vaccines had previous temperature excursions. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
had cancer; sore throat; suffering from all of the symptoms; body aches and pains; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (had cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (had cancer) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (sore throat), ADVERSE EVENT (suffering from all of the symptoms), MYALGIA (body aches and pains) and PYREXIA (fever). At the time of the report, NEOPLASM MALIGNANT (had cancer), OROPHARYNGEAL PAIN (sore throat), ADVERSE EVENT (suffering from all of the symptoms), MYALGIA (body aches and pains) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Following the second Lymerix shot, I developed severe burning, hypersensitivity, muscular cramping, and joint pain in low-mid back, buttocks, pelvis/perineum, hips, legs, and feet.  These systems have persisted for 4 years at moderate to severe intensity.  This has impacted every aspect of my and my family's lives.  I have seen numerous specialists who have ruled out (through MRI, discogram, nerve conduction, and other tests) a primary neurologic cause.  I have received numerous blood tests.  The ELISA/western blot test for Lyme prior to the vaccine was negative.  However, recent DNA tests for Lyme were positive.  The Lyme specialist I am presently seeing, believes I may have had dormant Lyme prior to vaccination (based on similar problems I had from 1990-1992, which inexplicably went away)and that is was reactivated by the vaccine.
Patient received 2nd Pfizer Bivalent dose at pharmacy 02/08/2023. Pharmacist later found out patient had first Pfizer COVID bivalent at pharmacy on 10/6/22. Patient thought he needed to get a booster every 4 month. Vaccine card was not presented at the time of administration. Patient was advised to report to the pharmacy if adverse effect occurs after vaccination.  No adverse events observed at the time and 15 minutes after injection.
chest painful; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "chest painful".  Additional information: Nurse mentioned her daughter started to experience chest painful after having received comirnaty.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-MAR-2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided) The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Patient recieved 2nd dose and experienced dizzyness , face became pale and diaphcretic EMS was called patient quickly recovered.
Pt had headache for 3 days and had arm sweeling and pain for 5 days from the injection site all the way down to the elbow.
1/16/08 Patient reports wideapread joint and muscle pain.  Upper left arm was swollen, with a red rash and warm to touch. Entire left arm was painful. 1/17/08 Left arm continued to swell and swelling spread into axilla. Pain in joints and muscles continued and patient generally did not feel well. 1/18/08 General aches and pain was less. Left arm rash continued to spread to above left shoulder and extended to above elbow. A firm lump the size of a "golf ball" developed in the left axilla. The swelling continued into the left breast. The left arm remained very painful. 1/19/08 The swelling and rash started to diminish.  1/22/08 Almost completely resolved.
Fever over 102 that did not respond to Tylenol or Motrin. Remained with elevated temperature until the next morning.
I woke up around 100 am on 5/3/21 and my whole body was shaking and I was cold. I took a pain reliever. The next day I had brain fog and was very achy throughout the day. This lasted for about 36 hours. My left armpit was very sore for about a week.
5 minutes of administration pts left arm above elbow red and warm to touch, redness extending around injection site and extending to above elbow. Red blotchy pattern to entire LUE. No other reaction. Benadryl IM given. Redness resolving. Benadryl given for home use.
Chills; Fever; Sinus congestion; headache; Very tired; Could not lift up arm; Arm pain up to shoulder and neck / Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired), CHILLS (Chills), PYREXIA (Fever), SINUS CONGESTION (Sinus congestion) and LIMB DISCOMFORT (Could not lift up arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Fever.    The patient's past medical history included No adverse event. Concomitant products included LORATADINE, FEXOFENADINE, MONTELUKAST, CETIRIZINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) 500 milligram. On 20-Mar-2021, the patient experienced FATIGUE (Very tired), LIMB DISCOMFORT (Could not lift up arm) and PAIN IN EXTREMITY (Arm pain up to shoulder and neck / Arm pain). On 21-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), SINUS CONGESTION (Sinus congestion) and HEADACHE (headache). At the time of the report, FATIGUE (Very tired), CHILLS (Chills), PYREXIA (Fever), SINUS CONGESTION (Sinus congestion), LIMB DISCOMFORT (Could not lift up arm), PAIN IN EXTREMITY (Arm pain up to shoulder and neck / Arm pain) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 99 (High) 99 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
HEAVY CONTINUOUS MENSTRUAL BLEEDING, CRAMPING, BLOOD CLOTS, ABDOMINAL PAIN
Experienced low grade fevers for days after vaccine and experience a high fevers (105) several days after vaccine.
experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, 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 HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-592989, MOD-2022-593014 (Patient Link).
My menstration paused for 3 months following vaccination; This is a spontaneous report from a non-contactable nurse, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and shellfish allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date, the patient's menstruation paused for 3 months following vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstruation paused for 3 months following vaccination was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had a seizure (with a fever of 100.5F) approximately 4 hours after receiving MMR and Varicella. I am unsure of the site of injection or the brand of the vaccination I just saw him in the emergency department.
LEFT ARM BURNING SENSATION, SLIGHT SWELLING & EXTREME PAIN ON GOING, ACTIVE FROM 04/01/2021 - PRESENT DATE.
morning after both dose 1 and dose 2 I had a brief nose bleed when I blew my nose after waking up. It stopped immediately both times.
diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 21Jun2022, outcome "recovered" (Jun2022), described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient had breakthrough covid infection despite previous vaccination with both Moderna vaccines. Patient had runny nose and sore throat
Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 4/8/2021. Covid + 1/18/22. Presented to ED on 1/22/22 after falling out of bed and found down without oxygen. Admitted for acute hypoxemic respiratory failure 2/2 Covid PNA c/b elevated LFT, trop, BNP and elevated CK. Placed on 6L NC O2. Hypoxia worsened throughout admission.  Treated with paxlovid, solumedrol, remdesivir. Transitioned to comfort care. Patient expired 1/31/22.
It was reported that prior to vaccination, the pt was asked by the health care provider if she was pregnant or planned to get pregnant and the woman said no. The pt's husband later told the health care provider that the woman was pregnant, but hadn't wanted to say so in front of the other children. A pregnancy test was done which confirmed she was 4-8 weeks pregnant. The woman made an appointment with her ob/gyn for two weeks later. When the woman arrived at the doctors office, she was spotting and she miscarried. A D&C was done. No further information was available.
Patient came to the pharmacy and showed us a red upper arm, and said that immediately after the vaccine she had pain, redness, and itching where the vaccine was given. The arm had some redness and she said she applied benadryl cream to it and that helped the itchiness.
This is an initial spontaneous report from a Pfizer sales representative for a contactable physician who reported for a patient. This 70 year old, female patient received PREVNAR 13 on an unknown date at an unknown dose and frequency for an unknown indication. Relevant medical history and relevant concomitant medication was unknown. The patient experienced a hard red 2 inch long bump, pain and swelling at the site of injection while being on PREVNAR 13 on 18Nov2013. Relevant laboratory tests were unknown. Status of PREVNAR 13 therapy was unknown. Therapeutic measures taken in response to the events were unknown. Clinical outcome of the reported events was unknown. Follow-up (24Dec2013): Follow-up attempts completed. No further information expected.
palpitations, itching/ tingling in throat within 1-2 minutes after receiving first dose of vaccine.
Fever to 104F, 8 hours, post vax. Pt had fussiness and mother reports fever to 103F, immediately after as well as on 1/18/01.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Contact had received 1st dose of the Moderna COVID-19 vaccines in July. He has not received a second dose at this point in December.) and NO ADVERSE EVENT (No adverse event) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Contact had received 1st dose of the Moderna COVID-19 vaccines in July. He has not received a second dose at this point in December.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Contact had received 1st dose of the Moderna COVID-19 vaccines in July. He has not received a second dose at this point in December.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant product reported by reporter. No treatment medication reported by reporter.   Reporter did not allow further contact
Severe arm pain, sick to stomach, chills, could not sleep first night do to pain. I had limited ability to raise my arm for three days after receiving,
pt had fever 103 2hrs p/vax given lasted for 3 days; mom gave APAP q 4-6 hrs for the fever;lt leg was sore & limp for 2 1/2 days; father has hx of febrile szs as a youth