chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with breast cancer; Flu like symptoms; Body Ache; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, METFORMIN, EZETIMIBE (ZETIA), CALCITRIOL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Surgery (Double Mastectomy) for Breast cancer. At the time of the report, BREAST CANCER (Diagnosed with breast cancer), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information in response to events was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded.  Although a temporal association exists, based on the current available information ,  the mechanism of action of mRNA-1237 vaccine,  and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.   This case was linked to MOD-2021-227876 (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 of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded. Although a temporal association exists, based on the current available information ,  the mechanism of action of mRNA-1237 vaccine,  and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.
given the wrong dosage. Given 0.25cc and it should have been 0.5cc
The pt experienced Varicella vaccine failure. Was vaccinated in 1996 and was seen in the office with approx 30 spots, red based, fluid filled first appearing on 6/3/01.
I was sitting at my work computer and I experienced a vertigo sensation which lasted for 10 min.  Next, I had tunnel vision with a bright light where I couldn't read the words on my computer screen.  This lasted for about 20 min.  Next, I saw Kaleidoscopic vision on the sides of both of my eyes.  This lasted for 1/2 hour more.  It then turned into a headache.  I have NEVER had anything like this in my life and went to the emergency room. They did a CT scan and found no abnormal findings.  My blood pressure and all labs were normal.  They stated it was "probably" a migraine with aura.  It happened again 2 days later and again yesterday.  I have an appointment to see my GP on 5/6/21.  Again, this is not normal and has never happened before in my life.
The immunocompromised patient received the booster dose which was half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The immunocompromised patient received the booster dose which was half dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient had since started long term steroid use.).   On an unknown date, the patient received third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (The immunocompromised patient received the booster dose which was half dose). At the time of the report, UNDERDOSE (The immunocompromised patient received the booster dose which was half dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient mentioned to pharmacist that since started long term steroid use, patient became  immunocompromised. Few months since the booster dose, but pharmacist wondered if the patient qualified for any additional doses and whether it would be a half or full dose. No treatment information was provided.
Painful injection site - during injections and immediately following. aches, chills, flu-like feeling for 2-3 days following injection. Red, achy, painful injection site requiring pain medication, ice, and topical treatment.  Movement restricted in left arm for several days.
High fever, red eyes, swollen eyes, runny nose, cough, rash covering entire face, ears, arms, chest, and back. Some on legs.
Mother noticed redness and blotchiness to his face last night but he was ???, so nothing else was noticed on face. This morning he had extended areas of swelling to his hands, chest, back. Now 7 hours later, he has blotchy swelling to his arms, neck, legs, He says it does not itch.
Shingles developed almost a week after the 2nd dose was administered. PA thought it could be related to the vaccine and that the immune system was preoccupied with the vaccine.
Client started to complain of stomach pain, shakes, nausea, diarrhea, difficulty breathing few hours after the vaccine administration. She went to the Local Hospital Emergency room on the same night. Client felt weakness for 2 days after the vaccine administration.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 14-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The next day after getting the vaccination - client developed high fever up to 102 degrees Farenheit and L deltoid became swollen, red and very hot to touch. Mom gave her Motrin and fever only last for 1 day. Soreness last 2-3 days and child able to go to school. 9/3/13 Tuesday of follow up call today and Mom verbalized she is doing great!
Swollen and painful right arm, low grade fever 8-30-17 BENADRYL ordered, ice, elevation, acetaminophen seen by NP on 8/30/17and Dr. 8/31/17 Res reports improvement "No pain" 9/5/17, decreased swelling noted.
weak; achy; slight headache; Minor chills; This is a spontaneous report from a contactable other healthcare professional (HCP). An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at Left arm on 06Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal and to nickle (metal) allergy. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's Historical Vaccine included first dose of BNT162B2 in Dec2020 for covid-19 immunization. Patient felt fine immediately after the day 21 shot (second dose). One day after the day 21 shot on 07Jan2021, patient reported weak, achy, and slight headache. Minor chills were also reported. It was unknown if patient received treatment for the events. The outcome of the events was unknown. Information about batch/lot number was requested.
5min after leaving facility , pt felt lightheaded and dizzy.  Returned to entrance door and vitals signs checked by Paramedics (all normal) Observed and questioned for 15 min and started ambulating with no further symptoms. ambulated for 15 min and discharged to home
Expired Product Used; 63 y/o patient was given Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included stem cell transplant.   On 14th February 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and off label use. On an unknown date, the outcome of the expired vaccine used and off label use 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 details were provided as follows: The patient was administered a dose of Infanrix vaccine which was expired on 06th February 2022, which led to expired vaccine used. At the time of reporting, the patient had not been re dosed. Reporter stated that, they were aware the use of Infanrix in patient this age was off label, which led to off label use.  The patient was ordered to receive the series because they underwent stem cell transplant.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026699:Same reporter. FU1 - deleted.
I was very dizzy for almost a week. I was throwing up and had diarrhea  and low grade temp. My head felt numb and tingling.  I could barley get off the couch. I went to the Dr., they didn't know if it was from the shot or was having a sinus infection, they gave me an antibiotic and that's all they did. The symptoms lasted about a couple weeks.
Given DTAP/IPV/HIB/PREVNAR on 07/31/2003.  Mom noticed on right thigh red areas around both immunization sites.  Size of 50 cent piece.  Other size of small pencil eraser.  No temperature.
Uncontrollable shivering at 1:45 am following morning. Sat up with my wife and moved to the living room. Went unresponsive while sitting on couch for 45 seconds making a gurgling sound. I was disoriented when coming to and couldn?t hear. I went to the Er to be looked at and had a slightly abnormal ekg but felt comfortable discharging me even though my heart felt like it was squeezing.  I have since been dealing with more and more symptoms. Pain and numbness., shortness of breath, chronic pain, skin inflammation , palpitations, heart squeezing,  headaches, muscle weakness, facial numbness and pain, neurological symptoms  in limbs.
Injection site inflammation. Injection site redness. Injection site swelling. From initial information received on 24/Mar/2003 from physician's office regarding an adverse event occurring in the USA, it was reported that a 5-year old male patient received DAPTACEL, lot number C1245AA, given intra-muscular in the right buttock, IPOL, lot number W0625, given in the left buttock and MMR, MSD manufacturer, lot number 0530M, given i the right buttock on 26-mar-2003. The following day patient developed a large local reaction of redness and swelling. The patient was seen at doctor's office and was treated with antibiotics and steroids. Reportedly, it is unknown if the patient recovered from these events. The reporter of this case is the same reporter for case 2003-00480.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No medical history or drug allergies/reactions were reported. The healthcare worker reported that the patient was administered on an unspecified date in April 2012, the first dose of GARDASIL (lot #, dose and route not provided), then the patient received the second dose on an unspecified date in October 2012 of GARDASIL (lot #, dose and route not provided); and then the patient was in the physician's office on 14-AUG-2013, to received the third dose of GARDASIL (lot #, dose and route not reported). No adverse effect was reported. Additional information has been requested.
She is not feeling well; She is feeling sore throat; I take her temperature; her temperature go around, 99.86 degree Fahrenheit 47.7 Celsius; She feel little pain in the arm; She has pain in all over body; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on an unspecified date (at the age of 75-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced not feeling well, sore throat, temperature go around, 99.86-degree Fahrenheit 47.7 Celsius, little pain in the arm. On 29Mar2021, the patient experienced pain in all over body. It was reported that My mom to take this second dose of vaccine on Sunday and since yesterday she is not feeling well and today I take her temperature, she is feeling sore throat and her temperature go around, 99.86 degree Fahrenheit 47.7 Celsius. I need to know what to it, it could be some reaction from the vaccine. She starts not feeling well since yesterday, she has pain in all over body 29Mar2021.yesterday she feel pain in whole body. The patient underwent lab tests and procedures which included body temperature: 99.86 dg on an unknown date.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
(R) arm red swollen and hard at site where varicella was given when she got up 07/22 called clinic and told her to take BENADRYL 25-50 mg po. 7/23 symptoms worse and rash on upper legs, to clinic and had KENALOG IM and resolved.
Patient was administered a (2nd second) dose of AFLURIA. No adverse reaction noted as of today. Patient informal to report any abnormal symptoms. Presented to the office for another vaccine at the time.
Vaccine is believed to have triggered my severe and chronic case of Lyme disease. I've been sick for 1 1/2 years. Symptoms include; sleep disorder, headaches, fatigue, nausea, neck and shoulder pain, depression and anxiety.
Rash all over face and body, extremely itchy and hot. Swollen lymph nodes. Burning eyes
Severe Diarrhea, anything I ingest, water, food, is expelled within 25 mins. Severe abdominal cramping as well. Hot and cold sweats, extreme lethargy, metalic taste in mouth, cognitive delay, trouble focusing, short term memory recall
pt says after getting the vax he developed pain in left arm in the muscle at the injection site.  Pt says the pain has been lingering every since he got the vaccine.  He used his arm some and said it seem to aggravate the pain.  H he is still having pain to this day in the muscle at the injection site.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiry date were not reported) for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009621: US-009507513-1612USA008828: US-009507513-1612USA009620.
Started to feel dizzy about 9 hours after the injection.  Went to bed.  Woke up 8 hours later with an extreme headache 9/10 and nausea.  Took 325 Tylenol and brought the pain down to a 7/10.  Slept for a couple of hours and woke up with a headache at a 7/10 - took 650 mg Tyleno, drank some Focus Aid and ate some veggie straws.  After about 1/2 hour the headache was down to a 4/10,
pt devel inj site rxn of redness,swelling & itching p/vax.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/23/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-10 and he does not plan on getting revaccinated.
Pt's right thigh was swollen with redness and feels hot X 1 day.
KNOCKED OUT; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, fever and was knocked out for 12 hours straight after first J and J vaccine. (Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and knocked out was not reported. This report was non-serious. This case, involving the same patient is linked to 20211227884 (Dose number in series 2 case).
SWELLING OF LEFT ARM NEAR INJECTION SITE, 1 1/2'' IN WIDTH, REDNESS, PT.'S SYMPTOMS RESOLVED
Left-sided pre-auricular swelling,  submandibular swelling. Not witnessed in clinic.
a fever of 103 degrees; second dose on 05Jan2021; Strong headache on the left side/Strong headache but stronger on the forehead area; chills; overall body aches; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 17Dec2020 at a single dose, and then second dose (lot number: EL3246, expiry date not reported), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medications were not reported. The patient had not been tested for COVID-19 since the vaccination. On 18Dec2020, the patient had a strong headache on the left side, chills and overall body aches. On 05Jan2021, the patient had a strong headache but stronger on the forehead area, body aches, chills and on 05Jan2021, a fever of 103 degrees. This time the patient could not go to work due to these symptoms. No therapeutic measure was taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 103  on 05Jan2021, sars-cov-2 test: positive on 2020 prior to vaccination. Clinical outcome of chills and pain was recovered on an unspecified date while for the other events was recovering.
No other AE/PQC identified; expired dose of MMR administered; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not provided.  On 20-JAN-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters intramuscular route, Lot number S001322 and expiration date 14-JAN-2021 as prophylaxis.  Lot number S001322 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) does not match any company product as confirmed by lot verification team.
pt recv vax 3DEC96 & 24APR97 pt devel lesions & a fever of 101-102;pt described as being loaded w/lesions & the pt mom reported that they were all over;
Slight soreness of arm.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 04Mar2021 at 15:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had no known allergies to medications, food, or other products. The patient had received other medication within two weeks of vaccination for unknown indication from unknown date, which were not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 (also reported as at 00:00) the patient experienced slight soreness of arm and nothing else. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event slight soreness of arm was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Pt who reportedly completed second dose of vaccine in May was admitted for acute respiratory failure to the ICU. He tested positive for Covid-19 by PCR on 7/30/2021. At the time of reporting, patient remains tenuous in the ICU on BiPAP with the potential to deteriorate to intubation over the next 48 hours. Report is being submitted per recommendation of Dept of Health as it represents a breakthrough case with ICU level care.
Case number PHEH2014US022003 is an initial spontaneous report received from a health care professional on 31 Oct 2014. This report refers to a 54 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
On 12/30, patient began with acute onset abnormal chorea movements. Working diagnosis is acute rheumatic fever with Syndenham's chorea. Full evaluation is pending (eg. echo and MRI). Waxing and waning course with continued abnormal movements.