chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cromophobe renal carcinoma; cancerous tumor; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CANCER (cromophobe renal carcinoma) and NEOPLASM MALIGNANT (cancerous tumor) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced RENAL CANCER (cromophobe renal carcinoma) (seriousness criterion medically significant) and NEOPLASM MALIGNANT (cancerous tumor) (seriousness criterion medically significant). The patient was treated with Surgery for Renal cancer and Surgery for Neoplasm malignant. At the time of the report, RENAL CANCER (cromophobe renal carcinoma) and NEOPLASM MALIGNANT (cancerous tumor) outcome was unknown.            No concomitant medication was mentioned.  On May2021 patient was diagnosed with a cancerous tumor, cromophobe renal carcinoma, and had a surgical removal of it as treatment.  Company comment -This case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected event of Renal cancer and Neoplasm malignant. The events occurred on an unknown day in May, 2021 after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected event of Renal cancer and Neoplasm malignant. The events occurred on an unknown day in May, 2021 after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
The patient fell and hurt his elbow while in the store. He reported feeling light-headed. At 1:14 pm, an ambulance arrived and the patient was taken out of the store on a gurney.
WIFE OF PATIENT CAME IN TO PHARMACY AND SAID PATIENT WAS ADMITTED IN HOSPITAL DUE TO COVID
rapid heart beat all day long; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (rapid heart beat all day long) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HEART RATE ABNORMAL (rapid heart beat all day long). At the time of the report, HEART RATE ABNORMAL (rapid heart beat all day long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
He got his vaccine, he sat down for 20 minutes, he felt OK, went to his car and sat in his car and started feeling dizzy headed.  He felt like a panic attack, and felt uneasy driving.  He got home and sat for a while and noticed that his body was getting sore, and felt like he had the COVID virus and felt fatigued, joint pain that was worsening.  He did not have a fever and then had diarrhea and vomiting that lasted for a week.  He called an center after he talked to his doctor the first time, and they told him that he had to hang in there as 20-25% of their patient's were from the vaccine and that it would go away in a couple of weeks or so.   He possibly was exposed to COVID from somebody working in his house.   He took Ibuprofen for pain and soreness.  He is still having the fatigue and brain fog and sometimes can't get his words together.  He works part-time and is not able to do so at this point as a substitute teacher.    The symptoms are getting better, but he is still not back to his normal self.    He has lost a lot of coordination at this time, was an athlete and gets out of breathe walking 50 yards to his mailbox.
thought she was having a heart attack; cramping in abdominal area; finger went blue; sweating; chest pain/pain in chest; pressure near breast; back cramping/severe cramping; left pupil dilated; arm went numb; turned pale; Veins popping out of skin; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable consumer (patient) reported that an adult female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as 1 st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 48 hours after first dose of bnt162b2 (unspecified date), the patient felt side effects of cramping in abdominal area, finger went blue, sweating, chest pain and pressure near breast (has been receiving episodes of this pressure and pain for a week after dose), back cramping and left pupil dilated. Stated that side effects were only for left side of body, none on the right. Also reported pain in chest, arm went numb, sweating, turned pale, thought she was having a heart attack and left pupil larger, severe cramping and veins popping out of skin. The patient was supposed to get 2 nd vaccine yesterday wanted to know what to do. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/2/2023 &  2/4/2023  --  RECURRENCE OF SAME SYMPTOMS
Patient complained to his mother about 10 minutes after his shot that his vision was blurry  and he was having trouble seeing. Patient then became dizzy, light-headed, pale and then vomited. EMS was contacted and came to the pharmacy to check the patient out. Patient was found to have low blood pressure and remained pale. After about 10 minutes patient began to feel better and went home with his mother. I called his mother about 2 hours later and she said he was doing  fine and playing video games online with his friends.
hard above elbow in afternoon;denies redness, warmth;pain increased in evening radiating to back & neck;ER visit 10PM;
Whole upper arm was red, sore and itchy; Whole upper arm was red, sore and itchy; Reaction site was very hot; Whole upper arm was red, sore and itchy; Developed a fairly large rash on her arm where the vaccine was given; Slept all day/ slept for many hours; Running a temp of 100.5 F; dizzy; nauseated; Major headache; Metallic taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), HYPERSOMNIA (Slept all day/ slept for many hours), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy) and PAIN (Whole upper arm was red, sore and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015MC0A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  No treatment information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated). On 05-Mar-2021, the patient experienced HYPERSOMNIA (Slept all day/ slept for many hours). On 06-Mar-2021, the patient experienced PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given). On 05-Mar-2021, HYPERSOMNIA (Slept all day/ slept for many hours) had resolved. On 06-Mar-2021, DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given) outcome was unknown.
Took influenza at 130pm. At 6:00pm (R) eye began to itch & lower lid with lg amt of swelling. Took BENADRYL & 30 min later took another BENADRYL. Applied ice & 2 hrs swelling decreased some. BENADRYL repeated at 2am. Swelling cont to decrease next day. Eats eggs routinely.
no adverse event; Administered vaccine to a patient on 11JUN2023 after the published expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 27-DEC-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection (HSA; lot # M000768 expiration date: 05-JAN-2018; dose and route of administration were not provided). Administered dose of vaccine was exposed to the temperature excursion of 9.4 degrees Celsius for 1 hour and 30 minutes on an unspecified date. A digital data logger was involved. There were no previous excursions reported. There was no product quality complaint involved. Additional information has been requested.
Received FLU shot while at work, 10 minutes after receiving shot she started itching, skin got red, and she was sweating profusely.  Taken to ER for evaluation.
The day after the vaccine, I experienced fever, chills, nausea and fatigue.  Symptoms continued for 12 days.  Fever ranged from 100.2 to 102.3.  On Day 12 went to Urgent Care.  Chest x-ray showed atypical pneumonia in both lungs, similar to covid pattern of pneumonia.  Was admitted to hospital for 5 days on IV antibiotics.  Tested 3 times for covid, all negative.  I never had a bad cough or mucus or chest pain.
03/25/2010 - redness below area where vaccine was injected - somewhat larger than a dollar coin - soreness, swelling, itching.  03/26/2010 - Area of swelling around initial area of swelling was twice the size.  However, this area had a pinkish color rather than a deep red color and the swelling was less obvious. The itching and general discomfort became more of a problem.  03/28/2020 - There are signs of moderate improvement.
Initial report received on 31 January 2008 from an investigator participating in the above-mentioned trial. An 11-month-old male subject, with concurrent illnesses of respiratory Syncytial virus symptoms, developed meningitis and was hospitalized 63 days after receiving a first, intramuscular, right thigh injection of Menactra (Lot number U2172AA) on 27 November 2007. Per the mother, on 29 January 2008, i.e., 63 days after receiving the study vaccine, the subject was taken to the pediatricians office for persistent symptoms post respiratory Syncytial virus diagnosis. The primary care physician admitted the subject to the hospital the same day, after results of laboratory work revealed elevated white blood cell count. A lumbar puncture test revealed the subject had meningitis. At the time of the report, the subject was being treated for the meningitis. The subject's continuation status in the trial was not provided. The investigator considered the event of meningitis as life threatening. According to the investigator, the event of meningitis was related to the study vaccine.  2/11/08 Received via email from manufacturer: This subject has another SAE of Respiratory Syncytial Virus on 26 January 2008 reported in case 2008-00317.  This case was reported in an 11-month-old MTA37 study participant (site #009 ; subject #00031), with a 4-day history of RSV infection.  We did contact the site and requested the investigator to provide further information.  The study coordinator explained that they have not received any document from the hospital yet. She has spoken with the attending physician who explained that they couldn't get cerebrospinal fluid because apparently the epidural space was full of pus.  She also mentioned that the child was being considered as having MRSA but was not sure from where.  The site will contact us and will send any follow-up information as soon as they receive them.  2/29/08 Received via email from manufacturer: Follow-up information was received from the investigator.  The diagnosis was amended from 'Meningitis'  to 'Methicillin Resistant Staphylococcus aureus' infection and the causal relationship was also reassessed by the investigator as unrelated.   No hospital records, however, were available at the time of this follow-up report.  Further information is being requested.
Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Beyond 35 days for 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first 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, the patient experienced PRODUCT DOSE OMISSION ISSUE (Beyond 35 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Beyond 35 days for 2nd dose) had resolved.            It was also reported that the patient has taken the second dose and had no issues  Concomitant medication information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up received contained: Updated second dose; No AE experienced - Confirmation;
portion of the medication came out of the syringe; VACCINE UNDERDOSE; A spontaneous report  received from a health care professional concerning a 37 years old male patient who received Moderna's COVID-19 (mRNA-1273)vaccine and experienced device connection issue and vaccination under dose.  The medical history of the patient was not provided. No relevant concomitant medication were provided.  On  17-feb-2021 prior to onset of the event, the patient received the first of two planned doses of COVID-19 (mRNA-1273)vaccine (batch no.023M20A) via unknown route in left non-dominant arm for prophylaxis of COVID-19 infection.  The pharmacist reported  that a portion of the medication came out of the syringe.  Action taken in response to  (mRNA-1273) vaccine event  was not reported.  The outcome of event was not reported.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Information has been received from a physician concerning a female in her 60's who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not known). Subsequently the patient developed a " zoster like rash" on the palm of  her hand up to her arm. The patient sought medical attention by visiting the physician's office. At the time of reporting the patient was not recovered. Additional information has been requested.
Began as a red rash on forearms. Progressed to lips swelling and shortness of breathe.
Pt recv vax on 10/22/98; on same day pt exp hardness at vax site size of baseball, hot, itchy for 1 hr; treatment=ice.
Fatigue, chills, fever, muscle aches, headache, extreme soreness at injection site.  Symptoms began around 4:30 AM and subsided around 12:00 PM
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LINZESS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received vaccine. The patient did not have any known allergies. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 21Jul2022, treatment stop date: 25Jul2022, indication: Treatment of COVID-19. Adverse event: When I took Paxlovid I had a metal taste the entire time in my mouth. Adverse events start date: 21Jul2022.The patient did not receive any treatment for ae.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT SHOULD HAVE RECEIVED THE PRIMARY SERIES PFIZER NOT THE BIVALENT BOOSTER BECAUSE THIS WAS HER FIRST DOSE.
Vertigo; numb and tingling lips; numb and tingling lips; headache; chills; fever 101; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 64 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injec-tion; Lot Number: ER8732) via an unspecified route of administration, administered in Left Arm on 27Mar2021 at 15:00 (64-year-old at vaccination) as dose 2, single for COVID-19 immunization. The patient was non-pregnant at vaccination. The patient's medical history included hypothyroidism, eczema, psoriasis, shellfish allergy, known allergies to IV contrast. Past drug included Celclor, Doxycycline, patient was allergic to both the past drugs. The patient's concomitant medication(s) included levothyroxine sodium; amitriptyline; ALLEGRA; ADVIL. Facility where the most recent COVID-19 vaccine was administered was reported at facility. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Left Arm on 06Mar2021 at 15:00 (64-year-old at vaccination) as dose 1, single for covid-19 immunization. On 27Mar2021, the patient experienced numb and tingling lips, headache, chills, fever 101, and all resolved after 1 day, vertigo lasted 5 days and had returned on 28Apr2021. The patient underwent lab tests and procedures which included body temperature of 101 on 27Mar2021. The patient had not received any treatment medication for the resulted events. Device date was reported as 28Apr2021. The outcome 2nd occurrence of vertigo was unknown, while outcome of other events was recovered on 28Apr2021.  No follow-up attempts are needed. No further information was expected.
Pain in arm; headaches; tiredness; Fogginess; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52 year-old patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "unknown", described as "Pain in arm"; HEADACHE (non-serious) with onset 24Mar2021, outcome "unknown", described as "headaches"; FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "tiredness"; FEELING ABNORMAL (non-serious) with onset 24Mar2021, outcome "unknown", described as "Fogginess".  Follow-up attempts completed. No further information expected. Information about lot/batch number cannot be obtained.
No additional adverse effects were reported; The patient received both PROQUAD and VARIVAX; This spontaneous report was received from a medical assistant concerning to a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 08-JUN-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot# S030205, expiration date 25-MAR-2021 (dose, frequency and route were not provided); and with varicella virus vaccine live (oka/merck)(VARIVAX) lot# S025910, expiration date 20-AUG-2021 (dose, frequency and route were not provided), both administered for prophylaxis (inappropriate schedule of product administration). The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effects were reported.
Extremely emotional going from crying to laughing/anger outbursts/refusal of eating periodically/flat affect/unable to get her emotions under control/extreme sweats