chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Yesterday I got the first dose and today at wakeup I felt runny nose; blood on both nosetrils; Blood in my urine; My period came early by 10 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 14:00 (Batch/Lot Number: EP6955) as dose 1, single (at the age of 48-year-old) for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Graves' disease, hypertension and anxiety from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other products. Concomitant medications (other medications received within 2 weeks of vaccination) included celecoxib (CELEXA), meloxicam and famotidine all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated yesterday she got the first dose and today at wake up she felt runny nose, but it was blood on both nostrils and blood in her urine on 19Mar2021 at 02:00 AM and she went to the bathroom and noticed that her period came early by 10 days on 19Mar2021. Since the vaccination, the patient has not tested for COVID-19. No treatment received for the adverse events. The outcome of events was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Tiredness and shortness of breath, heart palpitations, and severe headaches. vertigo Excessive sweating with minimal exertion Also sweat smells extra bad. has since progressed into swelling and stiffness of both ankles and severe itching. Family doctor tested heart and lungs and a serious of blood test and found nothing. Was evaluated for POTS but a blood test revealed that I had PBC which is an autoimmune disease of the liver. For all intent and purpose this vacine has killed me but I'm forced to suffer
Joint pain, Onset on 3/1721 - mild. Increases on 3/18 and 19th.
Pt found unresponsive by baby sitter on 7/17/01. He was taken to ER and pronounced DOA. Unknown reason for death at this time.  COD as per autopsy report-- undeterminable
Dose adminstered to patient 1 day after 70 days of best use date once transfer into refrigerator. (gray caps)
I felt like I had the flu, I also had tingling , hand pain. and  2 days  later I had breathing problems.
This is a spontaneous report from a contactable consumer reporting for herself. This 22-year-old female patient received the first single dose of TRUMENBA intramuscular in the right arm on 05MAR2015 at 02:30 PM against diphtheria meningitis which was going around the campus that she was attending. The patient had not any other relevant conditions and hse had not received any concomitant medications. No other vaccine was administered in the previous eight weeks. On 05MAR2015 she had soreness at the injection site, on an unspecified date in MAR2015 (unknown if on 05MAR2015 or 06MAR2015) she experienced tiredness, on 06MAR2015 at 11 AM chills appeared, at 12 she had soreness stomach, a bad stomach ache and at an unknown time she experienced soreness on lower back, thighs and other arm. Due to the reported events, the patient did not visit medical doctor or emergency room. No relevant tests were performed. The patient did not recover from the reported events at the time of this report. Follow-up (15APR2015): Follow-up attempts completed.  No further information expected.
Large, raised, red patch on skin of left arm, above inside of elbow to armpit approximately 4" x 4" itches intensely, responded to use of CBD infused body butter cream, has lasted since 03/16/2021, and continues with improvement each day, but still present.
Trigger jChildhood Asthma; Loss of Muscle Control and Mass; Loss of Muscle Control and Mass; Brain Fog; Fatigue; constant balance and inner ear; Fatigue and constant balance and inner ear; sleeps 18 hours day; Memory loss; Blurred Vision; Weakness in Extremities; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FA7984) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Childhood Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ASTHMA (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Trigger jChildhood Asthma"; MUSCLE DISORDER (non-serious), MUSCLE MASS (non-serious) all with onset 10Aug2021, outcome "not recovered" and all described as "Loss of Muscle Control and Mass"; FEELING ABNORMAL (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Brain Fog"; FATIGUE (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Fatigue"; BALANCE DISORDER (non-serious) with onset 10Aug2021, outcome "not recovered", described as "constant balance and inner ear"; INNER EAR DISORDER (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Fatigue and constant balance and inner ear"; SOMNOLENCE (non-serious) with onset 10Aug2021, outcome "not recovered", described as "sleeps 18 hours day"; AMNESIA (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Memory loss"; VISION BLURRED (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Blurred Vision"; MUSCULAR WEAKNESS (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Weakness in Extremities". The events "trigger jchildhood asthma", "loss of muscle control and mass", "loss of muscle control and mass", "brain fog", "fatigue", "constant balance and inner ear", "fatigue and constant balance and inner ear", "sleeps 18 hours day", "memory loss", "blurred vision" and "weakness in extremities" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthma, muscle disorder, muscle mass, feeling abnormal, fatigue, balance disorder, inner ear disorder, somnolence, amnesia, vision blurred, muscular weakness.  Additional Information: Vaccine administration time was reported as 04:00 PM. Prior vaccination within 4 weeks and other medications in two weeks was reported as none. The patient did not had COVID prior vaccination. Patient did not have covid prior vaccination and has been tested for covid post vaccination. Facility type Vaccine was reported as pharmacy or drug store. AE resulted in: doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 1/5/99; on 1/16/99 pt exp maculopapular rash on trunk, occipital area & forehead
My chest is achy; my abdomen is achy; my lungs are achy; I have foggy brain; I have a headache; I was super exhausted; random deep body pains, they would come & rapidly disappeared; body aches; sweating/sweating profusely; weakness; Difficulty sleeping; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy) and ABDOMINAL PAIN (my abdomen is achy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). On 11-May-2021, the patient experienced HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness) and INSOMNIA (Difficulty sleeping). On 12-May-2021, the patient experienced PAIN (random deep body pains, they would come & rapidly disappeared) and MYALGIA (body aches). On 13-May-2021, the patient experienced FATIGUE (I was super exhausted). On 14-May-2021, the patient experienced CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain) and HEADACHE (I have a headache). At the time of the report, HYPERHIDROSIS (sweating/sweating profusely), ASTHENIA (weakness), INSOMNIA (Difficulty sleeping), CHEST PAIN (My chest is achy), ABDOMINAL PAIN (my abdomen is achy), PULMONARY PAIN (my lungs are achy), FEELING ABNORMAL (I have foggy brain), PAIN (random deep body pains, they would come & rapidly disappeared), MYALGIA (body aches), FATIGUE (I was super exhausted), HEADACHE (I have a headache) and VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.            Action taken with response to the events were not applicable. No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-132103 (Patient Link).
Information has been received from a physician who is the husband of a 78 year old female with a medical history of high blood pressure and several heart attacks who in 1998 and on 10/29/03 was vaccinated with a first and (second dose in the left upper arm) of pneumococcal 23v polysaccharide vaccine, respectively. It was noted that with the first vaccine she had no adverse symptoms. Concomitant therapy included blood pressure, nadolol, captopril, hormones, clopidogrel bisulfate, vitamins, clonidine and lysonopril. On 10/29/03, within 2 hours, the patient developed pain, slight swelling and decreased range of motion in the shoulder. On 10/30/03, the next day, the patient had severe pain described as continues with a knot of pain in the site and increased swelling. She was started on an unnamed steroid and has had physical therapy for 8 or 9 days for the symptoms. At this time she is using heat to the area and continuing physical therapy. It was noted that she did not receive physical therapy prior to this event. An x-ray of the shoulder was negative for bursitis or calcifications of the shoulder. It was also noted that the doctor received the pneumococcal 23v polysaccharide vaccine from the same vial as the patient and had no adverse symptoms. The physician feels that the joint lining may be inflamed from the injection placed into the synovium rather than the deltoid. Medical attention was sought. There was no product quality complaint involved. Upon internal review the severe pain, decreased range of motion in the shoulder and increased swelling were considered other important medical events (OMIC). Additional information has been requested.
27MAR2021 had heart attack; This is a spontaneous report from a support program, received from a contactable consumer. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 18Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that received first dose on 18Mar2021, scheduled to receive second dose on 08Apr2021. On 27Mar2021 he had heart attack. He was asking if he should receive second dose. He was taking LIPITOR and PLAVIX. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Client's mother called and stated L upper arm "very swollen." Skin is tight and c/o feels funny. Mother using cool packs to area. rotating Tylenol and Motrin routine. Will give Benadryl and salt baths to try to decrease swelling.
This spontaneous report was received from a licensed vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored M-M-R II (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
she felt nauseated; sick stomach; headache; body aches; really sore arm for a couple of days; This is a spontaneous report from a contactable other health professional (patient) received via Medical Information Team.  A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient medical history included arthritis from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced really sore arm for a couple of days on Dec2020, the patient felt nauseated, a sick stomach, she has a headache and body aches along with the sick stomach, all on Jan2021. The patient outcome of the events was unknown.   The information on the batch number has been requested.
Fever, fatigue, headache, body soreness, arm severely sore, irregular menstrual bleeding.
This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Per RN: Mother of child reports anterior & posterior swelling in upper left arm from shoulder to elbow that began 04/04/2019. Swelling persisted, along with purple discoloration and blister formation on upper arm of child. Child taken to minor care center 04/06/2019, pm & prescribed antibiotics for symptoms.
injection site inflammation; inflammation of right lower lip; leg twitching; hot skin; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. Relevant medical history included: "DIABETES" (ongoing); "HYPERTENSION" (ongoing). Concomitant medication(s) included: JANUMET LONG; FARXIGA; GLIPIZIDE; RAMIPRIL; LIPITOR [ATORVASTATIN]; VIT D; BENADRYL; ADVIL 12 HOUR. Vaccination history included: Bnt162b2 (Dose 1; lot number EN6205; administration time 08:00 AM,, Anatomical location : Left arm,), administration date: 01Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "injection site inflammation"; CHEILITIS (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "inflammation of right lower lip"; MUSCLE TWITCHING (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "leg twitching"; SKIN WARM (non-serious) with onset 22Mar2021 10:00, outcome "recovered" (2021), described as "hot skin". Therapeutic measures were taken as a result of vaccination site inflammation, cheilitis, muscle twitching, skin warm.  Additional information: The patient was administered COVID-19 vaccine at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was treated with BENADRYL, ADVIL for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
vaccine -VARIVAX- administered 10/6/08 varicelliform rash began 10/26/08 and is continuing to erupt in patches on the day of office visit, 10/30/08
Fever (100.5 F oral temp) Body Aches Headache Chills Fatigue Pain at Right Deltoid Injection site
-Hard raised red lump at the injection site that became present a week following injection -Early menstruation cycle: The previous bleeding part of the cycle concluded 03/07/2021.  Patient began experiencing PMS symptoms around 03/23/2021, and bleeding began again 03/26/2021. Patient's period is almost always regular. Patient's periods typically last between 2-3 days, but at the time of this report has been going on for 4 days now.
Missed the correct time window; Covid + between doses; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid + between doses) and PRODUCT DOSE OMISSION ISSUE (Missed the correct time window) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid + between doses). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the correct time window). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid + between doses) and PRODUCT DOSE OMISSION ISSUE (Missed the correct time window) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Soreness in left breast for 3 days, waves of chest tightness and extreme fatigue for 3 days.
Information has been received from a physician concerning a female teenager patient who on an unknown date was vaccinated with the first dose GARDASIL vaccine (yeast). The physician reported that after the patient received the first dose GARDASIL vaccine (yeast) she contacted him to say that she hadn't had her period. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 22 years old female patient who experienced redness, allergic reaction, hives and itching, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number) not reported via intramuscular route in the right arm. On an unknown date, the patient developed a non-serious bright redness 3 days after, received a flu shot from this company and had an allergic reaction to it, hives all down the backs of my legs and itching (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was redness, allergic reaction, hives and itching. The patient was treated with BENADRYL ALLERGY/COLD and HYDROCORTISONE. On an unknown date, the event outcome was unknown for all the events. List of document held by sender: None.
Initial report received from healthcare professional on 20 December 2013. A female patient (age unknown) whose medical history and concomitant medications were not reported received ADACEL (lot number U4046AB and expiration date unknown) intramuscularly (site and dose number not reported) on 19 December 2013. At time of vaccination (on 19 December 2013), the patient was pregnant. Date of delivery was unknown. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Injection into tricep instead of deltoid. Discovered next day by patient based upon pain location.
This spontaneous report as received from a registered nurse refers to a male neonate patient (currently 14 days old). Patient's concurrent condition and concomitant medication were not reported. No drug reactions/ allergies were reported. On an unknown date in 2017, the patient was vaccinated with RECOMBIVAX HB (lot# begins with "N00" and expiry date 08-NOV-2019) (strength, dosing details, anatomical location were unknown) for prophylaxis. The reporting nurse stated that when a dose of RECOMBIVAX HB was being administered to the newborn patient, the syringe separated from the needle and a small amount of the vaccine solution squirted in her eye. The vaccine dose was aspirated from a vial into an administration syringe and the needle was not firmly attached (product use issue). The patient received a partial dose of RECOMBIVAX HB. The patient did not experience any adverse event. The reporter doesn't know if the patient is going to receive another dose of RECOMBIVAX HB because she is at home at the time of this report. No PQC was involved. This report is cross linked with case#1706USA005501, due to the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1706USA005501.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3302), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 23Aug2021 as dose 3 (booster), single (Lot number: FC3103) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fighting Stage 4 Anal Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Oct2023 to 04Nov2023. clinical course: Patient no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366099 Same Patient, different drug/AE;
Immediate onset of chest tightness, respiratory difficulty and Sinus Rhythm with Supraventricular Ectopy.  Chest tightness and respiratory difficulty went away after two weeks. Sinus Rhythm with Supraventricular Ectopy persists to date and has been diagnosed with a 48 hour heart monitor.
Patient called pharmacy on Sunday stating his arm hurt a lot.  He stated that he was in extreme pain and could not life his arm above his shoulder.  I advised patient to go to an urgent care provider for further care.   I also followed up with patient on 8/12/19 and his arm still hurt a lot and he made an appointment to see his doctor the next day.
11/6/09: Received (R) thigh Flu/DTAP & (L) thigh H1N1 at 3:45pm. At around 8 pm both thighs red & tender. 11/7/09- thighs were more red and swollen & 11/8/09, 11/9/09 left thigh swelling went away, right thigh still red. RTC & treated with SEPTRA for cellulitis.