chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received the Janssen COVID-19 vaccine on 4/9/21 as documented in MIIC. This reporter has no other records of the day of administration.   Patient's last menstrual period was 07/22/2020 and Estimated Date of Delivery was Apr 28, 2021. On 4/11/21 at 0218, two days after administration of the COVID-19 vaccine, the patient was admitted to the University of Hospital Birthplace for spontaneous rupture of membranes x 7 hours contractions since 4/10/21 2330. Per discharge summary note 4/13/21 in EHR: ?The patient is a 33 year old now G4P2022 who presented to the Midwife service with rupture of membranes and subsequent onset of spontaneous labor. She was noted to have mild range blood pressure and transaminase levels double the upper limit of normal, meeting criteria for preeclampsia with severe features. This was noted just prior to complete cervical dilation and her delivery was completed by the service. She was subsequently transferred to the OB MD service for further management. Her postpartum course was uncomplicated. She was continued on magnesium for 24h postpartum. She was started on nifedipine XL 30mg for blood pressure management and her BPs were wnl. Her ALT downtrended from 137 to 109. Her AST downtrended from 139 to 70. Creatinine returned to baseline. On PPD#2, she was meeting all of her postpartum goals and deemed stable for discharge. She was voiding without difficulty, tolerating a regular diet without nausea and vomiting, her pain was well controlled on oral pain medicines and her lochia was appropriate. Her hemoglobin prior to delivery was 13.5 and after delivery was 11.2. Her Rh status was positive, and Rhogam was not indicated.? Per Labor and Delivery note 4/13/21:  ?Labor Course: arrived in active labor w SROM. Elevated BPs, abn PreE labs, new dx of PreE w severe features late in active labor, MD consult, plan to start Mag So4 after birth as patient was starting 2nd stage of labor as diag become clear. She progressed to complete and pushed, after which she had a spontaneous vaginal delivery.  No nuchal cord was noted. Apgars of 8 and 9   The cord was double clamped after 60 seconds and cut.  IV pitocin was started. The placenta was then delivered using gentle traction and suprapubic pressure. The uterus was noted to be firm after fundal massage.  The perineum was assessed for lacerations and none were noted. The placenta appeared intact with a 3V umbilical cord. See details in below: Pain meds: epidural IUP at 37 weeks gestation delivered on April 11, 2021.   SVD delivery of a viable Male infant. Weight : 6 pounds 4 ounces  Apgars of 8 at 1 minute and 9 at 5 minutes. Labor was spontaneous. Medications administered  in labor:  Pain Rx Epidural; Antibiotics No;  Perineum: Intact Placenta-mechanism: spontaneous, intact,  with a 3 vessel cord. IV oxytocin was given. QBLs was 243. Complications of pregnancy, labor and delivery: PreE w severe features Anticipated d/c date: 2 days?
24-48 hours of nausea with vomiting, headache, dizziness, fever, and malaise
SHINGRIX in Right arm, red, swollen (size of deck of cards), sore to touch, muscle aches, temperature, chills, upset stomach, and was weak feeling which started on Monday. Most symptoms gone by Wednesday night. However on Thursday still have red and swollen right arm on injection site (size still pack of cards). Very sore if anything touches it. Have taken TYLENOL and put cool cloth on injection site as it feels hot to touch and itches around the perimeter of area. Did not seek medical help. No reaction from flu shot in left arm.
arm hurt "a little bit" after the shot; night the arm that she received her shot in became sore; muscles in her arm were sore/muscles in her other arm became sore/muscle aches; she "rolled around a little bit"; sore spot where I got the shot; This is a spontaneous report from a contactable consumer (patient herself). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose in arm for COVID-19 immunisation. Medical history and Concomitant medication were not reported. It was reported that patient received her first dose of the Pfizer BioNTech COVID-19 vaccine and reported that her arm hurt "a little bit" after the shot. She reports that night the arm that she received her shot in became sore, stating it felt like the muscles in her arm were sore. She then states that a little later the muscles in her other arm became sore. She reports this was around midnight or 1:00AM and reports that she "rolled around a little bit" bit states that it was not excruciating pain, just "sore and ached." She reports that the next morning, the muscle aches were gone and didn't notice anything different, except "just a little sore spot where I got the shot." patient was wondering if because of these muscle aches, should she be concerned about receiving her second dose of the vaccine next week. The outcome of event muscle pain was recovered on unknown date, while for others was unknown.  Information on the lot/batch number has been requested.
Acute vulvar ulcers that were bloody and passing presented 1 day after vaccination. Patient was tested for herpes (negative) and denies sexual activity. Covid 19 test was performed to rule out a covid infection. The patient had "normal" vaccination symptoms of headache, extreme body aches, and chills which resolved within 12 hours of vaccination. The vulvar ulcers presented as minor sores on one side which opened up and quickly spread to both sides of the vulva and grew larger and had dark fragile scabs that frequently opened up with puss and blood. The sores grew worse for about 4 days increasing pain in walking and sitting activities. After 4 days the condition stabilized and started to heal up around day 7. The ulcers were gone around day 10. The vaccine is the only change in the patients' health over the time of the adverse event and is thought to have triggered an autoimmune disease.
itchy; rash on chest and back; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), VACCINATION SITE PAIN (soreness at the injection site) and RASH (rash on chest and back) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRURITUS (itchy), VACCINATION SITE PAIN (soreness at the injection site) and RASH (rash on chest and back). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy) and RASH (rash on chest and back) outcome was unknown and VACCINATION SITE PAIN (soreness at the injection site) had resolved.             No concomitant medication provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information was received on 14-May-2021, The outcome of the event was updated.
Fever, chills, sore throat, joint aches, Covid arm.  Injection site hot red and HARD.  Traveled to inner arm.  Hives on neck and
Patient wants to receive second dose past 35 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient wants to receive second dose past 35 days) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient wants to receive second dose past 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient wants to receive second dose past 35 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: ADR form attached.
High temperature starting at 3:00 am  (101.84, 38.8 Celsius),  severe headache, pain all over the body and shortness of breath, as soon as I tried to drink water I threw up, extreme tiredness and weakness. Slept basically the whole Sunday (1/17). Around late afternoon it started getting better and I was able to eat some soup. But still tiredness and weakness and shortness of breath. I took Ibuprofen 600 3 times that day but it didn't help. On Monday 1/18 headache got better but still extreme shortness of breath and weakness and back pain. Today 1/21 I'm still having shortness of breath and back pain.
Stomach issues, less than 2 weeks after vaccination, abdominal pain, diarrhea, grumbling stomach.
Pt was vaccinated in med eval area with vaccine and recovered 10 minutes lying down and ambulated to observation area with no dizziness.  Pt c/o dizziness after sitting in chair & diaphoretic.  VS taken 118/72 68P 20R 100%sat.  Pt brought to med eval area and lying down with icepack.  Recovered lying down, fluids offered.  Transition to sitting then standing and walking in med eval area.  Denies any dizziness.  Recovered for total of 25 minutes.   Feeling better after drinking, discharge ambulatory home.   HX:  fainting, dizziness with vaccines , labwork and BP taken.
Muscle cramps, achy, feels feverish no local reaction or fever lasted until Sunday.
About 10 hours post injection, the pt developed redness from the injection site to her elbow with moderate swelling @ injection site and very warm to touch. Redness and no swelling from 3" below injection site to elbow. symptoms lasted about 6 days. No other symptoms. No treatment other than an ice pack to swollen site  Has had this reaction for the last three years. But has gotten worse each year
head and face began to swell up all the time; head and face began to swell up all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 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: SWELLING FACE (non-serious), SWELLING (non-serious) all with onset 2022, outcome "not recovered" and all described as "head and face began to swell up all the time".  Additional information: Caller got the COVID-19 vaccine before year (2021) but he didn't really want to get it. He was kind of manipulated into getting it but he had quite a few people manipulated together so he ended up getting it. After having it, between Jan and Apr the present year (2022), he started having issue where his head and face began to swell up all the time and he couldn't really think when the swelling would occur. It happened in situations that he wouldn't think it would happen like depending where he goes, buildings, home, and places that he would go in and out and then sometimes when he was using a device. So he needed to do something about that and get to stop.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports feeling lightheaded, nausea, and clammy. Reports feeling better after a couple minutes and was cleared by EMS
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. On 14-NOV-2014, the patient was vaccinated with 0.5 ml dose of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015, intramuscular. Later that evening, also on 14-NOV-2014, the patient developed soreness at the injection site as well as redness at the injection site that went down the patient's arm after receiving PNEUMOVAX 23. There were no laboratory diagnostics studies performed. On 17-NOV-2014, the patient called into the pharmacy and spoke to the pharmacist who informed the patient to take ibuprofen. The outcome of soreness at the injection site and redness at the injection site was reported as recovering/resolving. This is one of several reports received from the same source. Additional information has been requested.
No additional AE; patient was administered expired MMRII; This spontaneous report was received from medical assistance referring to a 6-year-old patient of unreported gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 10-FEB-2022, the patient vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (Expired product administered) (subcutaneous injection, lot number T003384, expiration date: 28-JAN-2022, dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. There was no temperature excursion affected on measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II).   No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Retinal Vein Occlusion 4/14/21 to be repeated in 4-6 Weeks
Presented to ED 3 days after covid vaccine. Patient has history of Cancer of Ampulla of Vater/HTN/Asthma who presents with anemia.  Patient with metastatic ampulla of Vater cancer--+ carcinomatosis.  Patient was to have a Whipple procedure as treatment liver at time of procedure patient was found to have carcinomatosis and Whipple was canceled.  Patient states that he last had chemo approximately 2 weeks ago. In the past 2 weeks patient has had paracenteses performed--most recent paracentesis was today. Patient with "bloody taps" on both occasions. Patient has also had anemia. Patient had transfusion last Friday. Today, patient with worsening anemia. Patient with abd pain prior to paracentesis today-improved after procedure. Patient denies GI bleeding-no hematemesis/no coffee-ground emesis/no melena/no hematochezia.  States that the only time he has seen blood is during paracenteses. Patient is admitted for further evaluation of anemia. It was felt that the bleeding is from masses in his abdomen. He was treated with supportive care, transfusions prn and paracentesis via his catheter. When he felt improved he discharged.
Mom says swelling, rash itchy. Itchy rash (papular) noted on both deltoids. No swelling noted today. (Local reaction).
PEELING SKIN AT PALM OF HANDS AND TIP OF FINGERS // JUST LIKE WHEN SKIN PEELS AFTER RECOVERING FROM SUNBURN.
Information has been received from a physician concerning a 16 year old male with no allergies or medical history who on 20-OCT-2000 was vaccinated SC with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no physician's office with a large parotiditis. No other symptoms were noted and no treatment was needed. The symptoms resolved in four to five days and the patient recovered. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
Patient given pediatric Pfizer dose instead of 12y old and up Pfizer dose.
My hair has been falling out in clumps, kind of hard to describe the amount and duration- mostly noticing when in the shower. I run my hands through my hair and large clumps come out. No changes have been made to other medications, diet, or bathing/shampooing habits.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose number unknown, single (Lot number: FK9895) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Follow-up attempts are completed, no further information is expected.
This spontaneous report was received from an office administrator referring to a 25 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-FEB-2017, the patient was vaccinated with the third dose of GARDASIL 9 injection (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis, which was administered "too early" as the patient was supposed to receive it on 11-MAR-2017. No adverse events and no product quality complaint (PQC) were involved. Additional information has been requested.
It hit all of a sudden. I was getting dizzy. Within 10 minutes I felt nauseous. Made it to the bathroom with diarrhea.  Room spinning, could not lay down. Felt weak and tired within 30 minutes of symptoms. Several bouts of diarrhea over the next 8 hours. nausea intense and very noisy like loud gurgling (not normal for me). Never did throw up. didn't run fever, but felt hot and cold, hot and cold entire time. after about 8 hours, I could sleep and after nap woke up and could sit up. A couple hours later, nausea all gone. didn't eat anything rest of the day. Slept the night and little the next day. Feel fine now.
At ~0926 patient experienced a vasovagal response.  pt stated she blacked out momentarily and was assisted to floor in recumbent position. Was given juice and patient recovered several minutes later. At 0945, patient stated she was ok and was able to leave vaccine clinic independently.
Pain at the injection site radiating down arm, 99.9 fever, headache, nausea, joint pain, fatigue,
pt admitted to facility in city for worsening dementia; pt had a positive COVID test on 10/21/21 and passed away in the nursing home; per death certificate the causes of death were pneumonia and COVID 19
Documentation in database and at facility is conflicting  if patient has received 2 or 3 full doses with a possible 3rd or 4th dose being a booster given on 11/11/21.
Menstral cycle halted/delayed, however spotting black blood.; Menstral cycle halted/delayed, however spotting black blood.; Facial skin sensitivity; This is a spontaneous report from a contactable consumer (Patient).An 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 13:00 (Lot number: FF8879) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing); "PCOS" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "allergies"; Vicodin, reaction(s): "allergies". The following information was reported: MENSTRUATION DELAYED (non-serious), INTERMENSTRUAL BLEEDING (non-serious) all with onset 29Sep2021 14:00, outcome "not recovered" and all described as "Menstral cycle halted/delayed, however spotting black blood."; HYPERAESTHESIA (non-serious) with onset 29Sep2021 14:00, outcome "not recovered", described as "Facial skin sensitivity". Therapeutic measures were not taken as a result of menstruation delayed, intermenstrual bleeding, hyperaesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: None. Menstral cycle halted/delayed, however spotting black blood. I should have had my period on or even the day after the vaccine. Instead I'm spotting black and nothing else. Also have facial skin sensitivity. My normal moisturizer and lotion I use stings my face. Very sensitive. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.if covid tested post vaccination : No. Device Date : 30Sep2021  Follow-up attempts are completed. No further information is expected.
Needle was not properly connected to syringe, which resulted in some leakage from the injection site. More than half was administered to the patient.
Shortly after receiving his Pfizer vaccine, patient began to feel lightheaded.  He was accompanied by his mother at the clinic and had come prior to going to the family business.  Assisted in fanning patient and applying wet wipes to forehead and neck to cool down and he complained of being hot.  His face began to become flushed.  VS initially at 2:40 pm, BP=122/70-56 HR and regular-14-96% spot ox.  Recovered after ingestion of fruit snacks and 1 bottle of H2).  Stayed in observation for 30 minutes total and then left with mother.  Contact information given to patient to reach if any further problems.
adhesive capsulitis, both arms, worsening over time, in physical therapy as of 08/01/2021 (reporting date).  Injection site approximately 4 inches below the shoulder joint. (Injection was not given in bursa.)
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE,  Narrative:
SWOLLEN LUMP ABOVE THE COLLARBONE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 06-JUN-2021) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced swollen lump above the collarbone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lump above the collarbone. This report was non-serious.
I developed a headache within about an hour and that has continued for almost two days off and on. On the second day I developed a fever. I have also experienced lightheartedness and dizziness.
This spontaneous report was received from a health care professional via a company representative refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route, lot # unspecified). Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date the patient received GARDASIL and had an adverse event that was not specified. The specific dose within the series of the GARDASIL that was administered to the patient was not specified. The representative did not have the necessary information. No further event information was provided. Additional information is not expected. Consent to follow up was not provided.
Severe headache. Chills. Nausea. Myalgias. Rash on face and extremities. Shortness of breath. Discomfort swallowing/throat felt swollen. Palpitations. Large local reaction at injection site with swelling, discoloration and itching.
8 days after Moderna shot my left arm was swollen at the injection site,  along with very red round spot and very hot to the touch.