chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainting; Unconsciousness; Low blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "she had 12 screws put in her spine and neck" (unspecified if ongoing), notes: 12 screws in spine, neck, previous issues with pain, numbness; "had previous issues with pain and numbness" (unspecified if ongoing); "had previous issues with pain and numbness" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Unconsciousness"; HYPOTENSION (non-serious), outcome "unknown", described as "Low blood pressure". The events "fainting", "unconsciousness" and "low blood pressure" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: low. Therapeutic measures were taken as a result of syncope, loss of consciousness.  Clinical information: she got the vaccine at 10:30 and then was discharged from the emergency room at 18:00. Her blood pressure was low, and she felt unconscious for 7 hours. She was given intravenous fluid, unspecified but states she eventually woke up and felt better. She waited for her booster shot because she had to have a surgery. It has been 4 months since her surgery, and over 6 months from her second vaccine. She had 12 screws put in her spine and neck, and she has had previous issues with pain and numbness, this was her third surgery for this issue. She had this issue prior to her vaccines. She had two surgeries before her vaccines and then the third one was scheduled after the vaccine. Reporter stated that she experienced adverse events following her second dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). she was unconscious for a few hours and had low blood pressure.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202200100512 similar report from same reporter
Patient came in contact with military boyfriend who received smallpox vaccination 2 wks ago.  Has 4-7 lesions in various stages of development on lips, inside her mouth, and on her cheeck.  She has edema, pain, redness and itching at the lesions sites.
This spontaneous report as received from nurse refers to a patients of unknown age. On an unkonwn date the patient was vaccinated with PEDVAXHIB (lot# was not reported). The reporter reported PEDVAXHIB was improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Itchy sensation & very mild red spots X 3 at site of injection.  Itching extends to shoulder & upper back.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 5 (booster), single (Lot number: K9895) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Managed; "hypothyroidism" (unspecified if ongoing), notes: Managed. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Sep2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (02Sep2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: No other medication in 2 weeks, Return of Covid symptoms after taking Paxlovid and testing negative. Note testing positive again. Flu like symptoms. Adverse event start date 02Sep2022, patient was recovering, treatment ae No, No known allergies.
PATIENT STATED SHE STARTED NOTICING ITCHING IN THE ROOF OF HER MOUTH AND THEN A FEW MINUTES LATER STATED SHE STARTED NOTICING ITCHING ON HER LIPS. STATED SHE DID NOT HAVE ANY TROUBLE BREATHING OR ITCHING IN THROAT. ALL HAPPENED OVER THE COURSE OF 15 MINUTES FOLLOWING VACCINATION.
Rash with severe itching.  Lasted 3 days. The first night was the worst which was the next night after the vaccine I was awake all night. My arm where I had the injection was really sore for 3 days.
Day one - fever, general unwell feeling.   Worked  Day two-,fever, joint pain, unwell.   At home  Day three - no fever, increase in fatigue, aching joints  Day four- better but unwell feeling. Worked  Day five- thirteen-   felt very fatigued / headache  Day 14 on, better each day.
PT PASSED OUT HAD LOW PULSE AND VASOVAGIL SYMPTOMS. WE CALLED 911 ELEVATED HIS LEGS AND GAVE HIM O2.  PT REFUSED TO GO TO ER WITH THE AMBULANCE HAD A FAMILY MEMBER COME PICK HIM UP.
My periods have been 100% regular for the past three years since the birth of my daughter. I generally only experience mild PMS symptoms, and that also for only one day before my period starts. One week before my period was to start I began to experience excruciating PMS symptoms (heavy cramping, excessive mood swings, breast pain). My period did not start on the day that it was supposed to, and I am now four days late. The symptoms have only intensified since then, and over the counter medications have provided no relief. There's no chance I'm pregnant.
Feb 26, mammogram scheduled and they enlarged lymph node left side and went March 2021 sonogram and still enlarged and June 2021 it was smaller in June 2021, Didn't have any other symptoms.
left upper arm redness and swelling.  She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1.  She reports the area is red right after the vaccine.  She reports she has had increased swelling, redness, warmth.  She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after.  She reports she has had some fever and body aches that she associates with having the second vaccine.   Constitutional: Negative for chills and fever.  HENT: Negative for sore throat.   Eyes: Negative for visual disturbance.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative for dysuria.  Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain.  Skin: Positive for color change. Negative for rash.  Neurological: Negative for weakness and numbness.
Immed after administration of #2 Hepatitis vaccine IM, emp. c/o feeling as if "punched in right arm"/deltoid and hand felt "tight". 45 min later emp "just didn't feel right" and throat felt spongy". Denied shortness of breath - sent immed to ER. Rec'd Benadryl PO and Claritin.
ABOUT 18 HOURS AFTER VACCINATION, PATIENT DEVELOPED FEVER.  MEASURED AT ONE POINT AS 100.5 UNDER THE ARM.  LATER DEVELOPED LOCAL REACTION. APPROXIMATELY 3 INCH AREA AT INJECTION SITE (ON RIGHT ARM) AND ANOTHER AREA ABOUT 1 1/2 INCHES BELOW SITE BECAME RED, HOT & TENDER.  FEVER RESOLVED AFTER 3 DAYS.  LOCAL REACTION MUCH IMPROVED ON 9/22
Patient is 26 years old  female at 31w4d.   Hospitalized (1.13.22);  COVID-19 positive (1.12.22); fully vaccinated (no booster) Admission Date: 1/13/2022 Discharge Date: 1/15/2022 RECOMMENDED FOLLOW-UP: - will plan to follow up for regularly scheduled OB Visits  ASSESSMENT / PLAN: Patient is a 26 y.o. female at 31w2d who presents with coughing, fever, congestion, loss of smell, SOB, chest pain with coughing, and nausea.  1. COVID-19 in pregnancy  - Patient endorses symptoms since 1/11/22 (day 3 of symptoms), +COVID-19 PCR 1/12/22  - Symptoms of: shortness of breath, cough, rever, loss of taste or smell, nausea and congestion/runny nose - Vaccinated x 2 Pfizer  - Vitals: SpO2: 97 % BP 117/72  | Pulse 111  | Temp 36.9 °C (Oral)  | Resp 16  | Ht 1.651 m  | Wt 75.3 kg  | SpO2 97%  | BMI 27.62 kg/m²  HOSPITAL COURSE: The patient is a 26 y.o.  female at 31w4d who presented with symptomatic Covid in pregnancy. She was admitted and treated with remdesivir and dexamethasone for two days. Following treatment she voiced significant improvement in shortness of breath and was deemed stable for discharge. Will plan to discharge on Lovenox for 10 days.
I did not have any reaction to the vaccine. I did however develop symptoms of Covid-19 on May 22, and on May 25 I tested positive. Someone from V-safe called and suggested I report my breakthrough infection.
09/16/22 presents to EC ED for "altered mental status". PMHx of "carcinoma (with brain mets), HTN, HLD, CKD 3"
Patient presented to the ED with dizziness/lightheadedness and nausea, was diagnosed with TIA and elevated serum creatinine within 6 weeks of receiving COVID vaccination.
She has blood clots from her feet all the way to her lungs; She has blood clots from her feet all the way to her lungs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer) for a Pfizer sponsored program (159558). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization; BNT162B2 (DOSE 2), for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization), PULMONARY THROMBOSIS (hospitalization), outcome "unknown" and all described as "She has blood clots from her feet all the way to her lungs".  Additional information: The reporter stated that the patient, after taking her shots, was in the hospital and has blood clots from her feet all the way to her lungs. The patient already took the vaccine with a booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
07/30/13 pt received the Menactra and the HPV (# 1 for him) in left deltoid. Since then the area has become increasingly swollen and edematous; erythema noted. Pt. states no pain, but a lot of itching in area.
This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, latex allergy, antibiotic allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The patient vaccinated at left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced knot on arm. On 12-MAR-2021, the subject experienced rash and redness. On 12-MAR-2021, the subject experienced itchiness. On 12-MAR-2021, the subject experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from knot on arm, rash and redness, and soreness, and the outcome of itchiness was not reported. This report was non-serious.
Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA377A, expiry date 31st August 2021) for prophylaxis.   On 1st September 2021, the patient received Menveo (intramuscular) .5 ml. On 1st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: This case was reported by a nurse. The reporter stated that a dose of MENVEO was administered to the patient on 1st September 2021 that expired on 31st August 2021,which led to expired vaccine use. She gave a consent to follow-up with her.  She provided her contact information as well as email address. The reporter consented to followup.
This spontaneous report as received from a mother refers to her son, an 18 month old patient. The patient had no pertinent medical history. On an unknown date in December 2013 (reported as "about 3 months ago (specific date unknown)") the patient was vaccinated with a dose of VARIVAX (lot#, dose, route unspecified) for the prevention of chickenpox. No concomitant medication reported. On 06-MAR-2014 the patient inadvertently received 2nd shot of VARIVAX (lot#, dose, route unspecified). No treatment was given for the event and no lab diagnostic studies performed. Patient saw the doctor for medical attention. Additional information is not expected.
I only had a fever for a few hours. I was very tired and my sinuses and chest were very congested. I had a slight cough and sore throat. The sinuses were the worst. I treated with Sudafed and Mucinex. I felt better but was still tired. I finally tested negative for COVID on day 10. I did completely recover from all my symptoms
A 37 year old male patient was diagnosed with recurrent transitional cell carcinoma on 2SEPT2003. Treatment with Tice BCG was started with 6 weekly instillations from October 2003 through 7 November 2003. On 15JAN2004, the patient presented with significant pain in his lower back and groin, and GI upset. He was referred to the local ER where he was diagnosed with an "inflammatory prostate infection", and given Cipro and Anaprox for treatment . On 23JAN2004, his urologist prescribed him Flomax for further treatment of the prostate infection. On 28JAN2004, the patient had hematuria. His urologist took a "post massage urine sample" and sent it for AFB stain, which was found positive. On 6FEB2004, the patient's prostate condition was assessed as "prostate infection continued, prostate size less congestion". On 26FEB2004, due to positive AFB results , patient was referred to his county health department, and also referred to a pulmonary specialist , related to his active TB case." Case assessed as serious because of medical significance. Follow up informaiton 8 MAR 2004: Pt started with an abx for TB but developed an allergic reaction on 28FEB2004. No other information is reported.
Patient fainted about 5 minutes after receiving vaccine. Pharmacist checked patient and she had a pulse. Patient quickly gained conscious and laid down on the floor. Patient said she usually faints when she receives a vaccine or has her blood drawn. Pharmacist checked patient's blood pressure and pulse, within normal range.
Approximately 1 minute after receiving the vaccines the patient passed out without any warning - he had a mild tremor of the arms and legs that last for less than 1 minute and then he came arround.  Cold compresses, supine with legs elevated for a few minutes and he was fine.
Developed heart rate of 170bpm 10 minutes after event. Apple watch showed arrhythmia at that time. Was taken to ER. Arrhythmia terminated in the 15-20 minutes that it took to get to ER and get set up. Stayed in ER for testing and released home within 1.5 hours.
Patient states 9/24 being hypotensive and vomitting, but those symptoms have since resolved.  Patient has a rash from injection site down and swollen.   She was advised to take bendryl and she will be following up with a  doctor.
This 73    year old female received the Covid shot on 2/27/21      and went to the ED on  4/29/21   and was admitted  on   4/29/21     with respiratory distress, cardiac arrest and other symptoms and died on  5/1/21 .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
PATIENT PRESENTED 1 WEEK LATER WITH SYMPTOMS CONSISTENT WITH SHINGLES OUTBREAK ON LEFT ARM. PATIENT RECEIVED VALTREX 1 GRAM TID X7 DAYS BEGINNING THERAPY 9/21/21
Had MENACTRA vaccine Sat. morning. Woke up with hives on Sunday and swollen elbow, joints, lips. Went to urgent care, had a DECADRON shot. No hives on Monday. Woke up Tuesday the 2/27/18 with hives again and swollen lips.
fatigue; bad muscle pain; sweating; headaches; nausea; diarrhea; fever; body aches; cough; chest congestion; burning in her nose and mouth; burning in her nose and mouth; This is a spontaneous report from a contactable other HCP and contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and experienced bad fatigue. On an unspecified date, the patient experienced bad fatigue, bad muscle pain, sweating, headaches, nausea, diarrhea, fatigue, fever, body aches, cough, chest congestion and burning in her nose and mouth after the 2nd vaccine that improving some and she missed a total of about 6 days of xeljanz (1 day the 1st vaccine and 5 are days the 2nd vaccine) per her md while getting the vaccinations (she restarted again this morning). Patient said her neck, shoulder and back pain increased during the time of the recent missed doses. On an unspecified date, the patient underwent lab tests and procedures which included blood test: inflammation is under control (no specifics provided), sars-cov-2 antibody test resulted in negative and x-ray showed her lungs were clear but there were profound changes in her osteoarthritis in her spine. The patient MD was aware of tests. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The vaccine had been in the refrigerator for 30 days and about 18 hours when it was administered so it was outside the recommended 30 days at refrigeration. Patient was having no side effects the day following the vaccine.
Itching; Little rash(a few red spots); Pain in my arm; Light headaches; Redness at the injection site; Redness at the injection site the size of a baseball; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Redness at the injection site the size of a baseball) and FATIGUE (Fatigue). At the time of the report, PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Redness at the injection site the size of a baseball) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.    Reporter did not allow further contact
Mother called the office the morning after the immunization to report the infant had cried inconsolably for 3-4 hours. She reports that nothing worked to soother him, she tried breastfeeding, rocking, swaddling, Infant Tylenol 1.25 ml by mouth, swinging, walking the floors while holding him and warm bath without relief. After he stopped the continuous crying he remained irritable and wouldn't eat the rest of the night and the next morning, crying off and on. Mother reports the afternoon of 12/6/18 he finally breastfed and was back to his normal.
received the 1st and 2nd dose on 20Jan2021; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reporting for his 24 years old granddaughter. A 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on 20Jan2021 (Batch/Lot number was not reported) and second dose on 20Jan2021 (Batch/Lot number was not reported); both via an unspecified route of administration as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID on 08Apr2021. The outcome of the events was unknown.  The reporter had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE on 09Apr2021. He was asking how much protection and what was the duration of protection once he got the 1st dose of the vaccine. He also wanted to know how much of the population were protected after getting the doses. The reporter was provided with Table 6: Vaccine Efficacy-first COVID-19 occurrence from 7 days after dose 2, by age subgroup -participants without evidence of infection and participants with or without evidence of infection prior to 7 days after dose 2 - evaluable efficacy (7 days) population. The reporter was asking if the COVID 19 vaccine might cause a false positive test and if the vaccine would give COVID 19 to patients.  Information on the lot/batch number has been requested.
2 days after my second pfizer dose, I had residual pain in my armpit on the side ingot the shot.  While showering I noticed a large swollen lump under my armpit. Nearly 2 weeks later, the lump is still there,though 90% of the pain is gone. The lump has not reduced in size.
Patient reported to HR manager at school district that she had to go to the doctor for a sore arm from a flu shot. Patient stated that she felt the flu shot was given too high on the arm.