chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My fiance has now fainted 3x times 32 hours after having his second dose.; This is a spontaneous report received from a non-contactable consumer reported for 30-year-old male consumer (reporter's fiance). A 30-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16May2021 15:00 (at 30 years old age) (Lot Number: EW0173) at single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:00 (at 30 years old age) (Lot Number: EW0172) at single dose for covid-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter's fiance had now fainted 3x times 32 hours after having his second dose. The last time was just after a couple minutes of standing and he started to sieze before coming to. They wouldn't be able to work today because we need to monitor it. Reporter would bring him to the ER if it continued. Adverse event start date was 18May2021. Adverse event start time was 03:00 AM. No treatment was received for the adverse event. The event did not result in death and caused/prolonge hospitalization, was not Life threatening, disabling/incapacitating, congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Break through post menopause ovulation and menstrual cycle. Previously, last menstrual cycle May 2018. On May 11, 2021 - felt ovulation and on May 29, 2021 - starting bleeding.
1OCT92 p/c from grandma pt has rash, on chest & face & is fitful; 2OCT92 p/c from grandma pt rash all over body, is screaming, face begining to swell; told grandma to go to MD immediately; took pt to MD-MD felt case of measles; given DPH;
Patient had localized reaction to (R) deltoid after receiving DAPTACEL. Area was red, warm to touch, swollen (measured 10 cm x 11 cm). Instructed to take BENADRYL and apply ice to the affected area.
Our son started with extreme liquid diarrhea and reflux with unrelenting and inconsolable screaming. The diarrhea started first, but by day 6 my son would not stop screaming. Nothing could help to settle him down (breastfeeding, cuddling, rocking, etc.) I had him vaccinated further, because I did not think that this could be a possibilty, but on subsequent vaccines his symptoms became more pronounced more screaming (I walked him 14 miles a day for multiple naps so that he could sleep). He started hitting his head at 5 months, throwing it in all directions and the screaming was unbearable.
Chills at 2PM and 6PM 3-6-21 Tired all day 3-7-21
EXTREME BOUTS OF FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced extreme bouts of fatigue, and very scary / worrisome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme bouts of fatigue and very scary / worrisome was not reported. This report was non-serious.
Approximately 4 weeks after receiving the second dose of Moderna COVID-19 vaccine, patient experienced tingling and loss of muscle control on one side of his face.  He presented to Emergency department and was diagnosed with Bells Palsy.  The ED was not concerned that he had received the vaccine 4 weeks earlier and dismissed it as a coincidence.     Family and I decided it would be a good idea to report here just in case there is a pattern with other people.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # L048456, expiration date 25-MAY-2017) (lot # M001815, expiration date 20-SEP-2017) (lot # M009377, expiration date 17-JUN-2017) (lot # M011116, expiration date 17-JUN-2017) (lot # M017982, expiration date 13-SEP-2017) (dose and route unknown). The vaccine was exposed to temperature excursion od 32.7Fahrenheit degree (F), 34.2F, 35.0F, 35.4F for 123 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received fro the same report source. Additional information has been requested.
This spontaneous report was received from a nurse who is the primary reporter. The nurse is reporting 2 patients who were inadvertently administered VARIVAX lot # (668455/1310Z), on 11/12/2012, 1 DF VARIVAX (Merck) that had expired on 10/07/2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired drug administered. No treatment information was reported. The outcome of expired drug administered is unknown. Expired drug administered is not related to VARIVAX (Merck). No further information was provided. All drop-down fields apply to both patients.
This was my son's two month old shots-  Very fussy from the time it started throughout the night, diarrhea,  loud breathing sounds, and legs were swollen.
Transverse myelitis.  Recent illness thought to be hand-foot-mouth.  Also meets case definition for acute flaccid myelitis so working pt up for enteroviruses
chicken pox started 10MAR; 150-200 lesion evident 14MAR; low fever;
they experienced a temperature excursion for opened Ipol, reached a low temperature of 1.7C and out of range for 1 hour, with no AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6 years old female patient for whom it was reported they experienced a temperature excursion for opened ipol, reached a low temperature of 1.7c and out of range for 1 hour (product storage error), while she started therapy with vaccine IPV (Vero) [Ipol], suspension for injection, 0.5 ml once via unknown route (Batch number: R1D972M and Expiry date: 17-Jul-2021) for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided. Concomitant medication was not reported.   Final diagnosis was they experienced a temperature excursion for opened ipol, reached a low temperature of 1.7c and out of range for 1 hour.  No lab data was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding the batch number.
Presented w/SOB, cough. COVID in August w/no improvement. Admit for COVID PNA. Hx of HTN, CAD. Tx w/O2, abx, Vit C, D, zinc, neb, remdesivir.  Disposition:She will be discharged today to home with hospice
cirrhosis of liver; leaking blood; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 54-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney transplant" (unspecified if ongoing), notes: 54 year old kidney transplant patient; "diarrhea" (unspecified if ongoing), notes: (diarrhea may have been for last 7 years). The patient's concomitant medications were not reported. The following information was reported: HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "cirrhosis of liver"; HAEMORRHAGE (medically significant), outcome "not recovered", described as "leaking blood". The patient underwent the following laboratory tests and procedures: Hepatic cancer: No marker present, notes: No marker present or tumor found for liver CA; Hepatitis viral test: No hepatitis; Liver function test: No infection, notes: No infection in liver fluid; Stool analysis: No detected blood in diarrhea; Varicose vein: No bleeding, notes: No bleeding of varicose veins in esophagus as suspected. Therapeutic measures were taken as a result of haemorrhage. Clinical course included: Reporter (sister) and Mom met with 54 year old kidney transplant patient's (Patient) (brother's) medical care team at Medical Center. Patient still leaking blood and can't find source. Patient has received 2 units of blood, 30Apr and 10May and will receive more today. Confirmed cirrhosis of liver with no cause of onset determined. No infection in liver fluid. No bleeding of varicose veins in esophagus as suspected. No marker present or tumor found for liver Cancer. No hepatitis. No detected blood in diarrhea (diarrhea may have been for last 7 years). Using diuretic to get rid of fluid w/o damaging donated kidney. May have to withdraw fluid via needle again.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pain; clogging sound on her right ear/ it sounds clogged.; She can hear but not well; she notes it is like she has a lot of noise in her ear.; clogging sound on her right ear/ it sounds clogged.; it has gotten worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Jun2021 18:00 (Lot number: EW0177) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose- 19May2021, give about 6pm in the right arm, Lot- ER8736), administration date: 19May2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "pain"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset Jun2021, outcome "recovering" and all described as "clogging sound on her right ear/ it sounds clogged."; HYPOACUSIS (non-serious) with onset Jun2021, outcome "recovering", described as "She can hear but not well"; DEAFNESS TRAUMATIC (non-serious) with onset Jun2021, outcome "recovering", described as "she notes it is like she has a lot of noise in her ear."; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "recovering", described as "it has gotten worse". Therapeutic measures were not taken as a result of pain, ear discomfort, hypoacusis, deafness traumatic, condition aggravated, tinnitus.  Additional Information: Caller reporting on receiving the Covid 19 vaccine and who explains that all of a sudden her right ear, she is having difficulty with it but doesn't know how to describe it. It sounds like she is going under a tunnel or on an airplane, like her ear is popping and like she needs to put her finger in ear to clear it, it sounds clogged. This didn't start until the second dose and she has never experienced anything like this before. She has a doctor's appointment at the end of the month but is calling because that is a long time away. It is scaring her, she she going to lose her hearing. She can hear but not well. Have we heard of this happening before. She is looking for recommendations. When describing the event she notes it is like she has a lot of noise in her ear. It is starting to hurt, this is just the right ear. The noise is not really a static sound but like water and ringing. it is hard to describe. She thought she might have gotten water in it from the shower but it has gotten worse. The event - it was very mild in Aug2021.   No follow-up attempts are possible. No further information is expected.
Less than one month subsequent to receiving one dose of varicella virus vaccine live the pt developed varicella that consisted of 50 lesions on the head, neck, and back.
Patient was given a pfizer covid 19 booster at age 15, this is not recommended for patients under 18.
First day of symptoms included severe muscular pain throughout my body, followed by strapping chest pains, which required hospital emergency visit. Weeks to follow included pains throughout chest, legs, arms, face, head, tingling in scalp and soreness. Extreme fatigue. Tightness in calves. Continual weak legs, head soreness and lightheadedness to date (5/6 weeks).
Pt recvd vax & next day exp h/a, nausea, chills, dizziness & fatigue which persisted for 5 days; lab tests showed Hep B surface antibody neg;
Pt has a very large reddened swollen area on (L) arm. Area is warm to touch. Pt was given Ceftriaxone 1 gram IM. She also started oral antibiotic for cellulitis.
This case was reported by a pharmacist and described the occurrence of rash on trunk and arms in a 50-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included H1N1; manufacturer unspecified; unknown; unknown given on 22 March 2010.  On 22 March 2010 at 18:00 the subject received 1st dose of TWINRIX (unknown, unknown arm).  On 23 March 2010, 1 day after vaccination with TWINRIX, the subject experienced rash on trunk and arms and itching of trunk and arms which originated from the arm that TWINRIX was given in.  The subject started BENADRYL on her own.  Follow-up information received from pharmacist on 01 June 2010: The subject was 53 years-old.  Concomitant vaccination included H1N1 unspecified given on 16 March 2010.  The subject received TWINRIX vaccination (right arm) on 16 March 2010.  On 18 March 2010, 2 days after vaccination with TWINRIX, the subject experienced rash and itching.  The events resolved on 24 March 2010.  The pharmacist did not specify a causal relationship with TWINRIX, but did identify TWINRIX as the suspect product.  The vaccination series with TWINRIX was delayed until plan with primary physician.  The symptoms did not recur following subsequent administration.
Oval shaped erythema w/ mild warmth to injection site. 8 x 5 cm in diameter.
Large induration 2 hour cellulitis circumference of upper arm. Fever mild. Maculopapular rash on lower arm.
Developed intermittent severe abdominal pain.  Was seen in the Emergency Department and diagnosed with intussusception.  Abdominal ultrasound confirmed lymphoid hyperplasia.  Was hospitalized and had a recurrence and underwent second reduction.
Women who were pregnant when first vaccinated with no reported adverse event; Initial information received from on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was exposed to vaccine YELLOW FEVER VACCINE [YF-VAX] in context of women who were pregnant when first vaccinated with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Women who were pregnant when first vaccinated with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received an unknown dose of suspect YELLOW FEVER VACCINE (strength, formulation, frequency, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of women who were pregnant when first vaccinated with no reported adverse event (exposure during pregnancy) (latency: Unknown) following the administration of YELLOW FEVER VACCINE. Reportedly they were asking if women who were pregnant when first vaccinated are recommend to receive another vaccine. What would be the vaccine schedule. Do we wait 10 years or give the additional dose during the next travel and possible exposure.  Action taken: not applicable.  Outcome: Unknown  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
fever x 24 hours.  fatigue, headache x3 days and continues but has improved.
Information has been received from a physician via a field employee referring to a currently 17 year old female patient who was not pregnant. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On an unknown date the patient was vaccinated with GARDASIL (strength, dosage, dose number and frequency unspecified), intramuscularly. On an unknown date the patient developed an unspecified seizure disorder after she received the unspecified number of doses of GARDASIL. The patient's mother told the physician the patient had been consulting with an unspecified neurologist regarding the patient's seizure disorders, but she did not specified whether the neurologist had officially confirmed the diagnoses. The outcome of the event was reported as not recovered/not resolved. Causality was not reported. Upon internal review, the event of seizure disorder was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Hot and cold sweats  flu like symptoms ~4 hours after administration for approximately 2 days
Headache. pain and swelling in arm that got shingles vaccine.  Red and hot to touch.  101 fever. Chilling. Fatigued. No energy. No appetite.   Started 10/25 2019 round 830pm and have not abated.
Pt presented to ER with C/o palpitations, abdominal pain, and throat pain since first Moderna vaccine on 8/12/21. Pt states the palpitations/dizziness was so severe she pulled over in the car and summoned help. Pt states she sought medical treatment and was discharged with Anxiety as the diagnosis, and states she has never been diagnosed with Anxiety before and feels "something is wrong."
Patient had vasovagal reaction after receiving first dose of Pfizer kids, he was hyperventilating, pale with cold and clammy skin.  He was assisted to lying position and help practiced deep breathing. He recovered immediately and released with mother.
Patient was initially presented on 12/12/2021 with a chief complaint of worsening shortness of breath and cough the caregiver.  SpO2 88% in room air.  Patient also reportedly had fever but improving per caregiver.  Chest x-ray reported bilateral perihilar basilar infiltrates right greater than left finding consistent with COVID-19 pneumonia.  Patient is started on Decadron.  Remdesivir cannot be started due to liver function abnormalities.  She was started on Rocephin and vancomycin due to significantly elevated procalcitonin and CRP. Pulmonology service added doxycycline.  MRSA PCR was negative and therefore IV vancomycin is discontinued.  Received short course of Rocephin and doxycycline for secondary bacterial infection.  Patient was continued on Decadron 6 mg IV twice a day.  Patient worsen with respiratory status and required non-rebreather mask and required soft restraint as patient was keep taking the mask off and removing the IV access.  Subsequently patient started to improve significantly with respiratory status and she was able to be weaned off of oxygen.  Significant dry cough on admission also improved.  Subsequently Patient was discharged at stable condition.
This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration from an unspecified date to an unspecified date at 1 DF, single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced some muscle ache and pain lasted longer than 3-4 weeks on an unspecified date with outcome of unknown. The action taken in response to the event for PREVNAR was not applicable. No follow-up attempts are possible. No further information is expected.
swollen lymph node on the underarm of the injection arm/lymph node was still swollen and painful; swollen lymph node on the underarm of the injection arm/lymph node was still swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 13:30 (Lot number: EW0153) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; SYNTHROID; ASPIRIN [ACETYLSALICYLIC ACID]; ZYRTEK. Past drug history included: Zocor, reaction(s): "allergies", notes: known allergies: zocor; Sudafed, reaction(s): "allergies", notes: known allergies: sudafed. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, lot number= EN6207, administration time= 04:30 PM, dose number= 1, vaccine location= Left arm), administration date: 23Mar2021, when the patient was 60 years old, for Covid-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "not recovered", described as "swollen lymph node on the underarm of the injection arm/lymph node is still swollen and painful". The event "swollen lymph node on the underarm of the injection arm/lymph node is still swollen and painful" was 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 lymphadenopathy.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed a swollen lymph node on the underarm of the injection arm; it's been almost two months, and the lymph node was still swollen and painful. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. Patient had covid test post vaccination= PCR on 01Jun2021 with negative result (Nasal Swab). The event was reported as non-serious and event not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect.  Follow-up attempts are completed. No further information is expected.
Rash - started on 12/5 around the neck in the morning. noted the full body rash from ears to toes (literally toes). Runny nose and cough that started  on 12/5 as well. We just kept watch on it, and reported to her doctor. We decided it could be a reaction, but also could be a winter viral infection
I felt like I was high and I was warm. I was having shooting pain in my appendages. I also had pain in my left side. I called the nurse care line and was advised to put ice on my lymph node and take some Tylenol. I was also advised to monitor my heart rate due to being extremely. It resolved itself after about 6 hours.