chrisvoncsefalvay/vaers-outcomes huggingface dataset:
spontaneous Vertebral artery dissection in both left and right arteries within two weeks of receiving the second dose; This resulted in a stroke; This is a spontaneous report from a contactable consumer (patient).  A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left at the age of 37-year-old in May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Facility type of vaccine was Hospital. Medical history included Chronic regional pain disorder, orthostatic hypotension, COVID-19 (prior vaccination). Patient was not pregnant. The patient's concomitant medications were unspecified drugs (The patient received other medications within 2 weeks of vaccination). The patient previously took first dose bnt162b2 (Location of injection: Arm Right; Vaccine Administration Time: 12:00 PM) at the age of 37-year-old in Apr2021 for COVID-19 immunisation, acetylsalicylic acid (ASPRIN) and experienced drug allergy, NSAIDS and experienced drug allergy, clarithromycin (MACROBID) and experienced drug allergy.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced ''spontaneous Vertebral artery dissection in both left and right arteries within two weeks of receiving the second dose. This resulted in a stroke.'' (hospitalization, disability, life threatening) on 17Jun2021. The patient was hospitalized for events for 2 days. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of events (Radiology of varying sorts, anticoagulation, ICU). Ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. The outcome of events was recovered with sequelae in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a seven-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 06-Feb-2011. On 09-Feb-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 11-Mar-2011 and incorporated into case: no late occurring adverse events.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly stored doses of M-M-R II (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Patient was given accidently given a mixed series. Patient had Pfizer vaccine as a first dose and received Moderna vaccine as a second dose. Patient reported dizziness during the 15 minute observation period on 05/15/21. He drank water and started to feel better. On 05/16/21 patient had a low grade fever. Pt has felt fine since then.
History of Present Illness  Patient is a 68 year old man known to Dr at Oncology. He is followed for CLL. He was last seen on 12/9/21 with WBC of 84K. He has been asymptomatic and plan was for Acalabrutinib should he need treatment. Yesterday, he presented  with worsening shortness of breath. He was recently diagnosed with COVID on 1/27. He took a Z pack with improvement. Outside CXR was done and he reports this was normal. His oxygen saturations dropped in the 80's while sleeping in ED. He is requiring 2LNC. CXR showed edema and atypical pneumonia. Azithromycin and Rocephin started. We will admit for further management.
swelling on the base left neck, injection swelling and soreness, nausea, fever, shivers, muscle aches, fatigue
10-15 chicken pox lesions. DX Chicken pox 03/07/2006, post varicella vaccine 10/24/2000, TX Acyclovir.
SMALL CLUSTER OF PAINFUL HERPES LESIONS (FLUID FILLED PUSTULES) NOTED TO LEFT LATERAL LOWER LEG APPEARED 3 DAYS AFTER RECEIVING FIRST DOSE OF COVID PFIZER VACCINE
(M,61-65 years old) did not respond significantly to any of the tested streotypes; This spontaneous report was received from a non-peer reviewed article referring to a male patient aged from 75 to 80. The patient was not vaccinated with any pneumococcal vaccines before and no history of previous pneumonia. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On an unknown date (reported as "during the 2017 and 2018 seasons"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) to prevent pneumococcal infections.  The patient did not respond significantly to any of the tested stereotypes (therapy non-responder). The outcome of the event, and the causal relationship between therapy non-responder and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) were not reported.    This case was received from the same reporter with 2305USA002183, 2305USA003459, and 2305USA003460.
Patient was brought to the ED for a fall. Work up including CT of head imaging. Normal imaging. He was found to have left basilar infiltrate. He was COVID PNA positive. Decadron started. ID consult. Patient is fully immunized for COVID. Mild symptoms. Decadron stopped. Patient improved clinically. He was discharged back to the group home with instructions to follow up.
Sore arm (+) supraclavicular large tender L-N. Same arm 1 day later.
Extreme pain in the kidneys; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered in left arm on 01Feb2021 18:30 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not test covid-19 positive prior to vaccination. The patient had not been tested for covid-19 since the vaccination. Other vaccine date detail was reported as same date vaccine date 01Feb2021. The patient experienced extreme pain in the kidneys on 02Feb2021 16:30. No treatment was received for the event. Outcome of the event was reported as not recovered at this point of time.   Information on the lot/batch number has been requested.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
FORGOT TO TAKE THE SECOND DOSE OF VIVOTIF ON DAY 3; This spontaneous case report (PVX2019-2728) was received from a consumer on 04-Nov-2019. It described a male consumer who "forgot to take the second dose of Vivotif on day 3" (PT: Product dose omission), while being on oral Vivotif for typhoid fever.  Case report: It was reported that the consumer forgot to take the second dose of Vivotif which was scheduled on 03-Nov-2019.  Action taken with Vivotif with respect reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take the second dose of Vivotif on day 3" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take the second dose of Vivotif on day 3" was considered as not applicable.
Fever (100.1), extremely cold, dry mouth, exhausted, achy joints, headache.  Started at around 0400, 02Mar2021.  Morning temp was a 99.1 then elevated during the day.  By night time at around 2200, 02Mar2021 the temp started going down 98.1.  By 0500, 03Mar2021 the temp went down to 97.8.
In December 2020, my CT scan showed no cancer - as did the CT scans for the previous 3 1/2 years.  In May 2021, my CT scan showed the cancer returned.  Is there a correlation?
This spontaneous report as received from a nurse refers to an 11 month old female patient. On 08-MAY-2013 the patient was vaccinated with MMR II (strength, route, lot number and expiration date not reported) VARIVAX (strength, route, lot number and expiration date not reported) and VAQTA (strength, route, lot number and expiration date not reported) because she was going to be traveling out of the country. No symptoms were reported. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Intense pruritic rash started 1-2 h after first vaccine dose. Diffuse, blister-like lesions on upper arms and inner thighs. Did not receive second vaccine dose.
Inflammation and tenderness in one breast,  I?m very concerned because I have implant removed 6 months ago with breast lifting and fat grafting to breast, the tenderness and inflammation haven?t improved as today?s day. 4/4/2021
Went to ER with severe vomiting. Ultrasound found intussusception.
The day after Pfizer vaccine dose #1 pt c/o burning sensation to the chest, shortness of breath, fatigue and rapid heart beat. Same symptoms except for the rapid heart beat persisted until pt presented for dose #2 on 9/11/21- pt was informed he should seek medical attention to r/u cardiac involvement (myocarditis/pericarditis).
At 6:30 on Jan1 - painful irregular contractions continued despite hydration/tylenol - went to ER and they put me on monitor - normal fetal heartrate; observed contractions but were irregular. Discharged with pain medication and observation. Told to monitor contractions and if they became regular and within 5 min. to come back.  Continued to have some irregular and painful contractions but they are very infrequent so haven't had to go back to be monitored. Had a subsequent folow up with OB  (for a routine scheduled appt) and everything normal.  Due date: Feb. 5 and uneventful pregnancy; no abnormal ultrasounds.
muscle pain; This is a spontaneous report based on the information received by Pfizer from Merck Center (Manufacturer Report Number: 01214239). A contactable consumer reported that a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced muscle pain on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected.
Felt a little achey and a sore arm; This is a spontaneous report from a contactable consumer. An adult female patient of unspecified age was received first dose of BNT162B2 (Brand: Pfizer/BioNTech, lot number: unknown) via unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. It was unknown if other vaccine in four weeks. Patient felt a little achey and a sore arm on 21Dec2020. It was unknown if the patient diagnosed with COVID-19 prior to vaccination, it was unknown if the patient been tested for COVID-19 since the vaccination (unknown covid tested post vaccination). It was unknown if treatment received for the event. Outcome of the events was unknown. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.  Information on the Batch/Lot number has been requested.
Ears felt clogged, slight feeling of swelling in throat  that lasted about two hours.  Did not go to doctor.
Low count platelets; Convulsions after vaccination without lose of consciousness; A spontaneous report was received from a pharmacist concerning a 22-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced convulsions without loss of consciousness and low platelet count.  The patient's medical history was not reported.  Concomitant medications were not provided.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 28 Dec 2020, after getting vaccinated, the patient immediately started to experience tremors and shaking all over his body which was described as convulsions without losing consciousness.    On 05 Jan 2021, the patient had a blood test that showed a low platelet count. No treatment information was provided.  Action taken for the event was not reported.  The outcome of the events, convulsions without loss of consciousness and low platelet count, was considered unknown.; Reporter's Comments: This case concerns a 22-year old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected medically significant event of Convulsions without losing consciousness immediately after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Additionally, the patient experienced an unexpected non-serious event of Platelet count decreased. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Intense muscle and joint pain, fever of 102 degrees for 24 hours, nausea, fatigue, migraine-like headache
Patient received injection 8/23/11: 8/24/11 reports, soreness in arm. 8/25/11 had extreme pain, redness extending to mid forearm, difficulty lifting arm or bending fingers, and fever > 105 degrees patient went to local ER, reports was given IV medication, unsure of what meds. Pain completely resolved by 8/28/11. All effects felt only in left arm.
Broke out in big mass; Drug effect decreased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4357422-00 (Company).  A 57-year-old female patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Drug effect decreased"; MASS (medically significant), outcome "unknown", described as "Broke out in big mass". The action taken for adalimumab was unknown.  The reporter considered "broke out in big mass" and "drug effect decreased" related to BNT162b2.  Clinical Course: On an unknown date, the patient experienced broke out in big mass. In 2021, the patient experienced Humira stopped working. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown that if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab), The reporter' s causality for the event (s) of Broke Out in Big Mass and Humira stopped working was not provided. Causality for Pfizer BioNTech Covid-19 Vaccine Drug (Tozinameran), Unknown, Unknown, Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events mass and therapeutic product effect decreased and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Concurrent medical conditions included Lyme disease and Penicillin allergy. Concomitant products included VITAMIN D NOS, CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) and VITAMIN B COMPLEX for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (sore muscle in shoulder). On 24-Jan-2021, the patient experienced BURNING SENSATION (Burning sensation in arm) and VACCINATION SITE RASH (red rash on arm). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Vaccination site soreness) and TENDERNESS (Tenderness under arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (Burning sensation in arm), VACCINATION SITE RASH (red rash on arm), MYALGIA (sore muscle in shoulder), VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Vaccination site soreness) and TENDERNESS (Tenderness under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included  icepacks.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Patient demography updated, patient history updated, concomitant medications were updated, events were updated. On 19-Jun-2021: No new information
Swelling from groin to knee on anterior and medial left thigh. Treated with prednisone.
This spontaneous pregnancy report as received from a registered nurse refers to a 25 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1, .5 ml GARDASIL on 02-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The LMP and EDD is not known. Initial exposure to GARDASIL was at "6 weeks". The patient was exposed to GARDASIL during trimester 1. The outcome of drug exposure during pregnancy is unknown. Drug exposure during pregnancy is not related to GARDASIL. Follow up information has been received. Estimated date of delivery was reported as 2013. Additional information has been requested.
I was 12 weeks pregnant with twins at the time of vaccination. 2 days before the vaccine I had an appointment with my doctor and they said they were healthy I had no complications. My due date is 09/20/2021. On 3/10/2021 I got the vaccine in the evening and about 12 hrs later on 3/11/2021 in the morning one of the babies bag broke. I went to the ER. They did blood work and an ultrasound. They sent me back home. I had a follow up appointment with my doctor on 3/15/2021 and she said I will most likely end up having a miscarriage. Since then I see a  high risk pregnancy doctor every week. During the visits they noticed there was still a small fluid left on the sack but today 4/8/2021 that I went to the doctor they said the baby's heart beat had dropped.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-313106 (Patient Link).
CHILD VOMITED AFTER 7 A.M. FEEDING THEN AGAIN AFTER 11 A.M. FEEDING ON 2/28/13.
Pt states she didnt eat much all day, she became nauseous from the smell of food from in store deli and threw up and had substantial bleeding from her nose, Pt was alert when I arrived on scene, no epi pen was needed, Pt states she almost passed out.
p/vax pt started having mild rt arm (site) pain 10/14/99;woke 10/15/99 a very sore, swollen, red arm & nausea, rt side of neck was also sore;t99.0 po;
FEVER; HEADACHE; ARM PAIN; This spontaneous report received from a patient via a company representative concerned a 25 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain on APR-2021, and was recovering from fever, and headache. This report was non-serious.
Adverse event: Severe itching on neck and hands, bright redness to neck and vaccine site, pain and swelling to vaccine site; feeling jittery; Treatment: taken to the ER;  administered Benadryl, Solu Medrol, Pepcid. Outcome:  Patient is improving after receiving the above medications.
Shingles on the left side of my face, in my left ear and left side of tongue.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 08-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Administered vaccine that was mislabeled with a frozen expiration date rather than a refrigerated date. Vaccine was expired
The shot was given to me in a very flabby part of my arm and resulted in a HUGE red welt that still hasn?t gone away.  I don?t believe it was in muscle at all.  The following day I didn?t feel well just laid in bed, had a headache and spent most of the day in bed.  I felt the same way after the first shot but don?t remember having this big welt.  I am now concerned about the effectiveness of the vaccine.
early appendicitis; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (at the age of 40 years) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient began to have severe abdominal pain so he went to the emergency room and was evaluated and then about 8 am it was confirmed that he had early appendicitis. The event was considered serious for hospitalization. Patient would like to know if his appendicitis diagnosis is related to the COVID vaccine or if it is completely irrelevant. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
O V ZOSTER/HERPES VIRUS,  BENADRYL-MAALOX-XYLOCAINE,  KENALOG IN ORABASE
mom reported that pt cried for 1 1/2 days w/o stopping or sleeping rt p/getting vax;