chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe bradycardia; continual syncope; constant dizziness; kidney surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 68-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose Number: 1), for COVID-19 immunization. Clinical course: since 2 days after receiving his second Covid vaccine, the patient experienced continual syncope events and constant dizziness from then on. The patient had kidney surgery the end of Dec (as reported) and a pacemaker installed two weeks before the report to correct a severe bradycardia (heart would stop often up to 7 seconds. The patient was in excellent health before and he ran a 10K every day. It was obvious the vaccine was the cause The following information was reported: BRADYCARDIA (medically significant), outcome "unknown", described as "severe bradycardia"; SYNCOPE (medically significant), outcome "unknown", described as "continual syncope"; RENAL SURGERY (medically significant) with onset Dec2021, outcome "unknown", described as "kidney surgery"; DIZZINESS (non-serious), outcome "unknown", described as "constant dizziness". Therapeutic measures were taken as a result of bradycardia, renal surgery. The lot number for bnt162b2 was not provided and will be requested during follow up.
vaccination site wouldn't give consumer his second dose due to having an allergic reaction; This is spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient first dose was on 24Mar2021, 15Apr2021 was scheduled for the second dose, vaccination site wouldn't give patient his second dose due to having an allergic reaction, patient did not specify what his allergic reaction was to or from. Outcome of the event was unknown.   No follow-up attempts possible; information about lot/batch number cannot be obtained.
Death. Narrative: Patient received Moderna COVID vaccine #1 on 3/3/21. He is noted to be a dialysis patient. On 3/24/21, his wife took him to a facility ER due to intermittent shortness of breath over the previous week. He was admitted for fluid overload. On 3/27/21, he was found unresponsive and CPR was initiated and a code blue was called. He received defibrillation, epinephrine, IV calcium, sodium bicarb and amiodarone and was intubated; however he did not survive and time of death is recorded as 3/27/21 at 0138. No autopsy results available. 24 days from time of vaccine to date of death.
I had the first vaccine on May 1st and got positive on May 10; This is a spontaneous report from a Pfizer sponsored Program form a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first vaccine on 01May2021 and tested positive on 10May2021 and patient was now (May2021) negative for Covid. Her second shot was scheduled to 24May2021. She would like to know if she could get the second dose or dose she had to wait. The outcome of events was recovered on an unspecified date in May2021.   Information on the lot/batch number has been requested.
11/9/05 - tired, unable to work in garden.  Was able to walk and cook.  Did not feel like doing anything.  On 11/10/05 - eyes hurt and sensitive to light.  Did not see PMD or take Tylenol.  Public health nurse made referral to PMD if necessary.
Swelling at site. Swelling, redness axilla & lat. upper ant chest - infection.
Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the middle of the night with chills; Extremely tired; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscularly on 07Jan2021 10:30 at a single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history included hypothyroidism, hypertension, known allergies: penicillin. The patient previously took first dose of bnt162b2 (lot number: EK5730) via intramuscular on 18Dec2020 13:30 at a single dose in left arm for COVID-19 immunization. There was no other vaccine administrated in four weeks. Concomitant medication included losartan, bupropion hydrochloride (WELLBUTRIN), levothyroxine, colecalciferol (VITAMIN D 3), estradiol (ESTROGEN), and progesterone. On 09Jan2021 15:45, the patient experienced severe low back and hip pain along with general malaise, woke up soaking wet in the middle of the night with chills, and extremely tired. No fever. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No treatment received for adverse event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
103.5 temp, extreme weakness, diarrhea, lack of appetite, going to ER by ambulance
No adverse reactions per patient's mother. Note: patient had received prior dose of vaccine in October accidentally given second dose.
Large; painful; raised; warm; hard; reddened area extending down to elbow of her upper arm; with 1 1/2 blister formed. Given Tylenol PO and ice packs to area to reduce pain and swelling.
Patient woke up Saturday morning with hives and a red itchy rash covering her entire body.  She states it flares up and goes down when she ices it, then pops up again somewhere else.
about 14 hours after receiving vaccine i woke up with chills and very sensitive skin.  i fell asleep again after a couple hours and in morning woke up with nausea and fatigue.  i had an episode of vomiting, and then for the rest of the day i was very fatigued, and had mild intermittent headache.
Patient with no previous immunization allergy or contraindications had a serious adverse reaction the following day at their home. She called the pharmacy and spoke to me about having a reaction that sounded almost like hypoglycemia--shaking, irritability, inability to sleep, etc. I instructed her to go to the ER immediately. She was treated for an allergic reaction to the vaccine and sent home. Will follow up with patient on next shift.
Patient advised us of history of syncope after injections.  We monitored closely after vaccination.  Patient was fine for first several minutes, then began to feel lightheaded and nauseous.  He never lost consciousness, but did vomit a small amount.  Patient was monitored for approximately 30 minutes, felt recovered, and left with wife.  Smelling salts were kept close at hand, but not needed.
A large erythematous reaction on thigh medial to injection site which started 4 hours after injection and seen her at 48 hours.  None tender, central induration.
TINGLING IN LEGS, HYPER HEARING, INNER BURN AND SHAKE.
fell and broke her ankle; fell; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (fell and broke her ankle) and FALL (fell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANKLE FRACTURE (fell and broke her ankle) (seriousness criterion medically significant) and FALL (fell) (seriousness criterion medically significant). The patient was treated with Surgery for Ankle fracture. At the time of the report, ANKLE FRACTURE (fell and broke her ankle) and FALL (fell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment for ankle fracture included surgery.  Company Comment  Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: contact information provided; serious criteria updated for events; Sender's Comments: Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.
booster; Breakthrough covid case; Breakthrough covid case; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 46 year-old female patient (not pregnant) received BNT162b2 (BNT162B2, brand: Pfizer) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported IMMUNISATION (medically significant), outcome recovering, described as booster; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome recovering. The patient underwent the following laboratory tests and procedures covid test result positive. Therapeutic measures were not taken as a result of immunisation, drug ineffective, covid-19.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
respiratory tract infection; Blister like shingles; Cold; Injection site blister; redness; swelling; Blister on a left ankle, both feet and hands/ Injection site blister; This case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract infection in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included antibiotics nos (Antibiotics (Brand Names Not Known)).   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, swelling arm, blister and injection site blisters. On an unknown date, the patient experienced upper respiratory tract infection (serious criteria GSK medically significant), shingles and cold. On an unknown date, the outcome of the upper respiratory tract infection, shingles, blister and injection site blisters were not recovered/not resolved and the outcome of the injection site erythema and swelling arm were recovered/resolved and the outcome of the cold was unknown.   It was unknown if the reporter considered the upper respiratory tract infection, shingles, injection site erythema, swelling arm, blister, cold and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine 4 weeks ago from the date of reporting.  The patient reported that redness presented at the injection site the day of the administration which was resolved. A week later a blister formed at the injection site on her left arm that grew in size and resulted in her arm swelling. Another blister formed on her left ankle the same day. With the past 3 weeks, from the date of reporting, the blisters have spread to both feet and hands.  The patient also reported having an upper respiratory infection in the past two weeks from a cold. She described the blisters as looking like shingles. The reporter consented to follow-up.
I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood sugar dropped in the middle of the night; Sleeping a lot; Confusion; This is a spontaneous report from a contactable consumer, the patient.  A 48-years-old female patient received  bnt162b2 (BNT162B2, Lot Number Unknown)  via an unspecified route of administration on an unspecified date (at 48 years of age) as a SINGLE DOSE for Covid-19 Vaccination , insulin (INSULIN) 'regular Insulin for sliding scale' Lot Number Unknown 'number under the bar code C:1011:1030310691833329. via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin detemir (LEVEMIR) Lot Number 310018652576, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin aspart (NOVOLOG) Lot Number 374934031098, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , semaglutide (OZEMPIC) weekly, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose, weekly for diabetes mellitus.  Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL).  The patient reported  I am diabetic and my blood sugar dropped in the middle of the night, so my husband had to get up and give me something (Unspecified Medication) and then I am sleeping a lot and I do have some confusion on an unspecified date. The patient underwent lab tests that included blood glucose: dropped on an unspecified date. Treatment was given for diabetic and blood sugar dropping.  Consumer also stated, No, it is not that severe The clinical outcome of the events diabetic, blood sugar dropped in the middle of the night, Sleeping a lot and Confusion was Unknown. The action taken in response to the event(s)  for insulin was unknown, for insulin detemir was unknown, for insulin aspart was unknown, for semaglutide was unknown.  The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
Vaccine was administered to a 15 year old patient, who was not indicated to receive the vaccine on 5/3/21.
Patient was administered 0.3 mL monovalent Pfizer vaccine instead of intended 0.3 mL bivalent Pfizer booster.
sore arm for a few days; Initial information regarding an unsolicited valid non-serious case received from a consumer via media and transmitted to Sanofi on 13-Dec-2020.  This case involved an unknown age patient who experienced sore arm for a few days (Pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On unknown date, (latency unknown) Got flu shot every year. Patient reported never had a problem except a sore arm for a few days (Pain in extremity), while received vaccine influenza vaccine.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Patient had a seizure/convulsion immediately after the vaccination. I did not personally see them have the convulsion, but his wife observed this. By the time I had made it to the vehicle he had come to and was fine. Patient was also extremely anxious about receiving the vaccination. We believe his anxiety may have manifested as a seizure/convulsion in some way. No other issues or allergic reactions.
At 15 post vaccination patient complained of numbness in her left arm. Patient denied chest pain, dizziness, difficulty breathing,  blurred vision or pain.  Patient was evaluated by RN, vitals obtained, no signs of swelling, arm elevated at heart level. Patient alert and oriented, Range of motion within normal range.  Circulation check at fingers conducted, all within normal range. Vital within normal range. Patient observed for 30 additional minutes. Vital repeated at 10:20am, all within normal range. Patient verbalized numbness is less, circulation check normal. Patient left observation area at 10:30 with no signs of distress. Patient advised to continue to monitor any change in symptoms on contact clinic or PCP with any changes. Patient verbalized understanding.
Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L038132, expiration date 01-OCT-2017 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA008502: US-009507513-1709USA008504: US-009507513-1709USA008503:
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-MAR-2015 the patient was vaccinated with an expired dose of M-M-R II (batch# H018948, lot # 1646AA, expire date 18-OCT-2014, 0.5 ml) subcutaneously. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Mom was feeling fine the day of the vaccine.  Last spoke with her at 6:30 PM and she said she wasn't feeling anything but would go to bed early.  I said OK I will check on you in the morning.   She never woke up!
Tdap vaccine expired 9/9/2023. Pt received vaccine 9/18/2023. No noted adverse side effects.
Patient  transferred from  emergency room after CTA head/neck obtained for new onset left-sided weakness demonstrated multiple intracranial vascular abnormalities. Differential diagnosis for her clinical presentation include sentinel subarachnoid hemorrhage from rupture of one of the aneurysms, possibly the left anterior choroidal artery origin lesion versus small, subacute hemorrhage into the right pontine lesion. She underwent endovascular treatment of the left anterior choroidal artery aneurysm with coil embolization - treated and discharged. ED visit and hospital admission within 6 weeks of Receiving the COVID vaccine.
sister had reaction after 1st dose diagnosed with Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: PERICARDITIS (medically significant), outcome "unknown", described as "sister had reaction after 1st dose diagnosed with Pericarditis".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
9 days after the shot, little bit warm where I got the vaccine (delayed reaction); 9 days after the shot, red spot 2 inches high and 3 inches wide where I got shot (delayed reaction); Feelimg tired; arm hurt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (9 days after the shot, little bit warm where I got the vaccine (delayed reaction)), FATIGUE (Feelimg tired), VACCINATION SITE PAIN (arm hurt) and VACCINATION SITE ERYTHEMA (9 days after the shot, red spot 2 inches high and 3 inches wide where I got shot (delayed reaction)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (Feelimg tired) and VACCINATION SITE PAIN (arm hurt). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (9 days after the shot, little bit warm where I got the vaccine (delayed reaction)) and VACCINATION SITE ERYTHEMA (9 days after the shot, red spot 2 inches high and 3 inches wide where I got shot (delayed reaction)). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (9 days after the shot, little bit warm where I got the vaccine (delayed reaction)), FATIGUE (Feelimg tired) and VACCINATION SITE ERYTHEMA (9 days after the shot, red spot 2 inches high and 3 inches wide where I got shot (delayed reaction)) outcome was unknown and VACCINATION SITE PAIN (arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: iNarrative supplement updated, reporter details updated
Information has been received from a physician concerning a patient who on 19-MAY-2009 was vaccinated with a dose of VARIVAX (Merck) due to an office error.  No adverse reaction reported.  Additional information has been requested.  Follow-up has been received from the physician who stated that there was no adverse effect to reported.  "The patient was fine."  Additional information has been requested.