chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizures. Had first obvious seizure on November 11. However, likely had less obvious seizures a few days prior. Subtle symptoms so exact timing is difficult to say. Went to the ER on November 26 for suspected seizures. Patient was admitted to hospital and did a 48 hour video EEG. 2 focal seizures noted on EEG. Discharged from hospital and put on trileptal. Patient is currently still taking trileptal and is not having apparent seizures. Unsure at this point if seizures have stopped due to medication or if the seizure activity has resolved. Appointment with neurology scheduled for February.
Vasovagal Syncope episode 5 minutes post injection seizure with full body shaking and electrical shock like feeling throughout body. Amnesia and confusion
Patient fainted after vaccines while watching other family members get the vaccine. He did fall into a wall and and hit his head and then fell to the floor, but quickly regained consciousness. Out of caution, he was transported to a local ER for evaluation.
WAS TIRED..NEEDED NAP. THIS WAS AFTER MY BOOSTER SHOT DUE TO NO SPLEEN (IMMUNOCOMPRIMISED)
no adverse event; expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 96-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    Patient 's age was reported as 96 year 10 months.  No concomitant medications were reported. No treatment information was provided. ID was reported as 80777027399.  The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022
Information has been received from a physician concerning a female pt who was vaccinated SC with a dose of varicella zoster virus vaccine live. Subsequently the pt experienced a varicella like rash on both arms. Unspecified medical attention was sought. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested. Additional information from the registered nurse indicatedthat on 9/16/06 the patient developed a bilateral lower extremity rash. No cough, SOB, abdominal pain, nausea/vomiting, fever or pain was noted. Upon examination on 9/18/06 one vesicle was noted, others were macules/papules on the lower extremities. the patient also complained of itching. No adverse reactions were noted at the injection site. The deltoid was without redness or swelling. Recommendations included calamine lotion and avoid contact with others. The patient was instructed to go to the emergency room if SOB or temperature occurred. On 9/20/06 the patient was seen for follow-up, the rash was fading/drying on the lower extremities. No new lesions noted and temperature maximum 97.9. No other laboratory tests were performed. Subsequently the patient recovered in approximately 10 days. It was reported that the patient had a history of chickenpox at 7 years of age. There was no recent exposure to chickenpox or herpes zoster. The patient has had no adverse reactions with prior vaccinations. No further information is expected.
My vaccine was given too high in my shoulder. I have been having problems lifting my arm in certain positions, especially across my body and above my head and is causing pain still today. I have not seen a doctor yet, but I am planning on going to be evaluated for SIRVA.
Blood clot; Left leg pain; Discoloration (blue-purple); Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Clot blood in 2010. Concurrent medical conditions included Drug allergy (Dalaudid, Ambien and Demerol) and Hypertension. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE (AMARYL), ACETYLCARNITINE HYDROCHLORIDE (NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]), COLECALCIFEROL (CALTRATE VITAMIN D DAILY), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and VITAMIN D NOS for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain) (seriousness criterion hospitalization), SKIN DISCOLOURATION (Discoloration (blue-purple)) (seriousness criterion hospitalization) and SWELLING (Swelling) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was sent to hospital to remove clots. The patient stated that the clot was 2/3 size of thigh.  The patient scheduled to have a second procedure in May to remove blockages from iliac.  Action taken with mRNA-1273 was not applicable.   Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.
Neurological issues, unable to perform normal duties at work. Have a CT brain scan scheduled 2/16/2021@ 11:40am
Chest and left arm pain occurred the night of 6/18/21 with NSTEMI noted (elevated troponin with no acute ischemia on EKG). Thought to be from myocarditis. Patient started on aspirin and metoprolol as per Cardiology consult.
inappropriate administration of ACTHIB to a patient after it had expired with no reported adverse event; Initial information was received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported inappropriate administration of hib (prp/t) vaccine [ACT-HIB] after it had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect hib (prp/t) vaccine powder and solvent for solution for injection (lot UJ584AAA, expiry date - 16-Oct-2022) via unknown route in unknown administration site (strength, dose, frequency: unknown) for Immunization.  On an unknown date the patient reported a non-serious event of inappropriate administration of hib (prp/t) vaccine after it had expired with no reported adverse event (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
peed on sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0178) via an unspecified route of administration in the left arm on 25May2021 at 18:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient peed on his sleep, it never happened in his life before. The patient reported that if the patient had a need to pee while sleeping he suddenly wake up and go to pee, after 3 days of first dose he peed on his sleep and it happened only one time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event peed on sleep was recovered on 28May2021.  No follow-up attempts are possible. No further information is expected.
SIMPLE PARTIAL EPILEPSY, INTRACTABLE EPILEPSY, UNSPECIFIED OBSTRUCTIVE SLEEP APNEA
Information has been received from a pharmacist concerning a 66 year old female who on 21-JUN-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. It was reported that the patient developed a bruise at an injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Very sensitive skin; body/joint aches; body/joint aches; Headache; Tightness; Fast heart rate; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6206) via an unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis of neck. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lorazepam (ATIVAN), fluticasone propionate (FLONASE), omeprazole (OMEPRAZOL) and montelukast sodium (SINGULAIR) all for unknown date for unknown indications. The patient received tetracycline (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, reportedly experienced all after second shot; very sensitive skin, body/joint aches, headache and now almost 2 weeks after shot - patient was having check tightness and fast heart rate--- went to ER to check out and all ok with heart but not sure why had tightness. On an unknown date in Apr2021, the patient underwent blood test, ECG and x-ray and the results were unknown. The events of tightness and fast heart rate resulted in emergency room/department or urgent care. The clinical outcome of the events of sensitive skin, body ache, joint ache, headache, tightness and fast heart rate was recovered with sequelae on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
High fever 102.4-102.9 ,  nausea and vomiting, muscle aches, headaches, no appetite ,fatigue,, and dizziness on Feb 10 and 11th. Also sore and bruised arm that lasted almost 2 weeks.
Itchiness and scab on skin where shot administered; heart beat faster than usual by abt 10 beats/min; weakness; general "awful" feeling, headache, dizziness
Approx 5 min. after receiving immunizations, fell to floor and began seizing. Legs stiff, hands clenched, elbows bent with forearms up to chest. Lasted approx 15-20 sec. Alert as soon as "came to" 140/80 pulse 85 SPO2 98% BS - 85 had not eaten lunch. (Guardian reported pt has seized in past when coming down with flu). EMS called and arrived.
after receiving the vaccine, she started bleeding heavily and is still currently bleeding; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, a dispatch operator for a hospital, reported that she received the COVID vaccine a week ago on 22Dec2020. She stated that her period stopped two days prior to receiving the COVID vaccine. On 22Dec2020, after receiving the vaccine, she started bleeding heavily and is still currently bleeding. The patient wanted to know what she should do to stop the bleeding. The clinical outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Patient reported numbness in mouth.  Patient asked for water and stated that this happens when she hasn't eaten but it is resolved by taking meclizine.  The patient caretaker was not aware of this though.  We gave the patient a bottle of water and offered the patient peanut butter cracker however patient declined the crackers.  Also, gave patient 10ml benadryl and asked patient to remain an additional 15 minutes for observation.  Patient said the symptoms were resolving after about 8 minutes and was ready to go, but patient remained in pharmacy the additional 15 minutes.
Patient may have received Pfizer as second dose in series instead of Moderna. Patient completed observation period without incident.
Swollen lymph node on right side of upper neck, parallel to ear. began 3 days following first shot and lasted for two days. Slight sharper pain in left side of chest occurring a few times throughout the day. Began the day after first shot. Feels like a muscle spasm. Twitching of eye lid on left side beginning 3 days from this date. It is not constant, but comes and goes.
Pt states next day after Influenza vac administration on 10/4/10; developed nausea, vomiting, severe weakness, headache, chills, sx lasted for 3-4d.
The clinic gave me the shots --But the doctor at Medical Center checked by hearing losss. Shoulders hurt very bad and could not sleep on side. Still hurt now.  My hearing went bad between my two shots.  I did have hearing add's but after shots it really got bad and Doctor says I am a candidate for hearing implants now.
8 days after injection the injection site had red bumps and itching within approximately 3 inches
had a miscarriage after being around someone that had the Pfizer vaccine: Unspecified; had a miscarriage after being around someone that had the Pfizer vaccine: Unspecified; This is a spontaneous report from a contactable consumer or other non hcp. This is a spontaneous report received from a contactable consumer. This consumer reported for a female (neighbour patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced had a miscarriage after being around someone that had the pfizer vaccine on an unspecified date. The mother reported she became pregnant while taking bnt162b2. Reporter is calling regarding the Pfizer Covid 19 vaccine. She has been doing some research and her neighbour and her mother had the Pfizer covid virus vaccine. Reporter gave them a ride to pick up their car, which is about 15 minutes from her house. Ever since she gave them a ride , she (caller) has been having really horrible and very massive headaches. She has never had so much pain over her head in her life. Reporter had done some research and unfortunately, she was supposed to stay away from them. They were in her car. She got their spiked proteins and now could have inflammation in her brain, which is causing neurological brain damage by being in a confined area with someone who got the Pfizer vaccine. Report 3 of 3 is for the female that had a miscarriage after being around someone who had the Pfizer vaccine. The outcome of the event was unknown.  Information about batch/lot number has been requested  Follow-up (14Jul2021): 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 completed. No further information is expected.
Large local reaction to right arm extending below the elbow. Edema, warmth to touch, joint pain to right shoulder, elbow, and wrist present. Stiffness and limited range of motion noted. Rigth axillary edema noted upon elevation of right arm for 30 minutes or more.
There has been controversy about Hep B vaccine and Multiple Sclerosis.  Pt received the vaccine and several years later has now been diagnosed with MS.
Starting at 10pm fever and chills until 6am. Also headache and arm pain. Elevated heart rate started at 9pm and has persisted for 12 hours. Heart rate between 100-120 all night long, even while asleep. Usual number is between 50-70.
High fatigue; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and hazelnuts allergy. Concomitant medications included salbutamol (ALBUTEROL INHALER) and PORTIA birth control pill, both for an unknown indication and from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 04:45, the patient experienced high fatigue and injection site pain for 72 hours The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event high fatigue was recovered on an unknown date in 2021; while that of the event injection site pain for 72 hours was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Patient was feeling nervous after receiving vaccine. Patient said she didnot want EMS, just needed to sit down. Patient blood pressure is dangerously low and might need some fluids. patient refused and said she was fine. Patient signed refusal form and walked away.
This spontaneous report as received from a physician, via a company representative refers to a female patient of unknown age "who is over 60 years old". The patient had a history of "multi-melanoma remission patient". On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported). On an unknown date "two weeks after the patient received ZOSTAVAX", she developed shingles. On an unspecified date, the patient was admitted to the hospital in regards to this reaction. It was reported that no intervention to prevent serious criteria was needed. At the time of the report, the patient was recovering from the event of shingles: "she was ok". Additional information has been requested.
Patient said it felt like her throat was sore and tight. She called and spoke with her MD who advised her to take Benadryl. She did this every 4 hours until around 1am when she was starting to feel better
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.8 degrees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M204) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.8 degrees). On 09-Feb-2021, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.8 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 101.8 (Inconclusive) body temperature 101.8 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt recvd 1st dose of Engerix on 15JUL81; 11NOV91 pt exp burning during inject which cont for a few hrs; dose 2 of Engerix-B was administered 14NOV91 (?11NOV91);
6 hrs p/vax pt became limp, pale, lethargic-tachypneic; t102.2 R; given APAP & cool compress;
PATIENT CALLED ME ON 11/08/17 STATING THAT HIS ARM STARTED HURTING 2 WEEKS AFTER HE GOT THE SHOT AND IT'S GOTTEN TO A POINT WHERE HE CAN'T EVEN LIFT HIS ARM TO EVEN DRIVE. HE HAS BEEN DOING THE WARM COMPRESS AND ADVIL BUT STILL THE PAIN HASN'T GONE AWAY.
got covid in between the shots; got covid in between the shots/was currently asymptomatic; This is a spontaneous report from a contactable consumer reported for a female patient (mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetic, high blood pressure from an unknown date, both were controlled. The patient's concomitant medications were not reported. The patient got covid in between the shots in 2021, but had since been doing better and was currently asymptomatic. Outcome of event was unknown. Reporter wanted to know when her mother (patient) can receive the second dose of the vaccine.  Information on Lot /Batch Number has been requested.