chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; diarrhea; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 14Apr2021 (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 following information was reported: NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nausea"; DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "diarrhea".  Additional information: The events were reported as non-serious. The patient was asking if she could take any OTC medications for the events she was experiencing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT RECEVIED VACCINES AT 1050 IN OUR OFFICE, PATIENT WAITED 30 MINUTES AFTER VACCINES WITH NO S/SX OF REACTIONS. AT 1220 DAD CAME IN WITH PATIENT WHO WAS REPORTING FEELING DIZZY, HEADACHE, FEELING LIGHT HEADED. PATIENT WAS HAVING A HARD TIME KEEPING EYES OPEN. CLOSE TO PASSING OUT. PATIENT WAS SHAKING AND PALE. ALSO C/O ARM PAIN
Pt was standing in x-ray dept waiting for sibling and suddenly leaned against doorway and slid to ground. Pt quickly awoke and sat in wheelchair by time nurse arrived. Cold ice pack placed behind neck. Pt sat in chair for approximately 15 min had some orange juice then left.
12/25/2021: Event occurred after 2nd vaccine. 83-year-old male who comes emergency department today for shortness of breath. as feeling okay and then today became short of breath and he went to the ER to be evaluated.
abnormal bruising since vaccine in October; brain fog/feeling unable to think clearly often  after vaccine
pt recv vax & stated that did not feel good;pt told to sit down & put head down between knees;mom stated felt limp, blacked out for 3sec & started to cry;
The injection was given subcutaneously.   The next day developed a redness and swelling at the injection site which has continued getting larger
Day 1 - an hour after injection, on arm of injection, painful eflbow and wrist pain 7 out of 10, lasted about 4 hours. Narrative:
Rash on buttocks to back of knee on left leg, itching; occurred next day after ZOSTAVAX.
Initial misuse report received from a health care professional on 03 January 2014. A patient had received a third dose of ACTHIB, DAPTACEL on 19 October 2013 and fourth dose on 2 January 2014. It's an inappropriate schedule of vaccine administered. No adverse event was reported. List of documents held by sender: none
Pt with undiagnosed SCID was given ROTATEQ on 4/11/14. Pt age was 6 wk 3d at time of vaccine. Pos SCID screen received in office on 4/17/14. Pt's care was transferred to another Dr. R/T SCID dx.
I broke out in hives behind my ears and neck. Left arm swelled up twice the normal size.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication.
My arm was sore about 5 hours later.  About 6 hours later, my whole arm down to my fingers was numb and tingling.  About 7 hours after vaccine, my feet got red, swollen, and itchy.
Patient walked into health dept to report she was seen at urgent care by A.P.N. and was treated with antibiotics x 7 days and steroid dose pack for her left arm where she received vaccine, area is still hot, red, itchy and lumpy area over vaccination area. Pt. was seen at urgent care for this red painful arm.
high heart rate at rest (approx 150; Chills; fatigue; migraine; pulse ox; shortness of breath; very vivid dreams; sweats like a fever; sweats like a fever; could not function; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: 33030BD) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8735), administration date: 07May2021, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0150), administration date: 16Apr2021, for COVID-19 immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 20Nov2021, outcome "recovering", described as "high heart rate at rest (approx 150"; CHILLS (non-serious) with onset 20Nov2021, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovering", described as "fatigue"; MIGRAINE (non-serious) with onset 20Nov2021, outcome "recovering", described as "migraine"; PULSE ABNORMAL (non-serious) with onset 20Nov2021, outcome "recovering", described as "pulse ox"; DYSPNOEA (non-serious) with onset 20Nov2021, outcome "recovering", described as "shortness of breath"; ABNORMAL DREAMS (non-serious) with onset 20Nov2021, outcome "recovering", described as "very vivid dreams"; HYPERHIDROSIS (non-serious), PYREXIA (non-serious) all with onset 20Nov2021, outcome "recovering" and all described as "sweats like a fever"; IMPAIRED WORK ABILITY (non-serious) with onset 20Nov2021, outcome "recovering", described as "could not function". Therapeutic measures were not taken as a result of heart rate increased, chills, fatigue, migraine, pulse abnormal, dyspnoea, abnormal dreams, hyperhidrosis, pyrexia, impaired work ability.  Additional Information: It was reported that name of drug as reported was no with reaction: allergy. Seriousness criteria was reported as no for death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Reporter stated that I had only minimal reactions with the first two shots. I won't be getting a fourth shot! Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with a subcutaneous first single dose of Zostavax (Oka/Merck).  Subsequently the patient developed a rash on her arm at the injection site about a week after vaccination.  It was noted that the patient was gardening at the time she noticed the rash.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concomitant medications were reported.  On 18-FEB-2017, the patient was vaccinated with a single dose of improperly stored VARIVAX, subcutaneously for prophylaxis (the lot # for which was reported as M0038859 with an expiration date of 14-SEP-2018; however, the dose, frequency, dosage number, and anatomical location were unknown). The vaccine had experienced a temperature excursion of 40 F for a time frame of 24 hours. No previous temperature excursions had occurred and the stated one was called because of a data logger. Despite this, no adverse effects were reported. Additional information is not expected since consent to contact the patient's physician was denied.
pt recv vax & exp muscle weakness, pain in the lower extremities & chest pain;pt contacted the MD for eval the following day who observed pt walk to be unstable & c/o h/a;pt exp dysequilibrium & leg weakness;pt had excessive water drinking;Annual follow-up received 10/02/00 states that the pt has recovered.
pt recvd vax 9FEB95 & arm was sore & pt blacked out p/leaving facility while shopping w/mom; states was nauseated riding home from shopping; pt states devel a react to vax c/o h/a, nausea & blacked out;
Yesterday had no energy, real tired, heart beat rapid. Not normal for him. Slept yesterday a few hours. and then again at night.  Called facility and they stated that he should go to ER if needed and to call VAERS to report AE.  Patient is a DOD Firefighter.
Neck pain/ spasm left sided  - severe pain that lasted 1 week - moderate pain that lasted 2-3 additional weeks... mild issue still  Left-sided - Ear / Jaw and face pain started about 20 mins after vaccine and lasted 3-4 days
The next week my pulse was pounding, I could feel my heart work hard especially at night. i had tenderness in the perineum, achy teeth, overall myalgia and fatigue.
Experienced atrial fibrillation- after leaving site. Went to Hospital and without treatment, restored heart rhythm after several hours and was released to follow up with primary doctor
Large Red swollen itchy hot painful lasting for  15 days and still going on. Started antibiotic on day 11
erythema @ inject site is reported in a pt who recvd 1 dose of fluogen vax;
Shivering, chills, headache, body ache for two days after second injection.  Know at least three other associates who experienced the same condition day after their second injection. Responsive to  acetaminophen and ibuprofen.
severe left shoulder pain: seen by orthopedics.  the injection was placed incorrectly leading to bursitis
I have been suffering from extreme allergies as of 24 hours after the second shot.  constantly runny and stuffy nose.  sneezing , unable to sleep at night due to congestion.  no fever this is not a cold as it has persisted for 2 months.
brief shallow coughing with wheezing and slight inability to catch breath; brought on by episode of laughing- entire experience was singular
Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, frequency, lot# and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back aches; feeling clammy; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248, expiration date unspecified), via an unspecified route of administration on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 21Dec2020 and experienced fever, chills, myalgias, and some sensory changes to the left arm; and vancomycin and experienced allergies. On 11Jan2021, the patient experienced dyspnea and myalgias following her second vaccination today. It was reported that she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain was moderately severe and worse with deep inspiration. Patient was also having back aches and was feeling clammy. Patient represented to the vaccine site and was brought to the emergency room department/urgent care for evaluation. Patient denied any history of vaccine associated reactions. The patient received therapy for the events which included acetaminophen, ketorolac and intravenous (IV) fluids. The patient had no other vaccine in four weeks. Outcome of events was unknown.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. 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.
Febrile Seizure approximately 4-5 over course of 2 hours with accompanying fever.
large swelling beneath armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Oct2021 08:30 (Lot number: FD0809) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3249, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Jan2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 08Oct2021 08:30, outcome "not recovered", described as "large swelling beneath armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US020012, is an initial spontaneous report received from a pharmacist on 07 Oct 2015. This report refers to a 28-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1514501) intramuscularly on an unknown date. On 04 Oct 2015, she experienced severe pain and rash at the injection site on the top of arm, swelling at the injection site on the top of whole arm. On an unknown date, he developed bad itching at the injection site she wants to claw her arm out, warm at the injection site to the touch and swelling hurts to lift her arm up. Symptoms are not localized to injection site only moved to other parts of same arm. The outcome of severe pain, rash and swelling at the injection site was reported as complete recovery on 04 Oct 2015. The outcome of bad itching and warm at the injection site, swelling hurts to lift her arm up was not reported. The seriousness and causality of the events were not reported. No further details provided.
a couple of hrs p/vax pt had a constant high pitched scream for 2 hrs; then went to sleep & woke up smiling & then screamed for 1 1/2 hrs more;
Dizziness, Nausea, low temp (66 degrees F), chills, body aches, swollen & sore armpit lymph node
On 02/20/2023 patient received vaccine ActHIB that had expired 11/30/2022. Patient's mother informed of vaccine error by medical provider and was scheduled to come back for revaccination. Patient seen on 02/22/2023 and revaccinated with vaccine (not expired).  Lot: UJ636AAA, IM on RD. Exp:02/26/2023. Patient did not report any adverse signs or symptoms.
This spontaneous report as received from a nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAY-2013, the patient received the first dose of VAQTA 25/0.5 (units not provided), injection, lot # J000985, expiration date: 20-AUG-2015 (exact dose, route of administration and anatomical location were not provided). On 22-NOV-2013, the patient received her second dose of VAQTA 25/0.5 (units not provided), lot # J011712, expiration date: 21-SEP-2015 (exact dose, route of administration and anatomical location were not provided), which was several days prior to the recommended 6-month interval between doses. There was no adverse effect reported. Additional information has been requested.
Next morning I felt dizzy, nausea and generally unwell at 6  am. Got up to use bathroom and fainted after sitting on toilet. Fell forward and hit head left forehead. Could not stand and crawled about 40 feet back to bed. At 9:30 am tried to get up again and felt like I would faint again. Called my PCP and was referred to ER. where CT's found I fractured my neck at C4. I have contusions and bilateral black eyes and continue to feel sleepy and fatigued. I have to wear an Aspen collar until I see a spine surgeon next week.
The patient has reported no adverse events to this reporter at this time; patient received an MMRII vaccine that was mixed with expired diluent; This spontaneous report has been received from a nurse practitioner, concerning a 42-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 03-DEC-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) subcutaneous injection, in her right arm as prophylaxis (lot number U013035 has been verified to be valid; expiration date reported and established as 23-APR-2023) (strength, dose, frequency, vaccination scheme, and route of administration were not provided), diluted with sterile diluent solution for injection (lot number U035268 has been verified to be valid; expiration date reported and established as 09-NOV-2022) (expired product administered). The patient had reported no adverse events.
The vaccine did not hurt, just sore arm; about 30 days after, I started symptoms of pressure on my chest, hyper ventilating. I went to ER and had a scam and the doctor said I have problems with my thyroid and send me to a specialist for the lungs & thyroid. I have an elevated blood pressure (150/83 -156/84, which I never had before.  I will have a Colonoscopy, I have Diverticulitis. I am under inhaler. Most of the day I am fine, but at night I have like insomnia and feel hot.
Developed sudden onset of Bell's Palsy diagnosed and confirmed by 3 separate doctors. Currently on prescriptions for Prednisone (60mg/day for 10 days) and Valtrex (3g/day for 7 days) to treat Bell's Palsy symptoms but no results yet. This is day 3 after starting medication.
No additional AEs; TE for GARDASIL 9, product administered after the excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 05-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that was under a temperature excursion (1x dose, lot # W010661 has been verified to be valid, expiration date was reported and established as 19-OCT-2024; route was not reported) for prophylaxis (product storage error).    The storage temperature of the vaccine was 61.7 degrees Fahrenheit for a time frame of 4 hours 39 minutes. There was no previous temperature excursion. No additional adverse events (AEs) or product quality complaints (PQCs) were reported.
Seven days after receiving vaccine, a large area around the injection site became very red with intense itching and burning/stinging.  Very warm area to touch..  Slight swelling.  Did not seek treatment.  Applied cool cloths and symptoms began to improve in 2 to 3 days.  Three days after symptoms began (and 10 days after receiving vaccine) redness is nearly gone and only slight itchiness remains.
got Type A flu anyway; Initial information received on 20-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got type A flu anyway after receiving vaccine Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation, route, expiry date and administration site not reported) for prophylactic vaccination.  On an unknown date the patient got type a flu anyway (influenza) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event .  Outcome: Unknown
No additional AEs; VAQTA was administered during temperature excursion; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 01-AUG-2022, medical assistant called for evaluation of vaccine temperature stability and reported that there was an administration of the Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml/once (anatomical location, lot number and expiration date were not reported) as prophylaxis;  during temperature excursion (Product storage error), no additional adverse events (No adverse event).   On 01-AUG-2022, the patient received a dose of Hepatitis A Vaccine, inactivated (VAQTA) vial 25/0.5 (no units provided), 0.5 ml/once, administered as prophylaxis (route of administration, lot number and expiration date were not reported).
Muscle ache, fever of 101 p/1st capsule & fever of 102 p/2nd capsule; duration 4 days; took aspirin every 4 hrs;
Generalized itching and stinging, beginning in left arm at vaccine site and spreading throughout body. Lasted at least 5 days. Treated with BENADRYL only.
cellulitis; right lower leg was swollen  and bright pink; tiny blisters; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 at 14:30 (Lot number was not reported) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took sulfa and experienced drug allergy. On 05Mar2021 at 19:00, the patient experienced cellulitis, right lower leg was swollen and bright pink and tiny blisters seeping fluid. The events required physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.