chrisvoncsefalvay/vaers-outcomes huggingface dataset:
atrial fibrillation; disease recurrence; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 21Jan2021 for COVID-19 immunization. medical history included atrial fibrillation. Concomitant drugs were unknown. the reporting consumer received a message on 23Jan2021 stating that the  patient started having atrial fibrillation the night before. The outcome of the event was unknown.  Information on batch/lot number was requested.
Sugar blood level increased; Blood pressure high; Chills; Cough; Breathing difficult; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Sugar blood level increased), COUGH (Cough), DYSPNOEA (Breathing difficult), HYPERTENSION (Blood pressure high) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In September 2021, the patient experienced COUGH (Cough), DYSPNOEA (Breathing difficult) and CHILLS (Chills). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Sugar blood level increased) and HYPERTENSION (Blood pressure high). In 2021, COUGH (Cough), DYSPNOEA (Breathing difficult) and CHILLS (Chills) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Sugar blood level increased) and HYPERTENSION (Blood pressure high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: High. On an unknown date, Blood pressure measurement: High.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of CHILLS, ELEVATED SUGAR LEVELS, COUGH, TROUBLE BREATHING and HIGH BLOOD PRESSURE with HUMIRA(ADALIMUMAB) was no reasonable possibility.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  No treatment medication information was provided.
four people just got the booster and they are still sick four days later from Pfizer; four people just got the booster and they are still sick four days later from Pfizer; four people just got the booster and they are still sick four days later from Pfizer; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration on an unknown date, as dose 3, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) on an unknown date as dose 1, single and second dose of bnt162b2 (BNT162B2) on an unknown date as dose 2, single both for COVID-19 immunization. The reporter reported that there were four people just got the booster and they were still sick four days later from Pfizer on an unspecified date. The outcome of event sick was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Breakthrough case admission after 3 vaccines Pfizer 3/3/21 lot# EN6199;  Pfizer 3/24/21 lot# ER8732;  Pfizer 11/12/21 no lot#
56 year-old man with cutaneous T cell lymphoma on C1D8 of gemcitabine therapy who had asymptomatic COVID-19 (tested positive 1/15) and was given Pfizer vaccine on 2/1/2022 at 3:30 PM. Around 9:00 PM patient developed persistent sinus tachycardia (110s-130s).  Around 9:00 AM he developed fevers (Tmax 38.6). In the next 12 hours he developed symptomatic hyponatremia secondary to SIADH.  BP remained stable until about 6:00 PM when he became acutely hypotensive (MAPS 55-60) requiring transfer to MICU for vasopressors.  Patient was started on empiric antibiotics while we pursued infectious workup.  CXR was clear. UA was unremarkable. Blood cultures were ordered but, due to the patient's skin cancer, could not be obtained (all other labs were obtained from his PICC).  He recovered within 24 hours and was transferred back to the floor on 2/3.  Antibiotics were discontinued 2/4.
swelling in arm; Redness in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SJ20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included LISINOPRIL for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm). At the time of the report, VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) 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.   Reportedly, Red swollen injection site a week after vaccination is an expected effect and resolved in all the participants after a week or so.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Outcome updated,information added to the narrative; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
the injections site of the Juvederm-like product swell/injections site get puffy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (the injections site of the Juvederm-like product swell/injections site get puffy) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (the injections site of the Juvederm-like product swell/injections site get puffy). At the time of the report, VACCINATION SITE SWELLING (the injections site of the Juvederm-like product swell/injections site get puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant information were not reported by the reporter.
This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The patient was wondering about how long the adverse event would last. The patient provided details to the reporter. The follow up would be requested.
31MAY98 AM swelling, redness & pain @ inj site;1JUN98 AM c/o tingling lt arm, pain & swelling @ site;malaise, myalgia;2JUN98 swelling & pain dec;seen by MD; 4-5JUn hives bilat arms periodically during day;
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-SEP-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
TOOK FOURTH DOSE ON DAY 8; This spontaneous case (PVX2019-805) was received from a nurse on 03-Apr-2019. It describes a 58-year-old female consumer who "took fourth dose on day 8", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer did not take Vivotif doses according to the schedule. She took doses on day 1, 3, 5, and 8.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took fourth dose on day 8" was unknown.  Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.
Muscle pain; Joint pain; Headache; This is a spontaneous report from a non-contactable other health care professional.  A 46-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID19 vaccine bnt162b2 for COVID-19 immunization on 21Dec2020; lot number: EL0140 on left arm at 46 years old. On 12Jan2021, the patient experienced muscle pain, joint pain, and headache. The patient did not receive treatment for the events. The outcome of the events was unknown.    No follow up attempts are possible. No further information is expected.
This report described the occurrence of joint pain and arthritis in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was initially received as part of litigation proceedings and was subsequently medically confirmed through receipt of medical treatment records via the litigation process. The patient received injections of Lymerix on 8/14/01 and 9/14/01 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint pain, arthritis, fatigue, and rashes. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. Medical records forwarded by the attorney indicated the patient stepped on a rusty nail on 8/13/01. He saw his family practice physician on 8/14/01 after he began to develop pain and erythema at the puncture wound site. His physician ordered he receive a tetanus vaccine that day. He was sent to another facility since the physician did not have the vaccine available at his office. It is not indicated in the records whether he had the vaccine. There is also no evidence in the available medical records of him receiving Lymerix that day. On 2/19/02, the patient saw his physician for a one to two week history of pain in the right shoulder over the AC junction which developed when he was pulling an object and increased with internal rotation. He also complained of pain over the abductor tendons in the right hip. His physician attributed the pain to tendonitis and he was started on ibuprofen. By 5/30/02 the shoulder pain had worsened. A shoulder x-ray was negative. He was treated for subacromial bursitis with naprosyn. This did not control the pain. On 6/20/02 he received an injection into the bursa of kenalog plus xylocaine.
heart palpitations; flu like effects; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received first dose of BNT162B2 (BNT162B2) (Lot/batch no: unknown Not available/provided to reporter at the time of report completion) via an unspecified route of administration in the left arm on 13Mar2021 at 08:30 as 1st dose single for COVID-19 vaccination. Medical history included probable a fib but no episode since last summer. The patient reported there were allergies to medications, food, or other products; however not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (thyroxine, MANUFACTURER UNKNOWN) used within last two weeks of vaccination for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 10:00 a.m., the patient experienced heart palpitations lasted for three days and flu like side effects. The patient did not receive any treatment for the events. The clinical outcome of heart palpitations was recovered on 16Mar2021 and flu like side effects was recovered in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fatigue and headache, then after 2 days followed by severe sharp chest pain like being stabbed in the chest and could not sleep
pt had a sz consisting of myoclonic jerk, stiffening & inc resp for 3-4 mins, this occurred a few hrs p/receiving vax; pt t102.3 in ER:
Shingles with a few rash spots and horrible nerve pain on the same side as injection site (left). Burning, stinging, stabbing, extremely achy.  Very painful that I needed pain meds lyrica and tramadol.  rash could take up to 100 days to appear and postherpetic neuralgia can last from a few days to a few months.  Its been 3 weeks. Getting a nerve block. Also, it starts on left upper back, wrapping around torso to under my breast.
Third day post 3rd vax, this pt experienced fever. Fourth day he was very sore, stiff and couldn't turn neck. Knees stiff and swollen, aching. Physician prescribed Celebrex. Later requested X-rays. Osteoarthritis dxed.
Per MD office, patient got vaccination in Left arm. She experienced "strange" sensation across her chest/body, aching pain in Right arm, and also had some swelling in the throat.  They called pharmacy on 10/2 to inform pharmacy of reaction.
Phone call from pt on 9/16/02 states that on 9/14 was vomiting, R arm sore but shoulder and collar bone area red and swollen up to neck.
Pediarix was administered orally instead of the correct way (intramuscular) patient observed for 1 hour and no adverse reactions were noted
Shortness of breath, severe headaches, dizziness, fatigue,  fever after second dose, went to urgent care 5/30 - doctor called over to ER due to coming in with presented symptoms of blood clot in left calf,  ER performed ?standard? testing - and was dismissive to any symptoms I reported and my concern that this was related to vaccination.   I felt I was dismissed on my overall health at time of ER visit, and was never seen by an actual doctor.
Testicular pain; This is a spontaneous report from a contactable consumer(patient). A 15-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0185), via an unspecified route of administration on 03Jun2021 at 17:30 (at the age of 15-years-old) into left arm as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0173), via an unspecified route of administration on 13May2021 at 17:30 pm into left arm as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient 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. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021 at 12:30, the patient experienced Testicular pain. No treatment was received for the event. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected
Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Brain fog; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history included Sjogren's, asthma, low Igg, A-Fib, osteoporosis. The patient has known allergies: Methylparaben, Rocephin, lidocaine, oats. Concomitant medications included metoprolol, hydroxychloroquine sulfate (PLAQUENIL), apixaban (ELIQUIS), propafenone. On 16Jan2021 14:30, the patient experienced Headache, dizziness, lightheaded, gait and speech Disturbance, tired, brain fog. The outcome of the events was unknown. The patient did not receive treatment for the events.   Information on the lot/batch number has been requested.
Very ill evening post 2nd dose on 1/25/21 with extreme nausea, fatigue. Some headache, sore arm. Mid Feb began to experience heart palpitations, PAC and PVCs. Went to see Cardiologist and with stress echo dx with pulmonary hypertension. Getting right heart cath today
clammy; left side hurts, left arm injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COLD SWEAT (clammy) and VACCINATION SITE PAIN (left side hurts, left arm injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (clammy) and VACCINATION SITE PAIN (left side hurts, left arm injection). At the time of the report, COLD SWEAT (clammy) and VACCINATION SITE PAIN (left side hurts, left arm injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Patient in our clinic with multiple small tender lymph nodes in left axilla. Provider advised it is likely an immune response from flu shot, and to return to clinic in 2 weeks if not resolved, or come in sooner if worsens.
This is spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported the same event for two patients. This is first of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced shoulder bursitis on unknown date, after the vaccination. The outcome of the event was unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Body ache; Chills; Fatigue; Weakness; Lightheaded; Nausea; Headache; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable pharmacist, the patient. A 60-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 29Oct2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. Concomitant medications included calcium (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D) and unspecified multivitamin with minerals; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received bacitracin (MANUFACTURER UNKNOWN), neomycin (MANUFACTURER UNKNOWN) and cefalexin (CEPHALEXIN) and experienced drug allergy with all these medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified rout of administration in the left arm on 22Dec2020 (at the age of 59-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021 at 13:00, the patient experienced body ache, chills, fatigue, weakness, lightheaded, nausea and headache lasting into 01Nov2021, the third day, post vaccine. If scheduled to work, the patient would have needed 2 days off, he was a hospital worker. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, chills, fatigue, weakness, lightheaded, nausea and headache were resolving at the time of this report.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, dose, frequency, Lot. No. and expiration date were not provided). There was no concomitant medication described. On an unknown date, the patient experienced cold sores around the mouth. No product quality issue was involved. At the time of this report, the outcome of cold sores around the mouth was unknown. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Within 24 hours, 1cm red induration lesion at injection site with 2 other lesions on same arm. One 4cm; the other 1cm. All in deltoid region.
Covid-19 Symptoms:  Congested/runny nose, minor headache, loss of taste and smell Treatment:  Monoclonal antibodies  Course:  Symptoms other than loss of taste and smell resolved within a week.  Taste and smell began to return after about 10 days but took about four weeks to fully return
Got the vaccine on Sunday, noticed that I broke out with a tiny rash covering both arms on Monday, on Tuesday the rash spread throughout my body, covering both arms and legs, back and stomach; none noted on my face, neck or fingers at this writing.
Starting the day after vaccine shot, stool turned from normally solid to liquid and has remained mostly liquid, and frequent, to the current day.
Approximately 5 minutes after her second dose of the vaccine, patient stated she felt a "bad feeling" in her stomach and subsequently vomited a large amount of liquid in the post vaccination observation area. We transported her to the Health Unit where she was evaluated and observed approximately 2 hours. Patient's vital signs remained in a normal range. Her physical exam was unremarkable. Stated she felt fine prior to getting her vaccine.  She stated she felt much better when she left our Health Unit and returned to work.