chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: ?pt has had fainting with vaccinations in past, last covid was ok, she fainted within 5 min of shot today, was laid flat on ground wih feet elevated, when she felt better she had oj, bp normal- first responders came and evaluated, pt didnt watnt to go to hospital--was cleared to go home --pt was called at 7 pm-said obgyn said she didnt hit her head "hard". so she is ok.
Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine in September 2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by a weakened immune systems, which was diagnosed as herpes zoster, or shingles. On or about 11-MAR-2017, the patient was treated by another physician at a hospital emergency room for severe shingles complications including interference with her eyes. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, severe shingles complications, including interference with her eyes was considered medically significant. Additional information has been requested.
Information was received on 10-MAY-2017 from an attorney in the form of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 18-MAY-2015 the patient was vaccinated with ZOSTAVAX vaccine, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended (considered vaccination failure), but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-AUG-2016 the patient was treated at a medical center for a painful rash that was diagnosed as shingles. She was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I have thrown up 3 times; had the chills; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207; Expiration date was not reported), via unspecified route of administration in the left arm on 13Mar2021 04:30 PM (at the age of 19-years-old) as first dose, single dose for COVID-19 immunization at an urgent care center/ doctor's office. Medical history included COVID-19 from an unknown date (prior vaccination) and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. The patient has no known allergies. On 14Mar2021 08:30 AM (reported to be the morning after getting the vaccine), the patient experienced to have thrown up three times and had the chills. No treatment was taken for the events. The patient underwent lab test and procedure which included COVID-19 test: Positive on an unspecified date prior to vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
LOC, incontinent of urine x 15sec;3-4min following vax;
Approximately 10 minutes after vaccination, patient began to feel lightheaded.  She recognized the symptoms and knew she was going to pass out.  Her boyfriend alerted the pharmacist and they had the patient lie down on the floor.  Patient got an ice pack and after 5 minutes some orange juice.  After another 15 minutes of observation she felt normal.
the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder; Hot injection site; Itches; Welt on the injection site, a dollar size which progressed to like an apple size; Hard injection site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red). On 06-Sep-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder). At the time of the report, VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder) outcome was unknown and VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red) had not resolved.            No concomitant medication information provided. It was reported that patient had bivalent booster dose. No treatment information provided.   Reporter did not allow further contact
lightheadedness when walking, diaphoretic and had syncopal episode a couple minutes after injection. assisted fall but hit head with no signs of confusion, or contusion. first BP 69/48 PERRAL, A&Ox4, clear speech. laid patient on ground, elevating lower limbs, given PO fluids. BP was observed every 5 minutes last BP:112/74  kept patient for additional 45 minutes until he felt safe to drive.
The morning after my shot I had a fever of 102. Muscle pains, headache, sensitivity to light, vomiting. I did not have a bowel movement for the entire day of the 8th of may. Today, on May 9th I have been having diarrhea and intermittent slight chest pain when taking a full deep breath. I am still very fatigued but my fever is gone. Headache and body aches persist, though not nearly as severe.
Pressure and pain and in the the left heart area and above the heart in the chest; Waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack; Waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack; Intense adrenaline rush; Fatigue; Inability to concentrate; Anxiety attacks throughout the day; Pressure and pain and in the the left heart area and above the heart in the chest; Pressure and pain and in the the left heart area and above the heart in the chest; Pressure and pain and in the the left heart area and above the heart in the chest; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 and his son had the same reaction and that was waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack. Just intense adrenaline rush, fatigue, inability to concentrate. There are anxiety attacks throughout the day, there was pressure and pain and in the left heart area and above the heart in the chest and his son has probably been to 10 or 12 different doctors to try to figure out what was going on and nobody knows what it was and patient was having similar effects and he had been to a heart doctor twice. The outcomes of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873350 Same reporter/drug, events, different patient
Just a headache with the second vaccine; felt like I had flu; This is a spontaneous report from a contactable consumer(Patient) from a Pfizer sponsored program. A 65-year-old female patient received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as 2nd DOSE SINGLE for covid-19 immunization. The patient medical history and concomitants medications were not provided. The patient received historical vaccine of first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection; Lot number: unknown) for covid-19 immunization. On an unspecified date during an inbound call with the patient, the patient stated that her hands don't hurt all the time. she haven't felt this good in years and could walk down the stairs. She reacted to first Pfizer vaccine but not the second. Felt like she had the flu. Had Just a headache with the second vaccine. The patient is prescribed XELJANZ XR 11mg tablets. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pulmonary embolisms Elevated liver enzymes Elevated D-dimer Elavated and inflamed pancreas Gallbladder needed ingredients to be removed
Fever, chills, muscle pain, Headache, stomach pain, constipation, arm pain
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Drug allergies or reactions were not reported. On 15-MAR-2013 the patient was vaccinated with VARIVAX (merck) first dose (dose, lot number and expiration date were not reported). On 22-MAR-2013, the patient was inadvertently administered a second dose of VARIVAX (merck) administered by "intramuscular" injection (lot number 1912AA) (dose and expiration date were not reported). No adverse effect reported. The outcome of events was unknown. Additional information has been requested.
LIghtheaded( dizzy) worsened tinnitis, sudden fatigue, brain fog
chest pain, which describes as a pressure between sternum and clavicle; impaired inspiration secondary to pain; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER COVID 19 VACCINE; solution for injection, lot number was not reported), via an unspecified route of administration, on an unspecified date, at dose number unknown, single for covid-19 immunization. Medical history included the patient is smoker. The patient's concomitant medications were not reported. The patient experienced chest pain, which describes as a pressure between sternum and clavicle since the vaccination and after the vaccination. The patient underwent lab tests and procedures which included stress test, chest x-ray, electrocardiogram with no abnormal findings and impaired inspiration secondary to pain on an unspecified date.  The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose) and NO ADVERSE EVENT (no adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose).    No concomitant medications were reported.     The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   No treatment medications were reported.
Patient presented to the ED for evaluation of generalized weakness, reduced appetite, diarrhea, and shortness of breath that began one week ago.  Also reports dry cough.
Information has been received from an office manager and a doctor of pharmacy concerning the pharmacist's 15 year old daughter with drug allergy to CEFZIL and a history of migraine, headaches and allergies who on 27-DEC-2011 (also reported as 25-JAN-2012, by the pharmacist) was vaccinated IM with the first and only 0.5ml dose of GARDASIL (lot #670048/0963AA) (site not reported). No other vaccines were given concomitantly. Concomitant therapy included ZYRTEC as needed. The doctor of pharmacy reported that on 24-FEB-2012 (also reported as "last week"), the patient had her first migraine-induced seizure and was taken to ER. An electrocardiogram, electroencephalogram and computed tomography (CT) scan of the brain were normal. The patient was unable to walk, talk and her vision was blurred for several hours after the seizure. On 27-FEB-2012 the patient experienced her second seizure but with only blurred vision for a shorter period of time. The patient was prescribed TOPAMAX. A repeat CT scan and electroencephalogram were scheduled. The patient was scheduled to see a neurologist on 19-MAR-2012. The doctor of pharmacy did not consider the events to be disabling or life threatening. The physician's office manager stated that she was not aware of the adverse event. At the time of the report, the patient's outcome was unknown. Upon internal review, migraine-induced seizure and seizure were determined to be other important medical events. Additional information has been requested.
Patient was approximately 5 mins post-vaccination seated in car when husband requested for assistance for her stating that she appeared to be passing out in car. RN assessment on arrival, patient was in lying in reclined position in car but was able to independently sit upright and A&O x 3. Denied complaints of dizziness or other issues other than feeling tired. P Vitals: Temp 97.5 HR 64 RR 16 BP 118/63. Patient was given oral fluids with gatorade and water and symptoms resolved .
Hearing changes initially noticed in November (R) ear very sensitive to noise. Now bilateral ears very sensitive to noise. Vertigo started 12/26/2009 and has continued daily until present date. The vertigo consists of full blown spins, unsteadiness, sensation of head being pushed to one side or the ground, nausea, motion sickness. Unable to read or be on computer for more than a few minutes at a time. Unable to work for weeks and now only working part-time but with constant symptoms. Presented to family physician on 12/30/2009 for the vertigo. Was started on AMOXIL and Meclizine with no change in symptoms. Presented to Ear Nose and Throat specialist on 1/4/2010 at which time cerumen impaction was removed but vertigo did not resolve. Returned to family physician multiple times in January and February and the Epley Maneuver was performed without resolution. CLARITIN and VERAMYST were tried for several weeks with no change in symptoms in the interim. ENT performed ABR and hearing test with CBC, TSH and serum glucose which were all within normal limits. Symptoms moderately improved for 1 week February 15-21 and then returned with worsening symptoms on Feb 27. Symptoms were severe causing confinement to bed for 3 weeks in March. Balance testing was performed on 3/10/2010 showing significant nystagmus and conclusion of right inner ear permanent damage. VALIUM and ELAVIL were started with no resolution in symptoms after 6 weeks. Vestibular rehab was initiated with no significant improvement in symptoms after 7 weeks. I was unable to work during this time and have only been able to work part time since 3/30/2010. Symptoms are daily and have caused bed confinement on a weekly basis. Presented to Dr., an otoneurologist on 4/8/2010. He is unsure of the diagnosis and has weaned me off ELAVIL but started ROBINUL, with no significant improvement in symptoms. I will be starting TOPAMAX today but was informed that it will take up to four weeks for effectiveness to be known. Dr. is also suggesting that a neurologist be consulted. Also experienced numbness and tingling in bilateral arms and upper legs in January. this lasted about 3 weeks and has resolved. Legs felt weak during this time.
Anaphylactic reaction. EPIPEN, BENADRYL IM, and SOLU-MEDROL IM.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 168,32 and R; 840, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited report received from a Pharmacist on 29 May 2015. A patient, whose medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid (batch number, route of administration and site of administration were not reported) on unspecified date. On unspecified date, after vaccination patient experienced seizures. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: seizure. Documents held by sender: none.
Ringing in ear, hearing temporarily disappearing from one ear. Lasts about a minute and recurs about every other day.
pt devel marked erythema, induration to color (giant hive) anterior biceps lt arm 6 days post vax 30JUN98-no systemic problems;
I woke up in the morning and I could not focus my eyes and I was dizzy and I felt like I was going to faint and it lasted for hours I went to the emergency room via ambulance and they gave me anti-vert and Di as a PM. today I still have a headache but no dizziness?
Mother called c/o soreness in shoulder, upper body achy, more significant on rt side. Noted headache at 4 AM on Aug 17th. Rt. shoulder, deltoid area red/swollen. No fever or itching. No breathing problems. 5-22 spoke to pt. today, has recovered from vaccines.
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 48 years old male patient who received vaccine FLUZONE HIGH DOSE who was less than 65 years old. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. It was reported no other vaccine were used. On 24-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI981AB expiry date: 16-Mar-2019 via intramuscular route at right upper extremity. It was a case of actual medication error due to inappropriate age at vaccine administration. No specific symptoms are being reported. 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 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. List of documents held by sender: none.
Diarrhea on and off for 2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 13:15 (Lot number: EN6201) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometrial cancer" (unspecified if ongoing); "Melanoma" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; HYDROCHLOROTHIAZIDE; VITAMIN D NOS. The following information was reported: DIARRHOEA (non-serious) with onset Feb2021, outcome "unknown", described as "Diarrhea on and off for 2 weeks".  No follow-up attempts are possible. No further information is expected.