chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced "pain, sensitivity, and hypersensitivity at injection site 18 days after injection; experienced "pain, sensitivity, and hypersensitivity at injection site 18 days after injection; experienced "pain, sensitivity, and hypersensitivity at injection site 18 days after injection; This spontaneous report has been received from a physician via company representative, referring to a 11 years old female patient. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was unknown by reporter.   On 31-JUL-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose: 0.5 milliliter, route, strength, lot number and expiration date were unknown by reporter) in the right arm for prophylaxis.         On the same day, the patient experienced pain, sensitivity, and hypersensitivity at injection site 18 days after injection. The patient sought medical attention. It was unknown if the lab diagnostics or studies performed. It was unknown if the treatment was given. Dechallenge was also reported as yes (conflicting information). The outcome of the events was reported as recovering. The causality assessment between the events and suspect vaccine was not reported.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had seizure with 1st vaccine, pediatritian informed mother to have patient lay down if it happens again. Patient said she felt out of it (at 11am) after administration of this vaccine so we helped her lay down on the floor with her head proped up. Gave her water and turned on the fan to try and make her more comfortable. Patient decidede to try sitting up slowly after 10-15 minutes, then after another 10 minutes she was able to stand and felt back to normal and left the store 11:30am.
severe dry mouth; Nausea; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Vaccine immunization. Patient medical history and concomitant medications were not reported. On 28Jan2021 was her first dose of COVID vaccine. Seven and a half hours later she had a severe reaction had a severe dry mouth and had to go to the emergency room. Also had nausea. She was given steroids and BENADRYL. Second dose is scheduled 18Feb2021 and wondering if she can take BENADRYL before the next dose. Outcome of events was unknown.  Information regarding lot/batch number has been requested.
101.3 fever, nausea, debilitating headache day following vaccine.  Cold sores erupted in nose & on lip 2nd day after vaccine. On 3rd day after vaccine visited dentist & they noticed unusual gum irritation, swelling. Cleaning was very painful & this is unusual for me.
rash on lower back; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration administered in Arm Left 02Mar2021 14:00 pm UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history included high cholesterol. The patient had not been tested positive for COVID-19 prior and post vaccination. The patient had no known allergies. Patient had not received any medications in two weeks. Concomitant medication included Desloratadine, Rosuvastatin and Multivitamins and all were taken for an unspecified indication. It was reported that after receiving the dose of vaccine the patient experienced rash on lower back on 05Mar2021. The patient did not receive any treatment to treat the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Arthritis flared up and continued to get worse.  Arthritis in left shoulder - couldn?t raise arm - Dr recommended therapy - pulleys daily.  No recommendations for other areas. Pain in left wrist - unable to use it normally - fingers on left hand painful swollen - loss of strength in middle arm. Also pain in right wrist but not to same extent of left hand.
She reports she received IIV (lot number M51107 mfx CSL) and Tdap (per record vaccine is PPSV23 lot number Merck lot number 0322Z) together to her R arm which produced a local reaction of notable local edema, a 4 inch patch of erythema at the injection site, mild tenderness and pruritus, and lymphadenopathy and local edema to the axilla. The erythema resolved in about a week. She states the lymphadenopathy last for months and she was left with a local mass. She was concerned about breast cancer and imaging showed a benign mass. No further treatment. Symptoms: Enlargement, lymph nodes.
Lymph nodes swelled and tender around collar bone, in arm pit, and neck on right side about 12 hours after receiving the vaccination.
exp hot erythema sharply demarcated wheal firm on rt ant thigh 5cm x 6cm;5 x 3 1/2cm rt;
Patient claims this is her first dose, upon checking database, this is her 3rd dose. She claims she never receive any covid vaccine. She is 58 , 6 months apart from second, but with no medical conditon.
No treatment, MD told the patient not to get the high dose next year because the patient stated that she had a reaction last year as well. And to call back if it got worse.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The nurse reported that GARDASIL was improperly stored and was administered to unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected. No allowed to contact physician.
The patient was vaccinated with the chickenpox vaccine when she was 1 year and seven months old. Late in October she developed a really bad case of shingles on her left thigh.
Nine days after I received the vaccine, around 3pm my injection site started itching.  I did not scratch it.  Around 6pm, the injection site was red and warm to the touch, and I could feel small bumps under the skin.  I took a Benadryl and a 500mg Tylenol but did not notice a difference.  Upon waking at 5am the next day, the injection site was swollen, bright red, hot to the touch, and the small bumps had joined together and become a singular very hard lump.  The site was itching and burning, and my arm felt heavy and tired when I tried to do anything, such as holding a phone.  This continued for about 48 hours.  After that time, the symptoms began to slowly recede.  As of 2/3, I still have a faint brown oval discoloration at the injection site, but no other symptoms remain.
Working at the flu and Covid vaccine table. Resident approached the table requesting Covid booster and flu vaccine.  There were no previous vaccinations in database for her. Queried Immunization Registry via database. Verbally confirmed with her that she had not received her previous covid vaccination in the past 2 months. She confirmed confidently that she had not. Asked if she had a covid card and she did not.  Error message in database regarding giving Covid bivalent booster without previous doses administered, continued administration.  After giving vaccination, previous vaccinations loaded for reconcile showing this physician had received her bivalent covid booster 9/27/22. She still did not remember getting the vaccination after being informed of this. Discussed possible error in documentation.  Looked into her OB notes where it was documented and acknowledged that she must have received it.  Patient is pregnant with an EDD of 11/30/22
Patient woke around 8:30am on 5/18/19 complaining to spouse of dizziness, nausea, and ringing in the ear.  Spouse called pharmacy at approximately 9:30am to ask if symptoms were normal. I advised that dizziness and nausea had been seen in patients, but was unfamiliar with ringing in the ear as a side effect.  I recommended to take Emetrol or meclizine.  Patient's spouse told me that the patient would maybe try to take a Zofran to see if this would help the nausea.  When I called later on in the evening, spouse told me that patient's symptoms had completely resolved earlier in day.  Upon questioning patient on 5/19/19, patient stated symptoms lasted about 3 hours.
Severe headache for more than 12 hours; shaking chills for about 2 hours, nausea for about 6 hours, muscle weakness for 6 hours. Tenderness at site of injection for three days.
This spontaneous report was received from other health professional referring to an unknown number of unspecified patients. Information regarding the patients' pertinent medical history, and drug reactions or allergies were not provided. On an unknown date starting on or after 31-JUL-2017, an unknown number of unspecified patients were administered improperly stored (incorrect product storage) doses of VARIVAX (lot M47660, exp 02-DEC-2018; lot N001527, exp 13-JAN-2019; lot N009767, exp 24-MAR-2019). Lot information not available for properly stored sterile diluent (MERCK STERILE DILUENT) used to reconstitute improperly stored varicella virus vaccine live (oka/merck)(VARIVAX). No adverse effect reported. The doses were stored in a temperature of -14 degree Celcius to -10 degree Celcius for 2 hours. Data logger was involved. There was no previous temperature excursion reported. No additional information provided. Lot number M47660 is an invalid lot number for varicella virus vaccine live (oka/merck). This case is cross-referenced with 1708USA013525 (same reporter).; Sender's Comments: US-009507513-1708USA013525:
Information has been received from a Bachelor of Science in Nursing concerning a female patient who, on an unspecified date, was vaccinated with the first dose of GARDASIL (dose, route and lot # unspecified). Concomitant vaccine included a dose of MENCTRA. The nurse reported that the patient after receiving the dose of GARDASIL and MENACTRA, immediately experienced a syncopal episode (date unspecified). At the time of the report patient's outcome was not reported. It was not specified if patient sought for medical attention. Follow up information has been received from a health professional concerning a 15 year old female student patient with drug allergy or reactions to MOTRIN and no illness at time of vaccination, who on 27-JAN-2011 at 15:40, was vaccinated intramuscularly on the right deltoid with the first dose of GARDASIL (lot#0765Z). The health care professional reported that on 27-JAN-2011, "5 minutes after vaccine was administered" at 15:45, the patient experienced an episode of syncope. Episode lasted approximately 2 minutes and the patient fully recovered on 27-JAN-2011. No injuries were reported as a result. No lab diagnostic tests were performed to the patient. The patient did not seek medical attention. No further information is available.
Sore arm at injection site; Fever; Chills; body aches; This is a spontaneous report from a contactable physician (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 21Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020 to an unknown date and dust allergy. Concomitant medication included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient experienced sore arm at injection site, fever, chills, body ache (mini COVID as compared to when he had COVID in early April) on 22Dec2020 03:00 (reported as 12-13 hours later). Symptoms controlled with Tylenol for about 15-20 hours. The patient underwent lab tests and procedures which included nasal swab on 09Dec2020, 14Dec2020, and 16Dec2020, results are all negative. The outcome of the events was recovered.  Information about Lot/Batch number is requested.
This spontaneous report was received from a nurse and refers to a 69 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 07-OCT-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # M000592 and expiry date: 12-OCT-2017 (volume/dose reported as 0.5 (units not provided), (route was not reported) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. The patient was vaccinated with private funds. No adverse effects and no product quality complaint (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377: US-009507513-1612USA006597: US-009507513-1612USA006599.
I got COVID after Dose 3 got tested on March 8, 2022. I experienced burning on the back of the throat and a intermediate cough (described as a tingling cough), no fever, no difficulty breathing and symptoms lasted to Sunday March 13, 2022.
Itchiness, pain, warmth, redness and swelling around the injection site and no improvement a day after
Dizziness, passed out, fell from standing position to floor. Cut chin, fractured front teeth.
Patient given 1st dose of Covid-19 Pfizer at 8:46am. Patient reported facial flushing, chest tightness and SOB. PO Zyrtec given. Patients vitals stable. MD to bedside: lung sounds clear, heart rhythm normal. Pt Hx/ of anaphylaxis and asthma. See vital signs in flowsheet. Patient received IM benadryl and IM Epi x1, then reported continued hypersens systoms and reported back pain and chest pain, EMS called. Patient transferred to ED for continued monitoring.
shingles; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles in Mar2021. The clinical course was reported as follows: The patient started taking antiviral medications the morning of 17Mar2021, which included valacyclovir hydrochloride (MANUFACTURER UNKNOWN) 500 mg tablets in a dose of one tablet, two times a day for yet undefined virus which is shingles like, believed to be like herpes (as reported). Her second dose was scheduled for 22Mar2021. Therapeutic measures were taken as a result of the event as aforementioned. The clinical outcome of shingles was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Some injection site soreness; Joint pain; Muscle aches; A little temporary nausea; This is a spontaneous report from a non-contactable consumer. A 61-years-old male patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number FL1284, via an unspecified route of administration on14Jan2021 09:00 at SINGLE DOSE for COVID-19 immunization. Vaccine location: Left arm Medical history included cardiovascular disorder, colitis ulcerative and depression. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), colecalciferol (D3), fluoxetine (FLUOXETINE), mesalamine (MESALAMINE), rosuvastatin calcium (ROSUVASTIN), ubidecarenone (COQ10 [UBIDECARENONE]). On 14Jan2021 19:00, patient experienced injection site soreness with outcome of recovered, joint pain with outcome of recovered, muscle aches with outcome of recovered and a little temporary nausea with outcome of recovered. The action taken was not applicable. No follow up attempts are possible. No further information is expected.
Over three days developed moderate Rx of redness, warm, induration approx 8x12cm area.
HYPOTENSIVE, NAUSEA, DIZZINESS, PRE VACCINE BP 113/73, POST VACCINE BP 90/62.
Initial report received from a health care professional in the USA on 26 March 2007. A 40 year old, female patient (with no known allergies and a history of anxiety) developed localized swelling, redness, warmth, and pain at the site, within 24 hours after she received Tetanus Toxoid Absorbed vaccine (lot number U1715BA) intramuscularly in the right deltoid on 21 March 2007. She also complained of a dull headache at the base of the neck. The patient had a previous dose of Tetanus Toxoid Absorbed vaccine in 1997. She denied any illness at the time of vaccination and was taking Bactrim and Macrodentin. At the time of the report, the symptoms continued to persist and the patient had not recovered. Follow-up information received on 21 May 2007 from a health care professional. It was reported that patient had complete resolution of the adverse events on 11 May 2007. Per the reporter, the case was reviewed and no other additional information is available at this time. No further information is expected.
Numbness in right foot toes/Had similar sensation in left toes but to much losses extent; Tingling in right foot toes/Had similar sensation in left toes but to much losses extent; Short episode of disequilibrium; This is a spontaneous report from a contactable physician. A 49-years-old female Physician reported for herself that who received second dose of BNT162B2 (BNT162B2, solution for injection), intramuscular, administered in Vastus Lateral Right on 28Jan2021 15:55 (Batch/Lot Number: EL9262) (at the age of 49-years-old) as SINGLE for covid-19 immunization and was administered at hospital. Medical history included ongoing menstrual cycle management, ongoing general symptom, ongoing UCTD (undifferentiated connective tissue disease). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL) at 300mg daily oral for undifferentiated connective tissue disorder, methotrexate at 2.5mg weekly oral for undifferentiated connective tissue disorder, mycophenolate mofetil (CELLCEPT) at 750mg twice a day oral for undifferentiated connective tissue disorder, folic acid daily and magnesium, ergocalciferol (VIT D) 5000 IU/week oral for general health, vitamin B complex (VITAMIN B) daily, vitamins magnesium 400mg daily oral for general health, multivitamin 2-3 times per week oral and oral contraceptive for cycle control 1 tab daily oral. The patient historical vaccine included received first dose of BNT162B2 (BNT162B2, solution for injection), intramuscular, administered in Deltoid left on 07Jan2021 15:55 (Batch/Lot Number: EK9231) as SINGLE for covid-19 immunization and experienced disequilibrium, left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face, awoken by intense bilateral leg pain, left deltoid with prickly "itchy" sensation. Approximately one hour after second vaccine given on 28Jan2021, short episode of disequilibrium occurred, followed by numbness and tingling in right foot toes which lasted approximately 30 minutes. Had similar sensation in left toes but to much losses extent. The outcome of events was recovered on 28Jan2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a 21 year old female patient who on 24-MAY-2007 was vaccinated with Gardasil. On 25-MAY-2007 the patient experienced dizziness and nausea. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from a nurse practitioner and a licensed practical nurse concerning a 21 year old female student, who on 24-MAY-2007 in the am, was vaccinated IM in the deltoid with a second dose of GARDASIL (lot # 654272/0319U). On 25-MAY-2007 the patient experienced dizziness and nausea. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Hospital Course:  27 yo M with Bardet-Biedel syndrome manifesting with transitional AV canal defect s/p repair (followed by Hospital), blindness, developmental delay, multicystic dysplastic kidneys s/p DDKT 11/2/11 and living kidney transplant 1996 on azathioprine and prednisone c/b EBV negative CD20 negative PTLD (dx 10/2016 s/p rituximab in remission), hx of BK and CMV viremia, ?COPD on CPAP, CVID on IVIG every 3 weeks, ON of L hip s/p THR 2019, and DM presenting from OSH with COVID ARDS.    Patient lives in group home where several patients had COVID. Of note he is s/p 3 doses of Moderna. On 9/18/21, he was brought to the ER for SOB, headaches, myalgias and chills. He was found to be febrile, hypoxic and COVID positive. He was admitted for COVID pneumonia and developed progressively worsening respiratory status and was ultimately intubated 9/22. He was transferred 9/23 to Hospital (could not be transferred to location due to bed availability).    While at Hospital, he continued to have poor respiratory status despite max ventilator settings. He had a rapid response for subcutaneous emphysema, no acute surgical intervention was pursued. He was paralyzed and pronated to improve oxygenation. He also developed a lactic acidosis felt to be 2/2 hypoperfusion from hypotension and underlying sepsis. Per report 1/2 BCx with GPCs, not started on vanc due to hx of red man syndrome. S/p toci x1 9/23, 2 doses of dex 6mg (9/23 - ), 1 dose of remdesivir 100 mg 9/23. He was felt to be needed to transfer to a center with ECMO capabilities, thus was transferred to Hospital.    On arrival to the ICU, patient was intubated, sedated and paralyzed. He was satting initially on 78% with improvement subsequently to the 80s. He was subsequently proned.    HOSPITAL COURSE 9/24 - 9/27   #COVID ARDS The patient had severe COVID-19 infection and significant risk factors including immunosuppression for kidney transplant and CVID. Presented with hypoxemic respiratory failure, bilateral opacities on CXR with clear injury source and P:F ratio most recently of 56 c/f severe ARDS. Has been getting appropriate PCP ppx but potentially also has other overlying superinfection given immunosuppression, though he has no fever, leukocytosis. He arrived intubated. He was paralyzed, proning, and supported with lung protective ventilation. He was given diuretics, antibiotics and steroids. Evaluated for ECMO but determined not to be a candidate given his baseline lung disease. Infectious disease specialists were consulted and agreed with the management.    #Bardet-Biedel syndrome Patient with Bardet-Biedel syndrome with cardiac involvement manifesting as transitional AV canal defect with a primum atrial septal defect and cleft mitral valve as well as an LSVC to the coronary sinus.  He underwent surgery in 1994 for repair but was found to have residual subaortic stenosis and required a second surgery in 2007 to reassess subaortic membrane and accessory mitral valve attachment. Follows with Doctor from Hospital.