chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainting, seizures, lost motor skills. Patient was hospitalized for two days at the neurological wing of the hospital and she was placed on some medications for depression (Note) patient has never been diagnosed for depression. (Note) no neurologocal problems were found.  11/26/09 HP Admission for DOS 11/19/09: DX: Anxiety  Pt developed pain and swelling in her right biceps at the site of H1N1 vaccine injection few hours after receiving the vaccine. At the same time Pt developed SOB, lightheadedness, and near syncope.  Seen at the ER and diagnosed with anxiety. Valium treatment provided.  Pt's status improved.  The next day in the afternoon, Pt had a new onset of lightheadedness, SOB, and felt to her knees. Pt readmitted to the ER. Pt developed eye crossing, jaw locking and inability to speak. Neurological examination was negative for any cranial nerve problem, strength normal 5/5, 3+ reflexes, volitionally jerk of leg, generalized weakness, gait WNL, and Pt unwilling to perform sophisticated testing. Physician considered these episodes nonepileptic. Pt discharged home with a low Valium dose.  12/11/09 DC Summary received for DOS 11/19/09-11/21/09. Pt. admitted with recurrent jaw clenching episodes and crossing of eyes 2 days after getting flu shot. Discharged home on antianxiety agent. DC DX: nonepileptic seizures
Cold; Fever; Thinks had a breakthrough infection; Allergic rhinitis; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (Thinks had a breakthrough infection), RHINITIS ALLERGIC (Allergic rhinitis), NASOPHARYNGITIS (Cold) and PYREXIA (Fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced SUSPECTED COVID-19 (Thinks had a breakthrough infection) and RHINITIS ALLERGIC (Allergic rhinitis). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and PYREXIA (Fever). At the time of the report, SUSPECTED COVID-19 (Thinks had a breakthrough infection) and RHINITIS ALLERGIC (Allergic rhinitis) had resolved and NASOPHARYNGITIS (Cold) and PYREXIA (Fever) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-344005.; Sender's Comments: This case concerns a 86-year-old female patient with no previous relevant medical history, who experienced the non serious event of Suspected COVID-19 without laboratory confirmation and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 3 months after the second dose of Spikevax. Patient had nasopharyngitis and pyrexia, and the reporter suspected COVID-19 but the patient was not tested. The rechallenge is not applicable, since the schedule of vaccination has been completed and a further dose is not expected. The benefit-risk relationship of Spikevax vaccine is not affected by this report
Patient received a dose of Moderna Covid-19  vaccine on 10/9/2021 as the 2nd dose after receiving Pfizer's covid-19 vaccine on 9/18/2021 as the 1st dose in the series. Pfizer was available at the clinic on that date.
-extreme body ache (lasting 3 days) -bad headache -lost of appetite for two days. -extreme fatigue and sleepiness -round redness around shot area which is very sensitive.  Looks like a rash but it is not. -swelling in shot  injection area with the redness. -extreme sensitivity to left arm in shot injected area. -I cannot lift my arm all the way up without pain and cannot lean on it or sleep on it without pain.
Vaccinated through bandage; Soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinated through bandage) and VACCINATION SITE PAIN (Soreness at the site of injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinated through bandage) and VACCINATION SITE PAIN (Soreness at the site of injection). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinated through bandage) had resolved and VACCINATION SITE PAIN (Soreness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug information was provided by reporter.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow up received contain no significant information. On 21-Jul-2021: Follow up received contain no new information.
no advere event; expired product administered; caller reports the products was involved in a atemperature excursion; This spontaneous report was received from a nurse and refers to a 67-year-old patient.    The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 20-JAN-2022, the patient was inadvertently vaccinated with 0,5 milliliter of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T024556 with expiration date 08-JAN-2022) for prophylaxis. The vaccine was involved in a temperature excursion of 48.4 degrees Farenheit for 40 minutes. There was no additional adverse event reported (expired product administered, no adverse event and product storage error).
pt recvd vax; pt vomiting x 4days; redness on forehead & down right side of neck; pt had fever, refused food, swollen glands, light rash on body, stiff neck; t 104-105; mild inflammation of brain; had seizure due to high fever;
PATIENT HAD REACTION WITHIN ABOUT 10 MINUTES AFTER RECIEVING THE FIRST PFIZER DOSE. 911 WAS CALLED. PT WAS AMBULATORY AND WAS ABLE TO WALK TO GET ON THE STRETCHER TO BE TAKEN AWAY BY AMBULANCE. REACTIONS WERE: DIZZINESS, NAUSEA, HEADACHE, MUSCLE CRAMPS, CHILLS, COLD SWEAT, TINGLING SENSATION IN MOUTH, LIPS WERE VISIBLY SLIGHTLY SWOLLEN, BLOOD PRESSURE DROPPED 107/59 HR 84, THEN 99/54 HR 88, WEAKNESS/FATIGUE AND DIFFICULTY BREATHING. BLOOD PRESSURE WAS MEASURED BEFORE SHE WALKED TO THE STRETCHER, IT IMPROVED TO 124/80. PT WAS NOT TREATED BY EMS AT THE PHARMACY,  PT WAS AMBULATORY, AWAKE AND ALERT AND COHERENT.
Widespread urticaria/hives and severe itchiness 10 days following booster vaccination. Symptoms have persisted for >30 days. Treated with antihistamine medication; improvements, but lingering symptoms. Dermatographia and itchiness linger.
I was discussing patient's medications/profile with her and she stated that she had a reaction to ZOSTAVAX. Itching and rash all over. She did not report reaction to her doctor or the pharmacy until today. Says she still itches and has rash.
Swelling, redness, warm to touch to R arm started at injection site and spread to entire upper R arm.
heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.); heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.); my PLT count Keep dropping, from 200 to 156.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm left, administration date 18Nov2021 (Lot number: FH8028) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:15 AM), administration date: 31Mar2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Influenza vaccine, administration date: 23Sep2021, for immunisation. The following information was reported: HEART RATE INCREASED (medically significant), BLOOD PRESSURE INCREASED (medically significant) all with onset 19Nov2021 07:00, outcome "not recovered" and all described as "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)"; PLATELET COUNT DECREASED (non-serious) with onset 19Nov2021 07:00, outcome "not recovered", described as "my PLT count Keep dropping, from 200 to 156.". The events "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)", "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)" and "my plt count keep dropping, from 200 to 156." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Nov2021) 150; heart rate: (19Nov2021) 140; platelet count: (18Apr2018) 210; (23Jan2019) 226; (20Feb2020) 206; (24May2021) 195; (19Nov2021) 200 to 156; (22Nov2021) 175; (16Dec2021) 156. Therapeutic measures were not taken as a result of heart rate increased, blood pressure increased, platelet count decreased. Clinical course: On 19Nov2021 at 07:00, second day from third dose, heart rate and blood pressure increased (140 heartbeats, 150 blood pressure). Patient checked blood test record by accident and found out that PLT count kept dropping from 200 to 156. Since the vaccination, the patient has not been tested for COVID-19. Case was reported as non-serious.
Patient experienced shortness of breath and palpitaition after moderna covid vaccine, no headache, no dizziness, no rash.  She is able to communicate throughout the process. She sat down and was given one dose of epinephrine injection usp 0.3mg auto-injector (NDC 00093-5986-27). She had rested and sat down from 6:40pm to 7:15pm. She has been talking and laughing with her friend during the time. Pharmacist had been checking every 5  mins . She has been laughing and talking with her friend during the rest.  She stood up and walked for a while, and left pharmacy at 7:15pm. Pharmacist called her, confirmed that she has experienced no more symptoms. Patient said she will go ER in case she experienced any side effects.
Information has been received from a nurse practitioner concerning a 19 year old female with asthma, who on 10-MAY-2010 was vaccinated with "three doses of series" of GARDASIL. Concomitant therapy included montelukast sodium (MSD) and corticosteroids (unspecified). The nurse practitioner reported that "the patient received the first dose of GARDASIL and had an unspecified side effect. Then the patient received the second dose of GARDASIL, the date was unspecified, and after receiving the second dose the patient experienced a headache, fatigue and arm pain. Then on 10-MAY-2010 the patient received the third dose of GARDASIL and after receiving the third dose the patient had an irritated mouth, lips were infected, five inflamed taste buds, inflamed gums and it hurts to eat. Also the patient was sleeping a lot and had lost nine pounds between 10-MAY-2010 to 14-MAY-2010. The patient then saw a dentist who gave her amoxicillin for two days and then on 14-MAY-2010 the patient saw the nurse practitioner and the patient was diagnosed with Aphthous ulcer and it also said on her chart toxicity from vaccine. The nurse practitioner put the patient on VALTREX and viscous lidocaine and was told to finish the amoxicillin." The patient had not recovered at time of reporting. Additional information has been requested.
9:00pm at first my right arm started itching but then it spread to my whole body itching. No rash or hives. No closing of airway. Took 1 Benadryl at about 11:00pm. Woke up in the morning with sore arm but no more itching.
I had my vaccination on 04/29/2022. I tested COVID-19 Positive on 04/07/2023. I was prescribed Paxlovid. I am presently feeling ok but still have some fatigue on 05/01/2023.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. The patient was vaccinated on the left arm. This case was linked with case US2018158732 (2nd dose), reported by the same reporter for the same patient.
On day 7 after injection, my arm became red, itchy and rash late afternoon. By 3am that night, it was hot and red. The following day, redness expanded and arm remained hot all day. Went to urgent care - diagnosed with cellulitis and given keflex. At the time of this report, only  one dose of antibiotic has been taken
mom called 2 days p/vax & states fever 105, had been given pt APAP correct dose;t103 p/motrin & bath;mom states took pt to ER late the same evening d/t fever;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 05-JUL-2012, the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JAN-2016, he was treated by a physician/MD at an unspecified facility for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe Herpes Zoster, or shingles. The male patient has been prescribed oxycodone for management of his 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Received vaccine around 7 AM. Went home and went to sleep due to working night shift the previous night. Awakened around 1:30 PM with shortness of breath, body aches, headache and sore throat.
Difficulty breathing, fast heartbeat, dizziness, faintness, and muscle weakness. The dizziness, faintness, and muscle weakness were immediate and passed within a couple minutes. The difficulty breathing and fast heartbeat began immediately and increased rapidly over next 5 minutes. I sought medical assistance, took 50mg of Benadryl and used my rescue inhaler. Remained under monitoring for an hour but did not use EpiPen.  Over the next 48hrs I experienced continued but less severe difficulty breathing and occasional periods of muscle weakness.
A large red area where the flu shot was given that was painful, swollen and hot to the touch.  Saw a Dr on 10/21/15 and was told it was infected and given a course of antibiotics to take.
Patient was seen in the ER 05 at 0100 following an episode of shortness of breath. She had been crying for 3-4 minutes, very hard per parents, and then seemed to have trouble catching her breath. Parents denied seizure activity. They report she has had similar events in the past with crying fits. Patient had received vaccines the day before so they were giving her TYLENOL every four hours. Temp max was 100F rectally in the ER. Exam was benign and she was discharged home with BRUE. Patient returned to the ER at 0900 with concerns for seizure-like episode. Parents reported 3-4" episode of shaking and eyes rolling back in her head. The felt she had difficulty catching her breath. Seen in our office 05/04/18. Patient was admitted overnight for observation. With seizure precautions in place, no further seizures were observed while the patient was admitted. Laboratory workup however as remarkable for elevated WBC and liver enzymes (ALT and AST). She maintained normal feeding, voiding, and stooling. An EEG was performed and no abnormalities or epileptiform activity was seen during the recording. Due to concern of parent's observation that patient has ceased making sounds since onset of seizures (including cooing and other sounds), speech therapy evaluated the patient and concluded patient is high risk for speech/language delay and will benefit from early intervention ST to monitor early speech/language development and provide parent education, appropriate for outpatient therapy. There were no concerns for feeding expressed, as patient takes 6oz every 3-4 hours with occasional breast feeding. Occupational therapy evaluated the patient and further recommended close monitoring of development with early intervention as indicated. Patient was discharged with instruction for close follow up with PCP. Further outpatient workup of unprovoked seizures may include MRI of the brain. I spoke with Dr. via phone last week to discuss follow up. Mom reports no further seizure activity. Mom denies concerns regarding development. She does not feel patient has lost any previously achieved milestones. Follow up appt. 05/15/18 labs done. Hepatic function panel CBC with auto diff. Results normal. Patient had MRI and repeat labs all normal results. Started on KEPPRA. Seen for follow up here 05/22/18 and stable at that time.
possible reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (possible reaction) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (possible reaction). At the time of the report, VACCINATION COMPLICATION (possible reaction) 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 provided by the reporter.
This was my fourth dose of covid vaccine. This time the pain was very severe and mostly in my right sciatic nerve distribution into my foot down my leg in my knee. It also affected/inflamed my left knee joint, my left thumb/wrist tendon and joints with severe pain in my right hip flexors and hip joint
Patient was administered the Covid Bivalent Pfizer Vaccine instead of the Flu vaccine that patient had arrived at pharmacy to receive.
no issues; Expired VAQTA given last night; This spontaneous report was received from an office manager via a company representative, referring to an one-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 22-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) administered intramuscularly (exact dose, injection site and lot number were not provided, expiration date reported as 11-JUL-2020) for prophylaxis. His present status was described as no issues.  This is one of two reports concerning siblings.; Sender's Comments:  US-009507513-2007USA009441:
pt recvd vax 2SEP95  & 2OCT95 lab eval revealed a neg titer & therefore, pt did not seroconvert;No further details were provided;
Treatment of COVID-19/COVID-19 Test: Positive; Treatment of COVID-19/COVID-19 Test: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 Immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 Immunization. The patient's relevant medical history included: "MCI" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient had no known drug allergies. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19/COVID-19 Test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with both vaccines in this patient cannot be completely excluded.
inj site became red, hot, sore w/in about 8hr over course of 1wk was a large (1x2") site red, sl swollen/painful then itchy;1wk later darker red/bruised appearance;aches & chills;
Soreness, redness and small bumps in arm of injection; just a few inches right of injection site.
Headache starting that evening, chills, fatigue, nausea, muscle soreness/weakness, sore throat, muscle aches, red welt at vaccine site that is getting bigger by day.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Date of Refrigeration of vaccine was 07-MAY-2021  No Treatment information was reported.   This case was linked to MOD-2021-363716, MOD-2021-363032, MOD-2021-363226 (Patient Link).