chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 minutes after injection I d the left side of my face go numb. I was in my car and drove back to the site where I received the shot.  The nurses on site called 911. Paramedics came in about 15 minutes. by this time my BP went from a normal of 110/60 to 170/-not sure of lower number. I was also very nauseaous - though I never did vomit. I was taken by ambulance to Emergency. They diagnosed me as a possible stroke victim and proceeded with a battery of tests in the next 24 hours.
States at noon she was eating lunch, can't remember what she was eating but she had a lump in her throat.  States after a little bit she was able to drink milk, water and eat cottage cheese.  Thought it may have been carrot sticks she was eating.  Talked to her son (the doctor) and he told her it might be an allergic reaction.  States she was able to swallow normally after about 3 hrs.  States about noon she also had a temp of below 100 at noon, has not taken since then and was achy all over the rest of the day.  States then on 10/19 in the evening she got a cold and still has bronchitis has had to use her inhalation treatments and prednisone.  No other problems with swelling of her throat.
Patient received vaccine at noon, in the evening reported Nausea and Fever for 3 days. Her arm was swollen, red, hard and warm to touch for 4 days. She used cold compress to arm.
4 days following my injection of the Pfizer vaccine, I experienced severe muscle contractions on the right side of my neck and upper back muscles, where I could not move until I was advised by RN at Medical Center to take Over the Counter Motrin 200mg, until I was able to pick up the prescribed medication Flexeril 5mg to relieve the muscle spasms.  The symptoms subsided after about 45mins-60mins before I was able to have range of motion of my right side.
Initial report received from a healthcare professional on 25 September 2014. A 75-year-old male patient, whose medical history and concomitant were not reported, had received an intramuscular dose of FLUZONE HD (batch number U5024CA, expiration ate 12 May 2015, and dose in series not reported) in to the deltoid right, and a dose of PNEUMOVAX (manufacturer MSD) (batch number, expiration date, route, and dose in series not reported) in to the arm left on 23 September 2014. The patient had experienced pain in the arm down to the elbow and does not know if it was the right or the left arm on 23 September 2014. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was reported as unknown. List of documents held by sender: none.
paleness, weakness, then a few hours later chills, fever, extreme pain at the injection site, body aches, malaise
7 a.m. the morning following the 2nd vaccination, pt. got out of bed, walked a few steps to the master bathroom.  He was having some difficulty breathing so reached for his BREO & his legs wouldn't hold him up.  He collapsed to the floor.  His wife got him to bed where he stayed for a few minutes.  He got up again & walked a few steps to the master bathroom, started brushing his teeth & his legs collapsed again where his wife caught him & helped with controlled descent.  He could not remember some of the first collapse & none of the second collapse.   He crawled to bed & stayed for 1/2 hour.  Got up & felt fine the rest of the day & since then.
Patient states she felt dizzy within 10 minutes of receiving vaccine. Within 1 hour reported sternal chest pain, worse with palpation of sternum. Has persisted since that time
3 hours after receiving  2nd COVID shot, while at cardiology clinic appointment patient experienced syncopal episode and was taken to ED by ambulance
rash at sight - redness; swelling warmth. Low grade fever 100; headaches.  treated with zyrtec 10 bid; pepcid 20 bid and cold compresses
This case was reported by a physician to a sales representative and described the occurrence of fever in a 6-month-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unspecified date on or before 21 June 2005 the subject received a dose of Pediarix (dose number and lot number not provided). At an unspecified time after vaccination with Pediarix on or before 21 June 2005, the subject experienced a fever of 103 degrees Fahrenheit. The outcome of the fever was not reported.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). The reporter is the patient. A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Feb2023 as dose 3 (booster), single (Lot number: 6J6796) at the age of 71 years, in right arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective and COVID-19 with PAXLOVID from 08Mar2023 until 13Mar2023.   No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: Fe3594) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Apr2021 as dose 1, single (Lot number: 028a21a), in left arm and on 05May2021 as dose 2, single (Lot number: 016c21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (18Jun2022) Negative; (22Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product Paxlovid treatment started on 12Jun2022 to 17Jun2022 for indication to Treatment of COVID-19.  Clinical course: No known allergies. Other medication in 2weeks: Yes.
Vaccine was administered 12/15/08. Baby returned 12/16/08 with bloody diarrhea. Stool culture done- negative for O and P negative for salmonella, Shigella, campylo bacteria.
Onset of mild body aches and fever (3 on a scale of 1-10) eight hours after injection. These symptoms had worsed to 9 (same scale) by midnight. Could only "cat nap" for sleep until 3am when vomiting began and continued until 6am until there was nothing remaining. Body aches and weakness continued throughout the next day (01/05/22). Performed a self COVID-19 (BinaxNOW) test early afternoon on 01/05. The test was negative. Was limited to bed rest, only tolerating sips of water or watered-down gatoraid and low salt crackers. At 1am on 01/06/22 woke from sleep covered in sweat. After returning from the bathroom, noted considerable high-frequency ringing in both ears, but no apparent loss of hearing. [Continued on P.2]  A bout of abdominal cramps occured the evening of 1/5. Fever and body aches abated by mid-morning of 1/06. Contacted primary care medical provider (see Item #14) the afternoon of 1/5 of the symptoms experienced after third Moderna injection (first booster). High frequency ringing in the ears rediced in intensity over the following weeks and months, but has not abated. (Determined frequency at 1750 Hz - A6 on an 88-key piano).
Mom phoned H.D. stated welps on lt arm under site of inject;  Instructed mom to call MD;MD called appt made to see MD welps gone before visit;
She was throwing up; She felt really sick; Stomach feels empty; She feels tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (She felt really sick) and VOMITING (She was throwing up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ANASTROZOLE and MULTI VIT for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MALAISE (She felt really sick) (seriousness criterion hospitalization). On 28-Mar-2021, the patient experienced VOMITING (She was throwing up) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced HUNGER (Stomach feels empty) and FATIGUE (She feels tired). The patient was hospitalized from 28-Mar-2021 to 10-Apr-2021 due to MALAISE and VOMITING. At the time of the report, MALAISE (She felt really sick) and VOMITING (She was throwing up) outcome was unknown and HUNGER (Stomach feels empty) and FATIGUE (She feels tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood test: normal (normal) Normal. On 28-Mar-2021, Blood potassium: decreased (Low) Decreased. On 28-Mar-2021, White blood cell count: decreased (Low) Decreased.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included intravenous (IV) potassium for 24 hours, unspecified antibiotics, and unspecified medication for vomiting. Description: On 26 Mar 2021, the patient felt really sick, went to hospital, and was sent back to home. The patient's blood test was fine. On 28 Mar 2021, she felt really sick, and was throwing up. The patient went back to hospital, more blood work was done which showed white blood cells and potassium had dropped. The patient was in intensive care unit (ICU) for two and half days to three days in other part of the hospital for taking her blood levels to normal. On 10 Apr 2021, she was discharged from the hospital. The patient feels tired, and stomach feels like empty sometimes, puts crackers on it and it feels better.  Company comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
A report has been received from a Pharmacist and from a Health professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST (Intranasal), 0.2 millilitres, once/single administration for antiviral FLUMIST (Intranasal) started on an unknown date for antiviral EXPIRED DOSE OF FLUMIST was administered-Off label use. The action taken of FLUMIST was unknown. The outcome of the event of EXPIRED DOSE OF FLUMIST was administered-OFF LABEL USE and ADMINISTRATION OF AN EXPIRED DOSE is unknown.
Expired Dose; Initial Report Received on 28-Oct-2022 and 14-Nov-2022 (report)  This is a spontaneous report, received from a nurse regarding a female patient, aged 32 years, who received HEPLISAV-B for hepatitis B immunisation. The report was also retrieved (Disease Control) (ID 2494169-1) on 14-Nov-2022 and was noted as being reported on 31-Oct-2022.   There was no medical history reported.  Concomitant medications were not reported.  On 20-Oct-2022, dose 1 of HEPLISAV B (Lot #935841, expiration date 17-Sep-2022, NDC #43528-003-05), route not specified, was administered intramuscularly in the right deltoid for hepatitis B immunisation.   The dose was 33 days past the expiration date.   On 28-Oct-2022, an attempt was made to contact the patient when the error was discovered but was unable to reach the patient.  On 31-Oct-2022, the patient was contacted and made aware of the error and the need to re-vaccinate. The patient denied any adverse reactions. She was re-vaccinated on the same day.  Action taken with HEPLISAV B was not reported.  The event was reported as recovered and as non-serious.   No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Bloody nose, sometime during the night while asleep or in the morning on 3/21/21
Fatigue, tired, dizziness, palpitations, shallow breathing, lack of energy, diarrhea on 5th day after the vaccine shot
102.2 F fever taken rectally, fussiness, crying.  Tylenol given, slept through night, woke up with 102 F taken rectally, more Tylenol, woke up from morning nap at 1:30 with 102 F fever taken rectally, Tylenol given, 630pm 102.3 F rectal gave Motrin at 8pm, 930pm temp 101.8 F rectal, Tylenol given
shingles/herpes zoster without complication; This spontaneous report was received from a nurse practitioner via medical records and a lawyer regarding a case in litigation and refers to a 62 year old female patient with allergy to penicillin and seasonal allergies. The patient's historical vaccinations included: H1N1 vaccine and influenza vaccine. On 11-JUN-2014 at 10:26am, the patient was vaccinated with a 0.65 mL dose of zoster vaccine live (ZOSTAVAX) (Lot # J014566 exp date 18-FEB-2015) subcutaneously in the right arm for long-term prevention of shingles for zoster-related conditions and a 0.5 mL dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid at 10:24am.  On 31-OCT-2015, the patient presented to the ED due to rash that just started earlier on the same date as a red spot on her sternum and had spread under her right breast and around to her back. She stated it did not hurt or itch, but in the evening when she took her bra, she stated it became very irritating. The patient stated that when she was vaccinated for shingles she did not had symptoms. Skin examination showed skin was warm and dry. Rash was noted. Erythematous vesicular rash in patches along right side of chest and back. Did not cross midline. No weeping. The patient was diagnosed with herpes zoster without complication and was prescribed with acyclovir (ZOVIRAX) 200 mg capsule, 1 capsule 5 times a day. The patient was discharge to home/self-care. At the time of the report, the patient's outcome was unknown.  The lawyer consider shingles to be related to the use of zoster vaccine live (ZOSTAVAX).  The nurse did not assess the causality between shingles and zoster vaccine live (ZOSTAVAX).  All available medical records will be provided upon request.
Tiredness and nauseousness the day of the vaccine after receiving it, the next day I began vomiting, vomited everything and couldn?t even drink water, body temperature was flaring up then going back down. Went to the emergency room where I received IV fluids after vomiting for days after vaccine
Patient complained of redness in the left arm where vaccine was given, described it as dark red and descended down the arm. Patient did not complain of any fever or real pain. We were advised that it was no longer in the left arm. Patient states she had history of breast cancer in left side and some lymph nodes were removed. Patient did recover.
Patient states developed pain and soreness on day of injection 10/23/19. Arm continued to be sore and was still sore when he had well visit with this MD around 11/13/19---md advised that it should resolve itself. As of 12/3/19 patient still experiencing pain and soreness in his arm and he notified the pharmacy for the first time on 12/3/19. Patient advised by Pharmacist  to follow back up with MD for further evaluation and that I would submit a VAERS form
At 1440, patient reported to EMT and stated she had a "face rash" and feels "itchy" and "dizzy". RN assessed patient. Patient denied swelling of tongue/lips, difficulty swallowing and difficulty breathing. Patient reported she felt itchiness on her left and right cheeks. Patient appeared flushed. Patient reported history of allergic reaction to Toradol. Patient reported she had rashes on her face, hands and forearm. Patient reported history of hypothyroidism and current medication includes levothyroxine. Patient offered intramuscular diphenhydramine. Patient agreed to intramuscular diphenhydramine. Patient offered EMS. Patient declined EMS. At 1440, EMT  assessed patient vital signs: blood pressure 135/101 mmHg and pulse 87 beats/minute. At 1447, RN   administered intramuscular diphenhydramine 50 mg/1 ml in the right arm. At 1452, EMT  reassessed patient vital signs: blood pressure 143/93 mmHg and pulse 82 beats/minute. Patient stated she felt "better". At 1457, EMT reassessed patient vital signs: blood pressure 140/93 mmHg and pulse 84 beats/minute. Patient denied itchiness and appeared less flushed. At 1502, EMT  reassessed patient vital signs: blood pressure 142/91 mmHg and pulse 87 beats/minute. Patient denied itchiness, dizziness, lightheadedness and difficulty swallowing/breathing. At 1510, EMT reassessed patient vital signs: blood pressure 138/94 mmHg and pulse 80 beats/minute. RN assessed patient. Patient reported she felt "nothing" on her face. Patient denied itchiness and rashes on face. Patient's face was free from redness and flushing. Patient denied difficulty swallowing and difficulty breathing. RN asked patient if she had anyone to drive her home. Patient reported there was no one to drive her home. Patient reported she can drive herself home. Patient denied sleepiness and drowsiness. RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up with v-safe. At approximately 1517, patient left facility with unlabored respirations and steady gait.
DRY AND PERSISTENT COUGH FOR ALMOST 2 MONTHS. PAIN IN THE BACK, FROM CONTRACTIONS. EPISODES OF SHORTNESS OF BREATH.
pt says a few days after taking the vax he had arm pain that moved into his lower back.  He says his spine hurts around the waist and lower back area.  He has severe lower back pain when he moves around.  The pain will go away if he sits down but if he moves around it comes back.
Erythema Multiforme with joint pain and swelling. Treated with Benadryl and Prelone.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 19-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
dizziness; body aches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 27Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, body aches on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash all over body, itching eyes, pockets of fluid under both eyes, swelling on left and right sides of face, swelling worse on left side, left eye swollen 3/4 shut, swelling in neck. Called doctor, went into ER.
Pt c/o being hot and sweaty. Pt laid down on exam bed and given water. Pt stayed in clinic for 30 mins and stated she was feeling fine.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history, drug allergy and concurrent condition was specified. Approximately 4 weeks ago in January 2015, the patient was vaccinated with ZOSTAVAX (dose, unit, frequency, lot number were not specified) for an unknown indication. On an unknown date in February 2015 the patient had been prescribed a medrol dose pack for an unknown diagnosis. No product quality complaint involved (PQC). Additional information has been requested.
Administered on inner thigh; fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered on inner thigh) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included HYDROXYZINE, HYDROMORPHONE HYDROCHLORIDE (DILAUDID), DIAZEPAM, Pepcid, BACLOFEN, Dicyclovir, Zofran, CLONIDINE, TRAZODONE, Fluticasone nasal spray, TRIAMCINOLONE, Lidocaine patch, Albuterol, Benadryl and MUPIROCIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered on inner thigh) and PYREXIA (fever). On 23-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered on inner thigh) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.   This case was linked to MOD-2021-260234 (Patient Link).
Patient states that they have had no side effects or adverse events.  Vaccine was given from vial that had been in the refrigerator longer than 30 days
Thur 4/8: noticed circular red rash and swelling at injection site. Rash was approx quarter-sized. Over the next few days, rash grew in size and swelling increased. Area was hot to the touch. Area was very itchy, but not painful. On Sun 4/11, rash was approx 3-4 inches in diameter and very red and hot. On Mon 4/12, size and swelling had decreased. Color was more pink-ish. Today, Tue 4/14, rash is no longer visible, though there is still slight swelling in the area. I did not seek medical attention, because I searched my symptoms and found that this rash was a known, non-emergency reaction that had occurred in others approx 1 wk after dose #1 of moderna.
A day after the vaccine I had a severe headache, and my eyes were getting cloudy to where I could not see I could barely see with glasses, The vein in the center and top of eyes were inflamed,