chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up states additional information received on 01/10/2001 indicated that the patient is a 42-year-old female who developed redness, swelling, and warmth at the injection site. The patient recovered after 3 to 4 days.
I got COVID. First symptoms appeared 05Aug2021.; I got COVID. First symptoms appeared 05Aug2021.; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in arm left on 10Mar2021 at 13:00 (age at vaccination 27-year-old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, administered in arm left on 31Mar2021 at 13:00 (age at vaccination: 27-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No medical history was reported and no known allergies. No other vaccines were administered in four weeks of vaccination. The patient received birth control (unspecified) in two weeks of vaccination. The patient had no covid prior vaccination. The patient got covid, first symptoms appeared on 05Aug2021 at 03:00 AM. The patient had a vaccination failure. No treatment was received for the events. The patient was tested for covid post vaccination. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction) which was positive on 08Aug2021 (Nasal Swab). The outcome of the events was recovered on an unknown date in Aug2021.  No follow-up attempts are possible, no further information is expected.
Anaphylactic reaction; Contraindicated product administered; This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included allergy (allergic to polysorbate 40 and 80).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and contraindicated product administered. On an unknown date, the outcome of the anaphylactic reaction and contraindicated product administered were unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the father for his daughter. The reporter declined follow-up not wanted to provide additional information or demographics. The patient received a flu shot and had an anaphylactic reaction. The patient was allergic to polysorbate 40 and 80.  The reporter did not know the name of the flu vaccine and had no further details. The reporter said he would have his daughter call and provide more details.
Rapid heartbeat, flushed face, light-headedness, BP 153/133 (I always run low)-went to Urgent Care after nurse instructions-was given breathing treatment and clonidine to bring BP down.
This serious spontaneous case, initially received on 12-Feb-2018, was reported by other non-healthcare professional (patient's mother), concerning a female patient of unspecified age. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 mg (as reported), route of administration: intramuscular, anatomical location: left deltoid, batch number: 195210, expiry date: not reported). On 12-Feb-2018, after 4 months 14 days of vaccination, the patient was diagnosed with Influenza B virus infection. At the time of this report, outcome of the event (Influenza B virus infection) was not reported.
have a bruised appearance in the left palm; Itching; redness; puffiness; prominent bright blue vein in palm of left hand; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration in left arm on 15Jan2021 14:30 at first single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol. No COVID prior vaccination. No known allergies. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ), rosuvastatin, celecoxib (CELEBREX), ergocalciferol (VIT D). No other vaccine received in four weeks. On 15Jan2021 15:00, the patient experienced Itching, redness, puffiness, and prominent bright blue vein in palm of left hand. This subsided somewhat after about an hour, but even three days later she had a bruised appearance in the left palm. Treatment included longer post-vaccination observation and Benadryl. COVID was not tested post vaccination. Outcome of the events was recovering.
Large welts on left arm with rash and numbness and tingling and pain, happened in less then 24 hours of vaccination
My son in law came into town sick and tested positive for COVID-19. I began to have symptoms and tested negative 3 times. I came down with a sinus infection and was sick for about 5 weeks before getting better.
the 2nd dose of Moderna vaccine was given beyond the scheduled appointment; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.  No adverse reactions were noted at the time of reporting.
He is throwing up; My husband can't even move from his place; This is a spontaneous report received from a contactable consumer (patient's wife) reporting for her husband. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 06Jun2021 as unknown, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient's wife asked that she had her husband have the vaccine today (06Jun2021) COVID-19 and he was throwing up. In response to filing the Safety Report, she stated, she needs help, her husband cannot even move from his place and he needed her help. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Within the first 24 hours of getting the shot I  developed some tingling in my right arm and hand, and right leg and foot. Also pain between my shoulder blades. This subsided after two days.  Beginning 26 hours after the shot I had stomach cramping, nausea, extreme fatigue, body aches, headache, chills. This lasted for 3 1/2 days. Then I developed a severe cystitis flare up, which I had not had in years. I?m still dealing with the cystitis flare which causes fatigue, bodyaches, frequent urination, insomnia, pressure in the bladder and pelvic area, extreme discomfort, nausea and headache.  I?m taking 200 mg Advil every four hours, using a heating pad, drinking mint tea, and taking desert harvest freeze dried Aloe Vera capsules (6) daily.
No adverse effects were reported in the patient.; a patient received a vaccine following a temperature excursion.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength, lot #, expiration date were unknown), which had been following a temperature excursion (lowest temperature below 36 degrees Fahrenheit/2 degrees Celcius (35 degrees Fahrenheit) for 430 minutes) (incorrect product storage). There was no previous temperature excursion. No data logger was involved. No adverse effects were reported in the patient.
Patient brought back to office 8/13/10 by grandmother and father approximately 8 AM. (R) upper arm red, warm to touch. Erythema measures approximately 3 x 4 inches with approximately 2 inch area in center with raised, fluid filled blisters. Complains of itching, gave BENADRYL 8/12/10.
This spontaneous report was received from a nurse regarding a 3-year patient of an unknown gender. The patients' concurrent conditions and medical history were not provided. On 14-JAN-2019, the patient was vaccinated with an improperly stored dose of PROQUAD (route of administration, and dose were not reported) for prophylaxis (lots # and expiration dates: R020676, 15-JAN-2020; R020816, 16-JAN-2020; R020677, 15-JAN-2020; R020814, 16-JAN-2020), however, it was unknown which specific lots the patient received. A sterile diluent was used to reconstitute the vaccines was properly stored. No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments:  009507513-1901USA005742: 009507513-1901USA005741: 009507513-1901USA005743: 009507513-1901USA005739: US-009507513-1901USA005573:
17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067198, US-MODERNATX, INC.-MOD-2021-067510, US-MODERNATX, INC.-MOD-2021-067250 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067198:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067250:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067510:Cross link, same reporter
Fatigue, hot and cold, chills, headache, upper body aches, and some breathing problems.
feeling dizzy; Nauseous; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6198) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  On 10Apr2021 at 10:00 the patient experienced feeling dizzy, nauseous and vomiting. The patient had reported of feeling dizzy and nauseous before vomiting. The patient appeared to feel recovered approximately 12 hours later. No therapeutic measures were taken as a result of the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of feeling dizzy, nauseous and vomiting was recovered on 10Apr2021.  No follow-up attempts are possible. No further information is expected.
Sudden onset of double vision 3 days after vaccine.  Remained the same - no change.  Saw Opthalamologist on Monday 9/12 (2 days after double vision occurence).  A blood test and MRI was ordered.  Follow-up in office tests confirmed diagnosis of Ocular Myasthenia Gravis.  A Cat scan ordered - patient was referred to Neurologist- confirmed diagnosis.  Prescribed Pyridostigmine on 10/12/2022.  Slight improvement in vision at this time.  Neurologist is referring to experts.  Physicians seem to be more interested in treating than possibly making a connection to vaccine.  I respect this but feel should be reported for future possibilities with other patients.
AROUND 2100 MY SON C/O FEELING LIKE SOMEONE WAS SQUEEZING HIS HEART AND FEELING NAUSEATED. THE EKG ON HIS SMART WATCH WAS SHOWING SOME INVERTED, LONGATED WAVES. SO, I TOOK HIM TO THE HOSPITAL, EMERGENCY ROOM.
I'm sick, like the second dose has made a lot of people. I began to feel soreness at the vaccine site about 08:00 pm. I began to feel like I was getting sick about 10:00 pm. I went to bed then, and woke up at 02:00 am, feeling like I had the flu -- body aches & feverish. Not horrible, but enough that I didn't feel like moving. I got up to go to the bathroom, and was uncovered, and then I got chilled. I went back to bed, and now at 07:30 am, I don't feel much better. My temperature is 100.6. It'a normally 96 to 97.
Redden swollen warm to touch area about an inch lower to injection site. 2x2 inch area. Looks like a ??  Tender
Information received from the review of scientific literature on 02JUL2018. This is case 4 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 22-year-old active duty male who presented to the ED with aching centrally located chest pain approximately 9 days after receiving ACAM2000. His chest pain started earlier that morning, and was non-pleuritic, non-positional, non-exertional, and not radiating. The patient had no personal or family history of cardiac disease. His ECG showed sinus bradycardia at 53 bpm but was otherwise normal. A chest x-ray showed no acute cardiopulmonary disease. A troponin-I was elevated at 2.12. The case was discussed with Cardiology from an outside hospital and the patient was transferred for further care and evaluation of myopericarditis. As an inpatient, he had a normal cardiac catheterization and echocardiogram. After discharge, the patient was placed on a medical profile, made non-deployable, and was to be followed by cardiology as an outpatient. The patient's outcome was not reported in the article. Additional information has been requested.
Severe pain at injection site, vesicles, pruritus starting date of injection, vesicles appeared day after. When seen 6 days after, continues with severe pain at injection site, pruritus vesicles open/scabbed. Rx Benadryl, hydrocodone.
Hearing loss ...right ear one morning when I woke up. ...Then left ear a day later. My first doctors apt. was on 3/18/2021. They thought cleaning the ears would do.  Not so.  To schedule next apt on 3/6/21 was harder to get apt.  Iwas put on 50mg of Prednisone daily for 10 days.  I saw the doctor again today and he gave me a second type of steroid which was thru the ear drum into the nerve. I go back on 4/27/21.  I have got back hearing in the left ear but Iam only 30% in the right ear.
This is a breakthrough case. I tested positive COVID-19. My symptoms were coughing, fatigue, difficulty focusing, sore throat congestion, fever, elevated heart rate, and chest pain from coughing. The doctor recommend PAXLOVID due to my chronic lung condition. Severe symptoms lasted for a day, but the cough lingered for a couple of weeks.
Patient started to have rash on the left upper arm that spread to chest, upper and lower back, and lateral left forearm; Had itchy ears and nose but no wheezing, or shortness of breath. Patient is advised to use non-drowsy lnog acting antihistamine such as Claritin or Allegra during the day and take Benadryl at night. Rx also given for Prednisone 20mg daily x 7 days
By 10:00am the next day after getting the 2nd dose I had a fever and body aches. I rested that afternoon by leaving work early. When I woke up after a 2 hour nap I felt a little fatigued but other symptoms were gone. The next day I felt normal and had a normal Saturday, but in the middle of the night around 2:00am I woke up with chills, aches, headache, and nausea. I also had diarrhea. The chills with come and go but be replaced with being really hot. I spent all day Sunday in bed and went to sleep eventually in the evening. I woke up Monday morning with a small headache that went away and all other symptoms disappeared. I did feel tired or a lack of energy by Monday evening.
Information has been received from a physician concerning a 6 year old male who on 27-FEB-2007 was vaccinated subcutaneously with 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot#656079/1306F). Concomitant therapy included mometasone furoate (NASONEX) and flaticasone proplonate (FLONASE). On 01-MAR-2007 the patient experienced bump about 2 inches, swollen and red hot raised to touch at the injection site. Medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. It was reported that the patient's twin brother experienced an adverse event following vaccination (WAES3 0704USA02160). Additional information has been requested.
Administration of expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29-APR-2023) for prophylaxis.   On 04-MAY-2023, the patient received Engerix B. On 04-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received a Engerix B which was already expired, which led to expired vaccine used.
4/17/2019 at 9:40AM: immunization administered into right arm. No issues/no foreseeable reaction(s). Patient left without issues. 4/18/2019 at 6:00AM: patient reported waking up to a swollen upper arm that was approaching elbow, which was also quite swollen. Patient reports that the arm had started to itch significantly. Patient applied ice and hyrdrocortisone cream to limit the itch. 4/19/2019: at 10:00am: patient came into pharmacy with swelling of his right arm that had progressed further down his arm, now past his elbow and onto forearm. Patient reported itch was not any better even with use of hydrocortisone cream and ice. Elbow was still quite swollen. Patient initiated diphenhydramine 25mg every 4-6 hours to help with the itching. 4/20/2019 at 4:30pm: patient reported the swelling had begun to recede and the itching was not as bad. Patient reported that their bicep was tender/sore to the touch but confirmed that swelling of arms/elbow had begun to diminish.
Employee had red area slightly larger than the size of a quarter at the injection site. Area was warm and slightly swollen. Cool compress applied the night that redness was noticed (11/6/2020) and reports decrease in size of reddened area.
Fainted the next morning and split my chin open- went to clinic and then to ER- needed 10 stitches in my chin and split my lip and needed 2 stitches in my lip
PREVNAR 13 burning at time of injection.  Red hot welt appeared and grew to 8-9 inch diameter over several days with pain, itching, discomfort in entire upper left arm and later hives with itchiness continuing, chills with nightsweats first few days.
COVID-19 Test Positive; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 Test Positive) and DRUG INEFFECTIVE (Lack of drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021 at 11:51 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 28-Jan-2022, the patient experienced COVID-19 (COVID-19 Test Positive) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19 Test Positive) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  Company Comment: This is a spontaneous case concerning a 42-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI event of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred 11 months 8 days after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. Current COVID-19 pandemic is a confounder. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as Serious as per Regulatory Authority report.   This case was linked to MOD-2022-489190 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 42-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI event of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred 11 months 8 days after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. Current COVID-19 pandemic is a confounder. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as Serious as per Regulatory Authority report.