chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a nurse concerning a 17 year old female who on 06-MAR-2007 was vaccinated in the higher anterolateral area of the left thigh with a 0.5 mL second dose of GARDASIL (lot 655617/1447F). At the time of vaccination, the patient was alert and good spirits. The nurse did not notice any bleeding after the injection, but she placed a small bandaid at the injection site. The nurse asked the patient if she was okay, and the patient replied "yes". The patient walked to the check out counter and stated that she had a headache and was rubbing her head. The patient was advised to sit down for 15-20 minutes after the GARDASIL was administered but refused to be seated to passing out. The patient's blood pressure was slightly elevated while she passed out. The nurse was called to the waiting room after the patient fainted. Neurologic check grossly intact. One tooth was bleeding. The patient was taken to the emergency room and checked in. When the patient's father arrived, the patient stated that she did not want to stay. The father asked if patient was okay. The nurse informed him that she was okay, but the physician thought the patient should be evaluated at the emergency room. The patient's father refused treatment. At the time of this report, the outcome was unknown. No additional 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 51-year-old male patient received bnt162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced mild facial flushing within 10 minutes of vaccination of booster dose.  Temperature, HR and Pulse Ox unremarkable.  Denies all other symptoms other than flushed, warm cheeks and neck.
PATIENT IMMEDIATELY EXPERIENCED TIGHTNESS ON CHEST, HEAVY HEADACHE, DIZZINESS AND RINGING IN EARS AFTER RECEIVED VACCINE AT 10:56AM . PATIENT WAS LAYED DOWN ON THE FLOOR AND 911 WAS CALLED. EMT ARRIVED AFTER 5 MINUTES AND PATIENT WAS TAKEN TO HOSPITAL.
Symptom onset approximately 24 hours after 1st dose given. Experienced sudden onset orthostatic hypotension, weakness, and nausea for 36 hours.
Patient broke out with a severe and uncomfortable skin rash located in the chest area.  The red blotchy rash persisted for two weeks, temporarily leaving scars.  The rash did not appear until several days after inoculation.  I have photos of the rash if they are needed for further investigation.
This spontaneous report as received from a nurse via a company representative refers to a 21 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2008, the patient completed series of GARDASIL injection (lot#, expiration date, dose, and anatomical location were not reported), intramuscularly. In December 2015, the patient experienced an abnormal papanicolaou (PAP) smear test with load grade dysplasia (not specified what kind of dysplasia). No treatment was given, but there would be a follow up with another PAP smear test in about one year. The outcome of the events was reported as not recovered. The patient sought medical attention and visited an unspecified doctor office on an unknown date. The relatedness between the events and GARDASIL was not reported. Upon internal review the event of vaginal dysplasia (reported as load grade dysplasia) was considered to be medically significant. Additional information has been requested.
Pt. answered no to pregnancy, received VAR 5-6-15. Pt. states had (+) HCG a few days later. She is not having reaction.
Still suffering fatigue; Soreness in left arm; Chills; Fever; Headache; Sore arm; Bruising that went all the way down to the rib cage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), FATIGUE (Still suffering fatigue), MYALGIA (Soreness in left arm) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus since 2000, Drug allergy and Latex allergy.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (Still suffering fatigue) and MYALGIA (Soreness in left arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved and FATIGUE (Still suffering fatigue) and MYALGIA (Soreness in left arm) outcome was unknown.            Concomitant medication was not provided.  Patient was still suffering from fatigue and soreness in the left arm at injection site six weeks later.   This case was linked to MOD-2021-162127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient was received second dose. Updated the outcome of events (from  unknown to recovered). On 19-Jun-2021: Follow-up received on 19-JUN-2021. It contains significant information. Patient medical history was added and events were added.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 23-SEP-2014, the patient was vaccinated with an expired dose of ZOSTAVAX, injection (dose, route of administration and indication unspecified; lot # 0566AE with expiry date: 01-APR-2013). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates, the multiple unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # N003700, expiration date 11-NOV-2019, dose, route and frequency were not provided). No adverse effects were reported. The vaccines were stored in the temperature between 32 and 35 degrees Fahrenheit for 5 days. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA006119: Original Case : 1705USA006119 US-009507513-1705USA006154:
mom reports approx 10 vesicles & erythema @ inj site;approx 9 days p/vax pt seen w/approx 2-3 vesicles remaining w/o redness;
Arm pain within 8 hours of receipt.  Started at noon next day, 1/20 (~23 hrs after receipt) severe headache followed by fatigue, muscle aches, and chills that began around 5pm on 1/20 along with a fever that lasted 16 hours. All symptoms disappeared at 11am on 1/21, approximately 46 hours after vaccination (fever, chills, and body ache lasted ~16 hours as mentioned above).  This came on fast but left just as fast.  Was bedridden the whole time and could not function.  Woke up at 11am in drenched sweat and everything was gone. Crazy!
This spontaneous report as received, refers to a 72 year old male patient reporting on himself. On an unknown date the patient was vaccinated with ZOSTAVAX dose, route and lot # not reported. On an unknown date the patient experienced shingles in spite of having received the ZOSTAVAX. Patient stated that he had have already received a vaccine for shingles and there was no booster. The outcome of adverse event was unknown. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information is not expected.
RN administered injection incorrectly into the bursa, not IM. This resulted in extreme pain and inability to move arm. Began having muscle spasms in lower back using different muscle to reposition and for ADLs. Finally was able to see doctor 3-12-21. Given scripts for Tramadol and muscle relaxant. Had follow up appointment with Sports Medicine MD to receive a steroid injection in Left shoulder. Diagnosed with SIRVA (Shoulder Injury Related to Vaccine Administration) I now require Physical Therapy. I am unable to use my arm per MD and PT. I have difficulty dressing, cooking, routine housekeeping, etc. While I feel better since the injection, I am terrified the pain will return. I live alone and was unable to sleep, drive, dress, cook or do any ADLS including wash my hair or dress. The pain was completely debilitating. Even after the steroid injection, I have physical therapy and MD appointments, daily exercises and instructions to not use my arm.
Treatment of COVID-19; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: K9895) at the age of 73 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 as dose 5 (booster), single (Lot number: AS7149B), in left arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Hashimoto's Disease (thyroid)" (unspecified if ongoing); "minor COPD" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; CITALOPRAM, start date: Nov2015; CALCIUM + VITAMIN D [CALCIUM CARBONATE; COLECALCIFEROL], start date: Jan2010; STOOL SOFTENER, start date: Jan2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: though still tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Rebound Covid after taking Paxlovid. Day 9 felt fine, though still tested positive. Day 10 woke up with bad sinus headache and then restarted the nonstop runny nose I had had the first two days.
Patient and mother denied history of allergic reaction to food/medications or history of adverse reactions to vaccines in the past. Patient and mother denied health problem. Reviewed screening checklist for contraindications to vaccines for children and teens with patient and mother. After receiving vaccines patient became drowsy. Asked patient if she was ok, patient was able to  tell me her name and where she was. As I was going to get help patient loss consciousness on mom. Sitting up O2% was 75%. Laid patient down, elevated her feet. BP: 72/35 P: 58 O2%: 98%, EMS was called. at 1201 BP: 84/52 P: 59 O2% 98%. EMS arrived at 1205. EMS assessed patient and decided to take her to the hospital for further assessment. Mother was by her side the whole time and was kept informed about what was going on. Supervisor was notified.
forced to end his career after due to heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 22 years old male patient who was forced to end his career after due to heart problems while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient was forced to end his career after due to heart problems (cardiac disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (forced to end his career after due to heart problems).  At time of reporting, the outcome was Unknown for the event forced to end his career after due to heart problems.
Pain the hand; Could not lift arm very high; Chills; Fatigue did not bother much; Slight headache; Fever/100.4°F after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain the hand), MOBILITY DECREASED (Could not lift arm very high), CHILLS (Chills), FATIGUE (Fatigue did not bother much) and HEADACHE (Slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (cancer survivor).   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain the hand), MOBILITY DECREASED (Could not lift arm very high), CHILLS (Chills), FATIGUE (Fatigue did not bother much), HEADACHE (Slight headache) and PYREXIA (Fever/100.4°F after first dose). The patient was treated with CINNARIZINE (VERTEX [CINNARIZINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain the hand), MOBILITY DECREASED (Could not lift arm very high), CHILLS (Chills), FATIGUE (Fatigue did not bother much), HEADACHE (Slight headache) and PYREXIA (Fever/100.4°F after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4°F.         Concomitant medications include Blood Pressure tablets.  Patient was advised to take Advil by HCP.   This case was linked to MOD-2021-283839 (Patient Link).
The night following  my second shot, I woke up to severe chills and uncontrolled shaking and quivering.  Shaking like I've never felt before in my lifetime.  This lasted approximately 2 to 3 hours.  After taking Tylenol and wrapping in blankets, finally subsided.   I called out of work and spent the next day in bed.  Following that, I felt reasonably normal and returned to work.  I did not visit a doctor since at this point I felt typical.
Extreme chills and shaking for several hours the evening I received the injection, followed by fever.  Temperature ranged from 100 to 102.  I experienced nausea in waves, but did not throw up.  The fever continued the next day.  The nausea continued for two days, on and off.  I had a bad headache for 3 days, starting the evening I received the injection.  The pain and redness in my upper left arm (injection site) worsened 2 - 3 days after the vaccine was received.  I went to a doctor who diagnosed a skin infection at the site of the infection because the area was hot to the touch, very red, and swollen. The antibiotics he prescribed caused severe stomach pain for two weeks.
Redness, swelling (7 cm diameter) (It's been 2 days).
ever since he got the second vaccine (is been to unintelligible); This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) (seriousness criterion medically significant). At the time of the report, MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported. Patient reported that ever since he got the second vaccine (is been to unintelligible), and after the booster dose, was worst, having to take naps during the day, had never been like this before.  Company comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Mental Impairment. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-399720 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Mental Impairment. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
New onset atrial fibrillation with rapid ventricular rate 13 days after receiving 4th Moderna vaccine.  Treated in the emergency department 5/25/2022 and discharged on diltiazem.  Returned 5/26/2022 due to return of tachycardia as well as shortness of breath and lightheadedness.
Gave patient her  second  dose early; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001C21A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early) to be not applicable.    No Concomitant medications were provided. No treatment medications were provided.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer Inc.) concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (No drug was reported), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received dose 2 with non-company suspect vaccine Moderna covid-19 vaccine (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 11-OCT-2021 for covid-19 prophylaxis. On an unspecified date, the patient experienced Covid-19 with mild symptoms. On an unspecified date, the patient experienced confirmed covid-19 infection with mild symptoms (Dose number in series 2) and had confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 05-JUN-2022 to 09-JUN-2022 for treatment of COVID-19.  On 09-JUL-2022, Laboratory data included: COVID-19 virus test Negative (day 5 from Paxlovid treatment). On 10-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 11-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 12-JUL-2022, Laboratory data included: COVID-19 virus test Negative (tested for three days and continued be negative). On 14-JUL-2022, Laboratory data included: COVID-19 virus test positive (04 days later from Paxlovid withdrawal on 14-JUL-2022 the patient wake up with rebound infection with symptoms of sore throat). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and treatment with Paxlovid was withdrawn on 09-JUN-2022. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000243173.; Sender's Comments: V0:20220740244-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
30 mins post-vax patient complained of "hot flashes", resp distress with tightness accross chest.  Face flushed, urticaria started to develop on neck and chest.  Audible wheeze on exam. Given IM benadryl 50 mg and combivent nebulizer given Pt verbalized improvement, vital signs stabilized and was transferred to ED via ambulance
Patient had received the vaccine and was sitting in the monitoring area when he fell face first off the chair. He hit his head on the floor and was not conscious for a period of 10-15 seconds. Patient came to and had significant bleeding from nose and mouth, paramedics were called to the scene. Pharmacist helped patient to a seated position and patient was given bottled water and an ice pack. Paramedics came in and took over care of patient within approximately 5 minutes