chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT went to parent's home w/questions about lesion on face and arm/chest. This was reported to a county health department. PT wrestled with vaccinated brother on 2/15/03. Noted red mark on arm 2/16. Has one add'l lesion under nose and one on chest beginning on 2/17.
administration of expired dose of VAQTA; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 15-FEB-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA), lot number S030588 with expiration date 20-OCT-2020 (dose, route and anatomical location were not reported) for prophylaxis.
Patient received both vaccines, was still sitting in chair and as the pharmacist had her back turned to grab her paperwork, patient passed out and fell face forward out of chair. She hit her head off of the wooden cabinet in front of her and had contusions to face, bleeding from face and nose. There was no sign that patient was feeling sick or going to pass out. This all happened within a five minute period. After coming to, patient said she felt hot and started to see spots while she was sitting in the chair before she blacked out. Patient's mother denied request from pharmacist to call 911 and called later that night to tell me patient was doing fine.
Started itching at and around site on Thursday, and warm to touch.  Friday morning also red and blotchy.
Customer reports that the finger flange has broken off and is separated from the barrel of the syringe; the patient did not experience any other AE; one of the GARDASIL 9 doses was administered to a patient before the defect was noticed; This spontaneous report was received from a consumer and refers to a 23-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-JUN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered into left deltoid, lot # T024831, expiration date 18-NOV-2022 (exact dose and route of administration were not provided) for prophylaxis. The reporter stated that finger flange had broken off and was separated from the barrel of the syringe (poor quality device used, syringe issue). It was reported that there was another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with the same issue from the same box and tray but it was not administered. No adverse event was reported (with an outcome reported as recovered). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Fever of 100 to 100.3 degrees from 8p til the next day, 8a. Fussy and crying all night.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-MAY-2016, the patient was vaccinated with improperly stored dose of MMR II 0.5 ml injection, lot# L027432, expiry date: 22-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
father verbalizes swelling of lt arm which began about 28hr p/vax;father called hotline & talked w/MD who said apply heat & ice alternately;child arm was red & hard, painful;inspection of arm 11DEC98 revealed redness, warmth, swelling
Started with sore arm and progressed to fever up to 103.0, chills, vomiting, body and joint aches.
Reportedly received Shingrix vaccine on June 1, 2023. The following 2-3 days, complained of symptoms of abdominal pain, nausea, vomiting. Presented to emergency department 6/5/23 with signs and symptoms concerning for diagnosis of diabetic ketoacidosis.
PT HAD A SEIZURE SHORTLY AFTER VACCINATIONI LASTING ABOUT 1 MINUTE - WAS ALERT AND ORIENTED AFTERWARD - PT CALLED HIS MOM TO PICK HIM UP AND SHE SAID SHE'D STAY WITH HIM TODAY.  PT DOES NOT CURRENTLY HAVE A PRIMARY CARE MD BUT WILL LOOK FOR ONE NOW.
I was having a lot of weird pain and a headache. It kept getting worse and worse. I went to the ER. They did not know what was going on. They said it could not be a stroke. They gave me Aspirin and another medicine but I do not remember which one. They did an MRI, which came back normal. They think I was having an anxiety attack but we do not know. Recently like 3-4 weeks ago it felt like I was getting my period, it was odd. I felt very sick. I had diarrhea. I also had vaginal bleeding. I was really sick for a few days. I went to get my annual PAP exam and they said it was normal. They want to do an ultrasound to make sure everything is ok. I have not had my period in a while since I am entering menopause.
Started menstrual cycle - i have been in menopause for 3 years; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 at vaccination age of 53-year-old via an unspecified route of administration, administered in the left arm on 28Mar2021 at 12:30 (Lot Number: ER8734) as dose 1, single for covid-19 immunization. The patient medical history was none. The patient did not have covid-19 prior to vaccination. The patient has no known allergies. The patient's concomitant medications were none. The patient received the vaccine in a pharmacy or drug store. The patient did not have other vaccine in four weeks. On 08Apr2021 08:00, the patient started a menstrual cycle, but the patient has been in menopause for 3 years. The patient did not require treatment for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021.
Fever 2 days prior rash starting on trunk spreading to arms, neck and face (slightly erythematous papular rash).
Abnormally tired; Mild soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 5318) via an unspecified route of administration in the left arm on 02Mar2021 at 13:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food or other products. 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. Concomitant medications included ibuprofen (ADVIL), paracetamol (ACETAMINOPHEN), colecalciferol (VITA D3) and monolaurate avail (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 02Mar2021 at 19:00, by evening, the patient experienced mild soreness at injection site. Injection site soreness increased overnight and decreased after exercise. On 03Mar2021, the patient woke up abnormally tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild soreness at injection site, that increased overnight and decreased after exercise and abnormally tired was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
10-02-12 started w/symptoms, pain in (lt) deltoid, fever 100.7 degree F, hot arm, swollen, & headache x 3 days. On exam warm , red, induration area at injection site measuring 19 x 10 cm.
Fever, chills, joint pain, felt like I was in a dream, also major arm soreness
low grade fever the following morning  pain and redness at injection site the following morning wheezing which began the following night
Came down with + Covid-19 test on 2/17/22.  Headache, sneezing, body aches for 4 days
Fever x2 days. 104.0 on 8/25/15. 103.9 on 8/26/15.
I have what's known as COVID arm: big red splotch on arm (around 4 in in diameter). Experienced firmness, redness and itching around the injection site.
Pt states after receiving the vaccine she started feeling faint. Pt fainted and fell from a standing position. Pt was unconscious for approx. 30 seconds. Pt was seated in a wheelchair and moved to the observation area. Pt denies any head, neck, or back pain. Pt states she is feeling better and would like to leave. Pt didn't require transport to the hospital.
coughing which is getting horrible; painful  throat cannot eat or drink water since her throat is irritated; Painful foot feels her foot frature that not healing as well; whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M204 and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats. Concomitant products included GABAPENTIN and VITAMINS NOS for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Allergic to cats, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experiencing all the events since 4 months and were still ongoing.
Information has been received from a medical assistant concerning a 7 year old female patient who on 10-JAN-2000 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
pt stated their wrists and ankles swelled up, they were in significant pain in those areas as well as the injection site.
Pt received MCV4, Tdap and HPV yesterday within 24 hour period, pt experienced bilateral eye swelling treated at home with OTC ibuprofen and BENADRYL. Pt at pt clinic, pt received prednisone.
patient received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event; patient received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, strength and lot number not reported via intramuscular route in unknown administration site for prophylactic immunization.  On 31-Aug-2022, (latency: same day) the patient developed a non-serious patient received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event (product preparation error) and (single component of a two-component product administered) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Woke up at 4:00 AM on 4/2 with severe headache; took an Excederin Migraine on 4/2 and it helped.  Headaches continue daily, nearly constantly with varying intensity; have not taken anything for the headaches Lack energy, continue to be very tired in the afternoon -- not usual for me
Pain and redness at injection site. Redness initially size of a quarter on day 1, 11 hrs after injection and increased to the size of a silver dollar on day 2.5. Remained silver dollar size through day 5. Also swelling of arm  2 inches above injection site through it to 2 inches below. Warm to touch. Itchy near injection all lasting 5 days. Symptoms subsided by day 5.   Treatment: Tylenol and Benadryl which were ineffective.
Arm pain; Tremors where a little stronger; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and TREMOR (Tremors where a little stronger) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease (He has tremors due to Parkinson's disease.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and TREMOR (Tremors where a little stronger). At the time of the report, PAIN IN EXTREMITY (Arm pain) and TREMOR (Tremors where a little stronger) outcome was unknown.            No concomitant medications were provided No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Breakthrough case admission after 3 vaccines Moderna 3/15/21 lot# 044A21A;  Moderna 4/14/21 lot# 031B21A;  Moderna 10/26/21 lot# 032F21A
C/o burning type discomfort 8-13-16 R arm. 8-16-16 while at school noticed 2 raised lesions with tiny blisters approx a 15mm and 25mm on the top anterior and lower anterior of r arm, not at injection sites.
Starting with headache that turned into a 4 day SEVERE MIGRAINE with 2 hours of shot.  Had some Flu like symptoms but it was the migraine that poor me down for almost 2 weeks. Need to ask people if they have history of these. Haven't had migraine this severe on several years.  Scheduling second shot but so scared after what happened first time.
Nerve pain; Spondylitis ankylosing aggravated; This is a solicited report from the marketing program FACILITATED COLLECT based on information received by Pfizer from (Mfr. Control No.: 21K-163-4103326-00).  A contactable consumer (patient) reported that a 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on Apr2021 (Batch/Lot number was not reported) and dose 1 intramuscular on Mar2021 (Batch/Lot number was not reported) both as single doses for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose, single for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced spondylitis ankylosing aggravated on 2021, nerve pain on Aug2021. Solicited report from the by a consumer of a 43 year old female with events of non-serious Ankylosing Spondylitis Flare Up and Nerve Pain In Lower Back with HUMIRA (ADALIMUMAB). In 2021, the patient experienced Ankylosing Spondylitis Flare Up. In Aug2021, the patient experienced Nerve Pain In Lower Back. In 2021, the Ankylosing Spondylitis Flare Up and Nerve Pain In Lower Back Resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. In Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovered in 2021.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of ankylosing spondylitis flare up with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of nerve pain in lower back was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event of ankylosing spondylitis flare up with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was Possible. The reporter's causality for the events of nerve pain in lower back was Possible.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Ankylosing spondylitis aggravated and neuralgia cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 09-Nov-2021.  The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains primary reporter address updated.
Some side effects that occurred were dizziness, fatigue, slight fever and achyness in muscles and arms. I started feeling different about one hour after administration of the vaccine. The second dose however was more severe with a definite fever and even more dizzy, all other symptoms stand the same. I did not get treatment.