chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented in clinic to receive vaccines for admission to community college, the program required MMR and Varicella. Pt and the nurse (writer) discussed his HIV status and whether needed to inform the school of positive status. Nurse (writer) administered both live vaccines, and discovered after administering vaccine that pt should not have received live vaccine due to HIV status, RN supervisor and pts Infectious Disease MD was inform of incident. Patient was informed of possible reaction to vaccines and to call another Dr.
Patient completed Pfizer primary series in April 2021.  But she stated on the consent form  on August 2 that she had not received Covid vaccine.  She received Moderna dose 0.5 ml as a third dose on August 02  before it was approved.
Cellulitis at injection site. Severe muscular pain. Unable to move arm. Throbbing headache/chills/fatigue.
pt presented w/fever 101, gen vesicular rash (approx 20 lesions) & hypersensitivity rxn @ inj site (5x5cm wheal)
I was feeling fine at first for 6-8 hours. After that, I took a nap for 1-2 hours.  When I took a nap, I felt sore on my left arm but not severed (the arm that I got shot.) I went to sleep around 12:00 pm. It was when I woke up from rest at 2:00-3:00 am out of nowhere, I was in pain in my body, couldn't breathe, my heart was pumping fast when I laid on my side for an hour. I sat on my chair for 15 mins and drank water occasionally to calm my body.  Around 5:00-6:00 am is when all the pains went away. My left arm right now is still sored.
Information has been received from a certified medical assistant concerning a 78 year old female with hypertension, gastrooesophageal reflux disease, cardiac disorder, penicillin allergy and sulfonamide allergy who in 1995 was vaccinated with her first dose of Pneumovax 23.  On 27-FEB-2007, the patient was vaccinated intramuscularly in the left arm with the second dose of Pneumovax 23 (0.5 ml) (lot # 655499/0988F).  Other vaccinations given on 27-FEB-2007 included Zostavax (Oka/Merck) (MSD) subcutaneously in the left arm and tetanus toxoid intramuscularly in the right deltoid.  Other concomitant therapy included WAL-DRYL ALLERGY RELIEF, PRILOSEC, estradiol, atenolol, folic acid, aspirin and ascorbic acid.  The patient called her physician and then presented to the office on 01-MAR-2007 to report having experienced a fever of 100 F, nausea, left arm pain, redness and swelling.  Treatment included an injection of an unspecified antibiotic.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 7/30/2007.  Initial and follow-up information has been received from a certified medical assistant concerning a 78 year old retired female with hypertension, gastrooesophageal reflux disease, cardiac disorder, penicillin allergy and sulfanamide allergy who in 1995 was vaccinated with the first dose of PNEUMOVAX 23.  On 27-FEB-2007, the patient was vaccinated intramuscularly in the left deltoid with the second dose of PNEUMOVAX 23 (0.5 ml) (lot # 655499/0988F).  Other vaccinations given on 27-FEB-2007 included ZOSTAVAX (Oka/Merck) subcutaneously in the left arm and Tetanus Toxoid intramuscularly in the right deltoid.  Other concomitant therapy included WAL-DRYL ALLERGY RELIEF, PRILOSEC, estradiol, stenolol, folic acid, aspirin and ascorbic acid.  The patient called her physician and then presented to the office on 01-MAR-2007 to report having experienced a fever of 100 F., nausea, left arm pain, redness and swelling.  It was also reported that the area was warm to touch.  Treatment included Reflex 500 mg twice daily times ten days.  At the time of this report, the outcome of the events was unknown.  No further information is expected.
Narrative:  hospice consulted for Senile degeneration of brain tissue. pt died a few days later
Approximately one week after injection the injection site began to itch and became very red. Red are was approximately 4 inches in diameter. The itchiness subsided in 2 days, but the redness continued for a week.
Information has been received from a nurse concerning a 12 year old female who on 30 Seo 2006 was vaccinated with the first 0.5 mL dose of Gardasil reported as "oral". On 01 Oct 2006, the patient developed intense vaginal itching. The patient sought unspecified medical attention. On 03 Oct 2006, the patient recovered from the event. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from a medical assistant (previously reported as a nurse) concerning a 15 year old female student (previously reported as a 12 year old) with asthma.  On 04-OCT-2006, at 4:30 PM, (previously reported as 30-SEP-2006), the patient was vaccinated in the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 654540/0800F).  There were no illnesses noted at the time of vaccination.  On 04-OCT-2006 (previously reported as 01-OCT-2006), at 6:30 PM, the patient developed intense vaginal itching which continued to the day after.  It was reported then it stopped abruptly on Day# 3.  On 06-OCT-2006, the patient had recovered from the event.  Additional information has been requested.
PT STATED THAT ARM BECAME SORE AND RED ABOUT 24 HOURS AFTER INJECTION.  HAD TROUBLE SLEEPING LAST NIGHT BECAUSE OF THE TENDERNESS AROUND INJECTION SITE.  PT STATED SHE HAS APPLIED COLD COMPRESSES AND TAKEN TYLENOL TO HELP WITH THE PAIN/SWELLING.  SHE STATED SHE IS UNABLE TO TAKE IBUPROFEN.  RECOMMENDED APPLYING HYDROCORTISONE OINTMENT AND LIDOCAINE CREAM TO THE INJECTION SITE AND TO TAKE BENADRYL ORALLY AS WELL TO HELP WITH INJECTION SITE REACTION.  PT CAME INTO THE STORE AND I OBSERVED THE INVOLVED AREA AS APPROXIMATELY 4"X6" AND I TRACED THE BORDER WITH A PEN.  MINOR SWELLING, DID NOT FEEL HOT, AND WAS TENDER TO THE TOUCH.  I INFORMED PT TO MONITOR AREA AND TO REPORT WORSENING OR EXPANDING AFFECTED AREA AND TO
patient said hours after returning home her tongue and then throat began to swell and she had to go the ER
Approx 10 minutes after vaccine had nausea, dizziness, extremities were cold, facial sweating, throat tightening. 12/2/05- Per review of medical records chief complaint in ER was SOB & dyspnea. Received epinephrine in pharmacy prior to arrival at ER. Recovered. Rx in ER with Phenergan and given Rx for Benadryl to take home for PRN use. Final diagnosis was allergic reaction to flu shot'. Anaphylaxis was NOT circled on ER sheet.  Sent home in an hour.
Pt got Dtap #1 Lot = AC14B006BA with Exp date: 2/26/07 given 4/23/07 (vaccine date was expired = no reaction)
This was my daughter's 3rd set of vaccinations. After each vaccine appointment, she became extremely sick with a fever over 101.0 and was lethargic. She wouldn't eat and she was not herself. After the first vaccine appointment when she was 2 months old, we took her into the emergency room only to be told that it was "normal" After this 3rd vaccine appointment, about 2.5 weeks later, I noticed that my daughter was acting different and would start to do this involuntary like movement with her neck bobbling her head to one side-almost like a seizure. She did this multiple times that I documented with my cell phone video on July 5, 2017. I made her an appointment with her pediatrician who told me that she didn't know what it was on the video but that it was possibly a tantrum. To my surprise, after I left and looked at my checkout documents, I saw that she diagnosed my daughter with "gross developmental delay" which is astounding to me since she started crawling at 6 months, walking at 9 mo etc. I then decided to take her for a second opinion the next day with a different pediatrician- she also didn't know what this seizure like activity was so I asked for a referral to a neurologist. I went the following week as scheduled only to be told by the neurologist that " this must be my first child" and that there was absolutely nothing wrong with her and that it was her throwing a tantrum. This happened only once or twice more and then never again with no explanation whatsoever.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II, subcutaneously (lot # L007217 with expiration date of 03-MAR-2017; strength, dose and anatomical location were not provided) for prophylaxis. No adverse effects were known. Additional information has been requested.
another booster three weeks ago; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received a booster shot last year on an unknown date and experienced shingles, refer case US2021AMR186098).   In August 2021, the patient received Shingles vaccine. In August 2021, between 2 and 4 weeks after receiving Shingles vaccine, the patient experienced shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's neighbor. The age at vaccination was not reported. The patient had just got another booster dose of Shingles three week ago and now she had shingles. This case was linked with US2021AMR186098, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186098:same patient/ same reporter
Treatment of COVID-19; Treatment of COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient did not receive any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient had a return of symptoms and infected my husband on day 12 after testing positive. The patient had previously tested negative then removed her mask and infected him. The patient had a return of symptoms that lasted quite a while. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: previously tested negative; (2022) positive. Therapeutic measures were taken as a result of covid-19. The patient took Paxlovid for COVID 19 Treatment. The start date of the treatment was 18Apr2022 and stop date was 23Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She had high fever, loss of appetite, change of behavior, pain and weakness for 5 days. The treatment was with Tylenol for pain and fever.
The shot was given at 4:45pm IM into the left arm. The patient moved to an adjacent chair nearby. About 3 minutes later, bystanders noticed the patient sway forward and fall out of the chair. He had fainting and was unresponsive. At this time I had told one of the technicians to call EMS. Within a minute after fainting the patient had starting to regain consciousness. I made recordings of blood pressure readings every 5 minutes. No CPR, epinephrine or diphenhydramine was needed. EMS arrived around 5:00pm. Over the course of 15-20 minutes, he went from laying consciously on the floor to standing with a full recovery. He declined EMS but called his dad to take him home to be safe.
Pt relates pain -> s/s allergic cellulitis -> skin peeling - no with area of mild brown/pale discoloration & pain with ROM.
This case was reported by a healthcare professional via a sales representative and described the occurrence of flu-like symptoms in a 52-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Co-suspect vaccination included TWINRIX (GlaxoSmithKline) given on an unspecified date (same date as BOOSTRIX administration - opposite arm from BOOSTRIX vaccination). On an unspecified date the subject received 1st dose of BOOSTRIX in an unknown arm and 1st dose of TWINRIX in the opposite arm. One day after vaccination with BOOSTRIX and TWINRIX, the subject experienced flu-like symptoms. At the time of reporting the outcome of the event was unspecified.
A tiny bit of soreness for 24 hrs; Coughing; scratchy throat; diarrhea; no stability standing up; slight runny nose; Fatigue; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and BALANCE DISORDER (no stability standing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea), BALANCE DISORDER (no stability standing up), RHINORRHOEA (slight runny nose), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, PAIN (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea), BALANCE DISORDER (no stability standing up), RHINORRHOEA (slight runny nose), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 12/9/99, the pt developed a breakthrough case of chickenpox with approximately 25 lesions on his groin, back, legs, and face and a fever of 102. The child was treated with Atarax to relieve itching. On 12/10/99, the pt's temperature returned to normal.
This case was reported by a pharmacist and described the occurrence of rash-whole body in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). Immediately after vaccination with FLUARIX, the subject experienced rash-whole body, swelling all over body, swelling-feet and rash neck area. The pharmacist reported that the subject, an employee of the hospital, had immediate systemic reactions after receiving the FLUARIX vaccine. The subject reported a severe reaction with a rash on the neck and body immediately after receiving the vaccine. The subject also reported swelling in the feet and all over the body. At the time of reporting the outcome of the events were unspecified. This is one of three cases reported by this pharmacist, see cases A0809614A and A0809777A for the other reports.
On May 2, 2021 patient started experiencing back and anterior chest discomfort extending up to throat, transiently relieved with NSAIDs (seen by primary provider on May 7, 2021). During our follow up on 5/12/21, she endorsed chest pain worse when lying down, better when sitting up; clinical symptoms appeared suggestive of pericarditis. CRP was elevated at 16 mg/L (normal laboratory rage 0-10 mg/L) sedimentation rate was within range at 20 mm/hr (normal laboratory range 0-32 mm/hr). Echocardiogram demonstrated a trace pericardial effusion. Patient was started on ibuprofen and colchicine. Follow p inflammatory markers demonstrated normalization of CRP (0.4 mg/dL - normal laboratory range </=0.9 mg/dL0; ESR was within range at 9 mm/hr (normal laboratory range 0-30 mm/hr). Ibuprofen was discontinued on June 15, 2021. She remains on colchicine. Symptoms improved following initiation of therapy, and she no longer has chest pain.
I tested positive for COVID-19 on 9/16/22. I had very mild symptoms, stuffy nose, and a slight cough. I was prescribed PAXLOVID and it seems to be working well. My symptoms only lasted for about 2 days.
After receiving her second dose of Moderna, member was standing in the locked bathroom stall and states her abdomen hurt severely due to her chronic IBS and she "collapsed from the pain," witnessed by another person in the bathroom who called for help.  Patient was found on her back with her head next to the toilet and her right foot tucked backwards under her bottom.
@ 230pm, pt was seen walking wobbly down halls of high school. Reported feeling dizzy & hot & was carried into the school nurse ofc. @ 310pm-vital signs were B/P-98/56,P-84,R-20,T-97.2(not accurate T not measured long enough)
A non-serious spontaneous report of nosebleeds has been received from a pharmacist, who is the patient's parent, concerning a 42-month-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 15-Sep-2009. Since 15-Sep-2009, the patient has had six nosebleeds. No other problems were reported other than nosebleeds. The outcome of the event nosebleeds was unknown.
Pfizer 9/21/21 and 10/12/21. Positive on 1/27/22
Patient describes feeling nauseated and hot about 6 minutes after vaccine, she vomited in to garbage can in observation room. Patient sat for  5  minutes and reported that she is feeling better. Left with her mother
5 hours after receiving injection. She developed fever, headache, body aches and lightheadedness.
never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The patient never got the 2nd dose of Shingrix. No other information was available. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023082392:Same reporter, different patient
This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 at 57-year-old, via an unspecified route of administration on 22Jun2021 at single dose for COVID-19 immunization. Medical history included broke wrist, exhausted from walking, fall, and ongoing multiple sclerosis. Concomitant medications included ocrelizumab (OCREVUS), and fampridine (AMPYRA). The patient experienced MS flare up on an unspecified date with outcome of resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
C/O tongue swelling, dyspnea and feeling faint with AVA #1. Workup with Allergy Clinic with diagnosis of vasovagal response.
This spontaneous report as received from a nurse practitioner to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (0.5 ml, intramuscular, anatomical location, lot number were not reported). The reporter stated that a patient on an unknown date developed abdominal pain on the same day after receiving a dose of GARDASIL years ago. The reporter stated that the patient went to unspecified emergency room for the abdominal pain. She reported that the patient was not admitted to the hospital. The outcome of abdominal pain was reported as recovered/resolved (date unspecified). The relatedness between reported adverse event and GARDASIL was not reported. This is one of several reports from the same reporter. Additional information is not expected because the reported did not wish for follow up.
Patient received dose one of Moderna vaccine and was told before injection what she was receiving. Patient was given her CDC card with vaccination information. Vaccination was given to Patient with out difficulty. Mother stated after injection that her daughter was supposed to get the Pfizer vaccine because she is only 17. Patient became light headed and dizzy post injection. She is a known diabetic who has had this same thing happen after blood work or other shots. Problem self corrected with no medical intervention. Mother stated she knew she was to get Pfizer and the website gave her this site as an option.
Acid reflux, digestive, gastric, ulcer. skin acne,back pain, knee pain, arthritis and vision blind.
hot to touch; swollen; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE SWELLING (swollen) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        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.   No relevant concomitant medications were reported.   Treatment information was not provided.
BLISTERS ON INSIDE OF MOUTH, RED WELTS ON FACE, FEVER AND ACHES.
Vaccine administered after published expiration date.  We received the vaccine from the distributor  02/16/2023, the vaccine had expired 02/12/2023.  With multiple Moderna expiration extensions, the vaccine was labelled with the incorrect expiration date at our facility.  While double checking vaccine expirations, the discrepancy was discovered.  We contacted the distributor and they corroborated that the vaccine was sent after the expiration date had passed.  We contacted Moderna who then performed a vaccine analysis of that lot number.  We contacted the recipient of the Moderna vaccine notified them that the vaccine was administered after the expiration date.  Patient verbalized understanding and stated they would just wait for their bivalent vaccine and does not desire to repeat dose.  The patient was advised to talk with their PCP.
First notices hives/rash at 5pm but they had likely been there a couple hours and were hidden by clothes. Large hives that were dark red and welt-like covering groin, hips, buttock, belly button with small spots higher up body.  No other symptoms and he did not act differently so we gave him dose of cetirizine hydrochloride and rash started to subside.  However, it is now day 3 and rash remains prominent on arms and lower legs.