chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to a 61 year old female patient with hepatic cancer, diabetes mellitus and chronic pain. On 16-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L012215, dose of 0.5 ml with exp. on 13-JAN-2017, intramuscular in left deltoid. Concomitant therapies included Vitamin D2, promethazine (manufacturer unknown), PROZAC, metformin, lisinopril (manufacturer unknown), PERCOCET, REQUIP, NEURONTIN, AMBIEN and ZANTAC. On 16-OCT-2015, immediately following the PNEUMOVAX 23 administration there was mild pain at injection site. The nurse practitioner stated that the patient reported having "quite a bit of pain at the injection site when she went to bed". Then on 17-OCT-2015, the patient experienced a contusion referred as "she had bruising in her left arm above the antecubital area and was tender to the touch on the opposite side of the arm from the injection site". The nurse practitioner reported that there was "no pain, tenderness, or bruising at the site of injection". The patient sought medical attention by walking in to clinic and the treatment ordered for the patient was warm compresses. The nurse practitioner stated "they had a CBC drawn and ordered an ultrasound of the affected area to rule out blood clots". The outcome of contusion and injection site pain was reported as recovering. Additional information has been requested.
Upper respiratory virus before 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL UPPER RESPIRATORY TRACT INFECTION (Upper respiratory virus before 2nd shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 0088B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VIRAL UPPER RESPIRATORY TRACT INFECTION (Upper respiratory virus before 2nd shot). On 03-May-2021, VIRAL UPPER RESPIRATORY TRACT INFECTION (Upper respiratory virus before 2nd shot) had resolved.            No concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report as received from a healthcare worker refers to a 19 year old female patient. No medical history or current conditions were reported. On 02-MAY-1994, the patient was vaccinated with the 1st dose of RECOMBIVAX HB, (dose, route, lot # and exp date not reported). On 07-JUN-1994, the patient was vaccinated with the 2nd dose of RECOMBIVAX HB (dose, route, lot # and exp date not reported). On 10-JUL-2013, the patient was vaccinated with the 3rd dose of RECOMBIVAX HB, (dose, route, lot # and exp date not reported). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
24 hours after administration developed erythema and swelling at vaccine site only. 48 hours after administration decreased erythema, increased tenderness with raised papule, no blisters. Afebrile, malaise present.
Croupy event noc of vaccine. ER and DECADRON. Hematoma 2 days later. Has not repeated urine.
Approximately 4 days post-vaccination, pt developed L periorbital pain. The pain worsened over subsequent days and she also developed L eye swelling and mild decrease in vision 5 days post vaccination. She saw her primary care physician on 2/10/21. Eye exam showed mild L periorbital edema without erythema, warmth, induration, bilateral eyes PERRL, EOMI, conjunctivae clear, no photosensitivity on exam. Temporal arteries with palpable pulses and nontender. She was referred to an optometrist who on slit lamp exam diagnosed anterior uveitis, mild in severity.
This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unkonwn age and gender. Medical history and drug reactions or allergies were not specified. On 02-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
12/6 became fussy. 12/7 fever for two days of 99.5. Ever since she stopped sleeping through the night (8-10 hours she was sleeping) and wakes up every two hours. She Also had milestone regression and stopped rolling over from her tummy to her back. She still cannot do it to this day at 6 months. She started doing it at 3 months.
I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here; it messed up my left thigh, from my knees, back of my knees to hip; I got left belts wrapped around my thighs just so I can stand up; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here), LIMB DISCOMFORT (it messed up my left thigh, from my knees, back of my knees to hip) and DYSSTASIA (I got left belts wrapped around my thighs just so I can stand up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     Patient had no COVID diagnosis.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Lot: 050E21A.) on 08-Oct-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Allergy and Blood pressure high (Patient was taking blood pressure medicines.).    On 14-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here), LIMB DISCOMFORT (it messed up my left thigh, from my knees, back of my knees to hip) and DYSSTASIA (I got left belts wrapped around my thighs just so I can stand up). At the time of the report, GAIT INABILITY (I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here), LIMB DISCOMFORT (it messed up my left thigh, from my knees, back of my knees to hip) and DYSSTASIA (I got left belts wrapped around my thighs just so I can stand up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was taking blood pressure medicines.  No treatment medication was provided.
PUI was admitted to Hospital and stayed @3-4 days PUI has onset Dementia, COPD, and Anxiety
Itching in arms, chest, back, head, and face; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 02Mar2021 at 08:00 AM (at the age of 78 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included high blood pressure, sinus issues, and allergies to sulfa and avocado. The patient's concomitant medications included zolpidem tartrate (AMBIEN), valsartan (VALSART), and gabapentin. The patient previously took morphine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a health clinic facility. On 02Mar2021 at 01:15 PM, the patient experienced itching in arms, chest, back, head, and face. No treatment was administered for the event. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the event.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Delayed lymphadenitis  ~1 week after the vaccination was given in the lymph node under the same arm the vaccine was administered in.
8/9/21 history of stage 3 CKD, HTN, presenting with acute onset abdominal pain and persistent nausea
This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 14:00 (Lot number: EN6198) at the age of 77 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "tendonitis" (unspecified if ongoing), notes: she is taking a lot of natural vitamins for tendonitis and asthma; "asthma" (unspecified if ongoing), notes: she is taking a lot of natural vitamins for tendonitis and asthma. The patient took concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Single, Batch/lot number: EN6207, Time: 14:00PM, Site: Left Arm), administration date: 02Mar2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "little tired last night". Additional Information: The patient got the shot 23Mar2021 and was taking a lot of natural vitamins for tendonitis and asthma. She asked if that will affect the vaccine. She said the vaccine was very good and was well accepted on her body. She mentioned she was a little tired last night but it was midnight and she felt recovered today. She clarified she had the first dose of the Pfizer COVID 19 vaccine on 02Mar2021 at 14:00PM in the left arm; and the second dose on 23Mar2021 at 14:00PM in the left arm. The patient has no history of all previous immunization and has no additional vaccines administered on same date of the COVID-19 Vaccine. The event did not require emergency room or physician office visit. The patient has no prior vaccinations within 4 weeks and has no family history and relevant tests. No follow-up attempts are possible. No further information is expected.
Maternal exposure during breast feeding; A spontaneous report was received from a consumer concerning a 32-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced maternal exposure during breast feeding.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient received the Moderna vaccine while she was breastfeeding. She did not report any side effects at the time of the report. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, maternal exposure during breast feeding, was considered resolved on 04 Jan 2021.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 20-MAR-2017 at 14:31, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Erythema multiforme major possible KAWASAKI's Disease.  4/27/09 MR received for DOS 3/24-28/2009 with D/C DX:  Erythema multiforme major s/p amoxicillin use.  Possible MMR rxn.  Possible Kawasaki's disease. Pt admitted from PCP's office with fever, diffuse body rash and red, cracked lips.  Noted to be dehydrated on admission. Initially thought to be Stevens-Johnson syndrome. Concern for Kawasaki's so started on ASA and IVIG. Pt became afebrile and rash resolving. Some desquamation on the palms.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: Fn6205), in left arm, on 25Mar2021 at 10:30 as dose 2, single (Lot number: Er8727), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: Ff2589), in left arm and on 31Mar2022 at 15:00 as dose 4 (booster), single (Lot number: Fk9894) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild-moderate asthma" (unspecified if ongoing), notes: Mild-moderate asthma; "known allergies: Penicillin" (unspecified if ongoing), notes: related antibiotics. Concomitant medication(s) included: DESLORATADIN, start date: 24Jul2022; MONTELUKAST, start date: 24Jul2022; DULERA oral, start date: 07Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Negative; (16Aug2022) Positive; (25Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: After completing full paxlovid course on 11Aug2022, I tested negative on 14Aug2022 and had no symptoms on that date. On 16Aug2022 I tested positive and began experiences mild symptoms including low-grade fever. As of today 25Aug2022, I continue to test positive although I have been symptom free since 21Aug2022. Patient had other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected
This report describes flu-like symptoms, lightheadedness and transient loss of vision in a 55 year-old male receiving Havrix [this should be LYMERix-Ed Gaunt 4/15/02) for prevention of Lyme disease. This report was received from a vaccinee and has been verified by a physician. Twenty minutes post vax, this pt experienced chills, fever, flu and headache. He felt light-headed and "passed out." He stated that the health clinic could not "get" his blood pressure. Vaccinee stated that he lost his sight and faded into and out of consciousness several times. After getting home, he reportedly slept for 2 days, getting up only to go to the bathroom. Information recieved 07/24 reports the outcome of events resolved. The event of 'lost eyesight (temporary)' is considered medically serious. The events of 'headache, lightheaded,' and 'loss of consciousness' do not meet ICH serious criteria but are being admitted expeditiously for informational purposes.
WITHIN 2 MINUTES AFTER THE ADMINISTRATION OF ALL VACCINES:BOTH OF HER HANDS BECAME SPASTIC-SHE WAS UNABLE TO MOVE THEM, SHE BEGAN HAVING GENERALIZED NUMBNESS AND TINGLING. HER HEARING CHANGED AS WELL AS HER VISION BECAME BLURRY . SHE ATTEMPTED TO CLOSE EYES AND PASS OUT. SHE WAS ABEL TO BE AROUSED BY CALLING HER NAME.
devel fever 26DEC92; sore throat 27DEC; seen by MD 28DEC dx w/strep injection; tx PCN x 10 days;
After recieving IMZ pt felt a bit dizzy. I had pt stay in the IMZ chair until she said she felt better at which point she went to the post IMZ waiting area. On the way to the area, she got dizzy again and her legs gave out and her mom was holding her up. As I came out to get her, pt was awake and responsive. Unsure if she ever actually passed out or if she was just light headed. Laid pt on the floor with feet elevated for a few minutes with a cold compress on forehead. After a few minutes, pt felt better so had her sit up still on the floor with cold compress. After a few more minutes, pt felt better and had her sit in chair and finish post IMZ wait time. Pt felt fine and left.
Moderna COVID-19 Vaccine EUA Soreness at injection site for 2 days. On 10th day (4/7) rash appeared on arm at injection site. It?s about 3-4? across. No itching or pain, just redness. I noticed it when I woke up at 7 am and it?s still present now (about noon).
Pt. seen in clinic, received 6 month well child vaccines. Later in evening, pt. had fever of 101.0 degree F with forehead thermometer, while dad holding him. Started to have a febrile seizure (couple of mns.) then vomited up formula, baby was groggy but response afterwards. Fever went down to 98.5 degrees F and baby is back to normal by next morning.
01-28-2021, at about 1pm starting feeling extremely tired. My whole body ached and my body was cold. on 01-29-2021, my lymph nodes were swollen on my left under arm. I went to my PCP to get checked out, and he said it was probably related to the vaccine. My symptoms (lymph nodes, body aches and tiredness) lasted one week then they resolved.
arm was hurting a little bit; had a little slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 16:10 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01May2021, outcome "recovered" (02May2021), described as "arm was hurting a little bit"; HEADACHE (non-serious) with onset 01May2021, outcome "recovered" (01May2021), described as "had a little slight headache".  Additional Information: It was reported that reason for no lot number: of COVID vaccine: Other: Patient was on the way to work, and patient didn't bring her daughter's COVID vaccination record card with her. Expiry Date, NDC number of COVID vaccine: Unknown. Investigation Assessment was no reported. Vaccine Administered at facility was not reported. Vaccination facility was at Pharmacy. AEs had not resulted emergency room or physician office. No other vaccines were given within 4 weeks. Relevant family history related to AE(S) was reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4/6/15 at approx 10:18A child received his first MENACTRA (L) arm. He held his arm in very tense posture and was moving (anxious about shot). 4/8/15 Erythema, swelling with a well demarcated margin 8.75" longitudinally and 6" transverse. (R) arm unaffected 9.5" at distal deltoid, (L) 11 1/8" distal deltoid.
my glaucoma has increased and I'm partially blind now; my glaucoma has increased and I'm partially blind now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "glaucoma" (ongoing); "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GLAUCOMA (medically significant), VISUAL IMPAIRMENT (medically significant), outcome "unknown" and all described as "my glaucoma has increased and I'm partially blind now".  Clinical Course: I am a 68 year old man who has taken my first and second vaccine as well the booster. Does your company have records of your vaccine worsening/amplifying any underlying conditions from your users and are you keeping this type of feedback to evaluate for further patient awareness. I ask this because I was borderline glaucoma and had minimal tinnitus. After my first 2 injections, my glaucoma has increased and I'm partially blind now. After my booster my tinnitus has become unbearable.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A report was received from a health care professional on 11/17/03 concerning 2 vaccinees of unspecified demography who experienced vomiting and diarrhea an unspecified length of time after inadvertently receiving Fluvirin SC between 11/4/03 and 11//03. Between 11/4/03 and 11/5/03, 2 vaccinees experienced vomiting and diarrhea after receiving Fluvirin SC. The vaccinees missed work for 3 days after receiving the vaccine. The vaccinees recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Follow up pending.