chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient presents for Rash. This episode began 1 day ago. The symptom(s) are described as moderate and improving. Affected area(s) include left arm. The patient describes the affected area(s) as burning, itchy, red and pain. Denies aggravating factors. Denies relieving factors. Associated symptoms include erythema (skin) and pruritus. Pertinent negatives include bleeding and scaling. Additional information: She had a pneumovax-23 vaccine yesterday and got a rash and had pain in the area the evening after the rash and pain started. The pain is starting to subside a bit. She took TYLENOL and aspirin to help. She definitely has a rash after the pneumonia-23 vaccine. I will have our team report it to VAERS. I am concerned with the warmth that there could be some cellulitis. I will start her on a short course of KEFLEX to treat this. TYLENOL PRN pain. Do supportive care to the arm with ice packs 2-3 times a day as needed. You can use the arm as much as your pain will allow. TYLENOL as needed for pain.
Gardasil 9 injections directly into the tumours; Gardasil 9 used for tumours caused by HPV which have spread from her liver to her anus as the patient read about this treatment in a medical journal/article; This spontaneous report was received from the patient's chef concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), directly into tumours caused by human papillomavirus (HPV) (intentional product use issue) which have spread from her liver to her anus (dose, strength, specific route of administration and lot number were not reported).  According to reporter, the patient read about this treatment in a medical journal/article.  At the reporting time, the patient's outcome was unknown.
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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: Gj6739) at the age of 65 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: Ep7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: Er8732), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: Ff2593), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: Fm9992), in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2022, outcome "recovered with sequelae" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive; (31Dec2022) Negative; (07Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient tested positive for COVID on 22Dec2022. The patient started 5 day course of Paxlovid. Completed Paxlovid course as directed on 28Dec2022. Symptoms resolved and tested negative on 31Dec2022. Rebound COVID symptoms begin to reappear on 05Jan2023. Symptoms continued to get worse and tested positive for COVID again on 07Jan2023. Treated COVID symptoms with OTC cold flu medicine and slept 18 hours per day. The patient was beginning to feel much better on 11Jan2023.The patient had no known allergies.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 14-year-old female patient of an unknown ethnicity received on 07Oct02015 TRUMENBA at single dose. Concomitant medications and medical history were not reported. The patient came back on 08Oct2015 with headache, erythema, induration and limited arm movement. It was not clear if onset date was 07Oct02015or 08Oct2015. Outcome was not reported.
It started with rash/hives all over my body- head to toe I'm all red and Itching, running nose, itching eyes, sneezing, headache, shivers, hot and cold all the time, feel my head and face hot. I dont have fever don't had in more than 20 years, but it feels like i have a fever.
Approximately 2 days after receiving 2nd dose of Moderna vaccine, patient experienced severe diarrhea, nausea, vomiting, and also had a rash on both arms, top of feet, and on face / neck.
Received injection in LA on 10/07/2010. 2-3 days later started to have pain in LA especially in the elbow and the muscles surrounding it. Has had flu shots before with no reaction. Now has pain in both elbows and muscle tenderness around the elbows. Pain is off and on but whenever he moves arm or tries to lift it is painful, wakes him at nite. Never had H1N1 before. No doctor has no insurance.
Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH, Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 15:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced arm pain on 20Mar2021 at 22:45. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for event. The outcome of the event arm pain was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Pt reports immediate pain/lump/bruising-. States "quarter" size bruising and pain for 2 wks.
Headache; Fever; Chills; He is very weak; Balance past 2 to 3 weeks is little off; Exhausted; kind of impacting every area of his legs at this point; This is a spontaneous report from a contactable consumer reported for her husband. An 83-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration on 02Apr2021 (at the age of 83-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included shingles in the past and has had the shingles shot and the reporter thinks last year. Concomitant medications were not reported. The patient previously received Valacyclovir (MANUFACTURER UNKNOWN) for Herpes which is being dormant for many years. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 12Mar2021 (at the age of 83-year-old) as dose 1, single for COVID-19 immunisation and had no reaction. The patient had many health issues and was on many different medications. On an unspecified date in 2021, within 2 or 3 days of vaccination, the patient experienced headache, fever, chills, he is very weak, balance past 2 to 3 weeks is little off, exhausted and kind of impacting every area of his legs at this point. The reporter just wonders if the vaccine could have awakened all of these other viruses that the patient has that has been dormant and the patient was not showing any reasons from Herpes. The seriousness of the events was not specified. The patient received Tylenol 500 mg as treatment for the events. The outcome of all events was not resolved.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488774 Same reporter, different patient/events
A report was received from a health care professional on 10/24/03 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, 3 vaccinees less than 4 years of age inadvertently received Fluvirin. It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 11/24/03: Further information was received from a health care professional on 11/24/03 indicating the vaccinee was a 2 year old female who inadvertently received 0.25ml Fluvirin vaccine on 10/21/03. On 10/21/03 the vaccinee inadvertently received Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
6 hours after receiving, PREVNAR 13 patient had diarrhea that lasted 5 1/2 days. 2 days later patient experienced dry heaves and sores in mouth, headache, stomach pains, sore arm, wheezing, coughing, w/phlegm and chills that lasted 2 days.
insomnia; also have chills; soreness at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia), CHILLS (also have chills) and INJECTION SITE PAIN (soreness at injection site) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (insomnia), CHILLS (also have chills) and INJECTION SITE PAIN (soreness at injection site). At the time of the report, INSOMNIA (insomnia), CHILLS (also have chills) and INJECTION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Information has been received from a medical assistant and employee at a physician office concerning a 5 year old white male patient with a penicillin and amoxicillin (+) clavulanate potassium (Augmentin) allergy and history of a tonsillectomy, who on 25-June-1999 was vaccinated in the left arm with a dose of varicella virus vaccine live (Lot #630679/0427J). Concomitant vaccine therapy administered on 25-Jun-1999 included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #630633/0132J) administered in the right arm. The medical assistant reported that on 16-Jan-2004, the patient presented to the physician office with multiple vesicular lesions, approximately 20 lesions. Additional information from an employee at the physician's office reported the patient's rash stated on his chest, legs, neck, arms, ankles and bottom and he had one lesion in his mouth. The patient's mother told the nurse that the patient had a low grade fever, but no fever was evident at the office. The patient also had a headache. It was noted that the patient was seen by the physician, who prescribed diphenhydramine hydrochloride (Benadryl) and calamine lotion to treat the patient. There were no laboratory or diagnostic tests performed. There was no product quality complaint reported. The patient recovered on 20-Jan-2004. No additional information has been requested.
Severe headaches, aching muscles/bon pain, hyponatremia, enlarged/immature red blood cells, severe fatigue- 4 weeks of symptoms plus two more for recovery = total six weeks.
This patient received #1 Varicella immunization on 02/20/01 (employee had non-immune HZV Titer done on 01/12/01). On 03/07/01, he started running a fever and on 03/09/01, he broke out with slightly small red uniform papules with no pustules (which numbered approx 25 - 30 by 03/12/01) and was located on anterior and posterior trunk, arms, neck and legs. The lesions began with two close to the initial varicella injection site and then continued all over his body. Pruritus was also present with the lesion. Fever stopped on 03/11/01. The lesions stopped breaking out on 03/17/01. the fever ranged from 99 to 102 from 3/7 to 3/11.
had loose stools day of inj; devel fever & looser BMs 4 days later w/no basis of fever seen; fever, diarrhea persisted in spite of nl CBC, neg stool culture, neg blood culture; hospitalized 2JUL95-4JUL95 w/dehydration & rash
This spontaneous report as received from a 75 year old male patient refers to himself. The patient had history of shingles (date not reported) and unspecified problems with blood pressure and cholesterol. No allergies or reactions to the drugs were reported by the patient. ON an unknown date in 2007, the patient was vaccinated with ZOSTAVAX (vaccine administered once; dose, administration site and route of administration: unknown) (LOT # and expiration date: not specified) after he had shingles (date not reported). No concomitant medication was taken at that time by the patient. He stated that then he got shingles again, 2 years ago, approximately in April 2012, and hot shingles again about 6 months ago, approximately in November 2013, after getting the vaccine. The patient had sought medical attention and had received unspecified antivirals for treatment. The outcome of shingles was not reported. The relatedness of shingles and ZOSTAVAX was not reported. Additional information is not expected.
Pain, swelling, erythema at injection site; pain radiating into shoulder and neck; symptoms worst 2 days after receiving vaccine; pain improving spontaneously.
Her platelets went from 94 to 92; blood work showed low platelet and CD4 cell counts; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included HIV positive, Diabetes and Bleeding (Her bleeding risk was so high at the moment that she had to cancel her pain shot.).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) (seriousness criterion medically significant). At the time of the report, PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood test: abnormal (abnormal) abnormal. On 13-Apr-2021, Platelet count decreased: 92 (Low) Low.         No treatment information provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's concurrent medical conditions including viral infection (HIV) and diabetes may remain as confounders.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's concurrent medical conditions including viral infection (HIV) and diabetes may remain as confounders.  Further information has been requested.
COVID-19; COVID-19; Cataract; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on the information received by Pfizer from Facilitating Company (MFR Control No.21K-163-4084340-00).  A contactable consumer reported that a 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date at an unknown dose for rheumatoid arthritis. Medical history and concomitant medications were not reported. On unknown date in 2021, the patient experienced cataract and covid-19. The patient had cataract surgery. The action taken in response to the events for upadacitinib was unknown. The outcome of the events was recovering. Reporter causality was possible for the event covid-19, for the event cataract was not reported. She was still recovering from Covid 19 as of 16sep2021. She had a breakthrough case as she was fully Vaccinated. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events 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.
Patient reported a tingling sensation down his left arm approximately 10 minutes after receiving his second Moderna vaccine.  He then went on to experience a spike in blood pressure accompanied by headache and blurred vision in his right eye.  He took an extra dose of each of his blood pressure medications (Amlodipine 5mg and Valsartan Hctz 160-25mg).  Soon after his symptoms began to resolve and he left the store.  We advised him to follow up with his doctor regarding the high blood pressure event and blurred vision.
Vaccine given (L) deltoid. Persisting pain and left biceps weakness since administration informed MD on 5/9/19
Left arm swollen with big red hot knot. It was medium size early today now it?s spreaded wider and hurts
Vaccine (DTaP) administered on 9/10/02. Itchy rash noted over site on 9/12/02. Seen by MD on 9/13/02. Symptomatic treatment.
Arm was first sore and had a hard spot at injection site. After a day or two there were some bumps and itching  in the area. A week later there was a raised slightly red, bumpy, and itchy area approximately 2" oblong around the injection area.
i had a fever of 100.3; when i woke up i had felt super tried; body aches; my arm that received the shot was very sore; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0170) via an unspecified route of administration in arm left on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included blood clot (other medical history: blood clot for that she was taking eliquis for). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered at school or student health clinic. Concomitant medication included apixaban (ELIQUIS) taken for thrombosis. The patient's historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0150) via an unspecified route of administration in right arm on 02Apr2021 16:30 as dose 1, single for COVID-19 immunization and experienced pain in arm. On 24Apr2021 07:30, the patient experienced fever of 100.3, when woke up, she felt super tried, body aches and her arm that received the shot was very sore. She was able to sleep it off and after 24 hours she was feeling 100 percent. On 24Apr2021 07:30, her body temperature was 100.3. No treatment was given for the events. The seriousness of the event was non-serious. On 25APR2021, the outcome of the events recovered.   No follow-up attempts are needed. No further information is expected.
Fever; Extreme fatigue; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), PYREXIA (Fever) and FATIGUE (Extreme fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M0A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jul-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 23-Feb-2021, the patient experienced PYREXIA (Fever) and FATIGUE (Extreme fatigue). On 23-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PYREXIA (Fever) and FATIGUE (Extreme fatigue) outcome was unknown.            Concomitant medications was not reported . T Treatment history was not reported .   This case was linked to MOD-2021-010142 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR received contains , Patient denied further Follow up .
Hot spot at injections site, hard lump at injection site, low grade fever turning into 103 and higher for 4 so far days, 2-3 hrs after given fever reducer fever goes up, jerking, fussiness, poor appetite, swelling face, rash, glass eyes, crying, not sleeping well
CLOTS; ODD REACTIONS; This spontaneous report was received from a patient of unspecified age, sex, race, and ethnic origin  via a company representative. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, in APR-2021, the patient developed clots and other odd reactions (not specified). Laboratory data included: Blood test (result unknown). The patient spent 10 days waiting for the blood test, wondering if the clot would kill. The action taken with covid-19 vaccine was not applicable. The outcome of the clots and odd reactions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667066-COVID-19 VACCINE -Clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.