chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site became red (2x2 inches round); Injection site warm; Injection site swollen; little tiny spots at the injection site; Itching at the injection site; little soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness in her arm), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Injection site became red (2x2 inches round)), VACCINATION SITE WARMTH (Injection site warm) and VACCINATION SITE SWELLING (Injection site swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (little soreness in her arm). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE RASH (little tiny spots at the injection site). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site became red (2x2 inches round)), VACCINATION SITE WARMTH (Injection site warm) and VACCINATION SITE SWELLING (Injection site swollen). On 13-Jan-2021, VACCINATION SITE PAIN (little soreness in her arm) had resolved. On 20-Jan-2021, VACCINATION SITE PRURITUS (Itching at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site became red (2x2 inches round)), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE RASH (little tiny spots at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included calamine lotion  and hydrocortisone cream. Concomitant medications were not provided by reporter.   Reporter did not allow further contact
severe edema & erythema, pain @ inj site;area of induration 15cm x 8cm;
sick to the stomach; nausea; fever of 99.2°F to 99.6°F; very sick; mouth went numb; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), HYPOAESTHESIA ORAL (mouth went numb), ABDOMINAL DISCOMFORT (sick to the stomach), NAUSEA (nausea) and PYREXIA (fever of 99.2°F to 99.6°F) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Coronavirus infection in November 2020. Concurrent medical conditions included Allergy to antibiotic (Cephalexin), Drug allergy (Any kind of -cain product (Novocain, lidocaine)) and Seafood allergy.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced ILLNESS (very sick), HYPOAESTHESIA ORAL (mouth went numb), NAUSEA (nausea) and PYREXIA (fever of 99.2°F to 99.6°F). On 23-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to the stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, ILLNESS (very sick), HYPOAESTHESIA ORAL (mouth went numb), ABDOMINAL DISCOMFORT (sick to the stomach), NAUSEA (nausea) and PYREXIA (fever of 99.2°F to 99.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Body temperature: 99.2°f to 99.6 (High) 99.2°F to 99.6°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.
Gave client TD by mistake.  Should have given client DTAP.  Client called on 8/28/09 and message left.  Have not heard from client since the family left clinic on 8-18-09.
PATIENT RECEIVED THE VACCINE ON 3/15, HE PASSED AWAY ON 3/29
This literature marketed report has been received from authors of the literature article. Acute gastroenteritis (AGE) in hematopoietic cell transplant (HCT) patients caused significant morbidity and mortality. Data regarding the longitudinal assessment of infectious pathogens during symptomatic AGE and asymptomatic periods, particularly in children, were limited. This article investigated the prevalence of AGE-associated infectious pathogens in children undergoing allogeneic HCT.  This report referred to a child of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown.   On an unknown date, the patient vaccinated with 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, lot# and expiration date were unknown) orally for prophylaxis.  On an unknown date (reported as more than 2 years after 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)), the patient underwent HCT (inappropriate schedule of product administration). On an unknown date, the patient performed rotavirus test, however, rotavirus was not identified by real-time reverse-transcriptase polymerase chain reaction (RT-PCR) from the 2 specimens that tested positive by multiplex PCR, which may represent a false positive or low-level shedding.   A copy of the published article is attached as further documentation of the patient's experience.
Joint pain, lower back pain, fever, chills, dizziness, tunnel vision, muscle weakness, cold sweats, orthostatic blood pressure, patient collapsed and was taken to ER; prolonged joint pain; headache, soreness and pain in neck/throat muscles.
9:35 pm 10-29-10 parents reported child had hives with flushed swollen cheeks & swollen lips & a "different" voice. Parents were instructed to give BENADRYL po (1/2 tsp) and go to ER. ER saw and advised to give 10mg qd & discharged.
I woke in the night with both hands itching intensely.  I applied cortisone cream with no relief.  In about 15 minutes, I began developing red splotches all over my body.  I went to an all night shop to but Benadryl.  As I returned to my car, my tongue began to swell up.  I took the Benadryl and and preceded to the local emergency room.  By that time, my tongue was quite large, but my airway was not restricted.  I was given intravenous steroids and kept in the hospital until 3:00 AM.  I was prescribed 50 mg. Prednisone tablets.  I took the Prednisone and Benadryl for two days and discontinued because I had no further symptoms. I have no known allergies and have never had a reaction like this before or after.
Increased resting heartrate of 140 bpm Fever of 102.4 for 48 hrs Severe Body aches to the point I could not walk to the restroom without assistance Severe Migraine
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 47 Fahrenheit degrees (°F) to 77 Fahrenheit degrees (°F) for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Pt recvd vax 14AUG91 @ 3PM c/o arm hurting 9PM 14AUG91; APAP given; evening of 15AUG91 noted swelling & red streak going from arm to neck; taken to ER & rx DPH & Dynapen; swelling & redness started to dec @ 2AM;
A report was received from a health care professional on 11/04/03 concerning a 98 year old female vaccinee who was inadvertently administered 2 doses of Fluvirin, the first on 10/20/03 and the second on 11/04/03. On 10/20/03 and 11/04/03 respectively, the vaccinee was inadvertently administered 2doses of Fluvirin, the first into the left deltoid and the second into the right deltoid. There was no adverse events at the time of the report. There insufficient information to determine the reporter's causality assessment.  Update 1, 12/12/03: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reaction. No follow up pending.
Mild chills; Mild fever; Loss of appetite; Headache; swelling and redness below injection site; Lost day of work.
pt recv vax 26JAN95 & on 3FEB95 pt had to be taken to ER had sz but also had cold/flu sx,diarrhea,but afeb;lab test indicated low serum sodium immed p/vax & pt has ongoing problems w/this
Fatigue - rest - ongoing Myalgias - APAP - ongoing Chills - ongoing but improving  Headache - APAP - ongoing but improving ISR - pain - radiating from injection site down to forearm - ongoing but improving
Pain, inflammation, redness, itching beginning 48 hours post vax; treated with cold compress and Motrin. Inflammation unresolved.
-shortness of breath and dizziness walking from one room to the next -higher resting heart rate -reduced exercise capacity (low exercise tolerance) -get winded extremely easily and harder to catch breath -orthostatic hypotension -easily fatigued -feel like I have reduced lung and blood flow capacity  This all started after my COVID vaccine doses and are progressively getting worse, so now I decided to report them.  I thought it would go away but hasn't, only worsened.
Pt. called to report that approx. 3 weeks after receiving the Zostavax vaccine, he started to have painful pimple-like eruptions on his face, back and sides of chest.  He has a fever of 99.0 and is very uncomfortable. He has contacted his physician, and has an appt. scheduled 2/13/08 with Dr.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unspecified doses of improperly stored PEDVAXHIB lot # L042836 and expiration date 24-AUG-2018 (dose and frequency was not reported) for prophylaxis. No adverse effect reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA009980.
This spontaneous report was received from a physician, via company representatives and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 05-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions one for 48 hours and the other of 40 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 47 F (8.333333333 Celsius). The vaccine status was reported and "in excursion". The vaccine storage criteria and the vaccine excursion were reported as Refrigerator(R).  This is one of several reports received from the same reporter. Additional information has been requested.
High fever, body aches, massive headache, large swelling spot at site of injection, could not lift my arm.
This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided On an unknown dates, the patient was vaccinated with complete series of 3 doses of GARDASIL (dose, route, lot # and expiration date were not reported). On an unknown date (reported as after this), the patient was found to have become infected with an unspecified serotype of HPV (Human Papilloma Virus). The patient's outcome unknown. The relatedness between the event and therapy with GARDASIL was nor provided. Additional information has been requested.
Red pruritic rash encircling entire base of neck developed 48 hours after ZOSTAVAX administered without rash at injection site of R deltoid. Developed several hours after haircut at barber's but no topicals applied and no neck shaving. Improving but remains.
Extreme fatigue; Head was buzzing; Head cold; Stomach problems; Immune system was stressed out; Difficulty sleeping; Dizziness; Weakness; Night sweats; Could not function for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), HEADACHE (Head was buzzing), NASOPHARYNGITIS (Head cold), ABDOMINAL DISCOMFORT (Stomach problems) and IMMUNE SYSTEM DISORDER (Immune system was stressed out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Extreme fatigue), HEADACHE (Head was buzzing), NASOPHARYNGITIS (Head cold), ABDOMINAL DISCOMFORT (Stomach problems), IMMUNE SYSTEM DISORDER (Immune system was stressed out), INSOMNIA (Difficulty sleeping), DIZZINESS (Dizziness), ASTHENIA (Weakness), NIGHT SWEATS (Night sweats) and ASTHENIA (Could not function for 36 hours). At the time of the report, FATIGUE (Extreme fatigue), HEADACHE (Head was buzzing), NASOPHARYNGITIS (Head cold), ABDOMINAL DISCOMFORT (Stomach problems), IMMUNE SYSTEM DISORDER (Immune system was stressed out), INSOMNIA (Difficulty sleeping), DIZZINESS (Dizziness), ASTHENIA (Weakness), NIGHT SWEATS (Night sweats) and ASTHENIA (Could not function for 36 hours) outcome was unknown.            Treatment information was not provided.
Around April of last year 2021, I started to have headaches, So I took Motrin and Tylenol until I got a hold to my doctor. I don't recall the exact date but I was able to go in to my Doctor stated that he hope it wasn't the tumor again and he sent me to a neurologist He also prescribed me Topamax for migraines. I had a MRI in Oct of 2021. The MRI came back with no new findings.
After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
UNSTABLE ANGINA ACUTE ST ELEVATION MI, ANTERIOR WALL 2/13/2023,  2/10/2023,  2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Due to a fear of needles, as the vaccine was being adminitered intradermally the patient moved resulting in an incomplete dose. The dose was repeated subcutaenously, and was successful.
Client felt dizzy following vaccination. Client laid down, client had full recovery of symptoms with no noted exacerbation upon exiting the facility. Vital signs taken (below).
Local swelling and redness 30x26 cm area (entire length of upper arm) red, warm, painful, Resolving with Benadryl. No sx of Cellulitis.
Information has been received from a registered nurse concerning a 16 year old female patient with no allergies and no pertinent medical history who on 15-DEC-2010 was vaccinated with a first dose of GARDASIL (Lot # 666118/1539Y, exp date 10-AUG-2012), IM, and on 15-FEB-2011 was vaccinated with a second dose of GARDASIL (Lot # 666118/1539Y, exp date 10-AUG-2012), IM. There was not concomitant medication. The nurse stated that on 15-DEC-2010 the patient after the first dose of GARDASIL passed out in the lobby and within 10 minutes was feeling back to normal and on 15-FEB-2011 experienced lightheaded and clammy after the second dose of GARDASIL vaccine, but did not pass out. The nurse also stated that again within 10 minutes the patient was feeling back to normal. There were no laboratories diagnostics performed. There was no treatment given for the events. The patient sought unspecified medical attention. Follow-up information has been received which reported that the female student patient with no pre-existing allergies was vaccinated with a second dose of GARDASIL (lot # 666118/1539Y), IM on 15-FEB-2011 at 15:30. It was reported that on 15-DEC-2010 after received the first dose of GARDASIL the patient passed out and on 15-02-2011 after received the second dose of GARDASIL. The patient experienced clamminess, pallor and nausea but did not pass out remained seated for 15 minutes. It was also reported that the patient was completely recovered 20 minutes after each dose on same day of events. Additional information has been requested.
FATIGUE; ARM PAIN; SHAKES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced shakes. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes on 19-MAR-2021, and fatigue, and arm pain on 21-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210417720.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
vaccine leaked from the neck of the syringe(tip cap), was shot into the air and dripped onto the patient's arm with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old male patient and diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel] leaked from the neck of the syringe(tip cap), was shot into the air and dripped onto the patient's arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2023, the patient received a dose 1 at a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 18-Mar-2025 and lot U7671AA) via intramuscular route in the left deltoid for Immunization and on the same day vaccine leaked from the neck of the syringe(tip cap), was shot into the air and dripped onto the patient's arm with no reported adverse event (accidental exposure to product).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
his wife is experiencing a severe diarrhea after she took the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced experienced severe diarrhea after she took the 1st dose. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, joint pain and weird feeling. In August 2018, the patient experienced myalgia, light headedness, headache, shivering, fatigue and cough. On an unknown date, the outcome of the influenza-like symptoms, difficulty breathing, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, cough and weird feeling were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the joint pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, joint pain, cough and weird feeling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient stated that the next morning after receiving vaccine, he experienced a fever and body temperature was recorded as 100.2 F, his arm was discolored at the injection site, it was hard to breathe and his joints were aching and felt like he had the flu. Less than a week after receiving vaccine, the patient stated that he also experienced headache, myalgia, fatigue, shivering. Patient stated that the fever resolved within a few hours. Patient stated that he was feeling 75 percent better than he did on previous Thursday and stated that his arm was clearing up as well, however, it was a little red at the time of reporting. Patient stated that if he talked too much he started coughing and still felt a little weird. Patient went in to his physician's office and saw the nurse practitioner for his symptoms. The reporter also reported these symptoms to his pharmacy. Patient disconnected the call before any additional information could be clarified or provided.
Seen by MD on 8/21/16 for treatment of cellulitis with cephalexin 500mg 1 QID x 7d. Complains of not be able to life arm without pain.
Pt has experienced dizziness and intermittent increased heart rate since the day after her vaccine.
Patient should have received Pfizer for 5-11 year old 0.2ml but received adult pfizer 12+ 0.3ml , Mother reported no adverse effects at this time.