chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm lymph node pain; pain when swallowing; pain in the arm; itchy rash patch on the arm; itchy rash patch on the arm; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 01May2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and known allergies. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced left arm lymph node pain, pain when swallowing, itchy rash patch on the arm and pain in the arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left arm lymph node pain, pain when swallowing, itchy rash patch on the arm and pain in the arm was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.
Information has been received from a health professional concerning a 24 year old female with a tetracycline allergy and an erythromycin allergy who on 08/11/2000 and 09/15/2000 was vaccinated with a first and second dose respectively of 0.5 ml of varicella vaccine. There was no concomitant medication. In March 2001, the pt had undetectable titers. Unspecified medical attention was sought.
received dose from vial that had black particulates in previous syringe; received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minutes to 1 hour after the receiving the vaccine I developed some additional spots on my face and my throat felt like something was stuck in it. I purchased some oral Benadryl from the Outpatient pharmacy took 50mg and in 30 minutes my symptoms were resolving.
Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
SHAKING CHILLS; FEVER (104); SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total,  start therapy date was not reported for prophylactic vaccination (dose number In Series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced super sick with a 104 fever and shaking chills (both event dose number In Series 1). Laboratory data (dates unspecified) included: Body temperature 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever (104) and shaking chills was unknown. On an unspecified date, the patient received additional non-company suspect vaccine bnt 162 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination (dose number In Series 2).  On an unspecified date, following vaccination with bnt 162, the patient experienced recurrence of sore arm (dose number In Series 2). The action taken with bnt 162 was not applicable. The outcome of sore arm was unknown. This report was non-serious.
Information has been received from a medical assistant concerning a 10 or 11 year old female who in June 2008, was vaccinated with a first dose of GARDASIL vaccine (yeast) by intramuscular injection (lot number and injection site not reported). Immediately after administration, the patient experienced vomiting. Subsequently, the patient recovered from vomiting. The patient did not seek any medical attention. Additional information has been requested.
23 month old patient got a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 23-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: A nurse reported that a 23 month old male patient accidentally received a dose of Kinrix, which led to inappropriate age at vaccine administration. No symptoms were reported. The reporter consented to follow up.
Information has been received from a Nurse practitioner, concerning a 19 year old female patient with no pertinent medical history and allergy to CEFTIN and TOPAMAX. On 23-MAY-2012, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # and expiration date not reported), and on 23-JUL-2012, the patient received intramuscularly the second 0.5 ml dose of GARDASIL (lot # and expiration date not reported). Concomitant medications included drospirenone, YAZ and LEXAPRO. On approximately May 2012, after the patient's first dose of GARDASIL, the patient experienced a non itchy rash on her knees and thighs. In 2012, the patient's non itchy rash had subsided. On 06-AUG-2012, two weeks after the patient's second dose of GARDASIL, the patient's same rash reappeared on her knees and thighs. The patient sought medical attention through office visit. Hydrocortisone cream was received as treatment for the event. At the time of the report, the patient's outcome of non itchy rash on her knees and thighs was reported as not recovered. Action taken regarding GARDASIL was not applicable. Additional information has been requested.
Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain; Numbness in the right side of mouth; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) (seriousness criteria medically significant and life threatening) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) (seriousness criterion medically significant). At the time of the report, CEREBRAL THROMBOSIS (Small blood clot on the left side of the brain/ 2 others on additional on the right side of the brain) and HYPOAESTHESIA ORAL (Numbness in the right side of mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram head: abnormal (abnormal) Small blood clot on the left side of brain. In 2021, Magnetic resonance imaging: abnormal (abnormal) 2 others on additional on the right side of the brain.         No relevant concomitant medication information provided. No relevant treatment information provided.  Patient received both vaccine doses. About 3 weeks after the second dose, the patient experienced numbness in the right side of their mouth with no other signs of a stroke. Per patient, there was no apparent reason for the strokes and the diagnostics were normal.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Incorrect product administered as the patient's 2nd dose. Pfizer product administered - should have received Moderna.
chills; fever; headaches; aches and pains; flu like symptoms; very bad tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 35 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "headaches"; PAIN (non-serious), outcome "recovered", described as "aches and pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms"; FATIGUE (non-serious), outcome "recovered", described as "very bad tiredness".  Additional information: Reporter stated that, patient received first two doses of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) and afterwards experienced moderately to severe reactions close to 3 days with the first dose and for the second vaccine, the symptoms were the same, but patient had them for 4 days, which was longer than he expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Had gen rash-urticaria One episode of vomiting Fever 101.9 AM after injections. RX tylenol and benadryl
Increased temperature to 101F on the evening of 7/30/01. On 7/31/01, pt was fussy and had abdominal cramps since 08:00. Doubles over with pain; loose BM; vomited X 2; right arm was red (size of baseball, per mom). The pt temperature was 99.9F, using Tylenol and Mylicon. On 8/1/01, pt was much better. There was no temperature but arm still red.
dizziness, chest tightness, pressure. Evaluated by EMS-Refusal to transport.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.68 years.  Concomitant products were not provided.  On 09-Mar-2021, the vaccine with batch number 031A21A was moved to fridge. On 20-Mar-2021, 19 vials were moved to the clinic. On the same day between 09 AM to 10 AM, vials underwent temperature excursion with temperature of 34 and 37 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 08-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Within a few hours after receiving PREVNAR 13 #1 in my (L) deltoid, a red area of 1 inch appeared near the site. Over the next few days a 5 inch vertical and 3 1/2 inch horizontal area, very hot and painful developed. I reported this to facility. By Tues. I began to have a temp. Went to Dr., dx: cellulitis. Given antibiotics.
herpes simplex - information has been received from a physician concerning a 46 month old white female who on 16 Jun 1997 at the age of 12 months, was vaccinated with one dose of varicella virus vaccine live (site unknown) by another physician.  On 17 Apr. 2000 the patient developed a mild case of chicken pox with lesions on the lower abdomen and back and was seen in the physician's office.  the child had no fever and no other symptoms at the time of the report. follow up information received on 05 jun 2000 from a physician indicated that the patient was cultured and the result was herpes simplex 1, and not varicella as previously reported.  follow up information received on 06 jul 2000 from a physician indicated that the culture finally grew herpes virus type 1 and thin was not related to the vaccine. no further information is expected.
Patient presented to the ED and was subsequently hospitalized for CVA within 6 weeks of receiving COVID vaccination.
muscle and joint pain all over; muscle and joint pain all over; left arm sore at injection site; Clogged arteries; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31May2021 (Lot number: EW0186) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "heart" (unspecified if ongoing). Concomitant medication(s) included: LOTRIL [ENALAPRIL MALEATE] taken for blood cholesterol (ongoing); PLAVIX taken for cardiac disorder, start date: Sep2021 (ongoing); LOPROLOL taken for cardiac disorder, start date: Sep2021; ASPIRIN taken for cardiac disorder, start date: Sep2021 (ongoing); LIPITOR (ongoing). Vaccination history included: Bnt162b2 (Dose 1,, Anatomical location: left upper arm,, Batch/lot number: EW0176), administration date: 10May2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "muscle and joint pain all over"; VACCINATION SITE PAIN (non-serious) with onset Jul2021, outcome "not recovered", described as "left arm sore at injection site"; ARTERIAL OCCLUSIVE DISEASE (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "Clogged arteries". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: About a month and a half after he began experiencing severe muscle and joint pain all over his body. His left upper arm where he received the injection was very sore and it continues. His doctor found him to have clogged arteries and that was fixed. Before this patient was active and played golf. He was having muscle pain all over the place, states it was from his left knee then goes to left elbow, then to right elbow, to right knee, it changes. Reporter does not clarify treatment for muscle pain. Patient also has clogged arteries, diagnosed three weeks ago, states he had them fixed. States the doctors started him on other medication and now he does not know if it is the new medication causing this. States he was also sore in the left arm where he got injection. Caller states he was taking Lipitor, does not know if he was taking that for cholesterol or blood pressure, states he been taking this for years, 25-30 years, no further details provided. States he just started going to the doctor for this, states pain was unbelievable, in so much pain in his joints, no one seems to know, blood work has been fine. Patient has been taking Lotril for years. Patient just started Plavix, Loprolol, Aspirin two weeks ago. There was no patient history and investigation assessment.  No follow-up attempts are possible. No further information is expected.
On 11/20/09 it was discovered that patient had recorded on 10/18/08 that this pt received 2 vaccines. Both lot numbers recorded were for seasonal flu vaccine. No known harm to pt.
Missed second shot more than 42 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second shot more than 42 days after first shot) in a 5-week-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hepatitis B.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second shot more than 42 days after first shot). On 25-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Missed second shot more than 42 days after first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral load: high (High) High Viral load Hep B.         Concomitant drug was not reported.  Patient  had no side effects. She did not have a ride and she missed the second dose appointment. She was thinking about getting the second shot now.  Treatment medication was not reported.
Approximately 4 hours after injection, severe arm pain all the way to my hand. Next day, arm pain continued, fever of 100.1F (oral), headache, malaise. I was not able to do "normal activities." Took acetaminophen and ibuprofen and rested. The next day, the fever was gone and I felt nearly normal and resumed activities. Arm pain was down to manageable discomfort. Over the past couple of weeks, I have noticed my upper left arm is sore and does not seem to be getting better.
Right arm with marked redness, firmness and swelling with 24 hours of flu vaccine. No fever, no decreased ROM. Improved by 72 hours with Benadryl and Ibuprofen.