chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he felt so bad, went back to bed, it burns, sore/terrible pain on the inside of his thigh; burning and itching inner upper right thigh, kind of like shingles; he felt so bad, went back to bed, it burns, sore/terrible pain on the inside of his thigh; maybe a little rash, she can't tell/may be a slight rash; burning and itching inner upper right thigh, kind of like shingles; burning and itching inner upper right thigh, kind of like shingles; This is a spontaneous report from a contactable consumer from medical information team via Pfizer Sponsored Program. This consumer reported information for three similar patients. This is the first of three reports. An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 17Mar2021 (at the 80-years-old), at dose 2, single for covid-19 immunization. Medical history included shingles before, on his chest, several years ago, had postherpetic neuralgia pain, had a stroke on 16Jan (as reported) and blood pressure problems. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date (at the 80-years-old), at dose 1, single for covid-19 immunization. The patient experienced little rash, she can't tell/may be a slight rash, burning and itching inner upper right thigh, kind of like shingles, he felt so bad; went back to bed, it burns on Mar2021, sore/terrible pain on the inside of his thigh on 19Mar2021.  The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312432 Same reporter/drug and different patient/events;US-PFIZER INC-2021312433 Same reporter/drug and different patient/events
Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. Treatment information was not provided.
This spontaneous report as received from a pharmacist student refers to a patient of unknown age and gender. No concurrent conditions and medical history were reported. The pharmacist reported that on 27-AUG-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K004542, expiration date 19-AUG-2015) (Route and dose were not provided). No concomitant medication was reported. No adverse effects reported. Additional information has been requested.
101.6 degrees fever; Post vaccine fatigue; product storage error; product administration error; Expired dose administered to patient/Expired vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (101.6 degrees fever), FATIGUE (Post vaccine fatigue), EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Expired vaccine dose), PRODUCT STORAGE ERROR (product storage error) and PRODUCT ADMINISTRATION ERROR (product administration error) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002S21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Expired vaccine dose) and PRODUCT ADMINISTRATION ERROR (product administration error). On an unknown date, the patient experienced PYREXIA (101.6 degrees fever), FATIGUE (Post vaccine fatigue) and PRODUCT STORAGE ERROR (product storage error). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Expired vaccine dose) and PRODUCT ADMINISTRATION ERROR (product administration error) had resolved. At the time of the report, PYREXIA (101.6 degrees fever) and FATIGUE (Post vaccine fatigue) outcome was unknown and PRODUCT STORAGE ERROR (product storage error) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The reporter states that the patient received expired vaccine. vial that was opened on 01 September 2021 from the refrigerator was used that put back in refrigerator and took back out of refrigerator on 08 Sep 2021 and reporter states patient had an immune response due to fever 101.6 degrees fever and post vaccine fatigue
Information has been received from a physician concerning a 9 year old female with strabismus who on 21-APR-2009 was vaccinated with the third dose of VARIVAX (Merck) (lot# not reported) IM into the right arm. On 21-APR-2009 the patient developed chest pain, vomiting followed by urticarial rash around face and neck and rare on trunk. The symptoms relieved with MAALOX and BENADRYL. The patient had similar reactions at the age of 7 and a half years after the second dose of VARIVAX (Merck) (lot# not reported), but her parents didn't remember until after the patient was given the third dose mistakenly. Subsequently, on 21-APR-2009, the patient recovered from chest pain, vomiting and urticarial rash around face. The patient sought medical attention by visiting the doctor. Additional information is not expected.
Information has been received from a physician via a company representative concerning a male in his 60's who two weeks ago, on approximately Oct 28 2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. the patient was vaccinated with pneumococcal 23v polysaccharide vaccine and influenza virus vaccine ( unspecified lot # not provided) concurrently on separate sites. Two weeks ago, on approximately Oct 28 2005 the patient became hot, nauseated, had dry heaves and developed low blood pressure and bradycardia. An ambulance was called and the patient went to the hospital. The patient was treated with unspecified therapy. The patient was reported as recovered. There was no product quality complaint involved. Additional information has been requested.
Patient admitted with shortness of breath and cough, tested positive for COVID-19. Patient still receiving inpatient treatment.
flu-like symptoms; the achiness in my lower back has increased; mild headache; mild fever that ran up to 101F; achiness in joints; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (the achiness in my lower back has increased), HEADACHE (mild headache), PYREXIA (mild fever that ran up to 101F) and ARTHRALGIA (achiness in joints) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (the achiness in my lower back has increased), HEADACHE (mild headache), PYREXIA (mild fever that ran up to 101F) and ARTHRALGIA (achiness in joints). On 06-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (mild fever that ran up to 101F) and ARTHRALGIA (achiness in joints) had resolved. At the time of the report, BACK PAIN (the achiness in my lower back has increased) and HEADACHE (mild headache) outcome was unknown.
Pt. c/o lightheadedness and dizziness. Reports "this happens every time I get a vaccine or injection". Denies c/o itching, swelling, or rash. No SOB. Pt. pale. Moved to reclining chair and symptoms quickly resolved. BP 98/68, HR 76, O2 SAT 98% RA. Pt. drank H20, remained alert and oriented to person place and time. Repeat BP 104/72. Checked by NP and cleared for discharge.
Developed shingles along C5-6 on 9/25/05 with low grade fever (100). No pain or itch. No treatment. Developed headaches 8/1/05. No known assoc with rash. To have MRI 10/5/05.
Right thigh 4x2cm area of erythema and induration lateral to the injection site and warmth. Early cellulitis
Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored GARDASIL (lot # J013324, expiration date 12-FEB-2016; dose, route and frequency not reported). No adverse effects were reported. Additional information has been requested.
7/2 injection 1 day later high fever and inj site "size of softball" and hot to touch. Saw urgent care and prescribed Rx. 7/29 1 month later saw regular MD who dx "shingles" rash on left breast and inflammation on Rt leg.
Pregnant EDC 11/09/2021.  Complication = went to the hospital with contractions which lasted several hours, was placed on fetal monitor, hydrated, and released when uterine irritability improved.
huge hives all over her arms and leg; she was having a rare delayed response to the vaccine as her immune system kicks into high gear; fever and aches last night; fever and aches last night; bone aches; swollen lymph nodes; This is a spontaneous report from a contactable consumer.  A female patient in her mid 40s (5 decade) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient went to the doctor who said that she was having a rare delayed response to the vaccine as her immune system kicks into high gear. The reporter also took a covid test to be safe. The reporter doesn't know how long it will last but he's seen a few cases like this, swollen lymph nodes, hives, bone aches, over a week after the shot. The patient had fever and aches last night, and woke up with hives again. She will be seeing her doctor today. She developed huge hives all over her arms and leg 5 days after her second dose of the Pfizer covid vaccine. Outcome of the events was unknown.  Information about lot/batch number has been requested.
PATIENT DEVELOPED SEVERE SWELLING OF THE ARM WITHIN 24 HOURS OF MODERNA VACCINE DOSE 1
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/25/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 ANEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 ANEMIA R09.02 HYPOXIA 12/26/2021 ANEMIA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/25/2022 DIVERTICULITIS OF SIGMOID J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 DIVERTICULITIS OF SIGMOID J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 DIVERTICULITIS OF SIGMOID R09.02 HYPOXIA 12/26/2021 DIVERTICULITIS OF SIGMOID
Initial report received from a healthcare professional on 25 June 2013. A female patient (age was not reported) had received an intramuscular first dose of ADACEL vaccine (lot number: C4424AA, expiry date-10/03/2015, site of administration was not reported) on 25 June 2013. The patient was pregnant at the time of vaccination. Last menstrual period date was not reported and estimated date of delivery was on an unspecified date in July 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. Medical history and concomitant medications were not reported. At the time of this report. the patient had not experienced any adverse event. Documents held by sender: none.
This spontaneous report as received from a 79 year old male patient and refers to himself. The patient had allergy to penicillin and his concurrent condition included rheumatoid arthritis. On an unknown date in 2012 (within last year), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, route of administration, dose and frequency not provided). Concomitant therapies included methotrexate (manufacturer unknown), ibuprofen and PLAQUENIL. On 21-OCT-2013 (reported as "4 weeks ago") the patient developed shingles. The patient explained that the outbreak was itchy, however he has not had the nerve pain that he's heard was often related to the shingles. Patient stated that he still had blisters at that point, however they were "drying up". He also stated that he has been a patient on methotrexate (manufacturer unknown) 2.5 mg for approximately 10 years for the treatment of the onset of his shingles symptoms. Lab diagnostic studies were performed and included: routine blood work done every 6 weeks (results not reported). The patient was treated for the event with an unspecified antiviral medications given for 7 days. The outcome of shingles was reported as recovering/resolving at the time of the report. The patient sought medical attention via taking with physician. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested. This is one of several reports received from the same source (other: MARRS # 1312USA001250 - Same patient link).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
I got the vaccine and a few hours later tested on a new machine at my office and tested positive for Covid. I did not have symptoms prior to vaccine and had tested the same morning at 9:30AM and tested negative. Will having Covid and getting the vaccine result in additional adverse events?
Dermatographia/rash/hives (with severe itchiness and burning sensations) 12 days after booster shot/3rd dose, still unresolved days after initial appearance. Hives/rash occur all over my body if the skin was scratched or rubbed by clothing.   Swollen supraclavicular lymph node on same side as injection noticeable about 3 days post first dose (in March 2020). This lymph node is still palpable to this day, although no longer swollen.  Feelings of malaise, fever, and sore arm after all 3 injections, but most severe after first dose (in March 2020).
On the same day as receiving the vaccine, I began feeling very dizzy, lightheaded, nauseous, had a low grade fever, joint pain, extreme fatigue, sweating, headache, heart palpitations, chills, and intense bodily shaking. This lasted for roughly 24 hours. I returned to my physicians office 48 hours after administration.
Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization and medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.            No concomitant medications reported by reporter. Treatment medication not reported.  Company Comment: This case concerns a  55-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI  event of Appendicitis. The event occurred approximately 5 months after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-374276 (Patient Link).; Sender's Comments: This case concerns a  55-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI  event of Appendicitis. The event occurred approximately 5 months after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Info has been received from a person working in a physician's office concerning an 8 year old white male, who on 1/1/98 was vaccinated with a 1st, SC, dose of varicella virus vaccine live. There was no illness at the time of vaccination live. There was no illness at the time of vaccination. "Two weeks ago", in 12/05, the pt was exposed to varicella, and on 12/19/05, the pt's mother called the office and reported approximately 12 lesions on his body. There was no fever. Subsequently, the pt recovered. Medical attention was not sought. Additional info has been requested.
hypotonic-hyporesponsive reaction 4 hrs p/vax; recovered spontaneously;
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer survivor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient had done an antibody test and it was negative test (suspected immunological vaccine failure) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210860781 and 20210860500. This report was associated with product quality complaint.; Sender's Comments: V0: 20210860607- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.