chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetaminophen.  Pain consisted of sharp pain wrapped around my torso.  Symptom b) Nausea.  Symptom c) Tiredness  Day 2: Mild chills in the evening and night sweats  Day 3: Mild chills in the evening and night sweats  Day 4: Abdominal and Back pain for approximately one hour (pain reduced after taking acetaminophen.  Pain continued overnight.  Day 5:  Tiredness   Day 6: Felt great  Day 7: Severe Abdominal and back pain wrapped around my torso and burning sensation in my back
over 7 days of extreme weakness, chills and no pep or energy. I feel so sick.   Went to UR 3/17/2021.
This spontaneous report as received from a consumer (patient's mother) refers to a 20 year old male patient with CLARITIN allergy. In August 2012 the patient was vaccinated with the first dose of GARDASIL. The second dose was received in December 2012. Total dose and route were not reported. No concomitant medication was reported. On 16-MAY-2013 the patient had been diagnosed with Philadelphia chromosome-positive (PH) acute lymphoblastic leukemia (ALL) and experienced extreme knee pain. On an unknown date the patient was hospitalized. The third dose of GARDASIL had not been administered due to the patient's medical condition. In the hospital routine blood work was done (no results provided) and the patient received treatment (not specified). The outcome was reported as not recovered/not resolved. No causality assessment was provided. Upon internal review acute lymphocytic leukemia was considered medically significant based on the list of always serious events. Additional information has been requested.
Acute onset of lumbar radicular symptoms after 2nd Moderna vaccine. Has remote history of this. No new/exacerbating activities or injuries.
pt recvd vax 3DEC93 & approx 2 hrs later pt lips were blue & skin on extremities was dimpled; no erythema pt had violent shaking of the extremities for 15-20secs; taken to ER; t102.8; swelling @ inject site; 21FEB94 dx as shaking chills;
Patient received another flu shot at local pharmacy.  She did not have any adverse events but we felt this warranted reporting.
Patient experienced syncope, dizziness, respiratory distress, palpitations. BP 132/67, pulse 60.
5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. For the remainder of the day into the evening I had heart palpitations.  The following day I felt tired and nauseous until around 11am. My arm is sore and itchy.
Severe vertigo, ringing in the ears, nausea, fatigue. First episode lasted 2-3 days, second episode began 7/19/21 at 11:30pm and lasted 48 hours.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided.
She received the shot on Saturday and arm became red and painful Saturday night. Fever developed Saturday night and continued through Sunday Has been taking Tylenol for fever. She denies any nausea or vomiting.
Pt c/o chills, fever, nausea and dizziness/faint, total body aches about 5 hrs as described per patient.
tested positive for shingles; This spontaneous report was received from a physician via company representative and refers to a 11-year-old patient of unspecified gender. There was no information regarding the patient's medical history, concurrent condition or concomitant therapies details reported.  On an unknown dates, the patient was vaccinated first and second doses with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient developed shingles after being fully vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). No further information was provided. No additional adverse event or product quality complaint was reported. The outcome of the event was not reported.   The causality between the event and suspected vaccine was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  2304USA008295:Original Case : 2304USA008287 2304USA008287:Original Case : 2304USA008287 2304USA008294:Original Case : 2304USA008287
Currently having hives that feel like bruises.  might be totally unrelated to the vaccine.  I took prednisone and they went away but then came back whenever i stopped.
Elevated temperature of 101.0+ degrees Fahrenheit starting 4 days after vaccine. Temperature lasting 5+ days so far. Treating with TYLENOL every 4 hours or more.
On Thursday evening 12/02/2021, I experienced a heart attack. I went to the emergency room that night. The doctor noticed a blockage in the artery. Two stents were placed. This was all shocking to me because I have no prior history of heart problems or heart disease. I am a vegan and a runner.
Developed severe rash extending from injection site to elbow.  Began with itching, then turned to a rash.  Blistering occurred, with some oozing of blisters.  Reporting this on 5/5/2021 and rash is still present.  It is now drying up but is still extremely red.  Due to being on medication that suppresses the immune system, there was concern about celluitis and/or other infection, but that has not occured.  A rash also developed with the first dose of the vaccine, including bumps on the skin that did not become blisters. It took 2-3 weeks to disappear.  The reaction to the second dose of the vaccine was much worse. Other reactions were headache, fatigue, muscle aches (mainly in legs), which disappeared in a few days
per Pt, Pt arm cannot lifted the day after vaccine due to stiffness . pt said there was no swollen and not warm to touch.
Diarrhea after my second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after my second dose) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea after my second dose). At the time of the report, DIARRHEA (Diarrhea after my second dose) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Started developing chills, body aches, and rising temperature around 6-6:30pm on day of vaccine. Later in the night, I got nauseous, headache and arm pain was moderate. My temperature would go up and down during the night/early morning. The highest it got was 105.
Initial unsolicited report received from physician on 05-Sep-2018. This case involves a 6 months old male patient who was vaccinated with a first 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (Batch number, expiration date : UI182AB, 30-Jun-2018 site of administration: thigh, route was not reported) on 01-Sep-2018. The patients concomitant medications included was PENTACEL and PREVNAR 13. The patients medical history were not reported. It was a case of actual medication error due to expired vaccine used (vial that was injected turned out to be expired). It was unknown whether patient experienced any adverse event following vaccination but it was also reported that medical assistant informed him that there would not be an adverse effect in the child. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender : none.
Bell's Palsy, with half face without any movement; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell's Palsy, with half face without any movement) (serious criteria GSK medically significant). The outcome of the bell's palsy was recovered/resolved (duration 2 weeks).   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.   It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The shingles vaccination gave him/her bell's palsy for 2 weeks (with half face without any movement). The reporter stated that no pain but embarrassing. The follow up would not possible as no contact details were available.
Reaction; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction) and RASH (Rash) 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 VACCINATION COMPLICATION (Reaction) and RASH (Rash). At the time of the report, VACCINATION COMPLICATION (Reaction) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Information about concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Moderna COVID-19 Vaccine EUA Chills, hot flashes, body feels weak, headache
MYOCARDITIS,FATIGUE,JOINT PAIN,PALPITATION AND CHEST PAIN
This spontaneous report as received from a dermatologist concerning a 20 year old female patient. Relevant medical history was not reported. The patient did not have any allergies. On 18-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, route and frequency not provided). The patient had no concomitant medications. On 19-JUL-2014, 2 days after onset of therapy the patient developed a rash. The reporter saw the patient on 23-JUL-2014 and described the rash as unspecified systemic eczema. The patient's unspecified primary care physician initially prescribed an unspecified antihistamine on an unspecified date which did not seem to affect the rash. The dermatologist stated that the rash was on the patient's face, neck, trunk and extremities. The rash was very itchy. The dermatologist prescribed an injection of CELESTONE, an unspecified topical steroid and BENADRYL for the patient on 23-JUL-2014. The patient sought medical attention. The outcome of events was reported as not recovered/not resolved. The causality of the event with GARDASIL was not reported. Product quality issue was not involved. Upon internal review the events eczema, rash on the patient's face, neck, trunk and extremities and itchy rash was considered medically significant. Additional information has been requested.
nausea; sore arm; dizziness; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness) and HEADACHE (headache). On 04-Mar-2021, the patient experienced NAUSEA (nausea). On 04-Mar-2021, PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-045026 (Linked Report).; Sender's Comments:  MOD21-045026: US-MODERNATX, INC.-MOD-2021-036207:Crosslinked case
Pneumonia; Partial left lung collapsed; Injection site cellulitis, red rash around injection site which was tender and itchy; A spontaneous report was received from a consumer, who was a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced injection site cellulitis, red rash around injection site which was tender and itchy (injection site cellulitis), cough, pneumonia, and partial left lung collapse (pneumothorax).  The patient's medical history was not provided. Concomitant medications were not reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for COVID-19 infection.  On an unspecified date, a few days after vaccination administration, the patient experienced red rash around the injection site which was tender and itchy and was diagnosed by a nurse as cellulitis, which later resolved.  On 14 Jan 2021, the patient began coughing.   On 18 Jan 2021, the patient went to urgent care for a COVID-19 test and the results came back negative. The patient was prescribed dexamethasone for three days, but symptoms did not improve. She again went to urgent care where X-rays was performed which showed pneumonia and partial left lung collapse, she was prescribed erythromycin.   On 24 Jan 2021, patient went to emergency room and was given amoxicillin and advised to see their doctor.   On 27 Jan 2021, her doctor prescribed prednisone and the symptoms started to get better.  Action taken with mRNA-1273 in response to the events was not reported, although the patient expressed concern about getting the second injection.  The outcome of events, cough, pneumonia, and partial left lung collapse (pneumothorax), was reported and resolving. The event, injection site cellulitis, red rash around injection site which was tender and itchy, was reported as resolved.; Reporter's Comments: Although a temporal association exist, the report lacks critical details such as the patient's medical history and concomitant medications.  Noting that cellulitis and pneumonia are usually caused by an infectious agent, both events are considered unlikely associated with mRNA-1273. Pneumothorax is confounded by the pneumonia.
1st Lesion seen the day after 2nd booster/Lesions were now on both arms; This spontaneous case was reported by a patient and describes the occurrence of SKIN LESION (1st Lesion seen the day after 2nd booster/Lesions were now on both arms) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First booster) in 2021; for Product used for unknown indication: INFLUENZA VACCINE in October 2022. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE and MODERNA COVID-19 VACCINE. Concurrent medical conditions included Breast cancer (Treated with chemo, surgical lumpectomy and currently approximately 1/2 way through 6-months of every 3-weeks of infusions) since 2022. Concomitant products included LETROZOLE from 2022 to an unknown date for Breast cancer.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Dec-2022, the patient experienced SKIN LESION (1st Lesion seen the day after 2nd booster/Lesions were now on both arms). At the time of the report, SKIN LESION (1st Lesion seen the day after 2nd booster/Lesions were now on both arms) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had the 1st lesion on the day after 2nd booster on same arm the booster was given which was a year after the first booster and 2 months after Oct 2022 flu shot and the lesions were now on both arms.  It was unknown if the patient experienced any additional symptoms/events.
Phone call 11/14/05 Pt had flu vaccine given 11/03/05 about 3 pm (had some flushing but di not tell anyone) 1 hr (4 pm) had flushed feeling head to toe. Almost fainted lasted approx 1 hr then had cold chills. Pt did not see MD. Just wanted to know about a flu shot next year. Referred pt to MD.
2 month vaccines given and 8 days later baby developed eczema all over body. Baby is almost 4 months old and still has eczema all over her body.
Fluzone Quad was given to a patient instead of the recommended Fluzone HD with no reported adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves elderly (patient was over the age of 65) and unknown gender for patient whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] was given to a patient instead of the recommended INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered).   The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site prophylactic vaccination.  It was case of actual medication error due to wrong product administered (Latency: on the same day).  Details of laboratory data not reported.  At the time of report no adverse event was reported.  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.  There will be no information available on the batch number for this case.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 26-MAR-2015 was vaccinated with an improperly stored dose of VAQTA 25/0.5 (units not provided), intramuscular, lot # K005958 and expiration date on 09-FEB-2017, 0.5 ml, intramuscular. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
large flat red patch below the injection site.  Warm to the touch; not itchy or bumpy
Could not swallow, throat closing up, trouble breathing  Given benadryl  and cold compresses on back of neck and head Symptoms lasting around 2 minutes,
Approx one hr after immunization she developed nausea and malaise. Approx six hrs later she began vomiting, dizziness. Felt warm but did not take her temp. Following day n/v subsided. Malaise but better. 5/25/06 No symptoms.
shaking; fever; This case was reported by a consumer via call center representative and described the occurrence of tremor in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced tremor and fever. On an unknown date, the outcome of the tremor and fever were unknown.   It was unknown if the reporter considered the tremor and fever to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was mother of an 18 year old daughter. The patient expereinced shaking and fever after receiving a dose of Meningitis vaccine. The reporter stated that, it was unknown which Meningitis vaccine or manufacturer was given.  In database Meningococcal B vaccine was given. As it was unknown which Meningitis vaccine was patient had received, kept as reported.
sick; it felt pretty bad; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case from a patient via Social Media.   This case involves a patient of unknown demographics who complained of getting sick after a shot (illness) and that the patient felt pretty bad (feeling abnormal) while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date in 2019 (reported last year), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date in 2019 when the patient had received a shot and got sick (illness) and that the patient had felt pretty bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. The events continued for 4 weeks as reported by the patient.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was recovered for the events at the time of reporting.  There will be no information available on the batch number for this case.
A report has been received from a Health Professional concerning a 6 year old, male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 28-Jan-2014, the patient received FLUMIST (intranasal) but the vaccine was expired on 20-Jan-2014. At the time of reporting, the outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious by reporter.