chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SYNCOPE; This spontaneous report received from a other health professional (Nurse) via social media/news concerned a 37 year old white, not Hispanic female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, administered, 1 total, on 08-APR-2021 for prophylactic vaccination. The vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported. On 08-APR-2021, at 12:57, the patient experienced syncope, hypotension and bradycardia. The patient was evaluated by emergency medical services (EMS) and sent to hospital for further observation. The patient was discharged in good health. The patient recovered from syncope on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210415566.; Sender's Comments: V0: 20210441898-COVID-19 VACCINE AD26.COV2.S - Syncope. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
loss of appetite; diarrhea; fever 100.2F; body ache; nausea; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), FATIGUE (extreme fatigue), PYREXIA (fever 100.2F) and MYALGIA (body ache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 11-Mar-2021, the patient experienced FATIGUE (extreme fatigue). On 18-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), PYREXIA (fever 100.2F), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), FATIGUE (extreme fatigue), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever 100.2F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.
Right Elbow joint pain and weakness in my hand? unable to twist/ open jars or bottle caps.
CHRONIC HEADACHES; This spontaneous report received from a patient via a company representative . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chronic headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chronic headaches was not reported. This report was non-serious.
At least 2 days; side effects-chills, slight fever, fatigue, headache
Pt had arm pain after dose 1.  Sustained arm pain that improved, then got worse.  Saw PCP, dx with adhesive capsulitis.
Initial unsolicited report received from a physician on 10 November 2015. This case involves a two-month-old male patient who was vaccinated with a intramuscular dose of PENTACEL (batch number C4877AA, expiration date 19 August 2016, dose was not reported) in left thigh, a dose of PREVNAR (batch number L87117, manufacturer- Pfizer, dose, dose in series, route of administration was not reported) in right thigh and an oral dose of ROTATEQ) (batch number L002041, dose, dose in series was not reported) all on 10 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 September 2015, same day following the vaccination, the patient experienced sleeping more, looked a little pale, minor hand twitching, seemed limp when picked up, was staring and had crossed eye contact, no LOC (loss of consciousness). It was reported that the patient was not evaluated by the physician. Lab data and corrective treatments were not reported. Patient was recovered from events (as reported events lasted a few minutes). List of documents held by sender: none. Follow up information received from Physician on 22 February 2016. No additional information provided.
3 inch red circle around injection site with a sore/tender 1 inch round bump in the center.
pt started with arm pain that would not go away. On May 6, 2021 her arm swelled up to 3 times its size. She went to an urgent care and was diagnosed with a blood clot. She was given a prescription for Eliquis. She was not hospitalized and is doing OK now. She reported this to us on 06/10/2021
8/29/21 TESTED POSITIVE FOR COVID . 9/1/21 ADMITTED TO HOSPITAL.  WITH FEVER, OXYGEN SATS IN THE 80S. REPORTS NECK PAIN AND ACHING ACROSS LOW BCK. DX. COVIDWITH PREDOMINANT GI SYMPTOMS, MILD HYPOXIC. DISCHARGED ON 9/5/21 HOME
Nearly immediate return of rash to chest as after dose 2 with new rash covering the entirety of both shins. Generalized pitting edema. All onset w/in 10 days of the vaccine. Treated with nystatin cream per physician recommendation w/ no improvement. Intermittent inflammation to eyes causing broken blood vessels and pain. Sought treatment from dermatology in April 2022 and was informed the rashes were likely aggravated psoriasis d/t the vaccine triggering my auto-immunity. Treated w/ clobetasol w/ much improvement. Skin is still scaly. Saw ophthalmology also in April and started anti-histamine drops (Zaditor) w/ temporary relief (4-6 hours) of eye inflammation. Saw rheumatology for regular f/u visit in April and was advised to start increased dose of cosentyx for new severe psoriasis outbreak.
Initial and follow up reports have been received from a licensed practical nurse concerning a 47 year old adult female homemaker who on 08/09/01 was vaccinated IM in the left deltoid with the first dose of Hepatitis A virus vaccine inactivated. On 08/09/01 at 14;23, immediately post-vaccination, the patient developed hoarseness and her throat tightened. There were no other symptoms. Subsequently, 20 minutes later, the patient started to "feel better" and her voice returned. She denied SOB, lip or tongue swelling, or any fever or chills. Her vital signs improved over 30 minutes and she was noted to have been a little hoarse, but had no stridor and her lungs were completely clear. It was reported that due to the mild allergic reaction, the patient could not be administered dose two. Her heart had a regular rate and rhythm and was without murmur when she galloped or ran It was noted that serology testing was performed in 03/02, but that results have not been returned. The patient  recovered from the experience. Unspecified medical attention was sought. The reporter considered the mild allergic reaction to be another important medical event. No further information is available.
Mother reports pt developed significant flatus and subsequent diarrhea (>8 times daily) beginning three days after being vaccinated (5/14/07).  Diarrhea has been watery and explosive and at times there has been blood and mucous streaking. This has continued for 2 weeks.
Flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from Patient.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, expiration date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
syncope; orthostatic intolerance; autonomic dysfunction; fatigue; dizziness; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced syncope, orthostatic intolerance, autonomic dysfunction, fatigue, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event; Sender's Comments:  US-009507513-2301USA006946:
Recurring pustular rash similar to initial major vaccine reaction - 4 months out. With pustular drainage/clear vesicles and scabbing extending around the initial vaccine area - approximately 5x9 cm in size.
Fever, every muscle ached, pain in every joint, extremely tired, nauseous (threw up once), no appetite, unable to function out of bed.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pt reported her upper arm was numb and unable to move it. She was able to move her fingers. She reported numbness as well as pins and needle feelings around the injection site / upper arm area.
excessive blood in her stool; Initial information received on 07-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves an 8 weeks (age at the time of report is 10 weeks) old female patient who experienced excessive blood in her stool (haematochezia), while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient had ongoing Milk allergy (she was breast feeding).  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, (unknown latency) following the vaccination the patient experienced excessive blood in her stool (haematochezia). This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was blood in stool.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case involves an 8 weeks old female patient who presented with blood in stool after vaccination. Time to onset is compatible with the role of the vaccine. At the time of the event, the patient had ongoing Milk allergy (she was breast feeding). More details regarding patient's medical history, previous vaccination history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information, the role of the vaccine cannot be assessed.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Between 07-APR-2016 and early May 2016, the unspecified number of patients were administered unspecified dose of oral ROTATEQ (lot # L035508, expired on 12-MAY-2017 immunization series, which were improperly stored. The temperature was 65F and the time frame was 11 hours as reported. There was no previous temperature excursion. No data logger involved. No adverse effect was reported. No further information provided. Additional information has been requested.
still little sore, legs sore/soreness in the legs; Light red rash / discoloration, 2 inches in diamater; discoloration near the injection site on the left arm; Occasional itching; Heaviness in legs; Muscle tightness in legs; Extreme Arm Soreness, cannot lift arm,; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2023, the patient received the 1st dose of Shingrix. In February 2023, less than 2 weeks after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the pain in extremity was not recovered/not resolved and the outcome of the red rash and skin discoloration were recovering/resolving and the outcome of the pruritus, heaviness in leg and muscle tightness were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR028514   Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment: This case was self reported by the patient. The patient received first dose of Shingrix on left upper arm.  The patient experienced extreme arm soreness in left arm, where could not lift arm.  This subsided after 3 to 4 days, but the left arm was still a little sore.  The arm soreness from the Shingrix was lasting longer in contrast to what experienced with the Tdap.  About 4 days after receiving the Shingrix vaccine, the patient developed a very light red rash or discoloration near the injection site on the left arm, which was about 2 inches in diameter, and experienced occasional itching.  The rash or discoloration was less red now than it was last week.  Earlier this week, the patient went for a walk, and was experienced heaviness, muscle tightness and soreness in the legs.  The adverse event was file. The reporter did not consent to follow up. The patient declined to provide date of birth. After 4 day, the patient experienced red rash, skin discoloration, pruritus. This case had been linked with US2023AMR028514 same patient.; Sender's Comments:  US-GSK-US2023AMR028514:Same reporter
Low grade fever, chills, body aches, muscle aches, stomach pains, fatigue
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # R003534, expiration date 3108-2019 for prophylaxis. The vaccine underwent a temperature excursion of 0 to 1 degrees Celsius (or above) for 12 hours. There was no previous temperature excursion. The digital data logger was involved.
Varicella type rash/rxn per np. Rash over whole body. Family states started 4 or 5 days ago. Pt in today, 4-27-07
On January 6 i developed a rash on the injection site and 1 day after skin is peeling off
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a white, non Hispanic or Latino male of unspecified age. 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, batch number and expiry were not reported) dose was not reported, dose number in series 1, administered 1 in total on 27-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, patient experienced chills, headaches, body aches and cough (dose number in series 1). On 25-DEC-2021, antigen rapid test was performed and the results came out to be negative. On 27-DEC-2021, patient took another antigen rapid test (BinaxNOW) twice and the results came out to be positive (suspected clinical vaccination failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000209037; Sender's Comments: V0: 20211258606-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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
3RD DOSE OF MODERNA COVID VACCINE GIVEN 11/09/1921, LOT #066F21A. 4TH DOSE OF MODERNA COVID VACCINE GIVEN 07/29/2022, LOT #060A22A; pt passed away 11 days later. pt had a positive COVID test on 5/27/22 in SNF  pt's condition deteriorated while in the facility, eventually placed on hospice 8/3/22. pt passed away in the SNF.
Joint pain and bowel issues. I've also been having heart palpitations. I still have bowel issue and rectal bleeding. I'm not sure if its related to the vaccine.
Gave vaccine to under age person,  was unaware at the time when vaccine was administered.  Follow up only symproms reported was sore arm for one hour after vaccine administration.
A patient  who was 4y 7mo was given a pediatric immunization approved for 5y and older,  patient did not exhibit any symptoms, there were no adverse reactions
Experienced dizziness, diaphoretic, tingling of hands and feets, elevated bp and heartrate, chills, stiffness and pain of neck and shoulders. Also reported painful throat, loss of taste and smell.  Seen by on-site MD; given cold compress; given one dose of metoprolol; slept until picked up by husband; blood pressure stabilized
2/13/03 Employee called in sick; complained of chest hurt at Xiphoid area, SOB, chest pain increasing and nauseous. Sent to medical center for evaluation. Diagnosed with gall stone in duct; gall bladder surgery and removal of stone recommended. Surgery 2/14/03. Discharged home 2/16/03.
Bad Chills, fever, headache, tiredness/fatigue, joint pain, nausea, stomach pain,  injection site pain and swelling.  I still don?t feel back to normal. The worst symptoms lasted about 24 hours.
Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment was provided by the reporter.
Painful muscles in left arm. Injection was given in left arm. Arthritic pain in knee joints. Started within 14 hours of injection.
Patient received third dose/booster dose; Heavy breakthrough menstrual bleeding 4 weeks after second Pfizer dose and again 5 weeks after third Pfizer dose.; This is a spontaneous report from a contactable pharmacist, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Jan2021 (at the age of 37-years-old) and received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Oct2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ongoing ethinylestradiol/norethisterone acetate (JUNEL) for birth control from an unknown date and famotidine (PEPCID) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Dec2020 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 18Feb2021, 4 weeks after second dose and 5 weeks after third dose, while the patient was on birth control she experienced heavy breakthrough menstrual bleeding. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent PCR-SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the event heavy breakthrough menstrual bleeding was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.