chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 69 yo M presents to the ED via private vehicle c/o fever onset last night around 1630. Pt reports chills onset yesterday at 1630 accompanied by a 101F fever when his temperature was taken at 2200. Pt took 1 EXCEDRIN PM before bed and woke up afebrile but began feeling chills again around 0730 this AM. Pt's fever then returned accompanied by lightheadedness, nausea without vomiting, and sore throat. Pt took one more EXCEDRIN PM this AM. He did not have any other antipyretics at home to use, as he is travelling out of town currently. Pt also noticed a rash on his forehead, denies itching. Notes mild discomfort right anterior neck near jawline, was using heating pad to the area with relief. No stridor, no change in phonation. Wife reports pt is confused and was not oriented to the date and was talking about his SIL caring for his FIL, but the father in law has been deceased "for decades" states wife. Denies HA, CP, abd pain, SOB, cough, rhinorrhea, or sore throat. Pt and his wife received 2nd dose of SHINGRIX vaccine on Thursday (4/18) and reported mild arm pain that resolved, no other sx. Pt is a poor historian secondary to clinical condition and AMS, wife provided all details and is considered reliable.
Delirious; Violently sick; High fever; Shakes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation in "Other" facility type. The patient's relevant medical history was not reported. There was no known allergies. There were no concomitant medications. The patient did not receive other medications within two weeks and not receive other vaccine within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown as unable to locate or read the details, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 38 years old, for COVID-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested COVID-19 post vaccination. The following information was reported: DELIRIUM (medically significant) with onset 2021, outcome "recovered" (2021), described as "Delirious"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Violently sick"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "High fever"; TREMOR (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shakes". The patient underwent the following laboratory tests and procedures: body temperature: (2021) high.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose and route not provided). The health care worker reported, the storage compartments that contained PNEUMOVAX 23 were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the unmonitored vaccines in during the period of time from 03-MAY-2014 until the present. She states that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
Mother of child reported that after varicella vaccine (ProQuad) on 8/31/20, baby had itchy scabs (rash) all over body starting on 9/9/20 . Ped attributed it to chickenpox vax. Symptoms are resolving but still present. Took Benadryl.  Mother of child thinks he has low immune system, but pediatrician doesn't think so.
chills; achiness; felt wet; nausea; dry heaving; weakness; felt like they were going to pass out; tenderness around injection site; fever; night sweats; This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced injection site tenderness, fever and night sweat. On 23rd July 2020, the patient experienced chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint. On an unknown date, the outcome of the injection site tenderness, fever, night sweat, chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint were unknown.   It was unknown if the reporter considered the injection site tenderness, fever, night sweat, chills, pain, feeling abnormal, nausea, dry heaves, weakness and felt faint to be related to Shingrix.  Additional case details were reported as follows: The patient had No underlying medical conditions.  On 22nd July 2020, the patient received late afternoon and in less than 24 hours, tenderness around, injection site, experienced fever, night sweats.0 On 23rd July 2020 morning, 1day after vaccination, the patient felt  like fever, chills, felt wet, achiness, significant nausea, dry heaving not productive.  The patient was asymptomatic before vaccine and they took her temperature before vaccination and it was 99.5. She also has weakness and felt like she was going to pass out. The patient was very physically fit. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR141020:same reporter
Patient complained of facial and lip tingling and numbness. Patient was A&O x 4, no abnormal breathing, V/S where: 1st attempt at 10:36AM: BP 180/98; P -100; RR-20, 2nd attempt at 10:40AM: BP 170/88; P-88; RR 20, 3rd attempt at 10:48AM : BP 168/88; P: 86; RR-18, and 4th attempt at 11:06AM: BP 120/78; P-80; RR-16. Patient received 25mg (12.5mg/5mL) of oral Benadryl at 10:45AM after initially refusing, reports decrease in the amount of tingling. Patient asked to stay for full hour of monitoring, patient refused stating that she felt better.
prolonged & progressive localized reaction of discomfort affecting muscle & soft tissues (approx two weeks);
2.5" macular rash with tenderness at upper arm. Flu shot administered 23 hours earlier at another facility.
Data exchange was not properly working in EHR. Office process did not include reconciliation of immunizations. (Only GRITS) causing extra dose to be given.
Limited information adverse event report.; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Limited information adverse event report.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Limited information adverse event report.). At the time of the report, ADVERSE EVENT (Limited information adverse event report.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. treatment medications were not reported.
My child has been hospitalized 3 times since this vaccine was given to her with severe cluster migraines, passing out, seizures, vomiting, and diarrhea  Difficulty breathing, Hot red cheeks, and ears.  12/17/2007 MR received for DOS 8/6-10/2007 and 11/27/2007.  D/C DX for 8/10/07: Migraines with marked histrionic overtures. Pt was transfered from local hospital with dx of seizures. Pt reports having migraines from March 2007 following Menactra vax to May 2007, which resumed recently, with vomiting, photophobia and phonophobia. Pt had seizure activity several days prior to admission txd with Ativan. Seen again 11/27/2007 for c/o headache with passing out. Increasing cluster H/As noted with change in medication.  Pt had witnessed screaming then uncontrollable shaking followed by limpness.  Assessment:  Possible Cluster Headaches vs seizure (temporal lobe). 03/07/08 MR received for DOS 3/23-26/2007 with DX:  S/P dehydration resolved, headache, possible migraine vs histamine. Pt presented with several day hx of fever, gasping for breath, rash, and headache. Sent to ER for IVF and observation for orthostasis after several trips to ER over 48hrs. Pt had several episodes of headache, especially after IVF stopped. ? Allergy to Menactra vaccine. 03/07/2008 ER visits from 3/26/07, 3/27/07, and 8/17/07 with DX: Headache, Near Syncope and recurrent headache, near syncope and syncope, headache respectively. 03/11/2008 Additional records received for ER visit 8/3-4/07 with DX: Seizure event. Pt c/o severe H/A with syncopal episode preceded by vomiting. Convulsions reported by mom.  Severe H/a and photophobia noted on exam.  Per 60 day follow up: She has now become allergic to wheat, milk, apples & chicken, and also several chemicals. She continues to pass out in "seizure like" states. No warning signs before episodes. Yes-this is very traumatic. We don't know what affects it or when it is going to happen. This changed her diet drastically -episodes still happen. She can't eat anything pre-packaged or with preservatives.
Nausea, dizziness, sharp pains to shoulder and neck, pain, redness, swelling at sight (right tricep area).
Symptoms began 5 hours after injection. It started with chills & body ached all over. I went to bed at 9pm with a fever of 101.6. During the next 4-5 hours it continued to rise as high as 104.6. I took Tylenol for the pain & fever. I took a tepid shower around 12 midnight which brought the fever down a bit. At this time Monday 8/29/08,6:30 pm CDT,  my fever & aches continue.
Stabbing/throbbing pain to upper arm (left). Numbness & tingling to entire arm/head (left). Hives (face neck) - swelling lip tongue - sudden warmth over most of body.
19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Onset time of event provided as 02:03 PM  No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials.16 patients received 0.25 ml booster dose.3 patients received 0.5 ml full dose.All patients tolerated vaccine administration well, without any complications in the office after observed for 15 minutes per protocol. As of 10-18-2021, no adverse reactions have been reported to office staff or medical staff.
Tested COVID positive, symptoms include sore throat, cough, shortness of breath, chest pain, nausea/vomiting, and headache.
pt experienced flushing, redness, back spasms, chest pain, left hip pain, and left leg pain within 2 minutes of second dose shingrix administration. BP was elevated.
Patient develops rash allover after 10 days of vaccine administration per mother  Patient was see by his PCP and he advised Benadryl  as needed  Patient doing well per mother
Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and 'urgency' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling 'like my legs are disconnected from me, like my quads are weak.' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn't mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent.  End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L>R; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.
TINGLING-NUMB(ish) FEELING Where: Entire face and tongue  When:  Began - Roughly 5min Following Injection  (08/16/2021 - 8:30pm) Ended - Prior to Morning Rise (08/17/2021 - 8:00am)
Patient started with soreness and aches all over body the night of getting the vaccine and injection site arm was warm to the touch. Patient reports not being able to sleep, and in the morning all of her muscles in neck, arm, back are extremely tender and sore.
This spontaneous report as received from a consumer refers to a 77 years old female patient with cancer and chemotherapy. On 16-AUG-2012, the patient was vaccinated with ZOSTAVAX 1 time. Concomitant therapy included blood pressure meds (3 total) and vitamin D (unspecified). On 18-AUG-2012, the patient experienced nausea, numbness in the toes, tingling, headache and joint pain. The outcome of all events was unknown. The relatedness for nausea, numbness in the toes, tingling, headache and joint pain was unknown for ZOSTAVAX. Additional information has been requested.
sick; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a patient (unknown demography) who was sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient every time got sick after flu shot.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 23-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 78 year old adult female, with no known medical history and no known drug reactions/allergies reported, who on an unspecified date was vaccinated subcutaneously in the forearm with a dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  The administering person thought that it was for "TB" tuberculin skin test.  Subsequently the patient developed swelling at the site.  Unspecified medical attention was sought.  At the time of this report the patient's swelling at the site had not improved.  Outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Rash on body and extremities, acne like eruptions with puss skin itching.
Pt admitted with hemorrhagic shock status post spine surgery.  Admission was on 2/5.  Pt was tested for COVID on 2/10 prior to rehab placement and found to be COVID positive.
Sweating/Chills. Stiffness in neck. Cough, headache, fatigue, runny nose soreness where the shot was given. Went to Occupational Health Services/but no response.
Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration on 24Mar2021 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included depression. The patient had no allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT), fluticasone propionate (FLONASE) and vitamin D (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, immediately after the vaccination, the patient experienced severe tinnitus. It was reported that the patient never had tinnitus before and the event had not subsided 2 weeks later. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event severe tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Moderna  COVID-19  Vaccine  EUA Vomiting multiple times, migraine, nausea, fatigue. Still have dark spot in peripheral vision of right eye.
(arm) hot; arm very very red; (arm) itching; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH ((arm) hot), VACCINATION SITE ERYTHEMA (arm very very red), VACCINATION SITE PRURITUS ((arm) itching) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (headache). On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH ((arm) hot), VACCINATION SITE ERYTHEMA (arm very very red) and VACCINATION SITE PRURITUS ((arm) itching). At the time of the report, VACCINATION SITE WARMTH ((arm) hot), VACCINATION SITE ERYTHEMA (arm very very red), VACCINATION SITE PRURITUS ((arm) itching) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided No treatment  information was provided; 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.
This lot of the Pfizer Bivalent Booster vaccine for ages 12 and older was accidentally given by a RN on the clinic staff team as a first dose to a 10.5 year old child.  The patient's parent has been notified and educated. The RN has also been educated appropriately and thoroughly.  There were no adverse reactions.