chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lower-than-authorized dose volume administered of the correct formulation. Patient indicated on screening form immunocompromised, but given .25mL Moderna booster dose instead of full dose during third vaccination appointment. Vaccine recipient notified.
Exhausted, fatigue; I have a adverse event. It is a covid positive test after three shots with Pfizer.; I have a adverse event. It is a covid positive test after three shots with Pfizer.; three shots with Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Nov2021 (Lot number: HE8030) as dose 3 (booster), single, administered in arm right, administration date 2021 (Lot number: ER8733) as dose 2, single and administered in arm right, administration date 01Apr2021 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 28Nov2021, outcome "unknown", described as "three shots with Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Nov2021, outcome "unknown" and all described as "I have a adverse event. It is a covid positive test after three shots with Pfizer."; FATIGUE (non-serious), outcome "unknown", described as "Exhausted, fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Dec2021) positive, notes: PCR results on 02Dec. Therapeutic measures were not taken as a result of drug ineffective, covid-19, fatigue.  Additional information: Other medical condition and other medications: Consumer stated, "No. I am trying to do IVS, I am taking medications for that and then symptoms exhausted, fatigue."  No follow-up attempts are possible. No further information is expected.
After I got the  vaccine I started exp chills and body ache on 12/22.I went to employee health to get tested. Since then I returned to work on 1/4 still can't smell/taste .I have to wait 90 days until I receive my 2nd dose Covid vaccine.
Right after I got it I had a metal taste in my mouth. About 45 minutes later I started seeing little light like Christmas lights, it lasted for about a half hour.  The next morning I woke up, I felt like I got hit by a truck, I felt so bad, no chest and body hurt. I got up and did a breathing treatment. I went to the Dr. because it sacred me, she gave me antibiotics , cough medicine with codeine- I couldn't stop coughing.  I asked her to change my nebulizer treatment because it wasn't working.  The Dr. suspected that this would happen.
Occasional chills and aches; Occasional chills and aches; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient experienced occasional chills and aches on an unspecified date. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Developed abdominal pain and purpuric rash on buttocks, legs, and arms on 19 days after the first dose of Pfizer Covid Vaccine consistent with Henoch-Schonlein Purpura  (HSP);  THe patient did not receive steroids.  He was treated with NSAIDS and recovered fully without any long-term sequelae.  The second dose of his COVID-19 Vaccine has not been given and with be help pending futher analysis and recommendations.
The patient was given doses of Vaxelis and doses of Hepatitis B (Recombivax HB), he did not have any type of adverse effect, but the report is made because he was given an additional dose of Hep B.
Mom states 48 hours post vax pt became very sleepy and unresponsive, hypotonic for five minutes. Shallow breathing and pulse.
red, raised oval lesion that was hot and itchy but not painful. No fever, no lymphadenopathy, +muscular pain, the lesion measured >9cm
Knot on left arm and armpit, right side of jaw knot, headache, muscle pain and vomiting.
Myocardial Infarction (STEMI) of inferior wall, emergency care, surgery and S/P drug eluting coronary stent placement, cardiac rehabilitation, arrhythmia.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient is 34.70 years.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 30-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively,, 9 AM: 33, 10 AM: 36, 11 AM: 36, 12 AM: 40, 1PM: 40, 2 PM: 39, 3 PM: 38, 4 PM: 40 and 5 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Headache after the second shot; Pain all over body after the second shot; Low Grade Fever after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the second shot), MYALGIA (Pain all over body after the second shot) and PYREXIA (Low Grade Fever after the second shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Amputee (Left leg above knee).   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (Headache after the second shot), MYALGIA (Pain all over body after the second shot) and PYREXIA (Low Grade Fever after the second shot). On 18-Aug-2021, HEADACHE (Headache after the second shot), MYALGIA (Pain all over body after the second shot) and PYREXIA (Low Grade Fever after the second shot) had resolved.            No Concomitant Medications were provided. No Treatment Medications were provided.
pain at injection site (1800 hrs on 16FEB2021 till about 1300 hrs on 17FEB2021), chills (0400 hrs on 17FEB2021 to 0300 hrs 18FEB2021), muscle aches (0400 hrs on 17FEB2021 to current 1300 hrs 18FEB2021), sensitivity to light (1100 hrs on 17FEB2021 to 1300 hrs on 17FEB2021), dizziness (1630 hrs on 17FEB2021 to 1730 hrs on 17FEB2021), joint pain (1100 hrs on 17FEB2021 to current 1300 hrs on 18FEB2021). Took 975 mg every 8 hours x 3 doses then took 650 mg x 1
Red, swollen bump at injection sight, starting one week after vaccination. Slightly itchy, and warm to the touch.  Approximately 2 inches in diameter.
Myalgia, NauseaVomiting, chills and tingling in the hands Narrative:
a bit of a reaction; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced a bit of a reaction (unevaluable event) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a bit of a reaction (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got a flu shot 2 weeks ago. Had a bit of a reaction but it was gone in 12 hours and now I'm good to go."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient recovered (it was gone in 12 hours) from the event.  There will be no information available on batch number for this case.
BRIGHT RED BLOOD IN STOOL; ABDOMINAL PAIN; INCREASED WHITE BLOOD CELLS; POSSIBLE BLOOD CLOT; RECTAL BLEEDING; This spontaneous report received from a patient concerned a 40 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and rectal bleeding, and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) started on 27-Jul-2021 for moderate to severe ulcerative colitis.  On AUG-2021, the patient experienced possible blood clot, rectal bleeding, and white blood cells was increased. On 25-AUG-2021, the patient experienced bright red blood in stool, and abdominal pain. On the same day she visited emergency room (ER) on early hours, and was admitted for increased white cell count, rectal bleeding and possible blood clot. She was hospitalized for 1 day and discharged late on 26-AUG-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased white blood cells, possible blood clot, rectal bleeding, bright red blood in stool, and abdominal pain. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210904116-COVID-19 VACCINE AD26.COV2.S -Possible blood clot, Increased white blood cells. 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.  20210904116-COVID-19 VACCINE AD26.COV2.S - Rectal bleeding, Bright red blood in stool, Abdominal pain. 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: MEDICAL HISTORY, UNDERLYING DISEASE
About a 2cm red wheal appeared after 9 month immunizations given. No discomfort/problems noted, but wheal has persisted since shots (on right thigh).
tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Reporter's daughter tested positive for covid. Reporter mentioned that she and her husband have not been able to have the Pfizer covid 19 vaccine because because it is not readily available. Reporter mentioned that they feel urgent now and wanted to know if they can get one because they are exposed to a covid patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe flu symptoms occurring on date of second dose (11/20/2020) and for three days after, patient experienced severe nausea, headache fatigue, and full body soreness to the point that she could not move her arms or legs. patient also experienced sever joint pain in hands and feet. injection site has extreme swelling (size of a baseball) and experienced pain, erythema, and swelling for 5 days around injection site. she experienced the same adverse effects from the first dose in July of 2020, but they were not as extreme and only lasted around 2 days
Hypopigmentation in the shape of a circle, the size of the bandaid was noticed around May 18th. It coincidentally happened to appear after I stuck a round magnet on my arm after hearing the theory that Covina vaccines were magnetic. The magnet did not stick but the day following my arm was tender and it was shortly after I noticed the round circle appear. Photos are available.
Temp 103.1. Patient would scream and cry until he fell asleep. he slept 1-2 hours at most and then would awake screaming. Lasting day and night 3 days Motrin every 6 hours.
AE additional patient information provided/adverse events; 5 doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) and VACCINATION COMPLICATION (AE additional patient information provided/adverse events) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021). On an unknown date, the patient experienced VACCINATION COMPLICATION (AE additional patient information provided/adverse events). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) had resolved. At the time of the report, VACCINATION COMPLICATION (AE additional patient information provided/adverse events) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-354310 (Patient Link).
Information has been received from a certified medical assistant concerning a 66 year old female patient with no medical history who on 10-OCT-2007, was vaccinated into the left arm with a dose of PNEUMOVAX 23. Subsequently the patient developed redness, swelling and pain at the injection site. The area affected was from just below her shoulder to her elbow of her left arm. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Came to clinic on 25JUN93 for vax described vomiting, crying > 2 hrs & fever of 103;
Non-raised  rash to bridge of nose and side of right cheek x few days. Denies pain or pruritus.
7 days after my first dose, I developed an itchy pink and hard bump about 3 inches below where I received my shot on my left arm. This later became a swollen red rash about the size of my fist.  This lasted about 3 days. When the swelling went down, I was left with a purple / red bruise that went away 2 days later.
Administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Cardiac Arrest/Death Date of death 03/03/2021 time 01:54 pm
Pain, swelling and tenderness at injection site, fatigue, headache, muscle pain, joint pain, chills, nausea and fever
This spontaneous case reported by a consumer, describes the occurrence of increased heart rate (rapid/raised heart beat) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced increased heart rate (rapid/raised heart beat). At the time of the report, increased heart rate (rapid/raised heart beat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
PATIENT PASSED OUT FOR A COUPLE MINUTES AFTER GETTING THE VACCINE. Pfizer-BioNTech COVID-19 Vaccine lot EW0168. SHE REGAINED CONSCIOUSNESS AND INTERACTED WITH US AFTER A FEW MINUTES. THE FIRE DEPARTMENT CAME SHORTLY AFTER AND BROUGHT HER OUT.
Felt faint after GARDASIL. BP 88/40. Appeared pale and diaphoretic. Given juice, layed down BP 90/58. Color improved after 15 mins. Released from office.
Patient developed DVT in right calf 2 weeks after first dose of vaccination on 3/4/2021. This occurred again after his second dose on 4/1/2021 with recurrent DVT.
Patient is mentioning that she has experienced vaccine related injury; unknown what kind of treatment patient  pt  had and what the outcomes are
Developed  heart Arrhythmia  and had to have cardiac ablation to decrease the extra beats.   Procedure seems to have been successful to date.
Changes in menstrual cycle.   Cycle following 2nd vaccine lasted 10 days and was very heavy.   Another cycle started 2 weeks after the first ended and was very light, stopped completely for about a day and then started back up for a couple of days.
Shingles; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via non licensed partner Pfizer via social media.  This case involves a patient who experienced shingles (herpes zoster), while he/she received vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and PNEUMOCOCCAL VACCINE POLYSACCH 23V.  The patient's past vaccination included VARICELLA VACCINE in JUN-2015. The patient's medical history, past medical treatment and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and PNEUMOCOCCAL VACCINE POLYSACCH 23V not produced by Sanofi Pasteur (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious shingles (herpes zoster) (couple days later) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and PNEUMOCOCCAL VACCINE POLYSACCH 23V.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown for shingles.  There will be no information received on lot number for this case.
Patient is 10 yrs old had varicella vaccine #2 on 2/23. On 3/6 started having pruritic rash. Diagnosed with varicella on 3/9/10.
Abscess. Patient received 2 month immunizations 9/27/02 in left thigh. Afterwards, increasingly swollen, erythematous/ecchymotic. Seen in ER on 12/27/02; sent home with warm soaks. 1/6 Seen in Peds clinic for 4 month immunizations, however vaccination held and referred to surgeon for evaluation I & D.
nausea, hot & cold flashes, diarrhea; 2NOV93 3PM cont w/cephalgia & diarrhea; sl improvement in aches, Cephalgia; no further emesis;
The patients started out with an itchy throat. We offered two benandryl and water. when we rechecked on pt. said her throat felt swollen. her lips felt swollen also. called 911. we waited with patient to monitor until ambulance got here. offered epi pen. pt denied epi pen. offered to call family member for patient also. EMT arrived very quickly. Patient left with ambulance. pt was still alert.
VACCINE FROZEN BEFORE GIVEN TO  PATIENT; PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced vaccine frozen before given to subject. On 13-MAY-2021, the subject experienced product storage error. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine frozen before given to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210535717, 20210534954, 20210536001 and 20210536595.