chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High blood pressure; A spontaneous report was received from a consumer concerning a female  patient  of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure/hypertension.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M204) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, High blood pressure.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, high blood pressure was unknown.; Sender's Comments: There is not enough information to assess the reported event as critical details such as vaccine administration date, onset date of the event, patient's medical history and concomitant medications are lacking.
patient recevied first menactra in June 2018 and on 03Jan20 instead of his 3rd dose of Trumemba he was given a Menactra, No AE; Initial information received on 04-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 20 years old female patient who was vaccinated first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in June 2018 and on 03-Jan-2020 instead of his third dose of MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] he was given a Menactra.  It was actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  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 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.  Information on the batch number was requested.
Pt awoke on morning after vaccines were administered, felt nauseated, had a loss of consciousness, shaking followed.
Day of injection (1/14), redness. Next day (1/15) redness, swelling, hot about the size of palm. Faded by 1/18. 1/22 itchiness, redness, swelling, warm knot returned and covered much bigger area on arm. Started antihistmine and took 8 days to return to normal.
Fatigue;    pain at injection site Headache on Right side of head Severe Nausea Muscle  and joint Pain Temp 100.3 Chills Lasted 24 hr Slept and try to stay hydrated
Child with eye twitching after Hep A vaccine. Neurology did testing which was normal. No treatment was needed it was self resolved.
Intussusception-melena, pain, crankiness and current jelly stool s/p Air enema x2 which failed and required surgical reduction. 5/6/08-records received for DOS 3/6-3/8/08-DC DX: Intussusception. Presented with projectile vomiting since 3/5/08-bloody stools followed that same evening. Well until evening prior to 6 month check up when he was crying an abnormal amount and fever 102.8 2 nights after vaccines. Oral intake decreased.Surgical laparotomy with reduction of intussusception.
This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported.     On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (route, dosage schedule, lot # and expiration date were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 25 minutes: more than 46 grades Fahrenheit but less than 77 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000488: US-009507513-1703USA000486: US-009507513-1703USA000487:
extreme stomach pain still on going, feels like I am being punched in the stomach felt weak & like I had the flu, hot flashes
PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site. This report was non-serious.
Hematoma; Small red almost like a blood blisters on my hand; the lesion is on my hand on the top of my hand; looks like a lesion or blister; Small red almost like a blood blisters on my hand; the lesion is on my hand on the top of my hand; looks like a lesion or blister; This is a spontaneous case received from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8737, expiration date: Jul2021), via an unspecified route of administration in left arm on 30Mar2021 14:45 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Mar2021 20:00, the patient experienced haematoma and small red almost like a blood blister on her hand; the lesion is on her hand on the top of her hand; looks like a lesion or blister. The patient did not undergo any lab tests. The patient did not receive any treatment for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No additional AE reported; Patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a healthcare professional, concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, drug reactions/allergies or concomitant medications was not reported.   On 18-JAN-2022, the patient was administered improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1742429, expiration date: 11-SEP-2022) administered orally for prophylaxis (strength and dose were not provided).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  was exposed to a temperature excursion of 34°F on 10-OCT-2021, with a time frame of 3 hours 36 minutes. Then, on 08-FEB-2022, the vaccine was exposed below 36°F (34.0°F) for 6 hours 4 minutes, on 10-FEB-2022, (34.3°F) for 23 minutes, on 11-FEB-2022, (34.3°F) for 21 minutes, on 17-FEB-2022, (34.3°F) for 22 minutes, on 18-FEB-2022, (34.5°F) for 18 minutes, on 23-FEB-2022, (34.7°F) for 19 minutes, on 24-FEB-2022, (34.3°F) for 5 minutes, on 25-FEB-2022, (34.3°F) for 18 minutes, on 02-MAR-2022, (34.9°F) for 16 minutes, and on 03-MAR-2022, (34.7°F) for 19 minutes.; Sender's Comments:  US-009507513-2203USA005825:
Breakthrough COVID Case; Breakthrough COVID Case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adolescent male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer Covid Vaccine, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Not, available/provided to reporter at the time of report completion, prev dose administration date=May2021, prev dose dose number=1), administration date: May2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "unknown" and all described as "Breakthrough COVID Case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Unknown. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Additional information: It was unknown if the patient received any other vaccine in four weeks. Prior to vaccination, patient did not suffer from COVID. Patient was tested for COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
13 yo previously healthy x ADD, takes Trileptal, Welbutrin, Concerta and Latuda, received second Pfizer Covid vaccine 2 days ago.  This morning, began with atraumatic mid-sternal chest pain.  Pain is constant, not affected by position - ie no change with sitting/supine/standing.  + fever to 100.5 tonight. + emesis x 1. Also had jaw pain that resolved after motrin. No cough, rash, diarrhea.   CHEST PAIN - MYOCARDITIS secondary to rare complication of Covid Vaccine vs MIS-C  Transport PICU nurse - spoke with Peds ED physician - they recommend IV and labs to evaluate for possible MIS-C.
Local symptoms- pain-discomfort. General symptoms- headaches, neck and upper back pain, swollen glands- left under arm pain Narrative:
Child given Varivax injection (2pm)and presented back to clinic ~15 minutes later with swollen eyes and lips, tightness in nose and throat and sever coughing. Given Epi Jr, O2 given and monitored O2 Sat. Given EpiPen (0.3mg) approximately 6 minutes later. Called 911. Child taken to ER.
Headaches, dizziness, and ABOVE ALL: DIPLOPIA -- I must cover one eye or see two images. I cannot drive,
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms (1st dose)), MYALGIA (body aches (1st dose)), PYREXIA (fever (1st dose)) and HEADACHE (bad headache (1st dose)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms (1st dose)), MYALGIA (body aches (1st dose)), PYREXIA (fever (1st dose)) and HEADACHE (bad headache (1st dose)). On 16-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms (1st dose)), MYALGIA (body aches (1st dose)), PYREXIA (fever (1st dose)) and HEADACHE (bad headache (1st dose)) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-307576.
I received the shot at 4:00 pm. Over the next two hours, my entire arm and shoulder muscles became extremely sore. After that, the pain had become so intense that I could not move my arm without assistance.  I went to bed around 10:00 pm with a headache and slight nausea. I woke up three times during the night with extreme pain in my shoulder, arm, and hand.  At 9;00 am, the pain is not as intense, but I am still unable to move my arm up or down without assistance. The headache and nausea are gone.
On 19JAN92 approx 4PM pt began to feel as if had flu, "ached all over"; later joints became painful requiring assistance to lie down; 8-830PM lost feeling & then use of hands & lost consciousness soon p/; LOC x 3-4min & was incoherent;
IT KICKED MY ALLERGIES INTO OVERDRIVE. STARTED OUT WITH RUNNY NOSE WENT INTO STUFFY HEAD .THEN IT PLUGGED UP MY SINSUS AND MY EARS. THIS WAS OVER A THREE WEEK PERIOD.
Patient presented to the ED on 2/23/2021 and was subsequently hospitalized for 4 days.
Arm is still sore 3 weeks after getting Hep A vaccine (04-22-08).  Aggravated it again pulling on bulgate.
On day 7 my injection site became  slightly  painful.  It broke out in a rash and began to swell and was very itchy.  The next day the rash spread and the swelling was still there and still itches.  Today the swelling is not as bad but the itching is still there.  It now appears to be getting better.
Large knot, over 1 inch redness at vaccination site. Lasted over a week and a half.
W/in 1 hr p/vax became pale, lethargic w/extensive emesis- returned to office immediately for observation, cont emesis & lethargy-transferred via helicopter to hosp.
Wife's side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Wife's side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 (Wife's side effects). At the time of the report, ADVERSE EVENT (Wife's side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided.   This case was linked to MOD21-099692, MOD21-099671 (Patient Link).
Initial unsolicited report received from a nurse on 18-Nov-2015. This case involves a 76-year-old female patient, who was vaccinated with FlLUZONE HD (Batch number: UI452AA, dose and dose in series not reported) via intramuscular route in left upper arm and 0.5 ml dose of PREVNAR 13 (manufacturer: Pfizer, Batch number: M13067, expiry date: Apr-2017) via intramuscular route in right upper arm on 22-Oct-2015 at 11:00 A.M.  Patient had no illness at the time of vaccination. Medical history and concomitant medication was not reported. On 22-Oct-2015, same day three minutes after vaccination, patient experienced dizziness and could hardly walk. It was reported that no Laboratory investigation and corrective treatment were required. On unspecified date patient was recovered from the events. Follow-up information received from a nurses on 22-Dec-2015. Patient's had medical history of anxiety disorder, Chronic obstructive pulmonary disease, coronary artery disease, aortic aneurysm, cerebro vascular disease, Gastro esophageal reflux disease, hypercholesterolemia, hypothyroidism, muscle cramps, osteoarthritis, peptic ulcer, peripheral vascular disease, Raynaud's syndrome, tobacco user and vertigo. It was reported that after the patient left pharmacy the dizziness continued throughout the night and then gradually tapered off throughout the next day. Since the patient had no problems. Documents held by Sender: none.
Patient got 3rd dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012a21a, 011m20a and 037k20a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine). On 15-Mar-2021, EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-044862, MOD-2021-044851 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Non significant follow up received on 06-APR-2021, no new information
Explosive diarrhea started March 29 @2:30 am and continues, though not as severe, and I started taking Imodium (generic) on Saturday April 10 and it has only delayed the ongoing issue a few hours each time.
worsening and more widespread numbness included exterior numbers on the lips, cheeks, and nose; Localized arm pain; Mild headache; Mild nausea; Mild chills; Slightly elevted fatigue from normal; Mouth went numb: roof of mouth, tongue, inside of cheeks, uvula and back of throat; Back of throat numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Mouth went numb: roof of mouth, tongue, inside of cheeks, uvula and back of throat), PHARYNGEAL HYPOAESTHESIA (Back of throat numb), HYPOAESTHESIA (worsening and more widespread numbness included exterior numbers on the lips, cheeks, and nose), PAIN IN EXTREMITY (Localized arm pain) and HEADACHE (Mild headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Blood disorder (Undiagnosed hereditary blood issue ( mother diagnosed)). Concurrent medical conditions included Drug allergy (Codeine - uncontrolled vomiting every few minutes for 24-72 hrs), Drug allergy (allergy to morphine ,its dervatives and anything that metabolizes into similar compound: uncontrolled vomiting every few minutes, for 24-72 hrs), Drug allergy (Tramadol - uncontrolled vomiting every few minutes, for 24-72 hrs), Fibromyalgia, Asthma and Overweight (9 months postpartum, emergency C-section ,BMI 30,5'9 and 210 lbs, was 245lbs at delivery).    On 07-Mar-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Mouth went numb: roof of mouth, tongue, inside of cheeks, uvula and back of throat) and PHARYNGEAL HYPOAESTHESIA (Back of throat numb). On an unknown date, the patient experienced HYPOAESTHESIA (worsening and more widespread numbness included exterior numbers on the lips, cheeks, and nose), PAIN IN EXTREMITY (Localized arm pain), HEADACHE (Mild headache), NAUSEA (Mild nausea), CHILLS (Mild chills) and FATIGUE (Slightly elevted fatigue from normal). At the time of the report, HYPOAESTHESIA ORAL (Mouth went numb: roof of mouth, tongue, inside of cheeks, uvula and back of throat), PHARYNGEAL HYPOAESTHESIA (Back of throat numb) and HYPOAESTHESIA (worsening and more widespread numbness included exterior numbers on the lips, cheeks, and nose) had not resolved and PAIN IN EXTREMITY (Localized arm pain), HEADACHE (Mild headache), NAUSEA (Mild nausea), CHILLS (Mild chills) and FATIGUE (Slightly elevted fatigue from normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-071422 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up was received on 03-MAY-2021, additional events were added and event outcome was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071422:2nd dose
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Vomiting-Mild
Information has been received from a company representative concerning an 11 year old male patient who was vaccinated with a dose of Hepatitis B vaccine recombinant. "Shortly" post vaccination, the patient experienced a 101 F fever and extreme fatigue. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a nurse refers to a male patient of age in his 50's. No medical history and no known drug reactions or allergies was reported. The patient was vaccinated with a dose of 1 ml of RECOMBIVAX HB (lot number reported as 1106AA and expiry date unspecified) given intramuscularly with first dose on 28-DEC-2011, second dose on 01-FEB-2012 and the third dose on 28-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently, on an unknown date in 2012, the patient experienced negative hepatitis B surface antibody titers. No treatment was given. The patient sought medical attention and visited the physician's office. The outcome of negative hepatitis B surface antibody titers was not recovered at the time of report. The relatedness for the event was unknown for RECOMBIVAX HB. The patient was in the process of repeating the 3 dose series of RECOMBIVAX HB. The case is linked to # 1209USA005863 and # 1210USA006250. Additional information is not expected.
pt recvd vax 4OCT94 & w/in 24hrs pt exp itchy subcutaneous rt cheek bumps ( 3 or 4);these bumps remained for approx 2wks;
non-responsive, pupils non reactive. Resident passed away at 1600 on 4/30/2022
pt devel swelling & itch w/in minutes of receiving vax; swelling extended to elbow & appeared patchy;
I started having very bad nausea around 9:00 pm the same day I had the vaccine.  The nausea was so bad that it made me vomit.
arthralgias of hands and wrists, flu-like symptoms, fatigue, knee and ankle pain starting 2-3 weeks after gardisil vaccine
Systems lasting 4 days: fever, unable to stay awake, kept on passing out, dizziness and light headed, fell, unable to eat only able to drink water.  Systems lasting 13 days:Extreme body and head pain, extreme dizziness and light headed, fell.
3/30/09 Rec. Yellow Fever Vaccine - woke up with itching mild noc, slight headache - In AM 3/31/09 noted rash (hives) chest, neck, arms and legs. Did not take any Rx, but began oral typhoid cap. Pt called health dept. Recom. MD eval or to come to Clinic, No dyspnea, swelling. Saw Dr. - told Yellow Fever reaction. Given steroid cream, but used Calamine lotion instead - decrease itching
\No other AE and no PQC.; HBP calling to report the office administered an expired dose of GARDASIL 9 to a patient.  No symptoms reported.  No other AE and no PQC.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 18-AUG-2023, the patient was vaccinated an expired vaccine of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (valid lot number U008900 [expiration date 12-AUG-2023]) (dose, dose number, frequency, route of administration, anatomical location, and vaccination scheme were not provided) for prophylaxis (expired product administered). No symptoms reported.  No other adverse event (AE).