chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some flu-like symptoms; fatigue/tiredness; sore throat; the injection site is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "some flu-like symptoms"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue/tiredness"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "sore throat"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "the injection site is still sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Off label use; I have a mild headache; body aches; I'm feeling a slight discomfort; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (I'm feeling a slight discomfort), EXTRA DOSE ADMINISTERED (Extra dose administered), OFF LABEL USE (Off label use), HEADACHE (I have a mild headache) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 012M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 20-Aug-2021, the patient experienced DISCOMFORT (I'm feeling a slight discomfort), HEADACHE (I have a mild headache) and MYALGIA (body aches). On an unknown date, the patient experienced OFF LABEL USE (Off label use). At the time of the report, DISCOMFORT (I'm feeling a slight discomfort), HEADACHE (I have a mild headache) and MYALGIA (body aches) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) and OFF LABEL USE (Off label use) had resolved.            The concomitant medication was not reported. The treatment information was not provided.
Patient reports strange pressure in the head and headache starting 3 days after vaccination - fairly constant and hasn't resolved yet. Also stated being irritable when she never was before, high pitches in music bother her, and reading is difficult for her.  She had an eye exam and they told her the pressure wasn't related to the eye.
Eye blinking, unresponsive x 1-2 min. Episode occurred on 3/12/17, 4-8 after admin (approx). Pt presented to ED. Admitted overnight for monitoring.  EEG negative.
no adverse reaction; vaccination date: 27-SEP-2002 and 18-MAR-2003; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet referring to a 56 years old female patient. On 27-SEP-2002, the patient was vaccinated with hepatitis b vaccine (manufacture unknown) (strength, dose, route, lot #, expiration date not reported) for prophylaxis by a physician. On 18-MAR-2003, the patient received another dose of hepatitis b vaccine (manufacture unknown) (strength, dose, route, lot #, expiration date not reported) (inappropriate schedule of product administration). There were no adverse reactions or side effects experienced.   This is one split report from a case in litigation (MARRS# 1907USA003404).; Sender's Comments:  US-009507513-1907USA003404:
Covid arm. Insanely itchy. It still feels prickly. Changed my arm skin texture. It's still bumpy in areas.
Patient had arm swelling that began 3 days after receiving vaccine. Pharmacist instructed patient to use ice and antiinflammatory and call physician
AFTER VACCINE PATIENT WAS COMPLAINING OF HER TONGUE AND THROAT FEELING A LITTLE TINGLY AND SWOLLEN. PATIENT DID NOT APPEAR TO BE IN ANY DISTRESS AT THE TIME BUT BASED ON HER COMPLAINT SHE WAS ADVISED TO HAVE THE AMBULANCE TRANSPORT HER TO THE HOSPITAL. IT TOOK ABOUT 20 MINUTES BUT AFTER TALKING TO HER FOR AWHILE AND FOUND OUT HER SON WAS AN RN I TOLD HER WE WOULD TRANSPORT HER THERE. SHE AGREED AND WAS TRANSPORT TO THE REQUESTED HOSPITAL.  I SPOKE TO HER TONIGHT AT 9:40 PM AND SHE STATED SHE FELT FINE
Client mistakenly given a dose pfizer instead of a dose of Moderna. Client was aware of the mistake when called and indicated thst he had been feeling well since the vaccination.
The patient was administered a 2 days expired vaccine/ no AE; Initial information was received on 22-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional (Reference number- 00694350) and transmitted to Sanofi on 23-Jul-2021.  This case involves a 15-year-old patient (unknown gender) and it was reported that he/ she administered a 2 days expired IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "I was just calling about your IPV vaccine for children and um this vaccine was administered to a 15 year old and it was 2 days expired. I was just wondering what the next action plans. Product used: Used".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
a 4 year old patient was administered DAPTACEL after the expiration date with no adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 4 years old and unknown gender patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] after the expiration date with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Sep-2022, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (dose, strength, formulation: unknown), (lot C5765BA, 28-Aug-2022) via unknown route in unknown administration site as Immunization.  On 01-Sep-2022 (latency: same day), the patient developed a non-serious event "a 4 year old patient was administered daptacel after the expiration date with no adverse event" (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (dose and route were not reported, lot # K004856 with expiration date: 07-DEC-2016; lot # L004743 with expiration date: 01-JUN-2017; lot # K012457 with expiration date: 04-JUN-2017) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
woke up feeling achy; with flu like symptoms; chills; low fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 12:00 (Lot number: 320308N) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 2, Time (24): 02:15 PM, Anatomical Site of Injection : Right upper arm, Route of administration : Intramuscular, Batch/lot number: EN6205 Expiry date: 30Jun2021), administration date: 13Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 1, Time (24): 12:45 PM, Anatomical Site of Injection: Right upper arm, Route of administration: Intramuscular, Batch/lot number: EL9266 Expiry date: 31May2021), administration date: 22Feb2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "woke up feeling achy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "with flu like symptoms"; CHILLS (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "low fever". Therapeutic measures were not taken as a result of pain, influenza like illness, chills, pyrexia.  Additional information: It was reported that previous doses were also Pfizer. No prior vaccination within 4 weeks. No Relevant Tests were reported. no specific relevant test for thromboembolic events With thrombocytopenia were done. The events were non-serious. It was reported that patient feel better from the second day.  No follow-up attempts are possible. No further information is expected.  Follow-up (06Dec2021): Follow-up attempts completed. No further information expected.
I got a flu shot at clinic, in 2009. The nurse said she would also give me a shingles shot. A few days later my eye sockets became bright red, that lasted 3 mos. The clinic offered no help. In 2011 I got a bad case of shingles that lasted 6 wks. My print out does not show a shingles shot. What other shot did she give me? I never had a problem before.
Patient states he received the pneumococcal and flu vaccine both in left deltoid. Left arm upper arm reddened and painful. Patient states he received the vaccine at his work through services provided by pharmacy.
1 of 4 pts immunized w/DTAP over the last 2 wks 11JUL-22JUL who exp a rash around inj site (raised/swollen: approx 1.5" diameter) no itching, fever or other systemic rxn reported; A 4yo had a 10cm area of erythema around inj site; resolved
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent conditions or medical history were provided. On 05-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiry date unspecified) at physician office. No concomitant medications were reported. The pharmacist reported that on 07-AUG-2014, the patient experienced redness "about the size of a tangerine" and pain at the injection site after receiving ZOSTAVAX. The patient sought medical attention - she saw the pharmacist, but no treatment was given. The outcome of the events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Exactly 24 hours after vaccine administration, spiked fevers of 104 degrees, swelling & erythema around injection site. Penile pain. H/O Kawasaki presenting symptom penile pain w/fever & swelling.
heart palpitations when she restarted taking Lexapro and Adderall; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations when she restarted taking Lexapro and Adderall) and DYSPNOEA (short of breath) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PALPITATIONS (heart palpitations when she restarted taking Lexapro and Adderall) and DYSPNOEA (short of breath). At the time of the report, PALPITATIONS (heart palpitations when she restarted taking Lexapro and Adderall) and DYSPNOEA (short of breath) outcome was unknown.            No treatment medications were reported.   Patient stated that she felt short of breath and heart rate sped up whenever she took stimulants like Adderall. States she adjusted the dosages and tried alternatives. Not ongoing as per patient.  And stated that she was away of the myocarditis and pericarditis reports and stated she has no cardiac history.   Patient stated that she had experienced heart palpitations when she restarted taking Lexapro and Adderall after the 2nd Moderna dose.
Cold symptoms; Loss of smell; More than usual clots during monthly period; Sore arm; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 22Apr2021 at 17:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to fresh mint leaf. 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. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 18:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine on an unknown date and experienced drug allergy. On 28Apr2021, the patient experienced sore arm, cold symptoms, loss of smell, headache, fatigue, and had more than usual clots during monthly period. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient underwent rapid test via nasal swab on 01May2021 and the result was negative. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL and Ibuprofen. The clinical outcome of the events sore arm, cold symptoms, loss of smell, headache, fatigue, and more than usual clots during monthly period were not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
I was monitored the recommended 15 minutes and was fine. I went to the car, was being driven home, and about 20 minutes after the vaccination I developed an odd sweet/metallic taste in my mouth, followed by increased saliva, some difficulty swallowing, nasal congestion, and some chest discomfort. They symptoms were already getting a little better by the time we got home (about 30 minutes after the shot), but I took a Benadryl and the symptoms resolved within 2 hours. After that I just had the expected arm pain and fatigue until the next morning. Since then I have been fine.
I was diagnosed with Meniere?s syndrome 15 years ago. 10 years ago, I underwent a procedure that eliminated the worst episodes. On Monday 18th Sept I received my second shingle vaccination shot at Pharmacy. Within 15 minutes of receiving the shot, I suffered a severe attack of vertigo and needed assistance to get to a car to drive me home.  This episode was the worst I have experienced in 15 years and continued for 4 days confining me to bed for most of this time. During this period, I had bouts of vomiting, muscle and arm pain, headache, and eye difficulty focusing.
Patients mother, called the pharmacy around 4pm to ask if swelling was normal after getting the flu vaccination. The pts mother was informed it was normal for swelling to occur. The patient's mother described the injection site to be red and raised. She stated that the reaction never occurred in the past. The mother was informed to give patient a BENADRYL and IBU to help with any inflammation and pain. The pharmacist informed the pts mother that he would follow up in the morning to see if anything has gotten better. On 9/23 the pharmacist, contacted patient's mother and asked how patient was doing. Patient's mother stated that it looked like it had gotten a little better but that it was still tender and swollen. Per patient's mother, patient was only given BENADRYL the night before. She was informed to give patient IBU to help with the inflammation and to also use a cold compress for 10 minutes on 10 minutes off. The pharmacist stated that he would follow up on 9/24/18 and asked patient's mother to contact him if things were getting better or worse.
Mass on the right side of the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THYROID MASS (Mass on the right side of the neck) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L80A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021 at 7:00 PM, the patient experienced THYROID MASS (Mass on the right side of the neck). On 18-Jan-2021, THYROID MASS (Mass on the right side of the neck) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Thyroid function lab: unremarkable Unremarkable. On 05-Jan-2021, thyroid ultrasound: ultrasound evaluation of the thyroid was performed Multiple bilateral thyroid cysts, the largest being over 2 cm in diameter on the right side. On 18-Jan-2021, Diagnostic aspiration: thyroid, right Negative for malignant cells.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was provided  Prior to this vaccine, the patient had no history of thyroid nodules or issues related to thyroid. Patient had never been diagnosed with / tested positive for COVID-19. Action taken with mRNA-1273 in response to the event was not applicable.  Patient saw physician on 04 Jan 2021. Residual effects were reported as thyroid nodules. Patient has to have continued surveillance thyroid ultrasounds to monitor the size of the other nodules.   This case was linked to MOD-2021-166820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: VAER form received; additional event details provided; patient date of birth and age provided; diagnostic results provided
Rash started 2 days after flu shot, face and chest, moved to hands and arms--peeling itching hot red rash, moved to entire body--back chest legs. 10/29/18 to clinic for salve for itch and med to sleep. No relief. 01/7/2019 flu symptoms, could not eat, feeling sick, 01/10/19 right eye swollen shut in am followed the next day with second and face swollen. 10/11/19 at clinic, pictures of face taken, she consulted with allergist, prednisone regime and antibiotics and home. Very, very ill, could not think straight. Better after 2 weeks of meds. I had not felt like myself since the flu shot on 10/02/18. This was my time of stronger dose. Good now.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-DEC-2015 at 13:08, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.4 and 6.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pain with movement in left arm from shoulder to just below elbow (Recommended patient discuss with her medical provider). No swelling or redness in area also.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with a history of chlamydial infection and no known drug reactions or allergies who received first, second and third doses of GARDASIL (lot number unknown) on 23-NOV-2007, 30-APR-2008 and 15-OCT-2010 respectively. Concomitant therapy included SPRINTEC. The physician reported that on 01-NOV-2010 the patient had a positive home pregnancy test. Her last menstrual period and her estimated date of delivery were not reported. Follow up information was received via telephone from a registered nurse who also was the mother of the patient and stated when she was asked about complications that the patient had experienced a placental abruption with the vaginal delivery and circulatory distress during delivery. She elaborated that cardiac medications were given in delivery to the patient (not specified reason why or medications used) and the distress was controlled within the delivery room. On 02-JUL-2011, the patient gave birth to a healthy baby boy. The baby weighed 9 lbs. The baby suffered no distress and did fine post delivery. The nurse was asked if the patient's hospital stay was prolonged due to the difficulty in delivery; she reported that her stay was a normal 48 hours. The nurse stated that she did not know the patient's exact LMP or EDD but stated that the patient was a "couple days overdue" for delivery. Upon internal review, circulatory distress during delivery treated with cardiac medications was determined to be an other important medical event. Additional information is not expected.
pt recv vax 27OCT97 & 13NOV97 pt devel red spots on head, chest, inside arm, & two on buttock;pt also devel a lump on the bony part of the back of ear;