chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-SEP-2014, the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 04-SEP-2014, the patient improperly stored ZOSTAVAX during transport to physician office. Patient received that dose of improperly stored ZOSTAVAX on 04-SEP-2014. No adverse effects were noted. Additional information has been requested.
Reticular rash primarily on hands, arms, neck, face and head Started with itchy, burning hands and moved up my wrists and arms to my face, neck and head within the course of an hour and continued to worsen throughout the day. I sought counsel from our campus physician and was able to see my PCP this afternoon. I am still experiencing the same symptoms 12 hours later.
Information has been received from a health professional concerning a 20 year old female, with a "psychological" medical history, who on 28-FEB-2007 was vaccinated with Gardasil.  Concomitant medication included sertraline hydrochloride (Zoloft) and topiramate (Topamax).  She received her second dose of Gardasil on 03-MAY-2007.  Subsequently, the patient had an abnormal pap smear which was positive for Human Papillomavirus.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were administrated unspecified number of improperly stored doses of ROTATEQ (lot number K006455 - expiration date 10-FEB-2016 and lot number K004468 - expiration date 08-DEC-2015) (oral, strength and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 09-APR-2015, the patient received an improperly stored dose of ROTATEQ (lot# K004468, expiration date 08-DEC-2015, oral, dose was unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 20 year old female with asthma, juvenile rheumatoid arthritis, a hypersensitivity to drugs ending in, "sporin" and a history of a right knee operation who on 12-JUN-2007 was vaccinated intramuscularly with a first dose of Gardasil.  On 10-AUG-2007 the patient was vaccinated with a second dose of Gardasil (Lot # 654702/0011U).  It was reported the patient had not eaten any food that day.  Concomitant therapy included AMBIEN, folic acid, ORTHO TRI-CYCLEN LO and ENBREL.  On 10-AUG-2007 the patient fainted.  The patient was treated with food and liquids.  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  Additional information has been requested.
10min p/vax onset of lips swelling-hands itching-ears/red & burning;p/arrival @ ER pt had diff breathing;
Patient admitted to hospital with COVID-19. COVID-19 vaccination confirmed.  Patients is fully vaccinated.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Information regarding the patient's current condition was not provided. On 31-DEC-2012 the patient was vaccinated with VAQTA (25/0.5) lot # 0628AE, expiry date- 26-JAN-2016, dose 1, 0.5 ml, intramuscular. On 07-MAY-2013 the patient was vaccinated with VAQTA (25/0.5) lot # H010145, expiry date-27-FEB-2015, dose 2, 0.5 ml, intramuscular (inappropriate schedule of drug administration). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
I started having muscle spasms in the injection arm that moved from top to bottom when I started home in the car.  The spasms continued but they started getting further apart as the day went on. Though I  was still having them approximately 24 hours later.   They gradually stopped.  I did not go to the Doctor but am very leery about getting the 2nd dose.
Pt received shots Monday afternoon.  Tuesday morning mom noted redness and induration on right thigh around injection site and child complained of pain.  Pt seen by MD on Thursday 3-12-09 and started on oral CLINDAMYCIN.
Maternal exposure during pregnancy; unwell; Miscarriage; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization prolonged, medically significant and congenital anomaly). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 01-Mar-2021, ABORTION SPONTANEOUS (Miscarriage) had not resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and MALAISE (unwell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABORTION SPONTANEOUS (Miscarriage) to be related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell).    It was reported that the patient was pregnant at the time she received the second dose, 1st trimester.  This was her first pregnancy. Right after she was given the vaccine, she started feeling unwell, 2 days later, she miscarried her baby No information on concomitant medication were reported. No treatment details were reported. Company comment: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine.; Sender's Comments: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine.
Bexsero was administered to an 8-day old female; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-day-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 11-OCT-2023, the patient received Bexsero. On 11-OCT-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero was administered to an 8-day old female). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 11-OCT-2023 The healthcare professional (HCP) reported that a dose of Bexsero was administered to an 8-day old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date 17-SEP-2016, (strength, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
hematoma at the site, and a red, itchy area also at the site.; hematoma at the site, and a red, itchy area also at the site; hematoma at the site, and a red, itchy area also at the site; when the vaccine was administered, a good amout of "serum" leaked out and ran down; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who experienced hematoma at the site, and a red, itchy area also at the site., hematoma at the site, and a red, itchy area also at the site, hematoma at the site, and a red, itchy area also at the site and when the vaccine was administered, a good amout of "serum" leaked out and ran down  while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma and Immune system disorder.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Immunisation.  On 21-OCT-2022 , the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  (lot U7549AA; expiry date: 04-NOV-2024)  via intramuscular route in the deltoid nos.   On 21-OCT-2022 the patient developed a non-serious events hematoma at the site, and a red, itchy area also at the site. (injection site haematoma), (injection site erythema), (injection site pruritus) , when the vaccine was administered, a good amout of "serum" leaked out and ran down  (incorrect dose administered) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  Corrective treatment: the patient was treated with ice and it resolved.   At time of reporting, the outcome was Unknown for the event incorrect dose administered and recovered/resolved for rest of the events.    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 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.
muscle tightness, especially in my chest, with a stabbing pain near my heart; fatigue/physical exhaustion; muscle aches; headache/long and random head pain; low-grade fever; minor chills; enhanced irritability; menstrual cycle became irregular, spotty, and abnormally painful, with two full periods in a month span of time and spotting in between; menstrual cycle became irregular, spotty, and abnormally painful, with two full periods in a month span of time and spotting in between; muscle tightness, especially in my chest, with a stabbing pain near my heart; muscle tightness, especially in my chest, with a stabbing pain near my heart; making it difficult to breath; I feel dizzy; disoriented like I forget where I am; I have swollen lymph nodes; my throat is constantly swollen; menstrual cycle became irregular, spotty, and abnormally painful, with two full periods in a month span of time and spotting in between; two full periods in a month span of time; mental and physical exhaustion; unable to perform job duties; stabbing pain near her heart, under arms and breasts; stabbing pain near her heart, under arms and breasts; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 26-year-old non pregnant female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Aug2021 at 13:00 (Batch/Lot Number: EW0183) as DOSE 1, SINGLE (at the age of 26-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. It was unknown if prior to vaccination, the patient diagnosed with COVID-19 or not. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine 12Aug2021 and by the next morning (13Aug2021), the patient had began to experience typical side effects of fatigue/ physical exhaustion, muscle aches, headache/ long and random head pain, low-grade fever, minor chills, enhanced irritability, her menstrual cycle became irregular, spotty, and abnormally painful, with two full periods in a month span of time and spotting in between. The patient stated she worked out every day, but directly after receiving the vaccine, she consistently felt muscle tightness, especially in my chest, with a stabbing pain near her heart, under arms and breasts with no relief after working out or stretching. This tightness in chest worsens when she lay down, making it difficult to breath. On same day (13Aug2021), the patient experience daily fatigue, long and random head pain, and feel dizzy often and disoriented like she forget where she, swollen lymph nodes, throat was constantly swollen. It was reported she unable to perform job duties for extended periods of time from mental and physical exhaustion. Since the vaccination, the patient was not tested for COVID-19. No treatment received for the events. The outcome of events reported as not resolved.  Follow-up attempts are completed. No further information is expected.
patient who was given expired dose of ACTHIB (14 days after it has been expired) with no reported adverse event.; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient who was given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (14 days after it has been expired) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2022, the patient received expired dose of 0.5 ml suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ661AAA, Expiration date: 06-May-2022) via unknown route in unknown administration site for immunization 14 days after it has been expired with no reported adverse event (expired product administered). It was asked "what are the side effects, what to look for and what to do to a patient who was given expired dose of ACTHIB (14 days after it has been expired)"  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient who was given expired dose of acthib (14 days after it has been expired) with no reported adverse 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.
Headache reported following administration. However, on 5/8 patient reported she had shaking chills, dizzy, fatigue- passed out twice in husbands presence. No fever.
When client entered the elevator after receiving his vaccines, he experienced a headache, slight nausea and dizziness as he was observed by his family.  Grandfather stated "he was out cold" Symptoms were looking straight ahead, clammy skin, pale skin, and leaned on his family member.  client did not fall nor hit any body part. Symptoms treated with seating him in a chair, fan used for increased air movement, cool compress, juice provided.  Bp taken.  Symptoms resolved within 15 minutes and client walked to the car with his family.
Patient had a head ache, fatigue, loss of taste and smell. Went to doctor and she is being tested for COVID-19.
extreme fatigue,  slow to walk, limbs heavy. injetion site for over a week
After receiving booster dose of 0.25mL patient started feeling numbness and tingling in left leg.  It has lasted for 3 days.  Also under left arm, and spreading to breast area, numbness.
Patient was administered vaccine around 1PM and was being observed as required after the dose. At around 1:05PM the patient began to convulse (which lasted about 15 seconds) I immediately had my technician call 911 as I tended to the patient. She was in and out of consciousness, as I grabbed our emergency kit to bring out she became conscious. She stated she was ok, but I still insisted on waiting for an ambulance and her husband agreed. I spoke more with her husband to see if the patient had any type of seizure condition and he said she did not. By that time the patient was able to drink water and seemed to stabilize. The EMS personnel arrived around 1:20PM and took over after that.
cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontaneous report from a contactable other HCP (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: not reported), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient experienced fever 103 white posture on knee that turned into cellulitis and lymphadenitis. The patient had IV antibiotics twice within 5 days of vaccine as treatment for events. The patient still had swollen from groin area down to knee. AE resulted in emergency room/department or urgent care. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was not recovered.   Information on the batch/lot number has been requested.; Sender's Comments: The event cellulitis is assessed as unrelated to BNT162B2 based on the information provided. The event onset date is not reported, therefore the drug-event temporal relationship is not clear. In addition, the BNT162B2 vaccine was administered in the arm but the reported cellulitis was at knee area. It is very unlikely that the cellulitis was related to BNT162B2.
She has a cough since two or three days before the first dose of the vaccine and it hasn't stopped; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (reporter's mother) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection),via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient medical history included cough from an unknown date (has a cough since two or three days before the first dose of the vaccine). The patient's concomitant medications were not reported. The patient experienced she has a cough since two or three days before the first dose of the vaccine and it hasn't stopped on an unknown date in 2021. It was reported that reporter's mother who received the first dose of the Pfizer Covid-19 vaccine from this week, two weeks ago and it's her turn to get the second dose of the vaccine today or tomorrow. She had a cough since two or three days before the first dose of the vaccine and it hadn't stopped, it's not a flu, she mentions that the cough was not constant, but it was every day and especially at night. She would like to know if her mom should receive the second dose of the vaccine. The outcome for event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I noticed it since the first vaccine; taste of the food doesn't change even if I have fish or barbeque; arms have been very heavy; peculiar taste; it makes me dizzy; once I put them on arm rest, pain up the arm to the back of my neck; once I put them on arm rest, pain up the arm to the back of my neck; the weird taste in my mouth is still there; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck) and TASTE DISORDER (the weird taste in my mouth is still there) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck), TASTE DISORDER (the weird taste in my mouth is still there), FEELING ABNORMAL (I noticed it since the first vaccine), FEELING ABNORMAL (taste of the food doesn't change even if I have fish or barbeque) and LIMB DISCOMFORT (arms have been very heavy). At the time of the report, TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck), TASTE DISORDER (the weird taste in my mouth is still there), FEELING ABNORMAL (I noticed it since the first vaccine), FEELING ABNORMAL (taste of the food doesn't change even if I have fish or barbeque) and LIMB DISCOMFORT (arms have been very heavy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant Medications includes Blood pressure, Blood thinner and Cholesterol medication. Treatment Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up added on 23-JUN-2021: contact information updated.
vaccine site is itchy warm to touch, swollen red with a bump. on day 6 post vaccine
Left leg developed 1 1/2 inches round red hard circle. Not warm, raised or painful. Continue observation and call MD of becomes painful or changes.