chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a male in the 8th grade who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. The patient was not hospitalized. There was no product quality complaint involved. Additional information has been requested.
A nurse reported that a 40 year old pt received an injection of FluShield in the right arm on 10/28/02. On 10/31/02, the pt developed "Bell's Palsy." This event is considered medically important (OMIC). No further info was available at the date of this report.
I received the COVID vaccine 1 at 2 PM.  At 5:40 PM, the left side of my face was numb.  I emailed my PCP as to what I should do.  She told me to go to Urgent Care as soon as I left work, which I did.  Because I had Bell's Palsy two years ago at this time, I panicked.  I was told by the Urgent Care doctor that numbness is a common side effect (which I had not previously read like I did Bell's Palsy) and the numbness would subside in about a week.  She told me to complete this report.
I started to feel achy, chilled and some coughing. I had been advise to take Advil or Tylenol as needed and we to bed. I woke up about 6:30 am with the same symptoms, plus diarrhea. No real significant fever(99.1) I've just been pushing fluids and Advil & Tylenol as needed.
patients were inadvertently administered an adult Havrix; patients each were inadvertently administered an adult Havrix; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix adult) (batch number J9587, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2022, the patient received Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 4th May 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were 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: 10-JUN-2022  Reporter's comment: Medical Assistant called in to inquire as how to proceed and what to look for a pediatric patients who was inadvertently administered an adult Havrix dose. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered an adult Havrix dose, which led to overdose and inappropriate age at vaccine administration. This case is linked with US2022091774, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091774:same reporter
approx 2hr p/vax pt started twitching movements of arms/legs & purplish discoloration of the feet;pt was afeb @ home;911 notified;t105 1hr later in ER:dx OM;
Swollen, erythematous L upper arm.  Erythema measuring 13.5 x 10 cm.  Mild induration approx. 5 x 5 cm area.
RASH OR LUMP UNDER ARMPIT OF RIGHT ARM; LASTED FOR 2-3 DAYS DISCOMFORT IN LEFT ARMPIT FOR 1-2 DAYS
Pt states arm is swollen & painful from site of injection, to wrist. Pt states symptoms began about 6 hours after vaccination. Pt states area is red & swollen around arm. Pt has taken TYLENOL & applied ice to area. Advised pt to take BENADRYL & seek medical care tonight.
Fever of 102 degrees F with shaking chills and sweats started approx 12 hours after receiving flu shot; sore throat, cough, and headache started approx 24 hrs after flu shot - symptoms began to improve after 3 hours.
Redness, approx. half dollar increase in size, firm, warm, extremely tender to touch, no fever, advised to see private physician.
Headache, Myalgia, Fever, NauseaVomiting, Sore arm, flushed, chills, sensitive skin, photophobia, Narrative:  Nurse observed after vaccine given Sore arm, flushed, chills, myalgia, Headache, sensitive skin, nausea, photophobia, fever 100.2. Pt treated with acetaminophen 650mg oral and aspirin 325mg oral. Second dose.
Mom unsure which Hep B brand. Pt had second Heb B at 1 month appt. Over the next two days he became increasingly irritable, high pitch cries every 20-30 minutes, lethargy, decreased PO and decreased urine output per mom. Mom brought patient in to ED 3 days after receiving vaccine for dehydration and "not acting like himself." Patient admitted to hospital for low Hgb and received two blood transfusions. Patient also experienced some emesis and rash on face while inpatient.
Shot given 7/12/004. Hospitalized 7/18/04 for cellulitis. Discharged 7/15/04.  Nurse follow up on 08/30/04 states: "Local reaction to vaccine."
No symptoms after first shot.  12 hours after 2nd shot I got chills, felt achy and had ringing in my ears.  4 days later the malaise is getting better, the chills and fever is gone but the ringing in my ears won't go away!
We found out after we gave his shot we realized that he had a first dose of the Pfizer vaccine but told us he never had any shot before. We called him immediately and hew told us he wanted to get the shot but changed his mind and never got the shot. We checked with the clinic where he was reported as receiving  the dose and they told us he actually received the shot, we asked them to send us a copy of the consent for he signed via fax or email but never got such a document sent to us. We are not really sure of  who is telling the truth. Several attempt to contact the individual has been unsuccessful.
Received vaccine at place of work. No problems after vaccine until arm pain in the evening, which was typical of other vaccines (COVID-19 and others in the past). However, about 7 days later, the arm pain persisted and escalated. It appeared to travel mostly to the left trapezoid muscle area. I associated with traveling along arm and caused weakness in that limb. I contacted my primary care provider. Had video visit (10/12/2021) describing pain and was given a prescription for Medrol Dosepak. Got incomplete relief and thought I was on the mends, though pain continued and escalated from when I was treated. I have trouble sleeping because the pain is sometimes sharp (seemingly in the deltoid area of my arm). When arm is dangling, I have sharp pain. I do not detect any swelling. Heat is a great relief. Ibuprofen does not relieve the pain. Possibly some relief from lidocaine patch. However, pain is always there. At its worst it is a 10.  Most of the day the pain rests at 4 or 5; with activity of any type it is at 7. I was advised to go to sports medicine.  I have not made appointment. Requesting CPK level prior to any additional medication administration.
Initial report received from the scientific literature on 17 January 2012. This reporter also reported another adverse event, which was captured in case number 2012-00728 and 2012-00738. A male child (age not reported) received an injection (route and site not reported) of influenza vaccine, manufacturer and lot number not reported, on an unknown date. The patient at age one year had a history of facial swelling after eating scrambled egg. During an egg oral food challenge at age 5-years, he experienced hives, cough, and rhinorrhea and received epinephrine and antihistamine. The patient had a history of egg and influenza skin prick test (SPT) responses which were both positive (10-mm wheal with a 20-mm flare and 4-mm wheal with a 5-mm flare, respectively). The patient had a history of previous reaction to influenza vaccine of eczema flare and hives on his wrists after 0.05 mL of influenza vaccine where he was treated with oral antihistamine and did not receive the remainder of the vaccine. He had no history of asthma. Verbatim from article: "The following year, the influenza SPT response was negative. He still received the vaccine in 2 doses. Six hours after the last dose of vaccine, facial swelling was reported, which was treated at home with oral antihistamine. A year later, his influenza SPT response consisted of a 2-mm wheal with a 3-mm flare. He had no reaction to the vaccine given in 2 doses". The outcome was not reported. Follow-up information was received from a health care professional on 28 March 2012. The patient received a dose two intramuscular injection of FLUZONE, lot number U2804AA on 14 November 2008. Six hours later on 14 November 2008, the patient experienced the facial swelling. The patient's outcome was recovered. Documents held by sender: None.
An elderly female patient was administered a pneumovax immunization vaccine, 0.5 mL, on 10Jan2007. On 12Jan2007, the patient presented back to the clinic for a possible cellulitis reaction to the pneumovax vaccine involving 3 areas of erythema in the right deltoid region. The areas were slightly swollen and hot. Due to the reaction, the patient was started on Septra tablets, one tablet twice daily. The outcome of the event is unknown.
16 year old received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-207241 (Patient Link).
75 yr old patient got sudden onset head pain, sweating, dizzyness while seated for dinner 11/3/2022. This event was 9 days after getting the Pfizer shot (4th one). No action taken but patient felt like he would collapse if he got up.  The next morning patient was dizzy getting out of bed and wife drove him to the ER.  ER did numerous tests but did not find cause & he was discharged 6 hours later. "unremarkable"   Patient saw Dr his GP, on 11/08/2022. who reviewed ER report. Nothing more found. Dr. and the ER suspect a Transient Ischemic Attack (stroke).TIA
Information has been received from a healthcare working concerning a patient who on 01-MAR-2010 was vaccinated with the first dose of ROTATEQ (therapy dose, route and site unknown). The healthcare working reported that the patient received the vaccine later than recommended; the patient received ROTATEQ on 01-MAR-2010, 14-JUL-2010 and 17-AUG-2010 and no adverse effect. Additional information has been requested.
patient signed up online for an appointment to get covid vaccine. the patient received Pfizer COVID vaccine from another healthcare provider on 3/10/2021.  Our system did state 1st dose appointments but the patient knowingly signed to get 2nd dose.  The nurse who was administering the vaccine at our locations did not verify the card that the patient had given him. on the card it dose state that the 1st dose was Pfizer.  We only give Moderna vaccine at our facility and the patient did not verify what type of vaccine we are giving.
administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date; administered with the monovalent vaccine on 01Dec2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date), WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date), WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date), WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date) and WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022).    No concomitant medication information was reported. No treatment medication information was reported.
After vaccine was cranky. Next day by 1pm right arm very swollen, lack of appetite, low grade fever called doctor who advised ice for swelling and Motrin for fever. Called again by evening because there was more swelling, area hand, spread all the way to wrist. Taken to DR on 11/10 and sent to specialist for possible cellulitis. Specialists confirmed that it was a severe case of cellulitis at the time area was red and hard as rock. Admitted to hospital on 11/10 by 2pm given IV antibiotics and finally discharged on 11/12 3pm. Pt continues antibiotic treatment (oral) 11/13 seen by doctor again for checkup. Swelling has decreased. Records received and reviewed DX: cellulitis Trauma induced soft tissue swelling No history of trauma) cat scratch disease (but no lymphandenopathy.
BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no problems and was extremely healthy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s booster (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, and batch number and expiry were not reported) dose, start therapy date were not reported 01 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got sick and tested positive for Coronavirus disease (COVID-19), hence suspected COVID-19 infection and suspected clinical vaccination failure. Patient also had blood clots (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, suspected clinical vaccination failure and suspected COVID-19 infection was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint (PQC): 90000218636 This case, from the same reporter is linked to 20220251156, 20220251028 and 20220250507.; Sender's Comments: V0: 20220250720-COVID-19 VACCINE AD26.COV2.S- blood clots. The event(s) 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(s). Therefore, this event(s) is considered unassessable. 20220250720-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
One week after receiving my 2nd vaccine, I got my period, which was not on schedule with when I should have. It lasted continually for 7 months. I dod not have any history of irregular periods prior to this. On the same day that my period began, I also had a severe Charlie horse cramp in my left foot and calf muscle. For the next 7 months I had severe cramps in my left leg and foot every 3-4 days. I did not have any prior history of this. The leg cramps and my period began on the first day, continued for 7 months and both ended on the same day.
Severe migraine since having the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine since having the Moderna 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 09-Sep-2021, the patient experienced MIGRAINE (Severe migraine since having the Moderna vaccine). At the time of the report, MIGRAINE (Severe migraine since having the Moderna vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Date of Admission: 10/13/2022 Date of Discharge: 10/16/2022     Discharge Diagnosis: Hospital Problems   Diagnosis o Primary Problem: COVID-19
"Yuky" feeling; COVID-19 virus test positive; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("Yuky" feeling), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and COVID-19 (COVID-19 virus test positive) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Oct-2021. On 06-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced FEELING ABNORMAL ("Yuky" feeling) and COVID-19 (COVID-19 virus test positive). On 06-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, FEELING ABNORMAL ("Yuky" feeling) and COVID-19 (COVID-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive covid-19 test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company Comment: This spontaneous report concerns a 28 year old female patient with no relevant medical history who was exposed to mRNA-1273 vaccine during pregnancy. The patient received both the doses of vaccine (first and second) at unknown weeks of gestation. The report states that the patient tested positive for COVID-19 (non-serious unexpected AESI) after receiving both doses of mRNA-1273 vaccine. In addition, the patient experienced sore arm (non-serious) after the first dose, and an abnormal feeling (non-serious) after the second dose of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-252852 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up document received, contains non-significant information including primary reporter's email address. Changes from initial version included removal of event, dose 1 information, updated start date, stop date and outcome of event; Sender's Comments: This spontaneous report concerns a 28 year old female patient with no relevant medical history who was exposed to mRNA-1273 vaccine during pregnancy. The patient received both the doses of vaccine (first and second) at unknown weeks of gestation. The report states that the patient tested positive for COVID-19 (non-serious unexpected AESI) after receiving both doses of mRNA-1273 vaccine. In addition, the patient experienced sore arm (non-serious) after the first dose, and an abnormal feeling (non-serious) after the second dose of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Threw-up after 2nd primary shot/Vomiting after 2nd primary shot; Headache after 2nd primary shot; Muscle Ache after 2nd primary shot; Chills after 2nd primary shot; Nausea after 2nd primary shot; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Threw-up after 2nd primary shot/Vomiting after 2nd primary shot), HEADACHE (Headache after 2nd primary shot), MYALGIA (Muscle Ache after 2nd primary shot), CHILLS (Chills after 2nd primary shot) and NAUSEA (Nausea after 2nd primary shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VOMITING (Threw-up after 2nd primary shot/Vomiting after 2nd primary shot), HEADACHE (Headache after 2nd primary shot), MYALGIA (Muscle Ache after 2nd primary shot), CHILLS (Chills after 2nd primary shot) and NAUSEA (Nausea after 2nd primary shot). In March 2021, VOMITING (Threw-up after 2nd primary shot/Vomiting after 2nd primary shot), HEADACHE (Headache after 2nd primary shot), MYALGIA (Muscle Ache after 2nd primary shot), CHILLS (Chills after 2nd primary shot) and NAUSEA (Nausea after 2nd primary shot) had resolved.            Concomitant medications was not provided by the reporter. The patient had events for 10 hours. Treatment information was not provided.   This case was linked to MOD-2022-557682, MOD-2022-557486, MOD-2022-557681 (Patient Link).