chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Havrix RD IM and Menactra RD IM then Tdap Boostrix LD IM and Gardasil LD IM.  Client had been quietly smiling and talking with me.  I put on the last bandaid and was going to start my documentation when client suddenly went into a full, generalized seizure - eyes open and averted to upper right, back arched throwing him back off his chair (I caught him in my arms so he did not fall), full flexion and extension of arms and legs, jaw clenching, skin color pale.  This lasted 5-7 seconds after which he slowly relaxed over about 30 seconds but remained unresponsive to his name for about two minutes with his eyes closed.  His pulse was elevated, breathing normal, and over the next several minutes he was slowly able to start responding to his name and nod or answer simple yes/no questions.  Client's mother stated that he had no medical problems, was not on any medications, had not been out on the heat of the day, and only noted that he had slept in late that day.  Since the client had no history of seizures 911 was called.  The squad came within 5-8 minutes and transported him to hospital.  In subsequent phone contact with parents I found out that Dr. had said he did have a seizure and he was transported to another facility for further testing.
redness & swollen lt thigh; lump devel from site; no SOB or difficulty swallowing
This spontaneous report as received from a physician refers to a 16 year old female patient with allergy to penicillin. The patient did not have any pertinent medical history. The patient that had received the second dose of GARDASIL (dose and lot # were unknown) intramuscularly on an unspecified date a year ago in 2012. The patient was now being treated for chronic pain syndrome, migraines, weakness, joint pain and general malaise. Physician stated that the onset of adverse effects occurred approximately 8 months ago (in November 2012) on an unspecified date. The patient had a seizure on 18-JUL-2013. Physician believes this was an isolated case. The patient had "passed out" and then experienced the seizure. The physician started treating the patient in January 2013 on an unspecified day. The treatment included: Amitriptyline hydrochloride, FLEXERIL and MOTRIN. The outcome of events was reported as not recovered/not resolved. The patient sought unspecified medical attention. Upon internal review, seizure was considered to be medically significant event. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 72-year-old patient of unknown gender. In or about 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for the following injury resulted from zoster vaccine live (ZOSTAVAX) used: shingles. The outcome of herpes zoster was not reported. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
administered only diluent (DTaP-IPV) at first/diluent not mixed with powder/physician then instructed MA to give a complete Pentacel by mixing a powder with another Pentacel DTaP-IPV diluent/received extra DTaP-IPV with no reported adverse event; administered only diluent (DTaP-IPV) at first/diluent not mixed with powder/physician then instructed MA to give a complete Pentacel by mixing a powder with another Pentacel DTaP-IPV diluent/received extra DTaP-IPV with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old male patient who was administered only diluent (dtap-ipv) at first/diluent not mixed with powder/physician then instructed ma to give a complete pentacel by mixing a powder with another Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] dtap-ipv diluent/received extra dtap-ipv with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Aug-2023, the patient received a dose 4 with dosage 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ843AB, Expiry date: 24-Feb-2024 with unknown strength) via unknown route at unknown site as Immunization.  On 03-Aug-2023 the patient was administered only diluent (dtap-ipv) at first/diluent not mixed with powder/physician then instructed ma to give a complete pentacel by mixing a powder with another pentacel dtap-ipv diluent/received extra dtap-ipv with no reported adverse event (product preparation error) and (extra dose administered) same day following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  It was reported "the patient received extra DTaP-IPV. The record shows the injection site as the left thigh. It does not specify which dose or if both were given in the left thigh. No other vaccines were administered to the patient today."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for 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 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.
want to report a vaccine event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (want to report a vaccine event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (want to report a vaccine event). At the time of the report, VACCINATION COMPLICATION (want to report a vaccine event) 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 reported.
Pt became diaphoretic, looked dazed, confused, and about to faint within 10 seconds of vaccination at 1pm. Pt's BP was 110/50, pulse 50. After 10 mins, pt seem to recovered from his symptoms. Later stated that he's had these vasovagal symptoms in the past with other injections. Said he was ok with the previous flu vaccine and didn't think to mention it to vaccinator. Pt stayed until 1:30pm (30 mins after vaccination) and reported he was ok to drive home. Pharmacy f/u in 2 days on 5/12/21 @ 9;15, who stated he is doing well and recovered from all symptoms.
My period started 5 days after the second shot. I have not had a period for 8 months prior to that. I thought I was in menopause but I am not. They have continued monthly ever since. I called my doctor a couple of days later because a friend suggested me to do it. They said not to worry about it. I had another period in May 17 and I called the doctor again and they told me to get in to get that checked out. I went in and got an endometrial biopsy on 06/16/2021, which came back normal.
This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported) (lot # 671326/1522AA, exp date 21-APR-2014) which was stored in a refrigerator reading 36-46F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Follow-up information has been received from the nurse reporting that patient #4 was a 15 month old female who on 11-JUL-2012 was vaccinated with the dose of RECOMBIVAX HB. The reporter also noted that the patient would be re-vaccinated at her next visit. This is one of several reports received from the same source. No further information is available.
After completion of vaccines (11:15 am ), per client  she was "woozy".  Her skin became clammy, BP 70/48.  She stated that she had a couple moments that it was hard for her to hear and see. No respiratory distress. BP taken at 11:20 was 76/56, and then a few minutes later 92/66.  Client was given water, and remained sitting.  She sat for approximately 5 minutes, and then she said she felt better.
Information has been received from a consumer, for the Pregnancy Registry, for HPV rL1 6 11 16 18 VLP vaccine (yeast), concerning her 13 year old daughter (who is her patient) with no pertinent medical history and with an allergic reaction to nickel who on 24-SEP-20007 was vaccinated with her third dosa of HPV rL1 6 11 16 18 VLP vaccine (yeast), injection (lot # not reported). There was no concomitant medication. The patient's mother said that on 24-SEP-2007, about 10 minutes after getting the third dosa of HPV rL1 6 11 16 18 VLP vaccine (yeast), her daughter had gotten violently ill. She got sick about five times, real weak, dizzy for about an hour, and tired. It was reported that it took about three days for her daughter to recover, and she did not go to school. On an unspecified date a home pregnancy test was performed. On an unspecified date the patient went to the physician's office to get an ultrasound and an unspecified blood test done (values not provided) (method of confirmation not reported). The patient subsequently found out that she was pregnant (date unspecified) (last menstrual period 11 weeks and 3 days, 03-Aug-2007). Estimated delivery date is 09-May-2008. The physician was going to treat the consumer's daughter during her pregnancy. Patient Quality Complaints (PQC) was not involved. Additional information as been requested.This is in follow-up to report (s) previously submittedon 11/14/2007. Follow up information was received on 12-Jun-2008. It was reported by the nurse that the patient had an uncomplicated vaginal birth of a 39 week IGGA male (full term) on 09-May-2008, who was healthy and normal, and weighed 3092 grams. Follow up information was received on 07-Jul-2008 (previously reported as congenital anomaltion and/or complications or abnormalities reported. There were no concurrent medical conditions reported. Follow up information was received on 17-Aug-2008. It was reported by the physician that the female baby's length was 49 cm, the apgar core was 9/9, and the head circumference was 14 cm. The patient developed 39 5/7 weeks from her last menstrual period. The infant was normal. No further information is expected.
Patient reports pain at the injection site lasting from 01/12/21 at time of administration until the morning of 01/14/21. Patient reports heart palpitations during the evening of 01/13/21 and hives/rash that developed on 01/13/21 starting on the upper back and has now spread to abdomen and both armpits. Patient took Benadryl on 01/14/21 around 8pm and itching/sensitivity is lessened. Patient reports fatigue on 01/13/21. Patient reports headache on 01/12/21 which subsided with the use of acetaminophen. Patient states headache returned on 01/13/21 to a lesser degree and resolved on its own. Patient denies continued heart palpitations.
Information has been received from a registered nurse concerning a 10 year old female with a penicillin allergy who on 19-MAR-2007 was vaccinated IM with a 0.5 ml second dose of Gardasil (Lot# 654741/0013U). There was no concomitant medication. On 19-MAR-2007 the patient developed a rash all over her body, especially near the injection site. The nurse reported that the patient was given BENADRYL for the rash. The patient went to see her pediatrician who reportedly prescribed the patient with prednisone an ZYRTEC. It was also reported that the patient did not have a reaction to her first dose of Gardasil. At the tiem of the report, the patient was recovering. The nurse felt that the patient's rash was an other important medical event. Additional information has been requested.
Approximately 20 min after receiving an Influenza vaccination, patient feet itching and hives. No shortness of breath. She denied allergy to eggs to nurse administering vaccine. However, when seen in ER, told PA she is allergic to eggs. Medical Record received on 1/12/2005 states
Information has been received from a 27 year old female consumer with sulfa drug allergy and pertinent medical history reported as none who on 08 Jan 2007 was vaccainted with GARDASIL (lot # not reported) 0.5ml injection. Concomitant therapy included Montelukast sodium, ALLEGRA and birth control (unspecified). The consumer reported that on 08 Jan 2007, she had a grand mal seizure after receiving GARDASIL. Medical attention was sought. Unspecified blood test were performed. At the time of reporting, the outcome was unspecified. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for Pancytopenia due to antineoplastic chemotherapy within 6 weeks of receiving COVID vaccination.
Pfizer-BioNTech COVID-19 Vaccine EUA:  One day period on day 13 of menstrual cycle, including typical cramping
Patient with complaints of itching on right side of neck, slight redness noted at site, and with complaints of throat itching.  At 9:35am B/P 117/91, HR 78, R 20, O2 sat 99%. Patient was evaluated by EMT and this nurse. Patient was offered to be seen in the Emergency Room as paramedics would have been called, and patient refused.  At 9:40 am, patient was administered Benadryl 25 mg  by mouth with sips of water. At 10:06 am , after much rest and some fluids, patient stated she felt much better, itching had subsided. Patient was released to her mother for transport home.
2nd shot not administered at 42 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd shot not administered at 42 day mark) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd shot not administered at 42 day mark). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd shot not administered at 42 day mark) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within 10 minutes of vax, the child developed raised hives with erythemic area encompassing hives. Right cheek and right side of forehead.
48 hours after the COVID 19 Vaccine I experienced SOB, cough and sore throat (along with the expected low grade fever, body aches and fatigue).
Cardiomyopathy; myocarditis; congestive heart failure; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Pharmacy or Drug Store via an unspecified route of administration, in left arm on 22Mar2021, at 29 years of age (Batch/Lot Number: ER8727) as single dose, and the second dose via administered at Pharmacy or Drug Store via an unspecified route of administration, in left arm on 22Mar2021 (to be clarified), at 29 years of age (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included hypersensitivity to sulfa based antibiotics from an unknown date. The patient's concomitant medications were not reported. The patient didn't receive any other vaccine in the previous 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. On 20May2021 the patient experienced cardiomyopathy, myocarditis and congestive heart failure, all assessed as medically significant and requiring Emergency Room Visit, Physician office visit and hospitalization for 7 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test via Nasal swab in May2021, which was negative. Unspecified therapeutic measures were taken as a result of the reported events. At the time of the report the reported events had not resolved yet.
received the Polio vaccine less than 24 after the first Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Polio vaccine less than 24 after the first Moderna vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Polio vaccine less than 24 after the first Moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Polio vaccine less than 24 after the first Moderna vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported. No treatment reported.
The patient had a vaccine, ten days later, the mother noted red "specks" not raised, on the child's face, arm, and stomach. The child also had a fever of 100.6.
shivering; achiness; feeling flush; This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd November 2019, 1 days after receiving Shingrix, the patient experienced shivering, pain and flushing. On 5th November 2019, the outcome of the shivering, pain and flushing were recovered/resolved.   It was unknown if the reporter considered the shivering, pain and flushing to be related to Shingrix.  Additional details were provided as follows: The patient reported that he was in his 60's. Limited information was provided by the patient. The patient planned to continue follow-up with his physician and pharmacy. Did not consent to follow-up.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE HYPOXIA 7/27/2022 -- RECURRENCE OF SAME SYMPTOMS
4 months after the vaccination she got COVID; 4 months after the vaccination she got COVID; high RA/RA flares up; Swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "chemo" (unspecified if ongoing), notes: she has had chemo; "ADHD" (unspecified if ongoing); "hyper" (unspecified if ongoing), notes: hyper. Concomitant medication(s) included: ESCITALOPRAM taken for anxiety. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "4 months after the vaccination she got COVID"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "high RA/RA flares up"; SWELLING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: she hasn't gotten the results back yet. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19, rheumatoid arthritis, swelling.   Clinical course: Patient reported that 4 months after the vaccination she got COVID. She clarified the vaccination to Pfizer, it is good for 6 months. She clarified that she got the two shot dose, first shot then two weeks later the second shot. She clarified the vaccination to Pfizer COVID-19 vaccine. She stated she does not have the NDC/LOT/EXPIRY. She clarified that she does not have her vaccination card, she had it last year. She stated she is never getting a vaccination again she will just deal with that. She stated she does not know the count size, no strength just that it is Pfizer that (Name withheld) had. She stated she had no idea, just a shot in the shoulder. She stated it looked like it was, they opened up the needle thing and it looked clean. She clarified that everything was brand new.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient got a FLUZONE HD shot on 9/9/15. Patient came to pharmacy to inquire about reaction to shot site. Patient proceeded to primary care doctor. Antibiotics given for cellulitis.
lump on neck and clavicle; Swollen lymph nodes on left side, neck and clavicle; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump on neck and clavicle) and LYMPHADENOPATHY (Swollen lymph nodes on left side, neck and clavicle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stones since 2019. Concomitant products included VITAMIN D3, BIOTIN from 01-Jan-2021 to an unknown date and MULTIVITAMIN [VITAMINS NOS] from 15-Feb-2021 to an unknown date for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on left side, neck and clavicle). On an unknown date, the patient experienced NECK MASS (lump on neck and clavicle). At the time of the report, NECK MASS (lump on neck and clavicle) and LYMPHADENOPATHY (Swollen lymph nodes on left side, neck and clavicle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Ultrasound  was performed left side of neck . Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Updated patient demographics, medical history, vaccine facility.Updated event neck mass. concomitant medications updated
No adverse effect from vaccine.    Breakthrough COVID infection; started feeling ill 5/3/2022.  Antigen test positive result  5/6/22.
I had a dry cough that got worse and worse. I took an at-home COVID-19 on 05/16/2022, and it came back negative. As the days went by, I got a fever and my cough got worse; I developed a runny nose and sneeze as well. I went to the healthcare center at my school to take a COVID-19 test on 05/20/2022, and it came back on positive. They gave me Tylenol, ibuprofen, and antihistamines to take at my discretion if my symptoms worsened. I decided not to take anything and just let the virus run its course.