chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having pain in her ovaries; fever at 100.8°F; she is a little chilly; first dose on 20Dec2020/second dose on 09Jan2020; a little headache/got a headache again; This is a spontaneous report from a contactable Consumer (patient's husband). A 69-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced having pain in her ovaries on an unspecified date with outcome of not recovered, a little headache/got a headache again on 27Dec2020, fever at 100.8°F and she is a little chilly on an unspecified date, all with outcome of unknown.  The patient got the first dose of COVID-19 vaccine on 20Dec2020, and she was supposed to get the second dose on 09Jan2020. On the 7th day after the patient got the vaccine, she got a little headache and then two or three days ago, she got a headache again, and she is a little chilly. The patient had a mild fever of 100.8°F. The patient was also having pain in her ovaries and she still had that pain at this time. The patient rated the pain as varying from a 7 to a 5 to a 3 on a pain scale. Because of this ovarian pain, the patient may have another type of infection but they are not sure. The patient no longer had a period, she was after menopause. The reporter asked for recommendations on receiving the second dose if symptoms are still present, and if positive to a COVID-19 test. The patient would get tested at the hospital where they work.   Information on the lot/batch number has been requested.
I26.99 ACUTE PULMONARY EMBOLISM 1/15/2023 ACUTE PULMONARY EMBOLISM I95.9 HYPOTENSION 11/16/2022 ACUTE PULMONARY EMBOLISM R09.02 HYPOXIA 11/30/2022 ACUTE PULMONARY EMBOLISM
8 mo patient received 3 doses of Haemophilus b Vaccine before 12 mo of age; This literature marketed report as received from the authors of a published literature article, titled as stated below, and refers to an 8-month-old patient of unknown gender. The patient was 33-week premature baby. There was no information about the patient's concomitant therapies or medical history provided.  On unknown dates, the patient was vaccinated with 3 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) injection (dose, route of administration, vaccination site, lot# and expiration date were not provided) for prophylaxis. It was considered to be an off-label use.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Had been achy more; Cold; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had been achy more), NASOPHARYNGITIS (Cold) and CHILLS (Chills) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Had been achy more), NASOPHARYNGITIS (Cold) and CHILLS (Chills). At the time of the report, PAIN (Had been achy more) outcome was unknown and NASOPHARYNGITIS (Cold) and CHILLS (Chills) had resolved.            Patient had no known allergies. No concomitant drugs were taken.  The patient took vaccine and had chills and cold. As of 08-Apr-2022, patient had bone marrow test, results not provide and checked inflammation. Treatment details not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
gentleman who received Fluzone High dose Quadravalent today but was advised that he also received the same vaccine only four months ago with no reported adverse event; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 83 years old male patient who received fluzone high dose quadravalent today(18-Feb-2022) but was advised that he also received the same vaccine only four months ago with no reported adverse event while receiving vaccine Influenza Quadrival A-B  High-Dose HV Vaccine[Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster Vaccine RGE (CHO) (Shingrix) for Immunisation.  On 18-Feb-2022, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B  High-Dose HV Vaccine(formulation: unknown, Strength: standard) (lot UJ775AB & expiry date:30-Jun-2022) via intramuscular route in the left deltoid for immunization.Therapy (1st therapy  patient took in Oct-2021) (dose: unknown).  On 18-FEB-2022, the patient who received fluzone high dose quadravalent today(18-Feb-2022) but was advised that he also received the same vaccine only four months ago with no reported adverse event (inappropriate schedule of product administration)(latency: unknown) following the administration of Influenza Quadrival A-B  High-Dose HV Vaccine.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.   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.
Information has been received from a medical assistant referring to a 12 months old male patient. The patient had no concurrent condition and medical history. Concomitant therapy included sterile diluent. On 30-AUG-2018 the patient was vaccinated with doses of VARIVAX lot # R009411, expiration date 29-MAR-2020 (strength, dose, frequency and route were not provided) for vaccination. Other suspect therapies included PREVNAR lot # T94425, expiration date April 2020 (strength, dose, frequency and route were not provided) for vaccination. On 30-AUG-2018, the patient experienced respiratory symptom, vomiting and "wasn't breathing well". The events were considered to be life threatening. The patient was taken to the emergency room where he received EPIPEN (also reported as unknown treatment) and was released. The outcome of the events was reported as recovered (approximately in August 2018). The causality assessment was not provided. No product quality compliance (PQC) involved.
Patient was given standard dose of Moderna instead of booster dose.  After it was identified of the incident occurring, the individual was notified of the situation and received guidance on what to expect/look out for the next 48-72 hours.  Patient was given a contact at the clinic to reach out to if there were any additional questions/concerns or felt the need to be evaluated.
Information has been received from a registered nurse (R.N.), for GARDASIL, a Pregnancy Registry product, concerning a 25 years old female patient with asthma and allergy to penicillin who on 17-AUG-2010 was vaccinated with her first dose of GARDASIL (lot # unknown). There was no concomitant medication. The nurse reported that the patient was pregnant when she received GARDASIL. On 25-AUG-2010, the patient took a urine pregnancy test which was positive. Therapy with GARDASIL was discontinued (reported on 25-AUG-2010). Last menstrual period (LMP): 22-JUL-2010. Her estimated date of delivery (EDD) is 28-APR-2011. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow up information has been received via telephone call from the nurse practitioner, indicating that on 01-APR-2011 the patient delivered a normal healthy 4 pounds 15 ounces male with no congenital anomalies via vaginal delivery. It was reported that the baby was "small for dates" during pregnancy. Also it was stated that oligohydramnios was noted. The baby's experiences were captured in WAES#1008USA03850B1. No further information is available.
CLT'S MOTHER WHO IS THE CLT'S GUARDIAN REPORTED THAT SHE TOOK HER SON TO THE BARBER SHOP FOR A HAIR CUT ON 5/7/08 WHEN SHE NOTICED HE HAD "PIMPLE LIKE" SPOTS ON HIS HEAD APPROXIMATELY 1:00PM. SHE THEN CHECKED HIS NECK AND FOUND 2 MORE SIMILAR SPOTS THERE TOO. ON 5/9/08 CLT'S MOTHER REPORTED THAT THE "SPOTS" HAD SPREAD TO HIS BODY TO HIS CHEST, BACK AND ARMS. CLT'S MOTHER DESCRIBED "SPOTS" AS HAVING A "WHITE HEAD" ON SOME OF THEM. CLT'S MOTHER DENIES ANY FEVER WITH "SPOTS" AND THAT THE "SPOTS" DID ITCH AND SCABBED OVER.  CLT'S MOTHER REPORTED THAT THE SYMPTOMS LASTED APPROXIMATELY 5 DAYS AND THAT CLT IS NO LONGER ITCHING AND THE "SPOTS" ARE HEALING (ONLY PINKISH SPOTS LEFT ON SKIN).  CLT'S MOTHER REPORTS SHE WAS UNABLE TO TAKE CLT TO HIS PRIVATE PHYSICIAN BECAUSE SHE WAS GOING OUT OF TOWN.  CLT'S MOTHER RERPORTED THAT SHE PLACED CALAMINE LOTION ON "SPOTS" AND THAT CLT WAS ALREADY TAKING ORAL BENADRYL WITH MEDICATIONS HE TAKES ON A DAILY BASIS TO PREVENT SIDE EFFECTS OF THOSE MEDICATIONS. THE OFFICE OF DR. CALLED TO ORIGINALLY REPORT TO HEALTH DEPARTMENT ADVERSE REACTION THAT MOTHER HAD CALLED INTO THEM.
6JUL93 fever 102-n/v x 2 same day &JUL93; fever 104 gave APAP & cool baths & fluids;
Arm was swollen; vomiting; Sweats; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HYPERHIDROSIS (Sweats), HEADACHE (Headache) and PERIPHERAL SWELLING (Arm was swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A. and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VOMITING (vomiting), HYPERHIDROSIS (Sweats) and HEADACHE (Headache). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm was swollen). At the time of the report, VOMITING (vomiting), HYPERHIDROSIS (Sweats) and HEADACHE (Headache) outcome was unknown and PERIPHERAL SWELLING (Arm was swollen) had not resolved. Not Provided          No concomitant medications were provided. No treatment details were provided.
received Pediarix at 3 , 5 and 10 months of age, received additional Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received HBV (Engerix B) (batch number 97KT7, expiry date 15th March 2024) for prophylaxis.   Previously administered products included Hepatitis B vaccine (the patient had received one birth dose of hepatitis B vaccine (unknown brand)), Pediarix (1st dose of Pediarix received at 3 months of age), Pediarix (2nd dose of Pediarix received at 5 months of age) and Pediarix (3rd dose of Pediarix received at 10 months of age).   On 16th August 2022, the patient received Engerix B 10 µg. On 16th August 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter was medical assistant. The patient received an additional 10mcg dose of Engerix B. The reporter consented to follow up. Additional Supportive Information: The patient received an additional 10mcg dose of Engerix B, which led to extra dose administered.
Patient was administered with expired Daptacel / No Ae; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old male patient who was administered with 0.5 mL dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5523AA and expiry date 20-Sep-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 21-Sep-2020 (expired product administered)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  Case details: Nurse called to ask if there is a leeway for administered expired Daptacel to consumer. He was wondering if he should give consumer another dose.  It was an actual medication error case due to expired vaccine used (latency: same day).   At a time of reporting no adverse event reported.  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.
Pt experience vasovagal event following administration of meningococcal conjugate vaccine and varicella live virus vaccine.
No adverse event; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old female patient. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 14-NOV-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events or issues reported in the patient (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
This case was reported by a physician and described the occurrence of a viral syndrome in a 62 year old female patient who received hepatitis B vaccine recombinant Engerix B. The physician reported that the patient was basically healthy. On an unspecified date in Feb 2005, the patient received the first dose of Engerix B in her deltoid. Approximately one week following the 1st dose of Engerix B, on an unspecified date in Feb 2005, the patient experienced flu like aches and muscle soreness in the arm that the shot was given, the soreness extended to the back of the arm. The patient was seen at a physicians office and was diagnosed with viral syndrome. The events resolved three to four days following the onset of symptoms, on an unspecified date in Feb or March 2005. The reporting physician considered the events to not be related to vaccination with Engerix B and probably due to the viral syndrome.
got my 2 vaccine back in October and I have shingls/ suspected Vaccination failure; I have shingls; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with dermatologicals nos (Cream (Nos)) and antibiotics nos. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 2 vaccine and had shingles now at the time of reporting, but luckily very little and no pain, treated with cream and antibiotic and that was it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
Information has been received from the registered nurse. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 18-DEC-2012 had administered dose of GARDASIL (lot # 670048/0963AA expiration date 09-NOV-2013) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the report from the same source. Additional information is not expected.
This is a 33-year-old female who presents with complaints diffuse and not improving headache and myalgias x2 days after receiving Johnson & Johnson Covid vaccine on 9/7/2021.  Patient received injection in her left arm and states she has since experienced intermittent paresthesias beginning in her left fingers radiating across her shoulders and into her right upper extremity.  She also reports numbness of her bilateral legs when sitting that improves with positional changes as well as intermittent dizziness associated with positional changes, predominantly from sitting to standing.  Patient's headache is diffuse, moderate and characterized as aching in nature which remains unchanged with over-the-counter Tylenol.  There is associated nausea without vomiting which the patient is treating with Zofran without relief.  She is unable to take over-the-counter ibuprofen due to history of gastric sleeve.  There is no associated diarrhea, cough, congestion, fever/chills, shortness of breath or chest pain.  Headache not associated with photophobia, diplopia or other visual disturbances. She denies near syncopal or syncopal episodes.
THE REACTION STARTED OUT AS HIVES, WHERE THE 4 INJECTIONS WERE ADMINISTERED. ON 03/05/2010, PATIENT'S ARM NEAR HER SHOULDER BECAME VERY SWOLLEN, RED AND HOT TO THE TOUCH. SHE ALSO HAS A FEVER BUT IT IS WELL BELOW 105 DEGREES. TREATMENT GIVING HER BENADRYL FOR THE ARM AND MOTRIN FOR THE FEVER AND PAIN. THE BENADRYL APPEARS TO MAKE THE GIANT(HIVE?) BETTER AS LONG AS THE MED IS GIVEN. SHE MIGHT END UP IN THE EMERGENCY ROOM, DUE TO THE FACT THAT AS OF TODAY, THE REDNESS AND SWELLING APPEAR TO BE HEADING TOWARDS THE CHEST AREA. ALTHOUGH SHE IS STILL ACTIVE AFTER TAKING HER MEDICINE.
Chills, headache, fatigue, muscle soreness. Day three after inoculation developed herpes simplex blisters on lip
This spontaneous report as received from a physical therapist refers to 19 patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown dates, between 23-FEB-2017 and 12-APR-2017, the patients were vaccinated with improperly stored VARIVAX lot # M039318, expiry date 20-SEP-2018 (dose, route of administration and anatomical location were not reported). VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse events reported. No previous temperature excursion was performed. No data logger was involved. Additional information has been requested.
Patient was given KINRIX on accident. Patient was supposed to get DTaP and Hib instead.
Shortness of breath; cramps in legs; joint problems; Fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), MUSCLE SPASMS (cramps in legs), ARTHROPATHY (joint problems), FATIGUE (Fatigue) and MYALGIA (muscle pain) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 042L20A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM and ATORVASTATIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), MUSCLE SPASMS (cramps in legs), ARTHROPATHY (joint problems), FATIGUE (Fatigue) and MYALGIA (muscle pain). At the time of the report, DYSPNOEA (Shortness of breath), MUSCLE SPASMS (cramps in legs), ARTHROPATHY (joint problems), FATIGUE (Fatigue) and MYALGIA (muscle pain) had not resolved.            Additional concomitant medications included a blood thinner (not specified) and a potassium pill.  Patient initially reported that after the first dose of the vaccine, he experienced fatigue, muscle pain, joint "problems", cramps in legs and shortness of breath periodically which continued through the 2nd administration of the vaccine and were ongoing.  No treatment medication was reported.  On 06-Aug-2021, the patient denied having experienced any side effects from the use of the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Narrative updated per information in TCR.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23 were stored improperly and administe5red to an unspecified number of patients on unspecified dates. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected since we cannot contact physician.