chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report was received from a 23 year old female patient reporting on herself. The patient had no known pertinent medical history and drug reactions or allergies. On approximately 25-MAY-2016, while she was 3 weeks and 4 days pregnant, the patient was vaccinated with a dose of GARDASIL 9 injection (exact dose, anatomical location, dose number, lot # and expiration date were not provided). There were no concomitant medications provided. At the time of the report, the patient was 17 weeks and 4 days pregnant. Last menstrual period was on approximately 16-APR-2016, estimated date of conception was on 30-APR-2016 and estimated date of delivery (EDD) was on approximately 21-JAN-2017. The patient pregnancy outcome was pending. Fetal outcome was unknown. The outcome of exposure during pregnancy was unknown. The patient did not seek medical attention. Following laboratory diagnostic studies were performed: glucose monitoring, ultrasound, pap smear and unspecified test for pregnancy, however the results and details were not provided. Additional information has been requested.
Since abatement I've had transient episodes of bradycardia/palpitations; Since abatement I've had transient episodes of bradycardia/palpitations; Within the week following second injection, chest pain, usually when lying down (supine or prone); I've also experienced shortness of breath issues in approximately the same interval; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0185, Expiration date not reported), via an unspecified route of administration, administered in left arm on 22May2021 at 10:00 (at the age of 33-year-old) as single dose for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was reported as none. The patient known allergies were reported as none. There were no concomitant medications reported. The patient did not receive any other vaccines in four weeks and no other medications in two weeks. Patient historical vaccine includes first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0171) as via an unspecified route of administration in an unspecified anatomical location on 01May2021 (at the age of 33-year-old) as single dose for COVID-19 immunisation at Pharmacy or Drug Store. Patient reported that within the week following second injection, chest pain, usually when lying down (supine or prone). Since abatement had transient episodes of bradycardia/palpitations. He also experienced shortness of breath issues in approximately the same interval on an unspecified date in May2021. Patient had no covid prior vaccination and patient did not tested for covid post vaccination. Patient did not receive any treatment for the events. The outcome of the events was resolved with sequel in 2021.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Passed out 2/9/2021,  admitted 2/14/2021 nerves burning top of both legs to toes - morphine shot stopped pain - put on predisone packs ,  after finishing nerve pain returned and admitted to hospital on 3/27/2021 with introveinus steroids for 3 days and 9 days of steroid pills. Test run X-rays, mri, nerve test, mylogram test!  No nerve problem from back!  2and 1/2 months from 2/5 my big toe would not move !  Dr completely puzzled!
Client presented to the vaccination site on 09/22/2022. The client notified Lead nurse,  that he received his Covid vaccine on 09/13/2022 at Health Center and brought documentation of his previous Covid Vaccine administered so that it could be entered in Immunization Registry today. Per client?s documentation, client received a Janssen primary series Lot # 1821281 in another country on 06/22/2021. Client had previously presented to vaccination site on 09/13/2022 and had requested a Covid Vaccine. A medical consult was done by lead nurse because client did not have documentation of previous Covid vaccine. Per client, he received a Pfizer first dose around March 2021, no adverse reactions to primary series, NKA, and no medical conditions. Medical consult was sent to Dr. at 1159 via text message. At 1204 Dr.  approved via text message for a monovalent Pfizer second dose. At 1219 client received Pfizer monovalent second dose Lot# FP7138 on left arm. Client stayed in the observation area, reported no symptoms, and left the facility in a steady gait.  Lead nurse explained to the client that because he had no documentation on 09/13/2022 and per what client had previously stated, he received a Pfizer monovalent second dose, but because his documentation says Janssen he should have received a Pfizer Bivalent booster per CDC guidelines. Client understood of the medication error. Client was informed that he could come back in two months for a Pfizer Bivalent booster. At 1110 client left the facility in a steady gait.
Client who is an employee registered for 3rd dose of Moderna. Client went into the vaccine room to the Moderna table to receive her vaccine with her vac card that documented two previous Moderna Vaccines. The drawer in the room, LVN handed the vaccinator a Pfizer Vaccine. The vaccinator vaccinated client with Pfizer vaccine instead of the Moderna Vaccine. The client sustained no adverse reaction post vac. Unit supervisors and RN notified.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-DEC-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Headache, nausea, general soreness through out body, chills, migraine, difficulty breathing with non-productive cough (on day 2).   treated with Tylenol, IBU, and routine migraine medication, hydration.
Vaccine was given one day after the BUD.  It had been stored in the fridge for 31 days, and should have been pulled after 30 days in fridge.
feeling tired; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "feeling tired"; RHINORRHOEA (non-serious) with onset Sep2023, outcome "unknown", described as "runny nose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stomach did not feel well after 2nd dose; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach did not feel well after 2nd dose) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach did not feel well after 2nd dose) and PYREXIA (Fever). In 2021, ABDOMINAL DISCOMFORT (Stomach did not feel well after 2nd dose) and PYREXIA (Fever) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient reported after the 2nd dose, they had a fever, and their stomach did not feel well.   This case was linked to MOD-2021-390846 (Patient Link).
Second dose given 21 days after 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 21 days after 1st dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not known by caller) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 21 days after 1st dose). On 11-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 21 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Stomach pain, extreme diarrhea, nausea. Got so dehydrated they put me an IV fluid at doctor's urgent care walk-in on 6/11/2021. My kidneys were hurting. Ciprofloxacin 500 mg 10 days, 1 tablet by mouth twice a day. Could have been a stomach virus. I still don't feel back to 100%. I still feel a little queasy every now and then. She wanted a stool sample, but I was too dehydrated for that.
A little pain; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little pain) and FATIGUE (A little fatigue) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (A little pain) and FATIGUE (A little fatigue). At the time of the report, PAIN (A little pain) and FATIGUE (A little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-118867, US-MODERNATX, INC.-MOD-2021-117969 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-118867:Husband case US-MODERNATX, INC.-MOD-2021-117969:Son case
Pt had a 102.8 fever and had a headache, chills, weakness and fatigue
Rt humerous osteomyelitis, strep pneumococcus bacteremia.  3/22/07 Received medical records from PCP which were vax record, labs & d/c summary from hospital. 3/22/07 Received medical records from hospital which reveal patient experienced pain & decreased ROM of right shoulder.  Seen by PCP & referred to Ortho.  Seen in ER for MRI & labs & then d/c to home.  Returned to ER for repeat MRI on 2/7/07 & was admitted.  No fever.  Nasal congestion & rhinorrhea x 1 wk prior to admit.  PICC line placed for long term antibiotics at home & was to receive serial MRIs & ESRs.  Ortho performed a glenohumeral joint aspiration, c/s pending. FINAL DX: Osteomyelitis of right shoulder; joint effusion right shoulder; synovitis; & lymph node enlargement; & strep pneumoniae bacteremia.
Technician warned possibility of flu like symptoms, take tylenol, rest, no strenuous activity.  By early evening same day started continuous headache and neckache and malaise, took tylenol, through 11/8/20.  On 11/6/20 also noticed very painful soft area above right collarbone, seems to be receding.  11/8/20 developed itchy, red, hot, rough type patch approx 4" x 5" around injection site.  Pharmacist advised draw a line around it, apply antibiotic Baci.... in case staphy infection, cortisone for anti itch.  By 11/20/20 redness & heat receding, occasional itch, did not expand.
Pt had the first dose of the Moderna Covid 19 Vaccination in office on 5/17/2021 at 1:35 PM in the left deltoid. Pt has had a self reported history of analyphaxis to a tdap vaccine and a flu vaccine in the past, so pt was counseled before receiving the vaccine and there was epi on site if needed. Pt did not have any acute reaction in office, but called the office on 5/21/2021 to report that she had been seen at an Urgent Care Facility for a sore throat, that she reports Urgent Care linked to her having the vaccine 4 days prior. The sore throat lasted for 7 days per patient report. Also, after both the first dose of Moderna, given 5/17/2021, and the second dose, given at a on 6/17/2021 into the left deltoid (Lot:  022B21A), pt reports break outs of rosacea, which she has a history of prior to vaccination,. Pt states that her dermatologist thought that there might be a link between the covid vaccine and the rosacea flare. Pt was given metronidazole gel for treatment of rosacea.
Fatigue, chills and migraine beginning within 2 hours and lasting approximately 36 hours. Another round of fatigue about 5 days after injection. Soreness in arm, then hard swelling, then red round rashy spot with itching at 7 days after shot.  12 days later arm is still itchy.
I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy; I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy; I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy; This is a spontaneous report from a contactable consumer. A 52-years-old patient of an unspecified gender received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; lot number: EW0171), via an unspecified route of administration, administered in Arm Right on 15May2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included Chronic pain, bilateral mastectomy. Patient known allergies to nystatin. The patient's concomitant medications was post op Pain medication, essential oils. On 16May2021 14:00 the patient reported I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any treatment for event. The outcome of the events were recovered.    Follow-up attempts are needed. Further information is expected
Patient was hospitalized 8/4/2021 with hypoglycemia, altered mental status and acute renal failure. On 8/11/2021, patient was cleared for discharge to nursing home. Routine SARS-CoV-2 PCR screen for clearance / admission to nursing home came back positive. No signs/symptoms of COVID-19; rather an incidental finding.
A 6 month old patient was administered Quadracel instead of Pentacel, no AE; A 6 month old patient was administered Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00628649) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 6 months old female patient who was administered 0.5 ml third dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA, expiry date: 26-Aug-2022, Injection) via intramuscular route in the left thigh for prophylactic vaccination on 04-Jun-2021 (Product administered to patient of inappropriate age) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Wrong vaccine administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), HEPATITIS B VACCINE and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Wrong product administered (latency same day)  At the time of report, no adverse event was reported.  The caller said that a health care professional (HCP) accidently gave a 6 month patient Quadracel which is for patients with ages 4 to 6 years and asked if there were any concerns. She was supposed to get Pentacel as one of her immunizations but, Quadracel was given    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.
Kept getting fever on and off since the day she got the vaccines. Hospital emergency room and urgent care visits all in the same week. The highest temperature she got was exactly 103.8. The office then told me the vaccines were a "system error" almost a week later.
I was sitting watching tv in my chair, drinking soda, 4 hours after shot when I started getting nauseous and I had to go vomit. I ended up passing out. I came out of it within a minute later and my heart was racing like crazy. I sat there, drinking cold water, and I stayed up because I was nervous to go to bed. The next day I felt fine, but I did have the usual side effects-muscle spasms and headache. A week later my chest got very tight and I started getting pain in my chest and I thought it was the muscle spasms. The next Sunday on 06/20/ 2021 I went to the urgent care because I woke up and didn't feel right. They did EKG, chest x-ray and they took blood and they got me into a cardiologist. I went to him on the 06/22/2021 and they did another EKG and it was normal and he told me that I could keep exercising (works out 5x a week). Last Friday my chest tightness was so bad when I left the gym so I went to the ER and they did another EKG and blood work and they did a cat scan and everything was normal - also an x-ray. He thinks it's inflammation of the chest wall surrounding the heart but he did not tell me it was a side effect of vaccine. I've never had tightness in chest or issues with heart. It was really scary and I'm wearing a heart monitor and just returned it today. I do have a few more appointments coming up with my PCP and cardiology. I've been taking Advil 2-3 times a day, and I think it might be anxiety a little bit and it's messing with my head.
After initial dose, had subtle itching and hives which developed 2 weeks after dose and subsided .After 2nd dose, symptoms developed with in 48 hrs and required ER trip. Dx with reaction to vaccine and given Hydroxyzine 25 mg & Famotidine 20 mg on 09/09/2002, Saw pt 09/11/02, Hives persisting as well as swelling and pain in toes, fingers, Advised to defer further vaccine.
At approximately 4:30pm, we just had an incident with our 15 year old patient just got her booster shot. She passed out after around 5 minutes of receiving shot, her lips turned blue, having seizure like symptoms for 10 seconds as reported by my NP. She passed out for a second time. The Mother verbalized her daughter has a history of passing out after receiving shots. The NP evaluated the patient, vital signs were normal after first passing out episode. But not normal after the 2nd passing out episode.  The paramedics were called by my LVN . The Paramedics came, they evaluated the patient  and stated she was stable, all Vital signs normal. And stated it may have been related to anxiety from getting the shot.
pt recv vax & one to two days later pt was seen in ER w/a rash; No further into was provided;
28 weeks pregnant received FluLaval twice; Two doses of FluLaval given on the same day; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of overdose in a 35-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 7PN5D, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number 7PN5D, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received FluLaval Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On 31st October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device and not applicable after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the overdose and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   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: 02-NOV-2022 Reporter's Comment: The reporter reported that the patient was 28 weeks of pregnant and she received two doses of FluLaval Quadrivalent vaccines on the same day. The reporter asked for safety information and wanted to know how to proceed with this patient. The reporter did consent to follow up. Additional supportive information: The patient had received 2 dose of FluLaval Quadrivalent on the same day, which had led to overdose. The patient was 28 weeks pregnant at the time of receiving 2 doses of FluLaval Quadrivalent, Which led to the vaccine exposure during the pregnancy.
This is an 86 year old male with O2-dependent COPD (on 2 L NC), CHF, atrial fibrillation, obesity, CKD. We are consulted for COVID-19 infection. SNF resident. This is his third hospitalization in the past few weeks. He was recently admitted to hospital from 8/1-8/7 & also admitted then discharged from hospital 7/23 after prior admission for pneumonia & Coumadin toxicity. He presented to this ER on 8/10 with upper abdominal pain, as well as cough and possibly mild shortness of breath.  His daughter called EMS, who noted that the patient was hypoxic on patient's baseline 2 L nasal cannula.  No reported vomiting, diarrhea, fever, chills.
Arthralgia, fatigue, rash arms and legs, mild induration, tenderness left upper arm, Advil 3 times a day.