chrisvoncsefalvay/vaers-outcomes huggingface dataset:
there is a 28 year old pregnant female who received the Fluzone HD/No AE; there is a 28 year old pregnant female who received the Fluzone HD/No AE; there is a 28 year old pregnant female who received the Fluzone HD/No AE; there is a 28 year old pregnant female who received the Fluzone HD/No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from consumer/non-hcp.  This case involves 28 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date, while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was also the case of actual medication error due to inappropriate age at vaccine administration, product use in unapproved population and overdose.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.  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.  Information on the batch number was requested.  List of documents held by sender- none.
no patient experienced symptoms; improperly stored doses administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9.4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005639: US-009507513-2006USA005638: US-009507513-2006USA005637: US-009507513-2006USA005635: US-009507513-2006USA005636:
This spontaneous report as received from a health care professional refers to a patient of unknown age and gender who on 10-APR-2015 was vaccinated with improperly stored doses of ROTATEQ lt # K011663 (dose and route were not provided) which were exposed to temperatures outside of the recommended range during 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
FREEZING COLD FEELING; NO APPETITE; SHAKING; SWEATING; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 11:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced freezing cold feeling. On 06-APR-2021, the subject experienced no appetite. On 06-APR-2021, the subject experienced shaking. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from freezing cold feeling, no appetite, and shaking on APR-2021, and had not recovered from chills, injection site pain, and sweating. This report was non-serious.
Patient developed swollen area around injection site along with red streaks and was painful. Was prescribed antibiotic which cured infection.
Approx 1 hour after vaccination of 2nd vaccine, I began having vertigo until noon of that day.  headache persisted multiple days after vaccination.  Next day after vaccination I developed systemic edema, rash on legs below knees, migraine, generalized pain, malaise, fatigue.  also developed reddened warm area to injection site, dx as cellulitis.  Psoriasis areas flared, psoriatic arthritis areas increased in pain.  Seen primary care physician after symptoms did not cease on day 6 (Monday) after getting dose 2.  Said it was side effect from vaccine and prescribed prednisone taper, doxycycline, and lasix
administered an expired dose/Expiration date / May 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered Bexsero, which was expired on 31st May 2021. The reporter did not consent to follow up.
just a little ache in left arm when the patient raise it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 02Mar2021 (Lot number: EL9267) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "just a little ache in left arm when the patient raise it".  Additional Information: Age was reported as 80, (unit: unknown). The reporter/ patient experienced the event after each dose. After dose 2, event experienced 4 hours after the vaccination. The reporter/ patient was asking if she is to expect more side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tremors increased, Raynauds symptoms were triggered, pain in left foot and massive headache all happened within minutes.  Went home after 45 mins.  Temperature dropped to 95 degrees and it took 3 hrs & many layers of clothes to warm up.  Arm became very painful within a couple hours.  Hurt to move or use for 2 days.  2nd day the headache continued, as did the increased tremors.  Ran a 99.9 fever for a few hours, then temp dropped to 95 degrees in evening.  This has continued every evening since.  On the 3rd day a rash developed on the injection shoulder.
When filling out form patient stated date of birth which would qualify her for high dose flu shot as she is 65 years of age.  The flu shot was offered to her at a local community senior event held at  senior living in which pharmacy was present to provide flu vaccinations.  At the time of billing her vaccination, it was rejecting by patient's insurance due to incorrect birth date.  We contacted patient and she stated she gave incorrect year and she is only 64 years old and does not qualify her tor receive the high dose and just the standard flu vaccination. When patient was contacted around 3pm 10/25 she did not indicate any adverse side effects.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-JAN-2019, the patient was vaccinated with improperly stored VARIVAX (dose not reported, lot # N028711, expiration date 13-OCT-2019) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# R002208, expiration date 06-DEC-2019). No adverse effects reported. Digital Data Logger was involved. The vaccine experienced temperature excursion from 9 degrees Celsius to 25 degrees Celsius for 17 minutes. There were no previous temperature excursions.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: cj6739) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "a fib" (unspecified if ongoing). Concomitant medication(s) included: FLECAINIDE ACETATE, start date: 2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (12Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received paxlovid from 07Aug2023 to 12Aug2023.. Clinical courses: Other medication in 2weeks product=flecainide acetate. Covid 19 rebound (14Aug2023) 2 days after testing negative. No known allergies.
Unexpected death. Patient was asymptomatic except for skipping lunch. Took his usual afternoon nap but expired during sleep. Autopsy today did not reveal a cause.  01/07/2010. Autopsy received. DOD 1201/2009. Cause of Death: 1. Undetermined. Manner of Death: Undetermined. Additional Information Abstracted: I. [History of Febrile Seizures]: Cerebral Edema and Congestion. II. Pulmonary Edema and Congestion. II. Postmortem Toxicology Results: A. Blood: 1. Atropine = 870 NG/ML. B. Vitreous Humor: 1. Sodium = 137 MEQ/L. 2. Potassium = 17.8 MEQ/L. 3. Chloride = Creatinine = 0.8 MG/DL. 5. Urea Nitrogen = 7 MG/DL. 6. Glucose = <20 MG/DL.
11/28/01-Received shots. temperature 103 given Tylenol 0.4 ml Temperature went down Temperature up in 608 hours. Given Tylenol 0.4 ml.  11/30/01-1600- mom found babe in his bed, lying on his side-baby was "cold, white, dead, eyes fixed" Mom started CPR and called 911. Babe airlifted to hospital
Day 1: sore arm, body aches, fatigue, headache --- resolved in ~36 hours Day 11+: hives (painful, red, itching). rashes (splotchy, patches, linear). hives and rashes are all over body. occasional lump at bottom of throat. hot skin where rashes appear. elevated heart rate (approximately 98 BPM when resting).
FELT LIKE IT BRUISED HIS ESOPHAGUS; DOSE WAS STUCK IN THE ESOPHAGUS OR THROAT FOR ABOUT 1.5 HOURS; COULD NOT GET THE PILL TO GO DOWN; This spontaneous case (PVX2019-828) was received from a consumer on 08-Apr-2019. It describes a 50-year-old adult male consumer who "could not get the pill to go down", "dose was stuck in the esophagus or throat for about 1.5 hours", and "felt like it bruised his esophagus" while taking of Vivotif for an unknown indication.   Case report: The consumer reported that he had a little bit of trouble when he took his first dose of Vivotif on 06-Apr-2019. He could not get the pill to go down and it was stuck in his esophagus or throat for about 1.5 hours, he had to eat and drink warm water, to help it go down. He felt like it bruised his esophagus. However, on 07-Apr-2019 he was fine.  Action taken with Vivotif with the event "felt like it bruised his esophagus" was unknown while with respect to the events "could not get the pill to go down" and "dose was stuck in the esophagus or throat for about 1.5 hours" was not applicable.  The clinical outcome of the events "felt like it bruised his esophagus", "dose was stuck in the esophagus or throat for about 1.5 hours", and "could not get the pill to go down" was resolved.  Company's Comment: In this case, it was reported that the male consumer "could not get the pill to go down", "dose was stuck in the esophagus or throat for about 1.5 hours", and "felt like it bruised his esophagus" following intake of first dose of vivotif. The events appear to be incidental finding and hence, the causality of the events is not related with Vivotif vaccine. ; Sender's Comments: Company's Comment: In this case, it was reported that the male consumer "could not get the pill to go down", "dose was stuck in the esophagus or throat for about 1.5 hours", and "felt like it bruised his esophagus" following intake of first dose of vivotif. The events appear to be incidental finding and hence, the causality of  the events is not related with Vivotif vaccine.
He was a perfectly healthy baby before these vaccines, within 6 hours he had a horribly swollen thigh, high fever and his first ever seizure. Once this vaccinations he no longer sleeps at night- he whines and rolls around and wakes up screaming bloody murder every hour on the hour. He has multiple seizures a week and no doctor can figure out what is going on or why, but NO one will even talk to me about it being from these injections. This cannot be a coincidence. He is losing weight and is not the same baby as he was before.
Pt. states that after receiving the 3rd Booster of Moderna 10/26/2021, started experiencing symptoms 10/27/2021 of muscle pain and joint pain throughout both arms and shoulder areas. Primary visit 11/19/2021 (Blood Work- Normal) recommendation for Follow-Up with Naproxen and Tramadol. Still experiencing symptoms.
Information has been received from a pharmacist concerning a child who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a chickenpox-like rash after vaccination. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Patient had the J and J vaccine offered at her college in 2020 and had no reaction to that vaccine. In Jan 2021 she had to get a booster even though there wasn?t one for J&J and J&J was pulled from market. Had to be boosted with Moderna  Jan 2021 in order to return to college. Difficulty breathing, within 15 minutes of injection,  irregular border hives all over trunk of body at 45 minutes which continued over the next couple hours. Pharmacy staff had no idea how to address adverse reaction, Just said it was rare and go to ER.  Pt only had the Moderna vaccine that day, even though pharmacy staff tried to push her to get flu shot as well. Our allergist was across the street and able to see Pt within 1.5 hours of reaction. Diagnosis of real allergic reaction to the Moderna vaccine. Due to this reaction our allergist stated it is not recommended for Pt to get any other mRNA boosters. Benedryl and albuterol inhaler administered. Was fine by the next day.
Patient received the vaccine and became hot, dizzy, and had a headache. The nurse attended and took the patients vitals and glucose. EMS arrived at 11:40 am and checked vital signs and 12 lead EKG. Patient became more alert as nurse was asking questions.  EMS and On-site nurse suggested to transport to hospital but patient refused.
respiratory reaction; throat started to tighten; I started coughing a lot; I couldn't catch my breath; I had tingling in my fingers; difficulty swallowing; itching; waves of nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown and expiration date not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received her first dose of the COVID vaccine to her left arm and on Monday around 2:30 in the parking lot by the hospital. She pulled up to the waiting section where they instruct you to wait for a bit to make sure you did not have a reaction. On an unspecified date, her throat started to tighten, she started coughing a lot, could not catch her breath, they gave Benadryl to patient. They checked her pulse and her oxygen, and they said she was getting enough Oxygen, so the patient did not need an epi pen. On an unspecified date, the patient had tingling in her fingers and difficulty swallowing and itching with waves of nausea. The patient was concerned about taking the second shot and asked that should she get the second shot after having a respiratory reaction to the first dose. The patient received treatment for throat started to tighten, she started coughing a lot and I could not catch my breath. The outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
pt recvd DTP/HIB @ clinic; later that morning devel a rash; seen by MD & had erythema multiforme; no involvement of mouth & eyes; tx w/DPH & resolved over 4 days;
Pain in left deltoid began immediately after receiving the second dose. The pain was similar to that experienced after the first dose. However, the pain continues to this day. Symptoms include: pain in shoulder without pressure applied, occasional pain in left arm that shoots down from shoulder, pain when pressing on shoulder (ie: when leaning on a door or wall).
I thought I was having an allergy attack. I was having tightness in my chest and runny nose in addition one evening. The next day, I had a steep cough and felt totally wiped out; I spent most of the day sleeping. I still felt pretty fatigue for the next couple of days. I decided to take a COVID-19 test on 02/19/2023, and it turned positive immediately. I called my doctor the next morning and was given PAXLOVID for treatment. Since then, I'm feeling better and back to normal activities; I haven't really had any residual symptoms other than fatigue sometimes.
allergic reaction; throat started swelling up; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction and throat swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction and throat swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction and throat swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient mentioned that 6 years prior to the date of report, had a flu vaccine and had an allergic reaction and throat started swelling up. The patient immediately took 2 Benadryl and used her rescue inhaler. The reaction lasted approximately 30 minutes. The patient thought it was from the egg protein in the flu vaccine. The patient did not consent to follow up.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "cardiac infusion" (unspecified if ongoing); "fluid on heart" (unspecified if ongoing); "had difficulty breathing" (unspecified if ongoing); "paralyzed vocal cords" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 04Jan2021, for COVID-19 immunisation, reaction(s): "tested positive 08Jan".The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Feb2021, outcome "unknown", described as "Said after vaccine, her mom was so much better like night and day"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Feb2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MISSED THE FOURTH DOSE; A spontaneous case report was received from a caregiver on 14-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000497 (PVX2019-1546; mother) and PVX201906-000498 (PVX2019-1547, eldest daughter) PVX201906-000499 (PVX2019-1548; son) and PVX201906-000500 (PVX2019-1549; youngest daughter) were created and cross-linked in the database.  This case describes a 9-year-old child female consumer who "missed the fourth dose", while being on Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 07-Jun-2019 and missed her fourth dose which was due on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000497:
Rash and face was swollen and covered entire body. Went to ER and was given SC Epinephrine and Oral Benadryl and Prednisolone.
Extremely sore arm that received injection and body aches within 1st hour. By noon on day after, slight fever 99°, very tired, chilled and continuing body aches.
Pt vacc. w/ DTP/HIB TITER/OPV; crankiness; irritability; painful rt thigh - red, hot; fever 103-105 (for several days); uncontrollable crying >6 hrs; would not eat for 2 days.
onset of fatigue which progressed to joint pains throughout body, SOB, hypoxia with oxygen sats 84% - 88% at rest and minimal walking from one room to next in home.