chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is 68 years old with past medical history of diabetes, hyperlipidemia, hypertension, atrial fibrillation, obstructive sleep apnea, obesity who presented to a HCF on 3/10 for shortness of breath, nausea and fatigue.  On arrival to the hospital, patient was hypoxic requiring 2 L nasal cannula; other associated vital signs were temperature of 101.5 otherwise stable.  Lab work in the ED was relatively unremarkable except for AKI with a creatinine of 1.5 and COVID-positive nasal swab.  Patient was started on steroids and broad-spectrum antibiotics and admitted to the hospital for further management.  Patient was able to quickly be weaned off of oxygen after admission and only required 2 doses of Decadron and 2 doses of remdesivir before these were discontinued.  Patient was set to be discharged home on 3/11 before blood culture collected on admission was positive for MRSA.  Patient was started on vancomycin at this time.  CT abdomen that was collected on admission was concerning for osteomyelitis of the pelvis/sacrum so MRI was performed to better assess.  MRI was not consistent with acute or chronic osteomyelitis but did show a 8.2 cm fluid collection in the deep pelvis with abscess unable to be ruled out.  General surgery was consulted who performed aspiration of a more superficial fluid collection that had formed to be a tract from the larger fluid collection.  This fluid was nonpurulent and it was suspected to not be primary source for patient's bacteremia.  However, this fluid did end up growing MRSA and general surgery recommended transfer to higher level of care capable of interventional radiology drainage of the fluid collection.  Transfer to a local Hospital was initiated at this time.  While awaiting transfer, patient was continued on vancomycin with repeat cultures collected on 3/13 with no growth to date.  On 3/15, pharmacy notified hospital medicine team that the MIC of the vancomycin for this specific strain of MRSA would require toxic levels of vancomycin for appropriate treatment and it was switched to daptomycin at this time.  Ultimately, patient was hemodynamically stable and discharged to a local Hospital on 3/16 for IR drainage and ID evaluation.   *TEE was going to be performed at a HCF to rule out endocarditis (TTE was normal). However, when abdominal fluid grew MRSA, we had a source so the TEE was cancelled. I would defer to RMH team/ID on need for TEE prior to discharge. *     Discharge diagnosis   Sepsis Acute hypoxic respiratory failure, resolved COVID-pneumonia MRSA Bacteremia Staph Aureus Positive Intra-abdominal Fluid Collection Acute kidney injury, resolved Nausea and Vomiting, improved Protein calorie malnutrition Pulmonary hypertension Obstructive sleep apnea Atrial fibrillation History of hypertension Hyperlipidemia Mood disorder
1st dose of Shingrix on 04Jan2020 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The patient did not receive his 2nd Shingrix dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Information has been received from a health professional concerning a 22 year old female who on 30-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot number 655327/1287U).  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On 03-APR-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot number 655327/1287U) and experienced injection site pain.  The patient's injection site pain persisted.  Additional information has been requested.
8 Feb 2021 - blurry vision occurred 9 Feb 2021 - blurry vision and then double vision.  Double vision has been 24/7 since the evening of 9 Feb 2021
Information has been received from a registered nurse concerning a 13-year-old male with asthma that is under control with medications, and an allergy to Cefzil, who on 23-AUG-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Advair, Flonase and albuterol. On 09-AUG-2007, the patient had a negative titer level of 0.58 for chickenpox. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Five days after I got the second dose of the vaccine I got a Bladder infection. I noticed blood in my Urine and it was painful. I had not had a Bladder infection for many years with the exception of one right after the first dose of the vaccine. I also came down with Bronchitis the day after getting my first dose of the vaccine. I had also gotten a Bladder infection within the first week of the first dose of the vaccine. Before my vaccines I had not had a Bladder infection for about 25 years. Both infections were treated and resolved with antibiotics.
expired dose of ADACEL was inadvertently given with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the pharmacist via Agency (Reference number- 00743665) and transmitted to Sanofi on 27-Aug-2021.  This case involves a 28-year-old male patient who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given to the patient.  On 26-Aug-2021, the patient received a dose of 0.5 mL of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Total, lot C5655AA, expiry date-15-Aug-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported, "Pharmacist reporting that on 26-Aug-2021 an expired dose of ADACEL was inadvertently given to a patient, she wanted to know if the dose was valid and what should be done."  At the time of report, it was unknown whether the patient had any adverse event and the outcome was unknown for the reported event.  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.
Couldn't breathe later in the day after given injection. Had intense neurological pain that continued for over a month after injection, and neurological pain has now returned in February of 2022. Nurse believes I may have fibromyalgia. I will be going into the doctor for further testing.
Flu like symptoms; Back was hurting; Achy all over-my skin hurts; Fever, temperature of 101.3; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Medical history reported as COVID-19) in March 2020, Pneumonia (Medical history reported as Pneumonia) in March 2020 and Back injury (Patient stated thatshe had hurt her back and was on Medrol dose Pack which she finished it 2 days ago.). Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) for Back injury, MULTIVITAMINS [VITAMINS NOS], ZINC, VITAMIN D3, CURCUMIN, PIPERINE (NANO CURCUMIN), ASCORBIC ACID (VITAMIN C ACID), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), ALBUTEROL [SALBUTAMOL], GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back was hurting), PAIN (Achy all over-my skin hurts), PYREXIA (Fever, temperature of 101.3), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.3 101.3.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Can acyclovir or valcyclovir for shingles be administer during Covid 19 vaccinations; This is a spontaneous report received from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was asked if acyclovir or valaciclovir for shingles could be administered during COVID-19 vaccinations, patient had received (reported as rec'd) first dose and due second dose in 5 days. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Site is painful to touch; looks like cellulitis/possible cellulitis; body aches; swollen at injection site; red at injection site; warm at injection site; armpit lymph node still swollen; This is a spontaneous report from a contactable nurse (patient).  A female patient not pregnant of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in right arm on 05Feb2021 18:00 at single dose for COVID-19 immunization. Medical history included Allergies: sulfa. Other medical history: none. Concomitant medication in two weeks included trazodone, omeprazole and BCP.  The patient previously took oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced Allergies, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular 18Jan2021 12:00 PM in right arm for COVID-19 immunization.  Facility type vaccine: Workplace clinic. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. After second injection, right arm became red, warm and swollen at injection site 6 hrs later. After 12 hours, increased redness, warmth, swelling and total body aches. After 24 hours, same as above. After 42 hours, injection site right arm very red, swollen. looks like cellulitis. 72 hours later saw PCp for possible cellulitis vs site reaction. Site is painful to touch, very red, hot, swollen. armpit lymph node still swollen but only pink in color. Script for Keflex sent to pharmacy. Event treatment: cefalexin (KEFLEX) Po. All the events were not recovered. AE resulted in Doctor or other healthcare professional office/clinic visit.; Sender's Comments: The reported event of suspected cellulitis with injection site reactions was possibly related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from the patient's mother concerning to her daughter a 12 month old female patient. Concurrent conditions, medical history and allergies were not reported. On 12-DEC-2014, the patient was vaccinated with a dose of M-M-R II, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The reporter stated that she got a call from the Doctor's office stating that her daughter was vaccinated with improperly stored M-M-R II. The reporter stated that the office wanted to revaccinate her daughter, because the vaccine was not effective. The reporter wanted to know if that was necessary. No adverse effects reported. Additional information is not expected. The reporter did not consent to contact the physician.
faint; dizzy; funny taste in mouth; urine issues; diarrhea; upset stomach; feeling abnormal; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (one is patient self). This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced faint, dizzy, funny taste in mouth, urine issues, diarrhea, upset stomach, feeling abnormal. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044692 Same reporter/ vaccine/ AEs, different patient
MOTHER REFERS THE CHILD DEVELOPED INVOLUNTARY TREMORS IN FACE THE SAME DAY OF VACCINATION. WAS TAKEN TO THE HOSPITAL. **PATIENT HAD CONTINUED TO RECIEVE THE SAME VACCINES AND HAD NOT DEVELOPED ANY ADVERSE REACTIONS IN THE SUBSEQUENT VACCINATIONS.
The injected arm was red/The redness slowly faded away but it took a week to fully resolve; Swollen arm down to her elbow/The swelling slowly faded away but it took a week to fully resolve; Arm pain went down to her wrist/The pain lasted about 30 hours; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine (received Covid 19 vaccines on an unknown date), Covid 19 vaccine (received last booster dose in October 2021) and Zostavax (received in 2013). Concurrent medical conditions included asthma. Concomitant products included budesonide + formoterol fumarate (Symbicort).   On 9th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than 3 weeks after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovered/resolved.   The reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into left arm and experienced significant reaction to Shingrix. The injected arm was red and swollen down to her elbow and pain went down to her wrist.  The pain lasted about 30 hours. The swelling and redness slowly faded away but it took a week to fully resolve.  At the time of the report the patient said she was fine and all symptoms had resolved.  She did not know for sure if the injection was intramuscular. The patient had not (yet) reported this to her doctor. The patient did not have the lot number or expiration date of the shot because the pharmacy did not provide her with any paperwork. She had provided the pharmacy's contact information as they should have the route and lot and expiray date on file. The reporter consented to follow-up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 07Mar20230 to 12Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt fainted approx 5 minutes after administration of vaccine. I saw small amount of blood from PPD site. Observed approx 5 seconds of twitching movement. Recovered on his own with no memory of incident
1) numbness in hand at time of injection on 11-19-09, left hand 2) numbness and extreme pain in left hand continuous since 11-22-09 still being evaluated
pt began crying & screaming about 45 mins p/shot were given; pt could not be consoled & cried for 9 or 10 hrs; straight; pt was better 24 hrs p/vax administered;
Dose 1 Moderna 2/5/2021 016M2oA currently has covid 19
Hospitalized 10/30/2021; COVID-19 positive 10/26/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 10/30/2021 Discharge Date: 11/02/2021 Presenting Problem: COVID-19 DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: This patient is a 70 yo female with past medical history of heart transplant 3/21/19, chronic immunosuppression, hx neutropenia and CMV viremia, OSA on CPAP, hx TIA, right hip OA s/p arthroplasty Aug 2021 and prior gastric bypass who was diagnosed with COVID 19 on 10/26, received monoclonal antibodies but required admission on 10/30/21 for worsened symptoms.  She reported fatigue, cough and decreased appetite.  She did not have any difficulty keeping her transplant medications down. Upon presentation she was mildly hypoxemic and her chest x-ray appearances of normal.  There was some question of volume overload since her BNP was elevated at 7000. She was given a dose of Lasix, but a repeat chest x-ray was no better.  However echocardiogram showed small IVC.  Her abnormal chest x-ray was thought to be more related to COVID than volume overload. She was placed on 2 L supplemental oxygen and was monitored closely.  Her CellCept 250 mg twice daily was placed on hold due to her COVID infection.  Infectious Disease Service was consulted and they recommended Decadron if worsening oxygen requirements. She was able to wean off oxygen and did not have ambulatory desaturation when assessed by Pulmonary Rehab.    She had a slight trend down in WBC/ANC. This would be monitored as an outpatient and did not require Neupogen while hospitalized. She was eager to discharge home where she could support and be supported by her husband who has mild dementia. She has Tandem 365 as a steady resource and a home pulse oximeter. She agreed to return to the hospital if her symptoms worsened or if she had oxygen desaturation. She was sent home in stable condition on 11/2/21.
Subsequently 4 days post vax, the pt experienced a generalized rash. The pt contacted her primary care physician and reported that the assessment from the reporting physician was that "it looked like varicella." The primary care physician did not request that the pt come in for an evaluation. Additional information has been requested.
7 days after vaccine skin rashes on chest, stomach and back. 14 days after vaccination visit to Dr. She most rash as Pityriasis Roses. Prescribed 400 mg Acyclovir 3 x day for 7 days.
BAD BODY PAINS; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced bad body pains, chills, fever, and fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fever, and the outcome of bad body pains and fatigue was not reported. This report was non-serious.