chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained the next day after her shot she had Charlie horse symptoms. could not get out of bed. Patient tried taking tylenol , but did not help. Has no fever or any other adverse effects.  Patient was advised to check with her doctor if symptoms don't improve.
Moderna COVID-19 Vaccine EUA Night of shot arm began to hurt. It became very painful by the time I went to bed. 10x worse than a flu shot Next morning at 8am, got up and almost passed out. Went back to bed. Got up at 10. Arm was painful to move.  Began fever at 12 noon.  Highest was 102. Terrible chills and aches and pains throughout entire body... lasted through bedtime. Tylenol did not  manage the symptoms. Day 3 I was much better. I did experience fatigue, but arm pain was wearing off quickly.
The patient received his vaccination on 1/13/2022 at 4pm.  During the early morning of 1/14/2022 he developed severe muscle pain especially in the bilateral costovertebral angles, fever, and severe headache.  Upon arising later that morning  he had dysuria and gross hematuria without clots along with the aforementioned symptoms.  Seen in the emergency department at Medical Center on January 14th.  Noted to have acute kidney injury with creatinine of 1.1 mg/dl, gross hematuria, normal C3 & C4, normal CBC including normal platelet count. Normal INR and APTT.  Urine grossly reddish brown in appearance with >100 RBC/HPF.  Urine protein/creatinine ratio is 0.882.   BP was134/72 mmHg.  Urine culture was sterile from that day.   Re-evaluated on 1/17/2022.  BP was within normal range for age at 110/78 mmHg.  Clinically free of edema.  Still with backpain that is remarkably tender and dysuria.  Compliant of severe headache.   His laboratory studies show a creatinine of 1.2 mg/dl.  Urinalysis with RBC and coarse granular casts.   Urine protein/creatinine ratio improved to 0.352
COLD SWEAT; ADMINISTRATION OF EXPIRED VACCINE; COLD ARM; LOT OF PAIN IN THE ARM WHERE SHE GOT THE VACCINE/ PAIN FROM SHOULDER TO ELBOW; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient experienced cold sweat. On 07-OCT-2021, the patient experienced administration of expired vaccine. On 07-OCT-2021, the patient experienced cold arm. On 07-OCT-2021, the patient experienced lot of pain in the arm where she got the vaccine/ pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweat, cold arm, and lot of pain in the arm where she got the vaccine/ pain from shoulder to elbow, and the outcome of administration of expired vaccine was not reported. This report was non-serious.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # M030598 with expiration date 13-OCT-2017, dose and route were not reported). The vaccine had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Nurse said that 23 patients received shots. Doses administered on 21 Feb 2022, after 30-day Use By Date with Beyond use date (BUD) of 16 Jan 2022. The vial was initially stored in the refrigerator on 17 Dec 2021. Not undergone temperature excursions.  Treatment information was not provided.
A four week old patient received Daptacel no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via a consumer/non-health care professional via Medical Information (MI) (Reference number- 00878868) and transmitted to Sanofi on 30-Nov-2021.  This case involves a 4 week old male patient who was received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 08-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot UJ585AAA, expiry not reported) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported "A four week old patient received Daptacel and not Adacel, Ipol, and ActHIB and she would like to know how to proceed with the patient. She states that e-mail is fine."  No other adverse event was 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 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.
Rib Pain; tenderness of muscle under injected arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Rib Pain) and AXILLARY PAIN (tenderness of muscle under injected arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L201A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib Pain) and AXILLARY PAIN (tenderness of muscle under injected arm). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Rib Pain) and AXILLARY PAIN (tenderness of muscle under injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician referring to a male patient of unknown age (elder than 40 years old). In 2015 the patient was vaccinated with ZOSTAVAX (lot#, dose, dose# and route unknown). The patient experienced hives all over body shortly after administration (in 2015). That could not be supervised without long term prednisone. Testing ruled out other causes, including cancer. Allergic testing identified that was definitely an allergic response, included by strong immune globulin (IG) g response. The patient was currently on medication for allergic reaction under the care of allergist (post approximately 1 year). The patient's medical history included that the patient received multiple immunizations without similar response. In high strep environment prior to administration of ZOSTAVAX at work. The outcome of the vent was reported as not recovered/not resolved. Additional information has been requested.
pt became pale w/in minutes of vax & collapsed-responsive to physical stimulation p/10 seconds; listless & c/o h/a; pulse 80;
This report describes joint pain in a 31 year old female who was vaccinated with Lyme disease vaccine recombinant for prophylaxis. This report was received from the subject and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions and concurrent medications were not provided. On 6/9/99, she reportedly received her second injection of LYMErix. The subject stated that, later that day, she began to experience "extreme" joint pain. She reported that she was seen by a physician. The subject stated that the joint pain persisted as of 11/11/02, but had "improved." The LYMErix immunization series was discontinued.
Light headed, extreme foggyness, confusion, body aches, chills, headaches, extreme fatigue, feeling of being drugged, extreme lower body & back pain, nausea, confusion, loss of appetite, low energy, stomach pain, feeling extremely sick all over
Narrative: Patient received second Moderna vaccine approximately October 2021 and had blisters and hives on both forearms for three months. The patient was treated with diphenhydramine.
she was inadvertently administered Engerix-B instead of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 59-year-old female patient who received HBV (Engerix B) (batch number AX225, expiry date 07-DEC-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 31-MAR-2023, the patient received Engerix B. On 31-MAR-2023, an unknown time after receiving Engerix B, the patient experienced wrong vaccine administered (Verbatim: she was inadvertently administered Engerix-B instead of Twinrix).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 1-Sept-2023 Pharmacist reported that the patient received a dose of Twinrix and when she came back for second dose, she was inadvertently administered Engerix-B instead of Twinrix.   The error was not discovered until the patient came back on one day before the reporting date (31st August 2023) for her next dose.   On 31st August 2023, the pharmacy did not administer anything to the patient.   At the time of reporting, no additional doses had been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient inadvertently administered Engerix-B instead of Twinrix as second dose, which led to wrong vaccine administered.
Fever, chills, nausea, muscle aches, disorientation, dizziness
After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (unspecified drug) and Factor V Leiden mutation.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On 29-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Company comment: This is a spontaneous case concerning a 33-year-old female  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately two weeks after the fourth dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Paxlovid was prescribed for treatment; after taking it and finishing 5-days course patient tested positive one week later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitant medications were reported. The patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment medication given to the patient for recurrent COVID-19.; Sender's Comments: Company comment: This is a spontaneous case concerning a 33-year-old female  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately two weeks after the fourth dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Paxlovid was prescribed for treatment; after taking it and finishing 5-days course patient tested positive one week later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left 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's relevant medical history included: "ADHD" (unspecified if ongoing); "ASD" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid, lot number: GA1529 given on 13Jun2022 for the treatment of COVID-19.  Clinical course: No known allergies. Within 2 days patient already 95 percentage improved. Only side effect was extremely bad taste in patient's mouth after taking Paxlovid.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information had been received on 19-OCT-2016 from a nurse who reported that a 10 year old female received four doses of "HPV vaccine". The first two doses of "HPV vaccine" were administered in another country on 13-APR-2015 and 13-OCT-2015 and the nurse was uncertain which HPV vaccine the patient received. The nurse assumed that the HPV vaccine the patient received was GARDASIL and she did not have access to the lot numbers and expiration dates of those doses administered on 13-APR-2015 and 13-OCT-2015. The patient then received the following doses on the following dates: GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017) on 12-AUG-2016 and GARDASIL 9 (lot# M011117, expiration date 07-DEC-2017) on 13-OCT-2016. The patient had not experienced any adverse effects. No additional information was provided. Additional information has been requested.
Nausea; pretty severe dizziness; confusion; fever; muscle aches; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (Nausea), MYALGIA (muscle aches), DIZZINESS (pretty severe dizziness), CONFUSIONAL STATE (confusion) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (muscle aches). On 24-Feb-2021, the patient experienced NAUSEA (Nausea), DIZZINESS (pretty severe dizziness) and PYREXIA (fever). On an unknown date, the patient experienced CONFUSIONAL STATE (confusion). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form and SCOPOLAMINE [HYOSCINE] for Adverse event, at a dose of UNK dosage form. At the time of the report, NAUSEA (Nausea), MYALGIA (muscle aches), DIZZINESS (pretty severe dizziness), CONFUSIONAL STATE (confusion) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-030149, MOD-2021-030149 (Patient Link).
pt recvd vax & 6 days later exp optic neuritis; No further details are available;
Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EN6207), in right arm and on 04Aug2021 as dose 2, single (Lot number: EW0198) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Flu like symptoms and diarrhea started beginning of dec. December 26 hospitalized for weakness in arms and legs, unable to walk, 12/29 diagnosed with gbs.
She tested positive for Covid 19; This is a Marketing Program spontaneous report (Stimulated Report) from a contactable consumer (Patient) and via Pfizer sponsored program (CEP ID: 159558). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 01Mar2021 the next day after the vaccination the patient had Tested positive for Covid-19 as she was exposed to someone with Covid 19. Patient enquired about that she could take the second dose of vaccine on time that at the 3 weeks. The reporter stated the events as non-serious. The outcome of the event was unknown.  Follow up (04Mar2021): This is a follow up spontaneous report from a Pfizer sponsored program. Information about Lot/batch number has been requested.
Hepatitis infectious mononucleosis; tired; Sore Left Injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, IBUPROFEN for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Injection site arm). On 06-May-2021, the patient experienced FATIGUE (tired). On 17-May-2021, the patient experienced HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN ongoing since an unknown date at an unspecified dose and frequency and AMOXICILLIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis), VACCINATION SITE PAIN (Sore Left Injection site arm) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Alanine aminotransferase: 620 (Inconclusive) 620. On 12-May-2021, Aspartate aminotransferase: 540 (Inconclusive) 540. On 14-May-2021, Alanine aminotransferase: 650 (Inconclusive) 650. On 14-May-2021, Aspartate aminotransferase: 330 (Inconclusive) 330.         Blood work was drawn on 19-May-2021; results unknown/ not reported.  Treatment: Patient received Azithromycin on 12-May-2021 but was not able to tolerate because of vomiting so he was switched to Amoxicillin which was stopped on 19-May-2021.  The patient had been taking levocetirizine for allergies since early spring 2021. 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.; 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.
antibiotic resistance/second hospital said they had one other case before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: PATHOGEN RESISTANCE (medically significant), outcome "unknown", described as "antibiotic resistance/second hospital said they had one other case before". Clinical course: Patient had antibiotic resistance. The doctor's were all stumped with no idea what to do.The second hospital said they had one other case before. Reporter did not want to provide contact details because of the government. And she just wanted to get to Medical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;