chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Breast cancer; Deviation from dosing schedule; This spontaneous case was reported by a nurse and describes the occurrence of BREAST CANCER (Breast cancer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included CELECOXIB (CELEBREX), PROPRANOLOL HYDROCHLORIDE (INDERAL), TIZANIDINE HYDROCHLORIDE (ZANAFLEX), BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), ACETYLSALICYLIC ACID (ASPRIN) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule). At the time of the report, BREAST CANCER (Breast cancer) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule) had resolved.        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.   Treatment medication not mentioned, but mentions she is undergoing treatment for breast cancer.  Patient diagnosed with breast cancer and this has led to delaying her second dose. Has not gotten it as of reporting time and the patient is questioning if it is too late to receive the second dose.  Company comment The patient was diagnosed with breast cancer after first dose of mRNA-1273 and very limited information regarding the event has been provided at this time. The patient also experienced Inappropriate schedule of vaccine administration for mRNA-1273, batch no. 038C21A. No further information is expected.; Sender's Comments: The patient was diagnosed with breast cancer after first dose of mRNA-1273 and very limited information regarding the event has been provided at this time. The patient also experienced Inappropriate schedule of vaccine administration for mRNA-1273, batch no. 038C21A. No further information is expected.
pt recvd vax & had blotchy area on L inner thigh the day after inject; taken to hlth dept 2 days after inject; seen by md; pt had mild local erythema w/ urticarial areas x 3-4. rt benadryl; was cleared completely 4 days after inject;
Feeling dizzy; Feeling some weakness; Occasionally short of breath; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included colon cancer in 2015 (treatment successful). The patient did not have any allergies to food, medications, or other products. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 23:00, the patient was feeling dizzy, feeling some weakness and occasionally short of breath. The first night the patient started feeling dizzy when laid down to go to sleep and felt dizzy all night, whenever the head was moved. This feeling has not gone away at night. The patient also felt it off and on during the day. Also, the patient has been felt some weakness, and occasionally short of breath. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events feeling dizzy, feeling some weakness and occasionally short of breath was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
Took four shots of the Pfizer Covid shots/had Covid; Took four shots of the Pfizer Covid shots/had Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Covid" (unspecified if ongoing), notes: She had Covid before about a year ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Took four shots of the Pfizer Covid shots/had Covid". The event "took four shots of the pfizer covid shots/had covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positve, notes: She got Covid; Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300252691 same patient, different product/event;
Breakthrough COVID-19 Case: It was an intense sore throat and a cough. I had one day of a runny nose or nasal congestion. Cough I still have and fatigue. I was prescribed Paxlovid.
patient received the Pfizer bivalent at dr visit. Patient has not received the first two shots. Patient has been informed and verbalized understanding.
This spontaneous report as received from a physician refers to a patient of unspecified demographics. On 21-APR-2014, the patient received an expired dose of ROTATEQ suspension Strength 2, dose 2 ml, oral (lot number H020559, expiry date 17-APR-2014). Concomitant therapy was unspecified. No adverse effect reported. No product quality complaint was involved. The outcome of the patient received an expired dose of ROTATEQ was unknown. No further information was provided. Additional information has been requested.
Fever 100.8, chills, minor congestions, body aches, inoculation site swelling began approximately 24 hours after booster.
Pt received Anthrax #3 on 5/8/00. Pt now has large circular lesion extending below elbow. Lesion erythematous with very dark red bulls eye (1
Chills; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Slight headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (Slight headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, CHILLS (Chills) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 98 (Inconclusive) t°98 something.         Concomitant medication not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Localized vaccine reaction with pain, moderate swelling and erythema. Symptoms x2 weeks, then exacerbated by injury to vaccinated arm. Subsequent worsening pain, swelling, and pruritis. New moderate axillary pain and swelling.
pt recv vax 14JUL98 & 19JUL98 pt devel a rash;rash is red, blotchy, itchy, confluent, w/little vesicles;
pt recvd vax & 20 minutes post inject dose 2 devel h/a & nausea; sx were treated w/APAP & resolved w/in 24 hrs of onset;
Pt recv vax on 12/14/98; on 12/16/98 pt exp LA redness, swelling, sore x 1 wk; tx=ice pack
HEART BEATS STRONGLY; MINOR MUSCLE ACHE; SHAKING WITH CHILLS; NAGGING HEADACHE; FOGGY FEELING; EAR PROBLEM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number :unknown) dose was not reported, administered on 07-APR-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced ear problem. On 07-APR-2021, treatment medications included: paracetamol. On 07-APR-2021 17:30, the subject experienced foggy feeling. On 07-APR-2021 17:30, the subject experienced nagging headache. On 07-APR-2021 20:15, the subject experienced shaking with chills. On 08-APR-2021, the subject experienced minor muscle ache. Laboratory data included: Heart rate (NR: not provided) 125-130 bpm. On 08-APR-2021 00:15, the subject experienced heart beats strongly. Laboratory data included: Heart rate (NR: not provided) 152 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beats strongly, foggy feeling, and shaking with chills on APR-2021, and had not recovered from nagging headache, minor muscle ache, and ear problem. This report was non-serious. This case, from the same reporter is linked to 20210420580 and 20210420637.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
A report has been received from a health professional concerning a 6 year old female patient. No concomitant drugs or relevant history was provided. The patient had been receiving FLUMIST Quadrivalent on 20-OCT-2014. The patient experienced hives on face, neck, back and stomach after receiving FLUMIST Quadrivalent and stomach ache which started on 20-OCT-2014. Patient was treated with oral BENADRYL 25mg. Patient pulse was 92. Action taken with FLUMIST was unknown. The patient recovered from the event of hives on face, neck, back and stomach after receiving FLUMIST Quadrivalent and stomach ache on 20-OCT-2014. The report was considered to be non-serious by the reporter. Summary of follow-up information received on 07-NOV-2014 from health professional: Events outcome changed to recovered and events stop date added. Narrative updated. Lab data added.
Information has been received from a female with many allergies and no pertinent medical history who in 1997 was vaccinated with doses of Recombivax HB. Concomitant therapy included allergy medications. In 1997, "soon after receiving the therapy", the patient experienced a cronic systemic yeast infection, with symptoms similar to lupus. Autoimmune test were performed. Unspecified medical attention was sought. The outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Patient called to report extreme pain lasting 7 days at site of tetanus, diphtheria injection. Some swelling locally. Pain radiates down to elbow and up into neck. Denies temperature elevation. Chills, aches, nausea/vomiting, rash, SOB.
I was coughing a lot; I went to my primary care physician who referred me to a pulmonary physician. My pulmonary physician took x-rays, she said my lungs looked like I had broken glass in my lungs. She diagnosed me with eosinophilic pneumonia, I was prescribed an inhaler to help me breath and prednisone. I get better, I get worse.
This spontaneous report was received from a pharmacist refers to a 62 year old female patient. No medical history and drug allergies were reported. On an unknown date in April 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported), 0.65 ml, intramuscularly. No concomitant medications were reported. On an unknown date in 2013, the patient experienced rash after receiving the ZOSTAVAX. No medical attention sought by patient. The Pharmacist stated that the rash was not shingles and the patient received no treatment for the rash, and that it resolved in a few days. Varicella zoster virus (VZV) packet declined. Additional information has been requested.
SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT; BLOOD AFTER INJECTIONS; Shoulder discomfort; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT BEARING DIFFICULTY (SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT), VACCINATION SITE HAEMORRHAGE (BLOOD AFTER INJECTIONS) and MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort). On an unknown date, the patient experienced WEIGHT BEARING DIFFICULTY (SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT) and VACCINATION SITE HAEMORRHAGE (BLOOD AFTER INJECTIONS). In 2021, MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) had resolved. At the time of the report, WEIGHT BEARING DIFFICULTY (SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT) and VACCINATION SITE HAEMORRHAGE (BLOOD AFTER INJECTIONS) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT unknown onset and BLOOD AFTER INJECTIONS was not provided. The reporter's causality for the event(s) of SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT onset 25 Mar 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
feeling uneasy; a little pain when being injected; feel a little bit uneasy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling uneasy), VACCINATION SITE PAIN (a little pain when being injected) and NAUSEA (feel a little bit uneasy) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID -19 Vaccination: Janssen.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced FEELING ABNORMAL (feeling uneasy), VACCINATION SITE PAIN (a little pain when being injected) and NAUSEA (feel a little bit uneasy). On 23-Nov-2021, FEELING ABNORMAL (feeling uneasy), VACCINATION SITE PAIN (a little pain when being injected) and NAUSEA (feel a little bit uneasy) had resolved.            Concomitant medication was not reported. Treatment information was not reported.   Reporter did not allow further contact
3/25/21 developed chills, muscle aching, diarrhea evening of vaccination--symptoms continued for 48 hours with poor appetite/nausea. lost 4 pounds over the next few days.  3/28/21 c/o dizziness, heart fluttering/irregular. 3/30/21 saw dr, and EKG showed afib. medication changes. 3/31/2021 repeat EKG a flutter. admitted observation to hospital.    NOTE: Does have a history of episodic afib/flutter--no episodes for the last few  years
Swelling/lump at injection site. Hives across arms and back. BENADRYL.
Rash and hives to (R) eye, face and back and upper torso. Treated with MEDROL dose pack, BENADRYL and ZYRTEC. Denies respiratory issues.
very lethargic & sleeping alot, would not eat, no other vax @ this time;
On 10/22/03 AM had about 3 hours of front sided tinnitus and partial deafness. Took aspirin 325mg, went to bed, woke up completely symptom free.
This spontaneous report was received from a pharmacist referring to an approximately 17 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-SEP-2015, the patient received the first dose of the GARDASIL for prophylaxis (strength, route, lot # and expiration date were not reported. Almost 8 months after, on 03-MAY-2016, the patient received the second dose of the GARDASIL for prophylaxis (strength, route, lot # and expiration date were not reported). Two years after, on 03-JAN-2018, the patient received the last dose in the three dose HPV vaccination series late with GARDASIL 9 for prophylaxis (strength, route, lot # and expiration date were not reported). No adverse effects were reported.
The pt developed generalized weakness, tired, low grade fever off and on (99-99.4 deg. F). These symptoms began one week later.  Pt also experienced no appetite and weight loss. On 03/24/2002 the pt was seen in ER with pneumonia and took Zithromax.
No adverse effect reported; one patient received an improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions and allergies was provided. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On 13-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# R026722, expiry date 17-MAR-2020 or lot # R023499, expiry date13-FEB-2020) for prophylaxis. The nurse did not have the specific lot number/ expiration date administered to the patient but it was one of the two listed. The vaccine experienced two storage temperature excursions (on 12-AUG-2019 and on 13-AUG-2019) from -14 Celsius degrees to -10 Celsius degrees (-11.91 Celsius degrees, multiple) for 8 hours. The data logger was involved. No adverse events were reported.  The outcome of product storage error and no adverse event was unknown.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA302794 (same reporter). This case involves a 6 months old female patient (reported as 6 month 25 day old) who inadvertently received single 0.5 ml of vaccine FLUZONE (lot UJ005AD and expiry date: 30-Jun-2019) instead of 0.25 ml on 22-Oct-2018 in left thigh via unknown administration site. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to overdose. Patient was given 0.5 ml of FLUZONE QIV in error instead of 0.25 ml as the administering physician did not know needle size and gauge. No adverse event occurred. 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 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. List of documents held by sender: none.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Apr2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 17Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hashimoto" (unspecified if ongoing), notes: Hashimoto; "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE PROPIONATE, start date: 31Oct2021. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical information: Anti-viral details: Product: COVID-19 Treatment, Brand: Paxlovid, Treatment Start Date: 05Jun2022, Treatment Stop Date: 09Jun2022, Indication: Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-NOV-2010, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not provided). On 11-JAN-2011, the patient was vaccinated with the second dose of RECOMBIVAX HB (the second dose was administered later than it should be according to the vaccine schedule) and on 01-MAR-2011, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not provided) (the second and the third dose were administered too close together). No known adverse effects were reported. Product quality complaint was not involved. Additional information is not expected, as there was no consent to contact with the reporter.