chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have had inconsistent menstrual cycle since vaccination - blood clots, heavier than normal, frequency varies, length varies
11-19-09 diarrhea 3X abd cramps. 11-20-09 - 4:30 103 (ear), dehydrated, lethargic, abd cramps - MD ->ER 3P Pt admitted - 4 days 5 nites. 11-21-09 Temp 105 degrees rectal @ hospital. 12/13/09 Pt recoup.
Attending Physician:  DO;* Date of Admission: 2/13/2022    CC:     HPI:   This is a 92y.o. male with medical history of A. fib , HTN, CAD, CHF,  multiple myeloma s/p chemotherapy, baseline bedbound,  from ECF, presents to the ED for mental status change.  Check patient in the ER, he is unresponsive.  Called to talk to his son, baseline orientated, bedbound, in the ER start heparin drip, received IV bolus 1 L in the ED, admit inpatient for further evaluation and management, infection disease consult# Metabolic encephalopathy/mental status change/unresponsiveness/elevated ammonia level  #  Sepsis/ COVID-19 infection without hypoxia  # Non-STEMI/elevated troponin /hx of A fib #  Transaminitis # Acute heart failure , elevated BNP level, unknown EF  # Lactic acidosis, improving,  # Urinary retention/UTI/leukocytosis  # AKI on CKD IV, elevated Cr. Level  # RLE DVT /elevated D dimer  # stage III pressure ulcer coccyx , no s/s infection  # hypermagnesemia
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 75-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date 8th February 2021) for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved. It was unknown if the reporter considered the localized erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right deltoid. The reporter stated that patient developed a red area across the stomach and naval area after receiving the SHINGRIX.
Baby began crying and then escalated to screaming and this continued for 3 days straight.  We called her doctor the next day and the doctor insisted the reaction was normal.  We then fired the doctor.  It was HORRIBLE to watch our infant daughter scream in pain for 3 STRAIGHT DAYS!
expired dose of Pentacel was administered to a patient (with no reported adverse event); Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient to whom expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received 4th dose of expired 0.5 mL dose of suspect suspension for injection of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Batch number: UJ786AA, expiry date: 12-Oct-2023) via intramuscular route in the left thigh as immunization (expired product administered; Latency: same day)   The caller was not aware of any adverse reactions, treatment, Doctor or Emergency Room visit necessary post administration.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
Off label use; Dose_number=3, brand=Pfizer, prev_dose_brand=Moderna; Chills; Headache; Muscle pain; Arm pain; Fatigue; Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FJ6369) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported that prior to vaccination the patient was not diagnosed with COVID-19. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: 038A21A), for COVID-19 immunization; Moderna (Dose Number: 2, Batch/Lot No: 037B21A), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose_number=3, brand=Pfizer, prev_dose_brand=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Covid test result=Positive"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. It was reported that patient has been tested for COVID-19 since the vaccination.  Clinical course: It was reported that seriousness criteria was not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Device date was provided as 26Jan2022.   No follow-up attempts are possible. No further information is expected.
received his first dose of the Moderna covid19 on the 22Sept2021 is not well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (received his first dose of the Moderna covid19 on the 22Sept2021 is not well) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (received his first dose of the Moderna covid19 on the 22Sept2021 is not well). At the time of the report, MALAISE (received his first dose of the Moderna covid19 on the 22Sept2021 is not well) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.
A 81y.o. female with history of non-small cell lung cancer diagnosed in 8/20/2021-s/p  radiation therapy, gamma knife on 6/11/2021, completed 5 fractions of palliative radiation therapy on 714 2 right chest wall nodule currently on Keytruda for every 3 weeks, COPD, hyperlipidemia, hypertension.  Patient presented with cough, shortness of breath.Labs showed white count of 24.3.  Chest x-ray showed large area of right upper lobe consolidation likely combination of atelectasis and pneumonia COVID-19 was negative was started on vancomycin and cefepime, azithromycin pulmonary was consulted started on prednisone for COPD exacerbation..patient completed antibiotics, steroids.
sick; sweating profusely; throwing up this thick mucus; vomiting/holding no food down/throwing up this thick mucus; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus). At the time of the report, ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Arm where I received the first vaccine started hurting like it's sprained/broken. The pain never went away and I went to the doctor and she said it's sprained and I need physical therapy in order to get better. The pain is coming from my shoulders all the way to my fingers, shooting pain, my elbow also hurts, kind of like tennis elbow problems. Lastly, I lost my strength and it's just painful, especially the more I use this arm.
6 month old was administrated with Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. In November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 22-AUG-2022 Reporter's comments: Nurse reported that a 6-month female patient was administrated with Kinrix. No adverse event was reported. The vaccination occurred on another facility. The Healthcare Professional (HCP) wanted to be contacted by phone. The expiration date was not provided. The reporter consented to follow-up. Additional supportive information: The patient was administered Kinrix while she was 6-month old which had led to inappropriate age at vaccine administration.
9 pm Neck and face swollen - had similar allergic reaction in past to poison ivy. 5/9/16 went to Urgent Care - Rx for prednisone for 8-10 days and self medication with ZYRTEC and ibuprofen. Swelling got worse and developed fever and was hospitalized for IV antibiotics for cellulitis and treated 3 days with.
Soon after he inhaled the vaccine his stomach began to be upset, lasted all day around 8 at night his stomach began to hurt more he took one bite of his food and began to have trouble breathing he bagan to vomit and we called ambulance we thought he was having reaction but he had previously had the same food many times with no reaction  by the time he got to hospital there were no reaction symptoms no swelling etc. but he started to hallucinate, I really believe it was the vaccine because that was the only new thing introduced to him.
Client presented to clinic for the Moderna bivalent booster. This nurse administered the Moderna 6-11 years vaccine inadvertently. Client was notified while in clinic, when this nurse realized the error. Advised client that this nurse had called Dept. of Health and Environment to find out next steps. Later notified client he could receive the Moderna bivalent booster in 2 months, per CDC guidelines. Verbalized understanding.
Chills, fever, diaphoresis, nausea, excruciating headache, sore arm with limited movement,
Seen back in office 2 days after vaccine with 2-3 cm of very warm, red, indurated skin in sharply demarcated area at the MMR injection site, treated for cellulitis with Keflex x 5 days.
First dose administered  7Apr2021 - 2nd dose not administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose administered  7Apr2021 - 2nd dose not administered) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose administered  7Apr2021 - 2nd dose not administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose administered  7Apr2021 - 2nd dose not administered) had resolved.        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.   No relevant concomitant medications were reported. No treatment information was reported.
Brain fog - improving  Sever Myalgia; arthralgia - Resolved.  Cognitive Deficit - continuous Word finding deficit / Aphasia  Executive Planning Deficit
Information has been received from a physician concerning a female who, on an unspecified date was vaccinated intramuscularly with her first GARDASIL (Lot # and site not reported). "About 2 weeks post vaccination", the patient developed a rash on her torso and the backs of her legs. The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested.
Initial information received on 04-Oct-2018 regarding an unsolicited valid serious case received from a non-healthcare professional. This case involves a 65 years old female patient who experienced anaphylactic shock, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; and TETANUS VACCINE (TETANUS VACCINE) for Immunisation on 02-Oct-2018. On 02-Oct-2018, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. On an unknown date, the patient developed a serious anaphylactic shock, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. Patient was taken by an ambulance to the emergency room at hospital but was not admitted over night. Lab test not reported. Final diagnosis was anaphylactic shock. The patient was treated with Prednisone, Loratadine and Famotidine. The patient was recovering from the event. List of documents held by sender: none.; Sender's Comments: Patient presented with anaphylactic shock after vaccination. Time to onset is unknown. Moreover, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Patient received vaccine and then fainted while still sitting in chair. Vaccinator caught patient and put her head between her legs. EMS was called, and patient work up before they arrived from next room.
mom presented to pharmacy to vaccinate daughter and was asked her age she replied 12 so consent forms provided when returning insurance card age and weight we asked again mom stated 12. daughter was vaccinated and waited 15 minutes then left. at data entry noticed birthday was, 11 years old.
tested positive for covid on 3/27/21.  person received doses of covid vaccine, last dose administered on January 9, 2021.  person is symptomatic.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and CLONAZEPAM for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) at a dose of 75 mg and ATORVASTATIN CALCIUM (LIPITOR) at a dose of 80 mg. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant medication also included Alopatine 5 mg 2 a day. Treatment medications also included unspecified blood thinners.  The patient stated that it had it about July the first had a Stroke or June 26th, not sure.; Sender's Comments: This case concerns a 76 year-old, female patient with concomitant use of atorvastatin calcium, who experienced the serious unexpected AESI of Cerebrovascular accident. The event occurred approximately 4 months after the second dose of mRNA-1273 vaccine, exact date not provided. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The use of concomitant medication atorvastatin calcium and patient´s advanced age, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a pharmacist concerning a 59 year old female who in approximately 1997 "over 10 years ago" was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown). On an unspecified date the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot# 657042/1347U). On 21-NOV-2007, the patient's right arm was swollen, painful and developed red streaks after being administered her second dose of pneumococcal 23v polysaccharide vaccine. Medical attention was sought. The patient was examined in the Emergency Room on 22-NOV-2007 and was not admitted. The patient was released that day after an injectable antibiotic was administered and oral antibiotics were prescribed. On 23-NOV-2007, the patient's arm was not as painful and the swelling had improved in the upper region of her arm but increased in the lower region of the arm. No further information was available. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a medical technician refers to a 27 year old female patient. The patient had no concomitant medication, pertinent medical history or drug allergies/reactions. ON 15-JUL-2014 the patient was seen in the office, at which time she was mistakenly vaccinated with a dose of (Oka/Merck) VARIVAX (injection, lot # J011125, expiration date 05-SEP-2015, 0.5 ml, subcutaneous). The medical technician stated 'we took a pregnancy test after the vaccine was given and it was positive". No treatment was given for the adverse events. The last menstrual period (LMP) and expected date of deliver (EDD) were not provided. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored ROTATEQ (lot#, expiration date, dose not reported, orally). No adverse effects were reported. This is one of the several cases from the same reporter. Additional information has been requested.
I don?t consider it an abnormal event given what is being reflected in the news but I thought if my story helped research, I would share.   I just wanted to describe the week I have experienced.  Saturday evening after shot at 4pm,  around 11pm, I began feeling some minor aching and fatigue. Woke up next day feeling groggy/foggy, aches,  and painfully tired but functioning , moving through morning. By mid afternoon Sunday, I could not hold back sleep, 2 hour nap, up 30 minutes, 2 hour nap, up 30 minutes,  then 101. 2 fever, chills (normal temp 97.5), took tylenol, 5 hour sleep, up 30, 5 hour sleep, up 30 mins, 5 hour sleep.  Joined husband on errands who also had fatigue but was doing much better.  Achy, foggy , zoned out mentally all of Monday,  late afternoon, sleep 3 hours, up 2, asleep easily by 11.  Tuesday fog better but muscles weak, tired, didn?t want to hardly lift arms but pushed through day at work. Wednesday almost back to normal.  Thursday corner rounded only now fever blister on mouth and in nose. A whole other reactive system that has brought On Bell?s palsy in the past.
Muscle pain and extreme joint pain within 6 hours, lasted 24 hours. Used Tylenol and cannabis to treat. 84 hours later, I had a herpes simplex sore appear before my eyes (3rd one ever, 1st one in 15 years) and appeared as soon as it began to tingle. All of the glands in my face and neck became inflamed and sore to touch. 101-102  fever arrived shortly after. 8 hours later (morning of 9/24), I developed a migraine with light and sound sensitivity that lasted for 4 days. Also experienced was a kaleidoscope migraine on the 2nd day of my 4 day experience. Sumatriptan was used to treat on the first day, but caused my heart to race. Continued to treat with cannabis and Tylenol. Fever lasted the entire 4 days, but broke today on 9/28 about 2pm. This was the first migraine experienced in several years as well. My lip is also finally starting to heal from the cold sore and my face glands are no longer sensitive to the touch. My neck glands still show sensitivity.
Nausea/Dizziness, Lightheaded, Muscle and Joint pain.  Next morning with severe muscle and joint pain.  Fever and racing heart along with Nausea and Joint Pain.
She woke at 4:30 am not able to move with major severe muscle aches and fatigue, headache, nausea, fever, she couldn't even put on her own shoes. Gave Benadryl at onset and used ibuprofen for fever, Gatorade because could not eat.
Puking sick for a month; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a patient (unknown demography) who was puking sick for a month (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who puking sick for a month (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.