chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received the influenza on 9/26/13 at arround 8am, at about 10.30am return with complaint of dizziness, and headache, vitals done all within range, due to dizziness 911 was called and client transfer in stable condition.
This spontaneous prospective pregnancy report as received from a midwife refers to a 32 years old female patient. The patient's history of previous pregnancies and live births was unknown. The patient was vaccinated with (Merck) VARIVAX (dose, route and lot # not reported), part of the Merck Pregnancy Registry products "in middle of June of 2012" and the patient was "4 weeks pregnant". The patient was not demonstrating or reporting any adverse effects. No other co-suspects were reported. No concomitant medications were reported. The patient's LMP was on 14-MAY-2012 and EDD was on 18-FEB-2013. Initial exposure to (Merck) VARIVAX was at 4 weeks(s). The patient was exposed to (Merck) (VARIVAX) during trimester 1. No treatment information was reported. The outcome was unknown. Follow up information received on 04-NOV-2014. A phone call was placed to the Midwife. The phone was answered by a receptionist who stated that without patient first and last name, there was no way to locate for outcome pregnancy data. The phone call was finally transferred to Ob/GYN Midwife area, and a message was left. The Midwife might remember the name of the patient. On the same day, a phone call was received from the Midwife. The Midwife was unable to re-call the name of the patient. The name of the patient was needed to recover the patient's records. The Midwife did remember that the pregnancy was without incident. The Midwife had no additional information to share. Additional information is not expected.
This spontaneous report as received from a nurse refers to a patient of 12 months age. It was reported that there was no pertinent medical history or drug allergies. No concomitant medications were reported. The reporter stated that on 20-JUL-2014 the patient was vaccinated with PNEUMOVAX 23, route intramuscular. No known adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
pt recv vax 21JUL97 & 27JUL97 pt exp fever greater than 100;
Administered Hepatitis A vaccine instead of HPV vaccine. Patient and patient mother notified of vaccine error, both voiced understanding. Patient remained in clinic 30 minutes post vaccine administration without adverse reactions.
Immediately after injection felt lightheaded, sweaty. No itching or dyspnea.  BP132/82, pulse 60-68/min, O2 saturation 98-99%, chest clear, no rashes. Improved with lying down on exam table and drinking water. No further symptoms. Considered vaso-vagal reaction. Will return for second dose.
No additional AEs were reported.; Medical assistant reported that a patient received a dose of VARIVAX which was reconstituted with polio vaccine (IPOL).; This spontaneous report was received from a medical assistant regarding a 5-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUL-2022, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose of 0.5 mL, lot #U022320, upon internal review the expiration date was established as 15-JUL-2023 (route of administration, and anatomical location were not provided) as prophylaxis, which was reconstituted with polio vaccine inactivated (reported as "IPOL") (4th dose, batch/lot #VIA021M) 0.5 mL (route of administration, expiration date and anatomical location were not provided) (Product preparation error). No additional adverse events were reported. The nurse mixed wrong vaccines instead of diluent, she did not pay attention to workflow. The vaccines had no experience temperature excursion reading from a digital data logger.
small pin-head sized hypopigmentation has occurred at the site of injection; first noticed 1 day after shot when the bandage was removed. area of arm of the injection site is very sore but still with full range of motion, no swelling, no redness
Left deltoid area became red and swollen the day after Dtap given. Small area on right arm 1 1/2cm.
achy; local injection site reaction with itching; local injection site reaction with redness; local injection site reaction with swelling about walnut size; She felt fatigued; queasy; as soreness in her joints which was worse than her baseline; She has also felt feverish and chilled; chilled/shivering; pain in her injection arm; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (She felt fatigued), NAUSEA (queasy), ARTHRALGIA (as soreness in her joints which was worse than her baseline), PYREXIA (She has also felt feverish and chilled) and CHILLS (chilled/shivering) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatigue, Depressed state and Surgery on 07-Dec-2020. Concurrent medical conditions included UTI and Hypertension. Concomitant products included VALSARTAN for Hypertension, LEVOTHYROXINE for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (She felt fatigued), NAUSEA (queasy), ARTHRALGIA (as soreness in her joints which was worse than her baseline), PYREXIA (She has also felt feverish and chilled), CHILLS (chilled/shivering), VACCINATION SITE PAIN (pain in her injection arm), INJECTION SITE PRURITUS (local injection site reaction with itching), INJECTION SITE ERYTHEMA (local injection site reaction with redness) and INJECTION SITE SWELLING (local injection site reaction with swelling about walnut size). On an unknown date, the patient experienced MYALGIA (achy). The patient was treated with Bed rest (AND PUSHING LIQUIDS) for Fatigue; Bed rest (AND PUSHING LIQUIDS) for Nausea; Bed rest (AND PUSHING LIQUIDS) for Arthralgia; Bed rest (AND PUSHING LIQUIDS) for Pyrexia; Bed rest (AND PUSHING LIQUIDS) for Chills and Bed rest (AND PUSHING LIQUIDS) for Vaccination site pain. At the time of the report, FATIGUE (She felt fatigued), NAUSEA (queasy), ARTHRALGIA (as soreness in her joints which was worse than her baseline), PYREXIA (She has also felt feverish and chilled), CHILLS (chilled/shivering), VACCINATION SITE PAIN (pain in her injection arm), MYALGIA (achy), INJECTION SITE PRURITUS (local injection site reaction with itching), INJECTION SITE ERYTHEMA (local injection site reaction with redness) and INJECTION SITE SWELLING (local injection site reaction with swelling about walnut size) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included Antibiotics.   This case was linked to MOD-2021-072822 (Patient Link).
Polymyalgia Rheumatica; had a fever of 100; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; Severe morning stiffness; ESR (sedate) was 52 mm/hr; C reactive Protein 32.3; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 06:00 (Batch/Lot Number: Unknown) as 2ND DOSE, single for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; tamsulosin hydrochloride (FLOMAX) taken for an unspecified indication, start and stop date were not reported; lisinopril dihydrate (PRINIVIL) taken for an unspecified indication, start and stop date were not reported. On 03Apr2021 (as reported), the patient had a fever of 100 after the second shot for one day and then he felt fine. About 6-7 day (on 03Apr2021, as reported), he started having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck. On 03Apr2021 (as reported) he experienced severe morning stiffness to where he couldn't even put on socks. He went to the doctor and had blood test drawn on 03Apr2021 with the results: "ESR (sedate)" was 52 mm/hr C reactive Protein was 32.3; he was diagnosed with Polymyalgia Rheumatica on 03Apr2021 (as reported). He was put on Prednisone (15mg) and within a few days he felt much better, but his doctor said he has to be on this from 6months to a year. The outcome of event "had a fever of 100" was recovered on 04Apr2021; Outcome of all other events was reported as recovering. It was reported that the patient receive treatment for all events.  Follow-up attempts are completed. The following information on the batch number has been requested.
Rash around eyes, swollen, puffy.  Have not changed anything in daily routine to cause this.  Have a coworker who has the same issue and also received J&J vaccine
pt recv vax OCT96 & 16DEC96 pt devel coughing, weakness & migraine;by 20DEC96 pt was feeling better;
She missed second dose because she was sick; She missed second dose because she was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She missed second dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (She missed second dose because she was sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She missed second dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (She missed second dose because she was sick). At the time of the report, ILLNESS (She missed second dose because she was sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She missed second dose because she was sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-048890 (Patient Link).
Patient had swelling, fever and redness at injection site starting the night of the injections. The following morning the symptoms on the left arm involved the entire forearm, part of left chest and shoulder. He had severe pain and the arm was hot to the touch. He also mentioned of increased frequency in urination.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 20-FEB-2009, patient received improperly stored VARIVAX dose 2, from batch/lot # 661445/0525X (dose and expiry date unknown) (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
got the flu; double doze of flu shot; Initial information received on 26-Nov-2022 regarding an unsolicited valid non-serious social media case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got the flu and had double doze of flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient who got the flu (influenza) (unknown latency) and had double doze of flu shot (extra dose administered) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (got the flu).  At time of reporting, the outcome was Unknown for the events.  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.
Facial swelling, hoarseness, agitation. Pt given BENADRYL and oral steroid in office, stayed in office for approximately an hour. The hoarseness went away, continued to have swelling to face. Did not have any resp distress.
This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, RECOMBIVAX HB doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004262: US-009507513-1706USA004261: US-009507513-1706USA004259: US-009507513-1706USA003526:
CHILLS; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and nausea was not reported. This report was non-serious.
none - booster dose inadvertently given to immunocompromised patient. Per current recommendations, pt was given third full dose today as a catch up and is eligible for one more booster in 4 months.
Information has been received from a pharmacist concerning a 6 month old patient who was vaccinated with the first dose of Rotateq past 12 weeks of age.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
First dose given 2/11/2021. Moderna. Lot # 031L20A. Left arm. Intramuscular
Developed elevated temp, HA, body aches and fatigue the day after receiving the vaccine. On 5/18, she developed increase in respirations and feeling like she could not take a deep breath. Hx of asthma, she used her inhaler with no improvement.Tried Benadryl with no relief. Felt like she had sinus congestion and nasal congestion, but able to breath through her nose fine. Feels SOB, worse on exertion. She also mentioned some difficulty swallowing. Denies cough/wheezing. O2 sat was 98 or above, even on ambulation. Cervical lymphadenopathy, tongue swelling, and flaring of her right TMJ was noted on . Prednisone was started. On May 20th, pt reported to PCP's nurse that she was feeling better.
This is a spontaneous report by a contactable nurse and from a contactable physician. A 64-year-old female patient received on 21Jul2014 at 15:26, first dose of PREVNAR 13 (Batch. 0005-1971-01, Lot. H95098 and expiration date 31May2015) at single dose intramuscularly in left deltoid. Relevant medical history included allergic rhinitis, classic migraine, PVA septum, gastro-esophageal reflux disorder (GERD), sacral lumbar pain, malignant melanoma, hyperlipidemia, unspecified thyroid condition, nausea, venous stasis, osteopenia and vitamin D deficiency, all ongoing; patient was also allergic to penicillin and sulfa. Relevant concomitant medications were unknown. Vaccines given on the same day and within the last four weeks were none. No illness at the time of vaccination and no administration of any antipyretic reported. On 21Jul2014, she experienced a local reaction at the injection point described as erythema in an area of 4x6 cm at injection site which was warm and tenderness. No culture and others diagnosed tests done. Therapeutic measure taken in response to the above mentioned events included oral KEFLEX 500 mg, one three times a day for 10 days, since 23Jul2014. On 11Aug2014 patient recovered. Nurse considered causal relationship between the adverse events and PREVNAR 13 as unknown. Physician considered there was a reasonable possibility that the events were related to PREVNAR 13; relevant etiological factors to facilitate the assessment included: "Local reaction was early cellulitis; Afebrile 4 cm x 6 cm. No abscess / adenopathy". Follow-up (19Aug2014): New information received from a contactable physician includes: vaccine details, event details (onset, outcome), treatment, comment/assessment, medical history. Follow-up attempts completed. No further information expected. Follow-up (25Sep2014): Follow-up attempts completed. No further information expected.
Dermatographism and hives developed about 10 days after the booster and have not resolved or improved in Almost 2 months post vaccine.  I?m having to take Zyrtec every day.  I did a steroid burst about 2 weeks after the booster but it did not improve my symptoms. I worked as a clinician in a Covid respiratory clinic today and my symptoms are worse than ever.
Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for Cancer.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient was given a topical ointment but it was still looking a little red and visited an acupuncturist.
Fever for going on 2 weeks now, varies between 100 degrees & went up to 103 degrees last night, headache, nausea, jaw pain, muscle aches, neck pain
Information has been received from a physician concerning his 12 year old daughter who on the morning of 10-Nov-2008 was vaccinated with GARDASIL , IM. Subsequently the patient got light headed and "woozy" after getting the vaccine. It was noted that the patient didn't have breakfast that morning. The patient was given some juice and recovered a while later. The patient sought medical attention through the reporting physician. No laboratory diagnostic studies were performed. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that 6 patients received the same lot number of PNEUMOVAX 23 and all 6 patients experienced the same symptoms. She reported "2 or 3 of the patients" had hypertension and hypercholesterolemia. The nurse said that the patients included both male and female gender. (The cases were captured in MARRS # 1606USA011560 and 1607USA004050). The nurse was not aware of the patient's drug allergies. In December 2015, the patient was vaccinated with PNEUMOVAX 23 lot # L031459, expiration date: 30-APR-2017, 0.5 ml, intramuscularly. In approximately December 2015 within 24 hours of vaccination, the patient experienced low-grade fever, redness and swelling at the injection site, pain in the vaccinated arm which spread to the armpit. The patient sought medical attention by visiting the doctor's office. The patient was treated with BENADRYL, ibuprofen and other unspecified over-the-counter products. One of the 6 patients was given an unspecified steroid shot. On an unknown date 3 to 5 days after the onset of symptoms, the patient recovered from the events. The relatedness between the event and PNEUMOVAX 23 was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a pharmacist regarding a multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients received improperly stored ZOSTAVAX (lot # M024700, expiration date: 18-JUL-2017; lot # M037014, expiration date: 22-NOV-2017) dose details and indication was not provided) subcutaneously for prophylaxis. It was reported that the vaccines were exposed to the temperature of 6F to 14F (7F) during a time frame of 38 days. It was verified with pharmacist that ZOSTAVAX was reconstituted with sterile diluent (MERCK) (unknown lot # and expiration date) and was correctly stored (also reported as improperly stored). Previous temperature excursion was reported. The call was because of data logger. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Tingling in fingers of left hand, 11/055/13 at 8:30 PM; Dizziness, weakness, mood change, diarrhea, 11/06/13 from 9:00 AM - 5:00 PM; Extreme weakness, lightheadedness, no appetite, heartburn, fever, chills, fatigue from 5:00 PM to 8:00 AM on 11/0713; difficulty breathing, extreme fatigue, nausea, extreme weakness at 8:30 AM on 11/07/13--called doctor, advised to go to the emergency room at hospital. Taken right away; cardiogram done, chest x-ray & blood work done.