chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal bleeding; Cannot move or raise her arm; Heat pangs; Back pain; Feels that her body is asleep; Intense pain on (injection) arm; Body pain; has been lying down all day; Headache; Nausea; Bone pain; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding), MOBILITY DECREASED (Cannot move or raise her arm), FEELING HOT (Heat pangs), BACK PAIN (Back pain) and FEELING ABNORMAL (Feels that her body is asleep) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METHOTREXATE, PROPRANOLOL and LISINOPRIL for an unknown indication.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced BONE PAIN (Bone pain). On 25-Jun-2021, the patient experienced MOBILITY DECREASED (Cannot move or raise her arm), FEELING HOT (Heat pangs), BACK PAIN (Back pain), FEELING ABNORMAL (Feels that her body is asleep), PAIN IN EXTREMITY (Intense pain on (injection) arm), PAIN (Body pain), SOMNOLENCE (has been lying down all day), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding), MOBILITY DECREASED (Cannot move or raise her arm), FEELING HOT (Heat pangs), BACK PAIN (Back pain), FEELING ABNORMAL (Feels that her body is asleep), PAIN IN EXTREMITY (Intense pain on (injection) arm), PAIN (Body pain), BONE PAIN (Bone pain), SOMNOLENCE (has been lying down all day), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported her experience was worse than the coronavirus.  Treatment also included use of an ice pack.
headache; chills; joint pain; nausea; dizziness; fast heartbeat at night; Swelling around injection site; Rash at injection site that is now gone; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea) and DIZZINESS (dizziness) in a female patient of an unknown age 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 information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea), DIZZINESS (dizziness), HEART RATE INCREASED (fast heartbeat at night), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE RASH (Rash at injection site that is now gone) and VACCINATION SITE ERYTHEMA (Redness around injection site). At the time of the report, HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea), DIZZINESS (dizziness), HEART RATE INCREASED (fast heartbeat at night), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE RASH (Rash at injection site that is now gone) and VACCINATION SITE ERYTHEMA (Redness around injection site) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
chronic cough x7 months, ongoing Do. cough asthma tx steroids, inhalers
Fever; Fatigue; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011QJ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: negative. On an unknown date, Hepatic enzyme increased: negativve. On an unknown date, X-ray: negative.  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.   No relevant concomitant medications provided.
received only the diluent; received only the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number 75PE7, expiry date 3rd June 2023) for prophylaxis.   On 24th May 2022, the patient received Shingrix. On 24th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-May-2022 Reporter's comments: The patient received only the diluent AS01B of Shingrix. The consent to follow up was given. Additional Supportive Information: The patient received only the diluent AS01B of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
moderna vaccine was given to two 17 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine was given to two 17 years old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine was given to two 17 years old). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine was given to two 17 years old) 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.   This case was linked to MOD-2021-059902 (Patient Link).
NAUSEA, DIARRHEA, SEVERE COUGHING, MUSCLE/ BODY ACHES, SEVERE SHORTNESS OF BREATH, PAIN WHEN BREATHING, HEADACHE MY HUSBAND WAS PUT ON FULLTIME OXYGEN TODAY
PATIENT RECEIVED A JANSSEN VACCINE BUT IS UNDER THE AGE OF 18.
Rash.  Persistent in the armpit, groin, areas.  Back, face, and chest, and moves within hours.  Example, rash noticed on forehead.  2 - 3 hours later the rash had moved to the left side of the head.
Temp 100.9. Vomiting 9 times (after vaccine 5/5/04) and 2 times 5/6/04.  Visited MD's office today- Reaction to vaccine explained, pedialyte given, advance diet as tolerated. (no diarrhea). Return to clinic/ED if vomiting persits. Parent given MD's pager for further questions.
His right eye looks very red; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207, Expiry Date-UNKNOWN) via an unspecified route of administration in right arm on 28Mar2021 10:00 as dose 1, single (at the age of 44 years-old) for COVID-19 immunization (patient taking Pfizer COVID-19 vaccine (Verbatim) due to possible overweight). Patient Medical History (including any illness at time of vaccination) was none. There were no concomitant medications (other Products). Family medical history relevant to ae was none. Vaccination facility type was other (pop up clinic) and vaccine administered at military facility. the facility name address was unknown. Additional vaccines administered on same date of the pfizer suspect additional administered vaccines if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. The patient recently experienced that his right eye looks very red on 31Mar2021. It was reported that action taken with drug was unknown. The report is not related to a study or programme. Patient questions about if this could have been caused by the COIVD-19 vaccine. Investigation Assessment reported as none. It was reported that patient doesn't have a doctor, didn't go see a doctor. Patient was not visited to emergency room and physician office. No therapeutic measures were taken for event. The clinical outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 28-JUL-2011, the patient was administered with a dose of VARIVAX (oka/merck) (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to 3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Hives present on both upper legs from hip to knee, First dose of Benadryl was given but some hives remained and after 4 hours a second dose of Benadryl was given and all hives went away.
STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via a social media and by a company representative concerned a male of an unspecified age, race and ethnicity. 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 and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. 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 patient had blood clots and stroke. The reporter described that the patient was nearly killed with covid vaccine. It was reported that "You all nearly killed my grandpa with COVID vaccine. He had blood clots and a stroke from it. All you fake pandemic pushers deserve to go to jail for fraud and crimes against humanity". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220942760-Covid-19 vaccine ad26.cov2.s-stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.   20220942760-covid-19 vaccine ad26.cov2.s-blood clot . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Fever, chills, severe body aches, sore throat, swollen glands in the neck, skin hypersensitivity to touch
Fever up to 101 F - began in early afternoon the day after vaccine was given. Improved by taking ibuprofen in evening and gone by morning. (Tried to report with vsafe, but ran into technical problems, so I am reporting here instead).
PNEUMOVAX23 VIAL RIGHT SHOULDER SORENESS COULD NOT SLEEP NEXT MORNING AND FOLLOWING DAY SORENESS REDNESS AND SEVERE SWELLING OF BICEP AND TRICEP ALSO NUMBNESS IN RIGHT HAND FIRST DAY AFTER WHICH DID PASS.
2 1/2-3" bright red, raised area around inj site;1/2" additional area around outside lighter red color;inner portion is hard, warm to touch, itches;
This spontaneous report was received from a physician regarding a male patient of unknown age. The patient's medical history and concurrent conditions were not provided. Approximately in 2014 (reported as approximately one year ago), the patient was vaccinated with his first dose of VARIVAX (Merck) (dose, lot number and expiration date were not provided). Concomitant medications were not provided. On an unknown date, the patient lost documentation of VARIVAX (Merck) administration and blood test was drawn to verify antibodies. Physician reported blood test result was a negative titer. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 02-JUN-2015, the patient was vaccinated with improperly stored GARDASIL (route of administration and dose were not reported) (lot # K023432, expiry date: 18-JUN-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
she can not stand; Weakness in the body; Weakness in legs; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), MUSCULAR WEAKNESS (Weakness in legs), ASTHENIA (Weakness in the body) and MOBILITY DECREASED (she can not stand) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BEVESPI AEROSPHERE) for COPD.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COUGH (Dry cough). In July 2021, the patient experienced MUSCULAR WEAKNESS (Weakness in legs). On 20-Aug-2021, the patient experienced ASTHENIA (Weakness in the body). On an unknown date, the patient experienced MOBILITY DECREASED (she can not stand). At the time of the report, COUGH (Dry cough), MUSCULAR WEAKNESS (Weakness in legs), ASTHENIA (Weakness in the body) and MOBILITY DECREASED (she can not stand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was  not provided.
Left arm, red, hard and swollen. Advised as long as can move arm well, no fever and minimal pain - not to worry by doctor.
24 hrs after shot in upper left deltoid pt had swelling of elbow and a cellulitis develop in a band around that elbow. Pt came in 2 days later (11/3/04) and was given antibiotics at a doctor's appt. Has resolved.
Patient was seen at the PRIVACY ER for c/o fall with injury, confusion and cough. Patient was found to be Covid positive and was placed in observation status for evaluation and treament.
Erythema, warmth of skin over deltoid, some firmness & tenderness of the deltoid.
This spontaneous report as received from a registered nurse refers to a 29 year old female patient. Current conditions and other relevant medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL (intramuscular injection, lot # J013324, expiration date: 12-FEB-2016, strength, route, dose number, anatomical location not reported). Concomitant therapies were not reported. The reproter stated that on an unknown date she administered a dose of GARDASIL to a 29 year old female patient. No adverse effects reported. No further details were provided. Additional information has been requested.
Soreness localised to injection site; similar to a bruise.; Soreness localised to injection site; similar to a bruise.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included acute lymphocytic leukemia (Childhood acute lymphocytic leukemia: 18 years post-diagnosis, considered cured for >10 years), seasonal allergy. The patient had no known allergies for products or food. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), and vitamins nos (MULTIVITAMIN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced soreness localised to injection site; similar to a bruise. It was reported that no adverse events six hours post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness localised to injection site; similar to a bruise was unknown.   No follow-up attempts are needed. No further information is expected.
the patient had inflammation redness from shoulder to elbow. it was difficult to move. pt said it started the afternoon/evening of imz.  she did not call us until today. she had a planned office visit with her md the friday after the imz , and it was better by that time. the imz was given 9-26-2020 and the office visit was 10-2-2020. the md stated that he felt it was due to the imz given in the same arm.
Bronchitis onset day 5, 3/30/03 of vaccination, saw PMD on day 7, 4/1/03 and placed on Augmentin, Clarinex and Albuterol inhaler, missed work until 4/7/03 and continues to improve. Contact dermatitis started about 4/7/03 with itching and reddness on right hand/wrist and left hand, using hydrocortisone cream and is improving but not gone
3:40 (15:40) 20 minutes after vaccines, child had hives on trunk, anteriorly and posteriorly with respiratory and expiratory wheezes. Given Epinephrine 1:1,000 subcutaneously 0.2 as per standing orders - 911 called 3:43pm. Child to hospital for observation. In good condition 16:15.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions,  medical history and concomitant medications reported. On 11-AUG-2015, the patient was administered with expired vaccine of (Merck) PROQUAD, lot# K002039, expired on 10-AUG-2015. No adverse effects reported. No product quality complained involved. Additional information has been requested.
Products were not good and needed to be returned with no reported adverse event; poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713(CLUSTER) and 2023SA129811(CLUSTER).  This case involves Infant and unknown gender patient for whom who poor quality vaccine administered with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date the cold chain break is reported where products were not good and needed to be returned with no reported adverse event (product storage error) and patient received a dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for Immunization with no reported adverse event (poor quality product administered) (latency: same day). Batch number was requested.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both 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.
Onset of itchiness and redness exactly one week post injection, which quickly evolved into a large, hard lump at injection site. Itchy and hot to the touch.
Soreness in shoulder that has continued for two and 1/2 months. Seems to be spreading to neck area.
Small rash appear, under her arm near her arm pit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash appear, under her arm near her arm pit) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced RASH (Small rash appear, under her arm near her arm pit). At the time of the report, RASH (Small rash appear, under her arm near her arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication was provided.
About 25 minutes after receiving the vaccine I felt a flush.  This occurred mainly in my midsection.  I drank some water and it went away.  It was a short lived event, maybe 10 seconds.
pt recv vax & devel a large red, hot swollen area @ the site of inj, which was as large as a baseball; the following day the area had dec in size & subsequently pt recovered; lab eval on 24MAr94 revealed pos anti-HBs;