chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART ATTACK; HIS IMMUNE SYSTEM ATTACKED HIS BODY; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer by a company representative via social media (J and J Corporate) and concerned a 35 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total was administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient was previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total was administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3)  (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported (01 total), start therapy date were not reported for covid-19 prophylaxis which was off label dosing frequency (dose number in series 3). Age at the time of vaccination 4 decade. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack (dose number in series 3). Patient was told that his body had a reaction, went into overdrive and his immune system attacked his body. The patient was hospitalized on an unspecified date for an unspecified number of days. (dose number in series 3).  The reporter reported that, "my 35 yr old had a heart attack after 2nd booster. Spent several days in the hospital. He was told his body had a reaction and went into overdrive. His immune system attacked his body. Still seeing a cardiologist." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, his immune system attacked his body and off label dosing frequency was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20221156298- Heart attack, His immune system attacked his body. The event has unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Blood clot; swelling in his leg; discoloration on leg; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a male 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.    In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling in his leg) and SKIN DISCOLOURATION (discoloration on leg). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (swelling in his leg) and SKIN DISCOLOURATION (discoloration on leg) outcome was unknown.            No Concomitants were reported. No treatments were reported.  Company comment: Very limited information was provided. However, based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be fully excluded. Therefore, causality is assessed as possibly related.; Sender's Comments: Very limited information was provided. However, based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be fully excluded. Therefore, causality is assessed as possibly related.
Patient received Moderna COVID-19 vaccine on 4/7/2021 and 5/5/2021. On 1/10/2022, patient tested positive for COVID-19. On 1/20/2022, patient admitted to our inpatient facility for NSTEMI. During hospitalization, patient underwent cardiac catheterization and found to have severe three-vessel CAD with P LAD CTO. Patient transferred to another hospital for consideration of CABG.
Drooping eyelid, the same side where she got the shot, that last for 24 hours; Could not close left eye; Most severe dizziness , which was never happened in her life, last for 10-15min; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Most severe dizziness , which was never happened in her life, last for 10-15min), EYELID IRRITATION (Drooping eyelid, the same side where she got the shot, that last for 24 hours) and OCULAR DISCOMFORT (Could not close left eye) 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 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Most severe dizziness , which was never happened in her life, last for 10-15min). On 07-Apr-2021, the patient experienced EYELID IRRITATION (Drooping eyelid, the same side where she got the shot, that last for 24 hours) and OCULAR DISCOMFORT (Could not close left eye). On 06-Apr-2021, DIZZINESS (Most severe dizziness , which was never happened in her life, last for 10-15min) had resolved. On 08-Apr-2021, EYELID IRRITATION (Drooping eyelid, the same side where she got the shot, that last for 24 hours) and OCULAR DISCOMFORT (Could not close left eye) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength). At the time of the report, UNDERDOSE (Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had receive Moderna vaccines then the Moderna booster shot and it was only 25 percent of the first two vaccines and the patient read it should have been 50 percent strength.   No concomitant and treatment information were reported by the reporter.
Extreme fatigue, chills, body aches, headache for the entire day after receiving vaccine (all day on 4/21)
Information has been received from a physician concerning a 26 year old female patient with no illness at the time of vaccination and no pre-existing allergies who on 31-OCT-2008 and 31-DEC-2008 was vaccinated with the first and second dose of GARDASIL (lot # 661766/0652X) in her buttock. On 29-APR-2009, the patient was vaccinated with the third dose of GARDASIL (lot# 0294Y) in her buttock. There was no concomitant medication. On 31-OCT-2008, after the first dose of vaccination, the patient experienced vaginal watery discharge. On 06-NOV-2008, the patient recovered. On 31-DEC-2008, after the second dose of vaccination, the patient experienced vaginal watery discharge. Medical attention was not sought. There were no laboratory diagnostic studies performed. On 06-JAN-2009, the patient recovered. Follow-up information has been received from a physician who reported that all three doses of GARDASIL administered to the patient were 0.5mL. There was no adverse event following prior vaccination. Additional information is not expected.
Patient received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml). No concomitant medications were reported. No treatment medications were reported. This case contains information for the 5th of 20 adult patients described by the reporter.
swelling at the injection site; itch at the injection site; dark spot at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site) in a t-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-May-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) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced HEADACHE (headache). On 14-Jun-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site). At the time of the report, HEADACHE (headache), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site) outcome was unknown.            No concomitant medications details provided. No treatment details provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) with response to events was not applicable.
Boostrix administered to a 5-year-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2LG35, expiry date 09-MAY-2025) for prophylaxis.   On 11-FEB-2023, the patient received Boostrix. On 11-FEB-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix administered to a 5-year-old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2023 The vaccine administration facility was the same as primary reporter. A dose of Boostrix was inadvertently administered to a 5 year old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
staff member reported  headache, diizinees and nausea. Staff member currently hospitalized at hospital
Patient was given immunizations while patient was standing up. Shortly afterwards patient fainted and hit her head on the immunization floor. After patient fell, she started to fling her arms around for about 10 seconds. Patient claimed she remembers leaning against the frig and then blacked out. Patient seen by doctor sent to ER.
Patient states that the night of the day she received the flu shot her eyes turned bright red, started oozing white pus, became swollen, her jaw on the right side started hurting.
covid-19 virus test positive; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and HEADACHE (Headache) 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 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 SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and HEADACHE (Headache). At the time of the report, SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  medication and treatment information provided.  Patient was advised by his doctor to not take the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up TCR attached. Outcome of events updated to recovered/resolved.
p/vax pt exp fever & rash w/pustules; exposed to chickenpox in daycare; currently being tx w/augmentin & nystatin for impetigo & yeast infect; examined in MD office & dx w/chickenpox; expected to recover
In the days and weeks following the second dose, my mother began experiencing itching skin symptoms, initially in March and much more severe in April.She began experiencing burning sensations across her entire body.   She went to seek treatment through a dermatologist and other medical doctors and was initially treated for other conditions.  In late July of 2021, she had a biopsy performed, and in August, she was diagnosed with Pemphigus Vulgaris. She began seeking medical attention for this condition, and on Wednesday, September 1, 2021, she received her first treatment of three injections for the drug Rituxan.   On September 19, 2021 my mother was admitted to the ICU and it was discovered in a CT scan that she had sever abdominal issues as a result of her reporting pain in the area. It was discovered that her stomach lining has thinned too much for corrective surgery to heal perforations in her abdomen and diverticulitis.   She was transferred to another healthcare facility and admitted to their ICU on September 21, 2021. Her admitting doctors decided she needed another CT scan which then discovered bubbles and a fluid build up as well as a severe infection in her abdomen.   They decided she needed to have emergency surgery to remove a part of her intestine and colon. She is in high risk of infection and other complexities as a result of the measures taken and is still undergoing treatment.
approx 8-9hr p/vax pt devel an inj site rxn characterized by an area of inflammation & tenderness measuring 2 inches in diameter;pt was examined by the MD;
Received MMR Vaccine on 12/27/05 - eleven days later, my son had a 103.8 temperature and a severe measle-like rash that covered his entire body.  The rash began mildly on his tummy and within hours had spread to his face/back/legs/hands and feet.  His temperament has completely changed.  He has not acted like my "normal" little boy since the day he received the vaccine.  Called an emergency number on 1/6/06 and was told to give him tylenol and fluids.  Took him to a walk in on 1/8/06 and we are still waiting for test results.
Patient refers that  she stared vomiting 1 hour after receiving the COVID-19 vaccine.
Her daughter was quite sick from 2nd dose of moderna vaccine; She had symptoms for 3 to 5 days.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Her daughter was quite sick from 2nd dose of moderna vaccine) and VACCINATION COMPLICATION (She had symptoms for 3 to 5 days.) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Her daughter was quite sick from 2nd dose of moderna vaccine) and VACCINATION COMPLICATION (She had symptoms for 3 to 5 days.). At the time of the report, ILLNESS (Her daughter was quite sick from 2nd dose of moderna vaccine) and VACCINATION COMPLICATION (She had symptoms for 3 to 5 days.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Initial report received 05/15/2006, from a health care professional. A 48 year old female patient with a medical history of hypertension, anxiety and hyperthyroidism had received and administration of Adacel, lot number C2455AA, in the right deltoid (route not reported) on 04/27/2006. Within 24 hours post immunization, the patient's right arm became swollen from the shoulder to her elbow and was red, warm and painful. The patient contacted the physician's office and her symptoms were treated as cellulitis, but no confirmation of the diagnosis was provided. She was prescribed a ten day regimen of Keflex. On 05/12/2006, the patient was evaluated by the physician for a persisting nodule. The patient had not recovered from these adverse events at the time of this report.
Information has been received from a 61 year old female consumer with a drug reaction to Compazine who on 02-JUL-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck) (lot # 657676/0619U). Concomitant therapy included PLAVIX, losartan potassium (MSD) and "Lavistatin". On 03-JUL-2007 the patient experienced cold sore and rash on her body. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. No further information is available.
Pharmacy gave Moderna Covid-19 vaccine past its beyond use date; The vaccine was administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vaccine was administered beyond 30 days use by date) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (The vaccine was administered beyond 30 days use by date). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vaccine was administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  It was reported that the first 9 patients received Moderna Covid-19 vaccine on 02 Mar 2022 past its 30 day beyond use date. Pharmacist didn't knew which dose patient received on which arm. The Pharmacist does not have any other adverse events or side effects to report.The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24 Jan 2022.
A few days after receiving the second covid vaccine - I developed heart palpitations.   These progressed a week or so until I felt I should seek medical attention.  While in doctors office - I had 2 EKGs that showed an arrythmia.  My doctor had me where a 3 day event monitor.  The palpitations subsided after a few weeks and by the time the event monitor was placed - it was normal.
Left arm, 80 cm x 80 cm area of redness, swelling. Warm to touch.
sweating; Body ache; injection site right arm itches; Headache; pyrexia; all joints hurt; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), MYALGIA (Body ache), VACCINATION SITE PRURITUS (injection site right arm itches), HEADACHE (Headache) and PYREXIA (pyrexia) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced MYALGIA (Body ache), VACCINATION SITE PRURITUS (injection site right arm itches), HEADACHE (Headache), PYREXIA (pyrexia), ARTHRALGIA (all joints hurt) and FATIGUE (Tired). On 27-Oct-2021, the patient experienced HYPERHIDROSIS (sweating). On 27-Oct-2021, PYREXIA (pyrexia) had resolved. At the time of the report, HYPERHIDROSIS (sweating), MYALGIA (Body ache), VACCINATION SITE PRURITUS (injection site right arm itches), HEADACHE (Headache), ARTHRALGIA (all joints hurt) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-367384, MOD-2021-367334 (Patient Link).
4 days p/vax fever 105; swelling of brain-hospitalized; had BC & spinal tap 11APR94;