chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 19-JAN-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Chills, Cough
Clinical narrative: HEART/CHEST HURT; BACK HURTS; EVERYTHING HURTS; COUGHING UP PHLEGM; CURL UP AND DIE; ARM HURT LIKE HELL; TIRED; SICK TO STOMACH; WEAK; CHILLS; CANNOT BREATH; COUGH; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 13-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 14-JAN-2022, the patient experienced cannot breath, cough, sore throat, runny nose, chills, and weak. On an unspecified date, the patient experienced heart/chest hurt, back hurts, everything hurts, coughing up phlegm, curl up and die, arm hurt like hell, tired, and sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt like hell, had not recovered from cannot breath, chills, weak, cough, sore throat, runny nose, back hurts, heart/chest hurt, everything hurts, tired, coughing up phlegm, and sick to stomach, and the outcome of curl up and die was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Nausea, Oropharyngeal pain
Clinical narrative: HEART/CHEST HURT; BACK HURTS; EVERYTHING HURTS; COUGHING UP PHLEGM; CURL UP AND DIE; ARM HURT LIKE HELL; TIRED; SICK TO STOMACH; WEAK; CHILLS; CANNOT BREATH; COUGH; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 13-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 14-JAN-2022, the patient experienced cannot breath, cough, sore throat, runny nose, chills, and weak. On an unspecified date, the patient experienced heart/chest hurt, back hurts, everything hurts, coughing up phlegm, curl up and die, arm hurt like hell, tired, and sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt like hell, had not recovered from cannot breath, chills, weak, cough, sore throat, runny nose, back hurts, heart/chest hurt, everything hurts, tired, coughing up phlegm, and sick to stomach, and the outcome of curl up and die was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Productive cough, Rhinorrhoea
Clinical narrative: HEART/CHEST HURT; BACK HURTS; EVERYTHING HURTS; COUGHING UP PHLEGM; CURL UP AND DIE; ARM HURT LIKE HELL; TIRED; SICK TO STOMACH; WEAK; CHILLS; CANNOT BREATH; COUGH; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 13-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 14-JAN-2022, the patient experienced cannot breath, cough, sore throat, runny nose, chills, and weak. On an unspecified date, the patient experienced heart/chest hurt, back hurts, everything hurts, coughing up phlegm, curl up and die, arm hurt like hell, tired, and sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt like hell, had not recovered from cannot breath, chills, weak, cough, sore throat, runny nose, back hurts, heart/chest hurt, everything hurts, tired, coughing up phlegm, and sick to stomach, and the outcome of curl up and die was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 36 year old male of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: Unknown) dose was not reported, dose number in series 1, 01 in total was administered on 08-JUL-2021 to left arm for prophylactic vaccination. On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, he had symptoms of corona virus disease (COVID) (suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection and route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, dose number in series 2, 01 in total was administered in mid of SEP-2021 for prophylactic vaccination which was off label use and inappropriate schedule of drug administration (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, the patient had symptoms of corona virus disease (COVID) (suspected covid-19 infection) (dose number series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, off label use and inappropriate schedule of drug administration was not reported (dose number series 2). This report was non-serious. This case, involving the same patient is linked to 20220140123.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYZED; This spontaneous report received from a consumer via social media through a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was paralyzed. The reporter stated, his brother was also paralyzed after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220150254 -covid-19 vaccine ad26.cov2.s - Paralyzed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid. Laboratory data (dates unspecified) included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220150408 and 20220150229.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: getting sick; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick) and COVID-19 (tested positive for COVID-19) 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 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 (getting sick) and COVID-19 (tested positive for COVID-19). At the time of the report, ILLNESS (getting sick) outcome was unknown and COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient queried when will he be able to get his Moderna booster dose.  No concomitant medications details were reported. No treatment information details were reported. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with unknown medical history, who experienced the unexpected, non-serious authority event of COVID-19. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. COVID-19 virus test was initially positive; however, recently, patient had a negative result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Follow up received on 24 Jan 2022 added No New Information; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with unknown medical history, who experienced the unexpected, non-serious authority event of COVID-19. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. COVID-19 virus test was initially positive; however, recently, patient had a negative result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: mRNA vaccine induced myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (mRNA vaccine induced myocarditis) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        Concurrent medical conditions included Hypertension and Prediabetes.    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (mRNA vaccine induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (mRNA vaccine induced myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: elevated (High) Elevated. On an unknown date, Magnetic resonance imaging heart: myocarditis Myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (mRNA vaccine induced myocarditis) to be related.    Patient has undiagnosed respiratory illness 6 months prior presentation. But further workup was negative for significant coronary artery disease (CAD) and their disease course was mild.  Concomitant were not reported. This is a literature case concerning a 59-year-old male patient with a medical history of hypertension and glucose tolerance impairment, who experienced the serious expected AESI event of myocarditis. The event occurred within 24 hours after the second dose of the mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no information on additional dosing available. The medical history of hypertension and glucose tolerance impairment considered as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.   This case was linked to MOD-2022-460654 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a literature case concerning a 59-year-old male patient with a medical history of hypertension and glucose tolerance impairment, who experienced the serious expected AESI event of myocarditis. The event occurred within 24 hours after the second dose of the mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no information on additional dosing available. The medical history of hypertension and glucose tolerance impairment considered as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary mass
Clinical narrative: lung nodules and am looking for my second booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PULMONARY MASS (lung nodules and am looking for my second booster) in a 71-year-old patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY MASS (lung nodules and am looking for my second booster). At the time of the report, PULMONARY MASS (lung nodules and am looking for my second booster) outcome was unknown.        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 concomitant medications and no treatment medications were reported. Patient was looking for second booster.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Flare ups; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Flare ups) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Giant cell arteritis (other giant cell arteritis).    On 16-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced CONDITION AGGRAVATED (Flare ups). At the time of the report, CONDITION AGGRAVATED (Flare ups) outcome was unknown.            No concomitant medication information provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: contracting COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (contracting COVID) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (contracting COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (contracting COVID) outcome was unknown.        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.   Patient is enquiring how long should be waited to receive booster shot after contracting COVID-19. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: Palpitations after Dose 2; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (Palpitations after Dose 2) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011520A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction and Hives (Urticaria). Concurrent medical conditions included Drug allergy (itching on body) since 14-Apr-2014, Hyperlipidemia since 07-Apr-2009, Gastroesophageal reflux disease since 07-Apr-2009, Hepatic cyst since 21-Feb-2012 and BPH since 24-Apr-2020. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) from 27-Dec-2021 to an unknown date for BPH, TADALAFIL (CIALIS) from 27-Dec-2021 to an unknown date for Erectile dysfunction, OMEPRAZOLE from 30-Mar-2018 to an unknown date for GERD, MAGNESIUM CHLORIDE from 10-Feb-2021 to 27-Dec-2021 for Nutritional supplement.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2021, the patient experienced PALPITATIONS (Palpitations after Dose 2). At the time of the report, PALPITATIONS (Palpitations after Dose 2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient had no allergies to food, other medications, asthma, hay fever and environmental factors that was known. It was unknown if patient had allergic history of anaphylaxis and had any previous history of allergic/hypersensitivity reactions to vaccine. Patient noticed palpitation for two weeks in Feb 2021 post dose two. Patient started his concomitant drug magnesium chloride.   This case was linked to MOD-2022-456526 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 booster doses administered past 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 booster doses administered past 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 booster doses administered past 12 hours post puncture). On 25-Jan-2022, EXPIRED PRODUCT ADMINISTERED (2 booster doses administered past 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. 1st booster was administered 25Jan2022 at 10:35 AM and the 2nd booster was administered 25-Jan-2022 at 11:45 AM. Date the vial was initially stored in the refrigerator: 18-Jan-2022 at 7:05 AM. Date and time vial was first punctured: 24-Jan-2022 at 9:20AM. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 24-Jan-2022 9:20 AM until 10:35 AM 25-Jan-2022 and until 2nd administration at 11:45 AM 25-Jan-2022.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: fatigue; More than 35 days between Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Covid-19 vaccines) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Covid-19 vaccines). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Covid-19 vaccines) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.            No Concomitant medication was reported.  No Treatment medication was reported.  Patient had received both vaccines in his right arm shoulder deltoid muscle.   This case was linked to MOD-2022-461692 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Follow up information was received contained siginificant information. Contact number was added.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving a dose from a vial after more than 24hours of first puncturing; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial after more than 24hours of first puncturing) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial after more than 24hours of first puncturing). On 26-Jan-2022 at 1:00 PM, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial after more than 24hours of first puncturing) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Significant information received on 26-JAN-2022 Included : Suspect drug Start date, Batch number updated, Dose number updated, Event Outcome updated
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: her arm was red; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (her arm was red) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (her arm was red). At the time of the report, ERYTHEMA (her arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  It was reported that the patient applied ice to reduce the redness.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Patient took an expired Moderna dose out of fridge for 12+ hours.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes near armpits,lasting approximately 36 hours; This spontaneous case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Nodes near armpits,lasting approximately 36 hours) 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.  In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. In December 2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Nodes near armpits,lasting approximately 36 hours). In December 2021, LYMPHADENOPATHY (Swollen Lymph Nodes near armpits,lasting approximately 36 hours) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.  The physician reports receiving 50 mcg vaccine booster dose in December and experiencing swollen lymph nodes near armpits, lasting approximately 36 hours. Resolved without further complications.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had an adverse effect from the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an adverse effect from the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse effect from the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had an adverse effect from the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaxination durning pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaxination durning pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3006324) 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) (Intramuscular) .25 milliliter. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaxination durning pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaxination durning pregnancy) had resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. grav in hebd 20+0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Underdose, Wrong product administered
Clinical narrative: 65 year old patient received the FLUZONE QIV instead of receiving the FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 65 years old male patient who received the fluzone qiv instead of receiving the fluzone high dose quadrivalent with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-JAN-2022, the patient received a  0.1ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On 17-JAN-2022 the patient developed a non-serious event, "65 year old patient received the fluzone qiv instead of receiving the fluzone high dose quadrivalent with no reported adverse event" (wrong product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "Nurse is wanting to know if the patient should get revaccinated with the FLUZONE HIGH DOSE QUADRIVALENT."  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (65 year old patient received the FLUZONE QIV instead of receiving the FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event).  At time of reporting, the outcome was Unknown for the event 65 year old patient received the fluzone qiv instead of receiving the fluzone high dose quadrivalent with no reported adverse 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.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 61 year old patient who was inadvertently given the Fluzone HD with no reported adverse event; Initial information received on 20-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 61 years old and unknown gender patient who experienced 61 year old patient who was inadvertently given the fluzone hd with no reported adverse event while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  (lot number, strength and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious 61 year old patient who was inadvertently given the fluzone hd with no reported adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE HIGH DOSE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (61 year old patient who was inadvertently given the Fluzone HD with no reported adverse event).  At time of reporting, the outcome was Unknown for the event 61 year old patient who was inadvertently given the fluzone hd with no reported adverse 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.
Sex: U
Vaccine: FLUX
Symptoms: Erythema
Clinical narrative: extra rosy cheeks; Initial information received on 19-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via digital media.  This case involves Adult of unknown gender patient who experienced extra rosy cheeks ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), 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 (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event" extra rosy cheeks" (erythema) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Yes  I got two vaccines and a booster and a flu shot and a shingles jab... I feel like by March I'll be ready for whole new reset with another new kind of vaccine. After the last flu shot I don't think I had any side effects except extra rosy cheeks."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (extra rosy cheeks).  At time of reporting, the outcome was Unknown for the event extra rosy cheeks.
Age: 2.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: injected only half of the dose (0.25) with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years and 4 months old child patient (10 kg) who experienced injected only half of the dose (0.25) with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received only 0.25(half dose) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE injection (strength, frequency was unknown, lot U7196AB and expiry date was unknown) via intramuscular route in Left leg for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "injected only half of the dose (0.25) with no reported adverse event" (incorrect dose administered) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported"Our child is 2 years and 4 months old (but weight only 10kg). Doctor tried to inject Menactra (series U7196AB) into the left leg (intramuscularly), but child unexpectedly moved. Doctor injected only half of the dose (0.25). Please advise, what should we do in this situation? Doctor suggests: enter another half dose (0.25) after 2 weeks. And then give a second dose after 3-6 months. Please, we need your advice."  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (injected only half of the dose (0.25) with no reported adverse event).  At time of reporting, the outcome was Unknown for the event injected only half of the dose (0.25) with no reported adverse event.
Age: 1.5
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Medication error, Peripheral swelling, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: child's arm is red and swollen; child's arm is red and swollen; 18 month old child was given ADACEL by mistake; Initial information received on 21-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 months old and unknown gender patient who whose arm is red and swollen, child's arm is red and swollen and 18 month old child was given adacel by mistake while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.25 mL to 2mL lot number not reported via unknown route in unknown administration site for immunization.In the context of COVID-19 crisis, the batch no and expiration date were not requested.  On 19-Jan-2022 the patient developed a non-serious event "18 month old child was given adacel by mistake" (product use issue) (latency-Same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 21-JAN-2022 the patient developed a non-serious event "child's arm is red and swollen" (peripheral swelling) (latency-2 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 21-JAN-2022 the patient developed a non-serious event child's arm is red and swollen (erythema)(latency-2 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "parents of an 18 month old child brought their child into the pharmacy today 21Jan2022; states 2 days ago they went to an urgent care nearby and the 18 month old child was given ADACEL by mistake. Pharmacist states that today the child's arm is red and swollen. Pharmacist asks what they should do and if there is any information about ADACEL given to a child that young".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (child's arm is red and swollen, child's arm is red and swollen).  At time of reporting, the outcome was Unknown for the event child's arm is red and swollen, was Unknown for the event child's arm is red and swollen and was Unknown for the event 18 month old child was given adacel by mistake.  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.
Age: 1.5
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: child's arm is red and swollen; child's arm is red and swollen; 18 month old child was given ADACEL by mistake; Initial information received on 21-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 months old and unknown gender patient who whose arm is red and swollen, child's arm is red and swollen and 18 month old child was given adacel by mistake while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.25 mL to 2mL lot number not reported via unknown route in unknown administration site for immunization.In the context of COVID-19 crisis, the batch no and expiration date were not requested.  On 19-Jan-2022 the patient developed a non-serious event "18 month old child was given adacel by mistake" (product use issue) (latency-Same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 21-JAN-2022 the patient developed a non-serious event "child's arm is red and swollen" (peripheral swelling) (latency-2 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 21-JAN-2022 the patient developed a non-serious event child's arm is red and swollen (erythema)(latency-2 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "parents of an 18 month old child brought their child into the pharmacy today 21Jan2022; states 2 days ago they went to an urgent care nearby and the 18 month old child was given ADACEL by mistake. Pharmacist states that today the child's arm is red and swollen. Pharmacist asks what they should do and if there is any information about ADACEL given to a child that young".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (child's arm is red and swollen, child's arm is red and swollen).  At time of reporting, the outcome was Unknown for the event child's arm is red and swollen, was Unknown for the event child's arm is red and swollen and was Unknown for the event 18 month old child was given adacel by mistake.  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.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: medical assistant administered the diluent portion only of a PENTACEL vaccine with no reported adverse event; Initial information received on 21-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom medical assistant administered the diluent portion only of a pentacel vaccine with no reported adverse event ,while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 21-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection (lot UJ57AAA) at a dose of 0.5ml via intramuscular route in the left thigh as prophylactic vaccination.  On 21-JAN-2022, the patient developed a non-serious event " medical assistant administered the diluent portion only of a pentacel vaccine with no reported adverse event" (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported"a medical assistant administered the diluent portion only of a PENTACEL vaccine."  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medical assistant administered the diluent portion only of a PENTACEL vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event medical assistant administered the diluent portion only of a pentacel vaccine with no reported adverse event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Parapsoriasis
Clinical narrative: I developed pityriasis lichenoide (per biopsy) within close proximity to booster with Pfizer. Per dermatologist could have been triggered by booster dose, also had flu vaccine 2-3 weeks prior.  If/when next booster is needed I will get Moderna.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Developed full body dermatographism after no previous history with the condition. Pressure applied to my skin results in an itchy welt that remains for 30-60 minutes. Unable to see my PCP at the moment, managing symptoms with antihistamines and lifestyle changes.