chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Sneezing
Clinical narrative: Sneezing; head feels stuffy; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing) and HEAD DISCOMFORT (head feels stuffy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 030l20a) for COVID-19 vaccination. Concurrent medical conditions included Cancer and Allergy. Concomitant products included GANCICLOVIR, METOPROLOL, PREGABALIN and MONTELUKAST for an unknown indication.On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SNEEZING (Sneezing) and HEAD DISCOMFORT (head feels stuffy). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (DAYQUIL COLD & FLU) for Sneezing, at an unspecified dose and frequency. At the time of the report, SNEEZING (Sneezing) and HEAD DISCOMFORT (head feels stuffy) outcome was unknown. Concomitant medication also included bupropion XR, allergy medications. Patient had experienced the following symptoms: sneezing, and head felt stuffy. Patient was about to have cancer surgery the following day 12-Nov-2021, diagnosis was received before receiving the first dose of the Moderna COVID-19 vaccine. This case was linked to -MODERNATX, INC.-MOD-2021-387014 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up appended on 15-Nov-2021 event occurred on 3 dose were provided. New case was created for booster dose (MOD-2021-387014). Sender's Comments: -MODERNATX, INC.-MOD-2021-387014:Case link to same patient containg dose 3 information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness after my first two Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness after my first two Moderna vaccines) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Flu shot (Over many years). Past adverse reactions to the above products included No adverse event with Flu shot.Concurrent medical conditions included BP raised (normal readings with medication. Lowered to 150mg) since 06-Jan-1999, Asthma on 04-Jan-2006, Sleep apnea (changing from CPAP to oral device) since 03-Jan-2020 and Penicillin allergy (Allergy to penicillin). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA) from 04-Jan-2006 to an unknown date and MONTELUKAST from 04-Jan-2006 to an unknown date for Asthma, IRBESARTAN from 06-Jan-1999 to an unknown date and HYDROCHLOROTHIAZIDE from 06-Jan-1999 to an unknown date for BP raised, COLECALCIFEROL (D3) for an unknown indication. 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 TENDERNESS (Tenderness after my first two Moderna vaccines). At the time of the report, TENDERNESS (Tenderness after my first two Moderna vaccines) outcome was unknown. Not provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TENDERNESS (Tenderness after my first two Moderna vaccines) to be possibly related.  Patient took flu shot years ago.No treatment information was provided. Company Comment: This spontaneous case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of tenderness following administration of the second dose of the Moderna mRNA-1273. The start date of the event was not provided. The rechallenge was not applicable since no information about the first dose is available. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.This case was linked to MOD-2021-385483, MOD-2021-367382, MOD-2021-367382 (Patient Link). Sender's Comments: This spontaneous case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of tenderness following administration of the second dose of the Moderna mRNA-1273. The start date of the event was not provided. The rechallenge was not applicable since no information about the first dose is available. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three). patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three). Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three).) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three).) 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 (patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three).) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three).) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three).) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment information was not provided. This case was linked to MOD-2021-382739, MOD-2021-385622 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patients that received vaccines from the affected lots after the temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Treatment information was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes swelling) in a 41-year-old female patient 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 LYMPHADENOPATHY (lymph nodes swelling). At the time of the report, LYMPHADENOPATHY (lymph nodes swelling) outcome was unknown.            No Concomitant medication was reported.     No treatment medications were reported   This case was linked to MOD-2021-385856, MOD-2021-385704 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction after the vaccine received last week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction after the vaccine received last week) 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 (Adverse reaction after the vaccine received last week). At the time of the report, VACCINATION COMPLICATION (Adverse reaction after the vaccine received last week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Glucose tolerance impaired
Clinical narrative: prediabetic; absolutely intense fatigue; Still a mess; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Still a mess), FATIGUE (absolutely intense fatigue) and GLUCOSE TOLERANCE IMPAIRED (prediabetic) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 16-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced CONFUSIONAL STATE (Still a mess). On 19-Oct-2021, the patient experienced FATIGUE (absolutely intense fatigue). On an unknown date, the patient experienced GLUCOSE TOLERANCE IMPAIRED (prediabetic). At the time of the report, CONFUSIONAL STATE (Still a mess) had not resolved and FATIGUE (absolutely intense fatigue) and GLUCOSE TOLERANCE IMPAIRED (prediabetic) outcome was unknown.            Concomitant medications were not provided. Treatment medications were not provided. Patient mentioned to discover to be prediabetic following the booster shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: Soreness about a quarter of the way from the injection site into my chest area; Soreness about a quarter of the way from the injection site into my chest area; Sweat; Soreness,Soreness has increased; Headache,Still have the headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness,Soreness has increased), PAIN (Soreness about a quarter of the way from the injection site into my chest area), HYPERHIDROSIS (Sweat), INJECTION SITE PAIN (Soreness about a quarter of the way from the injection site into my chest area) and HEADACHE (Headache,Still have the headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergies). Concomitant products included LORATADINE for Allergy, AMLODIPINE, ATORVASTATIN, GABAPENTIN, CINNAMOMUM CASSIA BARK (CINNAMON [CINNAMOMUM CASSIA BARK]), LOSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN), GUAIFENESIN (MUCINEX), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), FLUOXETINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN (Soreness,Soreness has increased), HYPERHIDROSIS (Sweat), HEADACHE (Headache,Still have the headache), CHILLS (Chills) and PYREXIA (Fever). On 12-Nov-2021, the patient experienced PAIN (Soreness about a quarter of the way from the injection site into my chest area) and INJECTION SITE PAIN (Soreness about a quarter of the way from the injection site into my chest area). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Soreness,Soreness has increased), PAIN (Soreness about a quarter of the way from the injection site into my chest area), INJECTION SITE PAIN (Soreness about a quarter of the way from the injection site into my chest area) and HEADACHE (Headache,Still have the headache) had not resolved and HYPERHIDROSIS (Sweat), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            The patient post receiving their booster shot stated they had a fever and had chills and sweat. The patient also experienced soreness and headache. On 12-Nov-2021, the patient had soreness about a quarter of the way from the injection site into their chest area. Reportedly, the patient still had the headache and soreness and reported that the soreness had increased.  Other treatment medication reported included Advio-PM
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Soreness about a quarter of the way from the injection site into my chest area; Soreness about a quarter of the way from the injection site into my chest area; Sweat; Soreness,Soreness has increased; Headache,Still have the headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness,Soreness has increased), PAIN (Soreness about a quarter of the way from the injection site into my chest area), HYPERHIDROSIS (Sweat), INJECTION SITE PAIN (Soreness about a quarter of the way from the injection site into my chest area) and HEADACHE (Headache,Still have the headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergies). Concomitant products included LORATADINE for Allergy, AMLODIPINE, ATORVASTATIN, GABAPENTIN, CINNAMOMUM CASSIA BARK (CINNAMON [CINNAMOMUM CASSIA BARK]), LOSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN), GUAIFENESIN (MUCINEX), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), FLUOXETINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN (Soreness,Soreness has increased), HYPERHIDROSIS (Sweat), HEADACHE (Headache,Still have the headache), CHILLS (Chills) and PYREXIA (Fever). On 12-Nov-2021, the patient experienced PAIN (Soreness about a quarter of the way from the injection site into my chest area) and INJECTION SITE PAIN (Soreness about a quarter of the way from the injection site into my chest area). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Soreness,Soreness has increased), PAIN (Soreness about a quarter of the way from the injection site into my chest area), INJECTION SITE PAIN (Soreness about a quarter of the way from the injection site into my chest area) and HEADACHE (Headache,Still have the headache) had not resolved and HYPERHIDROSIS (Sweat), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            The patient post receiving their booster shot stated they had a fever and had chills and sweat. The patient also experienced soreness and headache. On 12-Nov-2021, the patient had soreness about a quarter of the way from the injection site into their chest area. Reportedly, the patient still had the headache and soreness and reported that the soreness had increased.  Other treatment medication reported included Advio-PM
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caught COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Caught COVID) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (Caught COVID). At the time of the report, COVID-19 (Caught 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.   No concomitant medications were reported. No treatment medications were reported.  Batch number of the suspect product is unknown.  Around 01-Nov-2021, patient caught COVID and just got out of quarantine yesterday 11-Nov-2021. Patient's second dose of Moderna is scheduled on 18-Nov-2021. The pharmacist wants to know whether patient should be given second shot, or will it be delayed.  This case concerns a 33-year-old male patient without relevant medical history provided, who experienced the unexpected non- serious event of special interest, COVID-19. Reportedly, the event occurred about 10 days after the patient had received the first dose of mRNA-1273 vaccine (the exact start date of event will be requested). The outcome of the event was not specified at the time of this report, and information regarding the clinical course of the event was not provided. The re-challenge cannot be determined as the outcome of the event is unknown at this moment. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 33-year-old male patient without relevant medical history provided, who experienced the unexpected non- serious event of special interest, COVID-19. Reportedly, the event occurred about 10 days after the patient had received the first dose of mRNA-1273 vaccine (the exact start date of event will be requested). The outcome of the event was not specified at the time of this report, and information regarding the clinical course of the event was not provided. The re-challenge cannot be determined as the outcome of the event is unknown at this moment. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ILLNESS (Got very sick). At the time of the report, ILLNESS (Got very sick) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late; Interchange of vaccine products; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 (1st dose) in March 2021.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Feeling abnormal, Heart rate abnormal, Nausea
Clinical narrative: Diagnosed with Atrial Fibrillation; Heart started going strange; felt funny; Severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with Atrial Fibrillation) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0S(5)8F0IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation in 2006.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced NAUSEA (Severe nausea). On 03-Nov-2021, the patient experienced HEART RATE ABNORMAL (Heart started going strange) and FEELING ABNORMAL (felt funny). On 08-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (Diagnosed with Atrial Fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with Atrial Fibrillation), HEART RATE ABNORMAL (Heart started going strange), FEELING ABNORMAL (felt funny) and NAUSEA (Severe nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2021, Electrocardiogram: abnormal (abnormal) Atrial Fibrillation.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company comment: This case concerns a 76-year-old female patient with relevant medical history of Atrial fibrillation in 2006, who experienced the unexpected event of Atrial Fibrillation. The event occurred 6 days after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Atrial fibrillation in 2006 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 76-year-old female patient with relevant medical history of Atrial fibrillation in 2006, who experienced the unexpected event of Atrial Fibrillation. The event occurred 6 days after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Atrial fibrillation in 2006 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: is unusual this large welt; had a bodily reaction/never having a reaction like this before on any vaccine; arm start itching like crazy; arm started to swelled up; entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (is unusual this large welt), VACCINATION COMPLICATION (had a bodily reaction/never having a reaction like this before on any vaccine), VACCINATION SITE PRURITUS (arm start itching like crazy), VACCINATION SITE SWELLING (arm started to swelled up) and VACCINATION SITE RASH (entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033FC1A, 004M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (is unusual this large welt), VACCINATION COMPLICATION (had a bodily reaction/never having a reaction like this before on any vaccine), VACCINATION SITE PRURITUS (arm start itching like crazy), VACCINATION SITE SWELLING (arm started to swelled up) and VACCINATION SITE RASH (entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (is unusual this large welt) and VACCINATION SITE RASH (entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep) had not resolved and VACCINATION COMPLICATION (had a bodily reaction/never having a reaction like this before on any vaccine), VACCINATION SITE PRURITUS (arm start itching like crazy) and VACCINATION SITE SWELLING (arm started to swelled up) outcome was unknown.            Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Product administration interrupted, Product availability issue
Clinical narrative: My heart rate go up; An illness where I ended up having a procedure and surgery; I never received my 2nd dose due to issues at the time not getting them where I lived.; I never received my 2nd dose due to issues at the time not getting them where I lived.; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (My heart rate go up), ILLNESS (An illness where I ended up having a procedure and surgery), PRODUCT ADMINISTRATION INTERRUPTED (I never received my 2nd dose due to issues at the time not getting them where I lived.) and PRODUCT AVAILABILITY ISSUE (I never received my 2nd dose due to issues at the time not getting them where I lived.) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (My heart rate go up), ILLNESS (An illness where I ended up having a procedure and surgery), PRODUCT ADMINISTRATION INTERRUPTED (I never received my 2nd dose due to issues at the time not getting them where I lived.) and PRODUCT AVAILABILITY ISSUE (I never received my 2nd dose due to issues at the time not getting them where I lived.). The patient was treated with Surgery for Illness. At the time of the report, HEART RATE INCREASED (My heart rate go up), PRODUCT ADMINISTRATION INTERRUPTED (I never received my 2nd dose due to issues at the time not getting them where I lived.) and PRODUCT AVAILABILITY ISSUE (I never received my 2nd dose due to issues at the time not getting them where I lived.) had resolved and ILLNESS (An illness where I ended up having a procedure and surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose in Jan-2021 and never received their 2nd dose due to issues at the time not getting them where the patient lived. The patient was also concerned because the first dose they received made their heart rate go up but did not experience chest pains or shortness of breath. Reportedly, once 2nd dose was available, but the patient tends to an illness where they ended up having a procedure and surgery. Now it has been 10 months, the patient still didn't get their second dose. At the time of report the patient didn't had issues with their heart.  No Concomitant product use was reported. No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a rash on his arm from elbow to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 003B21A, and 027L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter. Concomitant products included ALLOPURINOL, METFORMIN, METHENAMINE, WARFARIN and ATORVASTATIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RASH. At the time of the report, RASH had not resolved.           No treatment information were provided.   Reporter did not allow further contact.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia, Vaccination site discomfort, Vaccination site pain
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of vaccination site pain (slight tenderness in the right arm after booster), vaccination site discomfort (discomfort in the right arm after booster), feeling abnormal (did not feel like himself after booster) and pyrexia (fever 100.2ºF after booster) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013F21A) for COVID-19 immunization. No medical history reported. On Nov 10, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient experienced vaccination site discomfort (discomfort in the right arm after booster), feeling abnormal (did not feel like himself after booster) and pyrexia (fever 100.2ºF after booster). On Nov 12, 2021, patient experienced vaccination site pain (slight tenderness in the right arm after booster). On Nov 12, 2021, vaccination site discomfort (discomfort in the right arm after booster), feeling abnormal (did not feel like himself after booster) and pyrexia (fever 100.2ºF after booster) resolved. At the time of the report, vaccination site pain (slight tenderness in the right arm after booster): not resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Inappropriate schedule of product administration, Insomnia, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION, PRURITUS, INSOMNIA, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 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 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced BURNING SENSATION, PRURITUS, and INSOMNIA. On 27-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 27-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved. At the time of the report, BURNING SENSATION, PRURITUS, and INSOMNIA outcome was unknown.            No concomitant medication and treatment reported. Patient stated they were only able to get 3 hours sleep because they believe it might be an interaction from the vaccine and drugs.  This is a case of Inappropriate Schedule of Product Administration concerning a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Burning Sensation, Pruritus, and Insomnia. The event occurred the same month after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since outcome of events from first dose was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-385687 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of accidental underdose (received a booster instead of a third dose/immunocompromised patient given 0.25mL dose for the third dose, instead of a full dose of 0.5mL) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 017F21A) for COVID-19 immunization. Concurrent medical conditions included immunocompromised. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25 milliliter. On Nov 10, 2021, patient experienced accidental underdose (received a booster instead of a third dose/immunocompromised patient given 0.25mL dose for the third dose, instead of a full dose of 0.5mL). On Nov 10, 2021, accidental underdose (received a booster instead of a third dose/immunocompromised patient given 0.25mL dose for the third dose, instead of a full dose of 0.5mL) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Nov 12, 2021: significant follow-up appended, reporter details, patient demographics and patient's current condition updated.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (9 year old received full dose of Moderna) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (9 year old received full dose of Moderna). On 11-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (9 year old received full dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria, Vaccination complication
Clinical narrative: a full body rash of hives/ full body welts; 1st dose on 13Jan2021 and 2nd dose on 2Feb2021; delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 13Jan2021 and 2nd dose on 2Feb2021), VACCINATION COMPLICATION (delayed reaction) and URTICARIA (a full body rash of hives/ full body welts) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 13Jan2021 and 2nd dose on 2Feb2021). In 2021, the patient experienced VACCINATION COMPLICATION (delayed reaction). On 05-Nov-2021, the patient experienced URTICARIA (a full body rash of hives/ full body welts). On 02-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 13Jan2021 and 2nd dose on 2Feb2021) had resolved. At the time of the report, VACCINATION COMPLICATION (delayed reaction) outcome was unknown and URTICARIA (a full body rash of hives/ full body welts) had not resolved.            No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-385754 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Rash
Clinical narrative: Seen on Reddit that others experienced rash and Bells Palsy after receiving the vaccine; Seen on Reddit that others experienced rash and Bells Palsy after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Seen on Reddit that others experienced rash and Bells Palsy after receiving the vaccine) in a  patient of an unknown age and gender 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 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 BELL'S PALSY (Seen on Reddit that others experienced rash and Bells Palsy after receiving the vaccine) (seriousness criterion medically significant) and RASH (Seen on Reddit that others experienced rash and Bells Palsy after receiving the vaccine). At the time of the report, BELL'S PALSY (Seen on Reddit that others experienced rash and Bells Palsy after receiving the vaccine) and RASH (Seen on Reddit that others experienced rash and Bells Palsy after receiving the 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.  Company Comment: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the expected event of Bell's Palsy. The event occurred on an unknown date after receiving an unknown dose number of mRNA-1273 Vaccine. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-386032 (Patient Link).; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the expected event of Bell's Palsy. The event occurred on an unknown date after receiving an unknown dose number of mRNA-1273 Vaccine. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammatory response; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammatory response) 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 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammatory response). At the time of the report, INFLAMMATION (Inflammatory response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given by reporter. No treatment medication was given by reporter.  Company Comment : This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event of Inflammatory reaction after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information was provided. The rechallenge is not applicable since only information about one dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event of Inflammatory reaction after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information was provided. The rechallenge is not applicable since only information about one dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Low white blood cell count after Moderna Covid-19 vaccine primary series; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (Low white blood cell count after Moderna Covid-19 vaccine primary series) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (Low white blood cell count after Moderna Covid-19 vaccine primary series). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (Low white blood cell count after Moderna Covid-19 vaccine primary series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, White blood cell count: low (Low) Low white blood cell count after receiving her primary series of the Covid-19 vaccine..         No Concomitant medication were reported. No treatment medication were reported.  The patient received her second Moderna Covid-19 vaccine on date not given.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: soreness in the arm for like 3 days; little fever of maximum 99°F for 3-4 hours.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm for like 3 days) and PYREXIA (little fever of maximum 99°F for 3-4 hours.) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm for like 3 days) and PYREXIA (little fever of maximum 99°F for 3-4 hours.). On 08-Apr-2021, PYREXIA (little fever of maximum 99°F for 3-4 hours.) had resolved. On 10-Apr-2021, PAIN IN EXTREMITY (soreness in the arm for like 3 days) had resolved.            The patient has an appointment to get the booster dose next Monday. They inquired if they should skip taking their supplements with bioflavonoids from grape seeds that act as blood thinner for that day. As concomitant medication the patient was taking 0.5mcg thyroid medication for less active thyroid and Metabolic supplement multivitamin twice, daily, not to get infections/inflammations natural products. regulates blood pressure.  No treatment medication details were provided.   This case was linked to MOD-2021-385733 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise
Clinical narrative: Not feeling to good; Heavy breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Heavy breathing) and MALAISE (Not feeling to good) 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 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced MALAISE (Not feeling to good). In November 2021, the patient experienced DYSPNOEA (Heavy breathing). At the time of the report, DYSPNOEA (Heavy breathing) had not resolved and MALAISE (Not feeling to good) outcome was unknown.            Relevant concomitant medications were not reported. Treatment information was not provided. Patient had heavy breathing during the call (per agent perception)