chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered from a vial punctured over 24 hours before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from a vial punctured over 24 hours before) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered from a vial punctured over 24 hours before). On 16-Jun-2021 at 3:00 AM, EXPIRED PRODUCT ADMINISTERED (dose administered from a vial punctured over 24 hours before) had resolved.        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 product information reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Sick). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Ache, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Ache, at a dose of 1 dosage form. At the time of the report, ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Treatment medication added, event added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Sick). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Ache, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Ache, at a dose of 1 dosage form. At the time of the report, ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Treatment medication added, event added.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: sore arm; a little tired; a little headache; a little nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (a little tired), HEADACHE (a little headache) and NAUSEA (a little nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Peripheral neuropathy (for the past 10 years).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (a little tired), HEADACHE (a little headache) and NAUSEA (a little nausea). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (a little tired), HEADACHE (a little headache) and NAUSEA (a little nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products were not provided. Treatment products were not provided.   This case was linked to MOD-2021-225645 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcomes were updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Vaccination site pain
Clinical narrative: Falls asleep and sleeps for 4-5 hrs; sore arm felt like having a flu shot; Fatigue that is immense and overtakes her body, exhausted, tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision (Ten lymph nodes were taken out due to cancer.). Concurrent medical conditions included Cancer.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired). At the time of the report, INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that after receiving both doses of COVID vaccine, every week the patient had a blow out day where she could not function. Concomitant medication and treatment drug were not reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to MOD-2021-226976 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was opened on 15 Jun 2021 morning around 9:30am and was used for that day and then it was put back to refrigerator and then next day on 16JUN2021, it was taken out of refrigerator and was used from that vial between 10:40am-3:30pm No relevant concomitant medications were reported.. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of pain in extremity (pain in the left arm) and pyrexia (a little bit of fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039B21A and 039C21A) for COVID-19 immunization. No medical history reported. On Apr 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 23, 2021, patient experienced pain in extremity (pain in the left arm) and pyrexia (a little bit of fever). Patient treated with Tylenol (paracetamol); unspecified dose and frequency. At the time of the report, pain in extremity (pain in the left arm) and pyrexia (a little bit of fever) outcome: unknown. Concomitant product use not provided. Patient did not receive any treatment after first dose of vaccine until second dose administration. This case linked to MOD-2021-225658 (patient link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Nausea, Pain in extremity
Clinical narrative: Sore arm; Tired for a couple weeks; Headache; Nausea; Peripheral neuropathy went away after 10 years; Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021), FATIGUE (Tired for a couple weeks) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Peripheral neuropathy (for the past 10 years; it was progressively getting worse.).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea). On 10-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.            No concomitant medications were reported.  The patient had the same side effects as with her first dose but a little worse.  No treatment information was provided.   This case was linked to MOD-2021-225639 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcomes updated.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Sore arm; Tired for a couple weeks; Headache; Nausea; Peripheral neuropathy went away after 10 years; Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021), FATIGUE (Tired for a couple weeks) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Peripheral neuropathy (for the past 10 years; it was progressively getting worse.).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea). On 10-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.            No concomitant medications were reported.  The patient had the same side effects as with her first dose but a little worse.  No treatment information was provided.   This case was linked to MOD-2021-225639 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcomes updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Pain spread to the entire body; Pain in the hip; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the hip) and MYALGIA (Pain spread to the entire body) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA) and SIMVASTATIN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRALGIA (Pain in the hip) and MYALGIA (Pain spread to the entire body). The patient was treated with CORTISONE at an unspecified dose and frequency and MELOXICAM at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Pain in the hip) and MYALGIA (Pain spread to the entire body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable  Treatment information included two rounds of oral steroids.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait inability, Joint injury, Limb injury, Myalgia
Clinical narrative: the legs hurt too; the whole body hurt; fell and hit her foot and knee; fell and hit her foot and knee; is not able to walk very well; felt very bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very bad), PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 14-Jun-2021, the patient experienced JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well). On an unknown date, the patient experienced PAIN IN EXTREMITY (the legs hurt too) and MYALGIA (the whole body hurt). On 27-May-2021, FEELING ABNORMAL (felt very bad) had resolved. At the time of the report, PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee), GAIT INABILITY (is not able to walk very well) and MYALGIA (the whole body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications included, medications for diabetes, cholesterol and burning/tingling feet associated to diabetes.  Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the legs hurt too; the whole body hurt; fell and hit her foot and knee; fell and hit her foot and knee; is not able to walk very well; felt very bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very bad), PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 14-Jun-2021, the patient experienced JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well). On an unknown date, the patient experienced PAIN IN EXTREMITY (the legs hurt too) and MYALGIA (the whole body hurt). On 27-May-2021, FEELING ABNORMAL (felt very bad) had resolved. At the time of the report, PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee), GAIT INABILITY (is not able to walk very well) and MYALGIA (the whole body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications included, medications for diabetes, cholesterol and burning/tingling feet associated to diabetes.  Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Painful injection arm that is hard to lift above the head; Painful injection arm that is hard to lift above the head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful injection arm that is hard to lift above the head) and JOINT RANGE OF MOTION DECREASED (Painful injection arm that is hard to lift above the head) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21a and 048b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful injection arm that is hard to lift above the head) and JOINT RANGE OF MOTION DECREASED (Painful injection arm that is hard to lift above the head). At the time of the report, PAIN IN EXTREMITY (Painful injection arm that is hard to lift above the head) and JOINT RANGE OF MOTION DECREASED (Painful injection arm that is hard to lift above the head) outcome was unknown.            Patient reported no known allergies and not taking any concomitant medication  Treatment information reported that patient not yet contacted his healthcare provider regarding the side effects and has not taken any medication to alleviate the pain
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: The red itches and has spread to above my elbow.; There is a large bump at the injection site and goes; It is dark red at the site where the needle was inserted.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.) 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 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.). At the time of the report, VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.) had not resolved.            Hello PII(32):Aeq9Braioi0yJBuRYUX2iX2XzwooAA==.  I received my 2nd vaccine on Thursday 6/3/21. I have a large red spot on my arm   It is dark red at the site where the needle was inserted. The red itches and has spread to above my elbow. There is a large bump at the injection site and goes
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Blood glucose increased, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Hives; BP getting higher; Shortness of breath; Chest pain; sugar off; Swollen lymph neck nodes; Fatigue; 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 URTICARIA (Hives), HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and BLOOD GLUCOSE FLUCTUATION (sugar off) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), BLOOD GLUCOSE FLUCTUATION (sugar off), LYMPHADENOPATHY (Swollen lymph neck nodes) and FATIGUE (Fatigue). At the time of the report, URTICARIA (Hives) had resolved and HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), BLOOD GLUCOSE FLUCTUATION (sugar off), LYMPHADENOPATHY (Swollen lymph neck nodes) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Lymphadenopathy, Urticaria
Clinical narrative: Hives; BP getting higher; Shortness of breath; Chest pain; sugar off; Swollen lymph neck nodes; Fatigue; 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 URTICARIA (Hives), HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and BLOOD GLUCOSE FLUCTUATION (sugar off) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), BLOOD GLUCOSE FLUCTUATION (sugar off), LYMPHADENOPATHY (Swollen lymph neck nodes) and FATIGUE (Fatigue). At the time of the report, URTICARIA (Hives) had resolved and HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), BLOOD GLUCOSE FLUCTUATION (sugar off), LYMPHADENOPATHY (Swollen lymph neck nodes) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Persistent unbearable nauea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Persistent unbearable nauea) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Persistent unbearable nauea). At the time of the report, NAUSEA (Persistent unbearable nauea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   no concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: I'm getting up and I feel like I was hit by a truck; the arm I got it in started hurting a lot, I can hardly move my arm; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (I'm getting up and I feel like I was hit by a truck) and PAIN IN EXTREMITY (the arm I got it in started hurting a lot, I can hardly move my arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 test positive (COVID positive) on 16-Jun-2021, Chronic bronchitis since 05-Jan-2017 and Type 2 diabetes mellitus since 07-Jan-2015. Concurrent medical conditions included Drug allergy (Percocet), Drug allergy (Tylenol with Codeine), Drug allergy (Oxycontin) and Drug allergy (Compazine). Concomitant products included LANSOPRAZOLE for Gastritis, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Herpes NOS, LISINOPRIL for Hypertension, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Major depressive disorder, BUPROPION for Smoking cessation therapy.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (I'm getting up and I feel like I was hit by a truck) and PAIN IN EXTREMITY (the arm I got it in started hurting a lot, I can hardly move my arm). At the time of the report, MALAISE (I'm getting up and I feel like I was hit by a truck) and PAIN IN EXTREMITY (the arm I got it in started hurting a lot, I can hardly move my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: added vaccination details, medical and drug history
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test abnormal
Clinical narrative: Abnormal liver function test; This spontaneous case was reported by a nurse and describes the occurrence of LIVER FUNCTION TEST ABNORMAL (Abnormal liver function test) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included BENZOYL PEROXIDE, CLINDAMYCIN PHOSPHATE (BENZACLIN TOPICAL) for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced LIVER FUNCTION TEST ABNORMAL (Abnormal liver function test). At the time of the report, LIVER FUNCTION TEST ABNORMAL (Abnormal liver function test) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose interval exceeded/2nd dose not received; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose interval exceeded/2nd dose not received) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose interval exceeded/2nd dose not received). On 08-Feb-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose interval exceeded/2nd dose not received) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not provided.  Concomitant medications was not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Lymphadenopathy, Pyrexia, Vaccination site discomfort
Clinical narrative: ball under my armpit on the same side that I received the vaccine, it was scary; Warm to touch around the injection site; it is a sensitive area, around the injection site; an incontrollable fever up to 108F; 2nd dose was given >36 days after the 1st dose; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose), PYREXIA (an incontrollable fever up to 108F), LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE WARMTH (Warm to touch around the injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2016, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose). On 15-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (an incontrollable fever up to 108F). On 16-Jun-2021, the patient experienced LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE WARMTH (Warm to touch around the injection site) and VACCINATION SITE DISCOMFORT (it is a sensitive area, around the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 milligram. On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose) had resolved. At the time of the report, PYREXIA (an incontrollable fever up to 108F), LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE WARMTH (Warm to touch around the injection site) and VACCINATION SITE DISCOMFORT (it is a sensitive area, around the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature: 108 (High) Fever.         No concomitant medication information provided.  Treatment also included Ice on patient's head on 15Jun2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   This case was linked to MOD-2021-225644 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: ball under my armpit on the same side that I received the vaccine, it was scary; Warm to touch around the injection site; it is a sensitive area, around the injection site; an incontrollable fever up to 108F; 2nd dose was given >36 days after the 1st dose; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose), PYREXIA (an incontrollable fever up to 108F), LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE WARMTH (Warm to touch around the injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2016, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose). On 15-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (an incontrollable fever up to 108F). On 16-Jun-2021, the patient experienced LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE WARMTH (Warm to touch around the injection site) and VACCINATION SITE DISCOMFORT (it is a sensitive area, around the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 milligram. On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose) had resolved. At the time of the report, PYREXIA (an incontrollable fever up to 108F), LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE WARMTH (Warm to touch around the injection site) and VACCINATION SITE DISCOMFORT (it is a sensitive area, around the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature: 108 (High) Fever.         No concomitant medication information provided.  Treatment also included Ice on patient's head on 15Jun2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   This case was linked to MOD-2021-225644 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: My lungs hurt when I breathe in; 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 PULMONARY PAIN (My lungs hurt when I breathe in) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (My lungs hurt when I breathe in). At the time of the report, PULMONARY PAIN (My lungs hurt when I breathe in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient informed that," lungs hurt when the patient breathe in", and this happened after the shot   . no concomitant and treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection site swell; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site swell) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site swell). At the time of the report, VACCINATION SITE SWELLING (injection site swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed second dose appointment; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed second dose appointment) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed second dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed second dose appointment) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Device connection issue
Clinical narrative: The needle detached from the syringe and the vaccine  spilled out; The needle detached from the syringe and the vaccine  spilled out; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (The needle detached from the syringe and the vaccine  spilled out) and DEVICE CONNECTION ISSUE (The needle detached from the syringe and the vaccine  spilled out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (The needle detached from the syringe and the vaccine  spilled out) and DEVICE CONNECTION ISSUE (The needle detached from the syringe and the vaccine  spilled out). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (The needle detached from the syringe and the vaccine  spilled out) and DEVICE CONNECTION ISSUE (The needle detached from the syringe and the vaccine  spilled out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.    Pharmacist called to report that when she went to give an injection in a patients left arm on 17Jun21 lot3 051C21A the needle detached from the syringe and  the vaccine spilled out.  She did not think the patient got very much of the dose if any. She was going to reinject in opposite arm.  She gives consent to be contacted.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product dose omission issue
Clinical narrative: Second dose Not received >60 days post first dose; Pregnant after First Shot and denied Pregnancy Registry sign up; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant after First Shot and denied Pregnancy Registry sign up) and PRODUCT DOSE OMISSION ISSUE (Second dose Not received >60 days post first dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant after First Shot and denied Pregnancy Registry sign up). On 17-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose Not received >60 days post first dose). On 13-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant after First Shot and denied Pregnancy Registry sign up) had resolved. On 17-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Second dose Not received >60 days post first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The doctor advised not to get the second dose if the patient wants to. The patient is two and a half month pregnant. No relevant concomitant medications were reported. No treatment information was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose after 12hrs of 1st puncture of vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose after 12hrs of 1st puncture of vial) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021 at 10:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose after 12hrs of 1st puncture of vial). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose after 12hrs of 1st puncture of vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was punctured on 15 Jun 2021 at 9am. It was not in the refrigerator and was at the room temperature all the time. No relevant concomitant medications were reported. No treatment information was reported.