chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: diarrhoea (last night); fatigue; left arm became swollen; left arm became red; left arm reacted more; Achiness; loss of appetite; upset stomach; "freezing to death"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (left arm reacted more), PAIN (Achiness), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (upset stomach) and FEELING COLD ("freezing to death") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 002A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to tramadol).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE REACTION (left arm reacted more), PAIN (Achiness), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (upset stomach), FEELING COLD ("freezing to death"), FATIGUE (fatigue), VACCINATION SITE SWELLING (left arm became swollen) and VACCINATION SITE ERYTHEMA (left arm became red). On 07-Nov-2021, the patient experienced DIARRHOEA (diarrhoea (last night)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (left arm reacted more), PAIN (Achiness), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (upset stomach), FEELING COLD ("freezing to death"), DIARRHOEA (diarrhoea (last night)), VACCINATION SITE SWELLING (left arm became swollen) and VACCINATION SITE ERYTHEMA (left arm became red) was resolving and FATIGUE (fatigue) had not resolved.            Concomitant medications were not reported. The caller reported his wife is feeling better on 08 Nov 2021
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back disorder, Gingival pain, Influenza, Pain
Clinical narrative: Sometime she has back problems., not comfortable. not normal.; Her arm hurt as well and was swollen; Her arm hurt as well and was swollen; Almost like the flu; She has no energy; Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over; Jaws hurt; Gums hurt; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Sometime she has back problems., not comfortable. not normal.), PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt), GINGIVAL PAIN (Gums hurt) and PAIN IN EXTREMITY (Her arm hurt as well and was swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Blood pressure high.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt) and GINGIVAL PAIN (Gums hurt). On an unknown date, the patient experienced BACK DISORDER (Sometime she has back problems., not comfortable. not normal.), PAIN IN EXTREMITY (Her arm hurt as well and was swollen), PERIPHERAL SWELLING (Her arm hurt as well and was swollen), INFLUENZA (Almost like the flu) and ASTHENIA (She has no energy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK DISORDER (Sometime she has back problems., not comfortable. not normal.) outcome was unknown and PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt), GINGIVAL PAIN (Gums hurt), PAIN IN EXTREMITY (Her arm hurt as well and was swollen), PERIPHERAL SWELLING (Her arm hurt as well and was swollen), INFLUENZA (Almost like the flu) and ASTHENIA (She has no energy) was resolving.      The patient was on unspecified medications for diabetic and high blood pressure conditions.  The patient received the vaccine in her left arm, which is the non-dominant arm.  The patient was feeling a little better, but she did not feel herself and still not back to normal. The patient was waiting to see her doctor, because the doctor will check her blood work and will check to see if the Moderna COVID-19 vaccine was working.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Peripheral swelling
Clinical narrative: Sometime she has back problems., not comfortable. not normal.; Her arm hurt as well and was swollen; Her arm hurt as well and was swollen; Almost like the flu; She has no energy; Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over; Jaws hurt; Gums hurt; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Sometime she has back problems., not comfortable. not normal.), PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt), GINGIVAL PAIN (Gums hurt) and PAIN IN EXTREMITY (Her arm hurt as well and was swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Blood pressure high.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt) and GINGIVAL PAIN (Gums hurt). On an unknown date, the patient experienced BACK DISORDER (Sometime she has back problems., not comfortable. not normal.), PAIN IN EXTREMITY (Her arm hurt as well and was swollen), PERIPHERAL SWELLING (Her arm hurt as well and was swollen), INFLUENZA (Almost like the flu) and ASTHENIA (She has no energy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK DISORDER (Sometime she has back problems., not comfortable. not normal.) outcome was unknown and PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt), GINGIVAL PAIN (Gums hurt), PAIN IN EXTREMITY (Her arm hurt as well and was swollen), PERIPHERAL SWELLING (Her arm hurt as well and was swollen), INFLUENZA (Almost like the flu) and ASTHENIA (She has no energy) was resolving.      The patient was on unspecified medications for diabetic and high blood pressure conditions.  The patient received the vaccine in her left arm, which is the non-dominant arm.  The patient was feeling a little better, but she did not feel herself and still not back to normal. The patient was waiting to see her doctor, because the doctor will check her blood work and will check to see if the Moderna COVID-19 vaccine was working.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; A little tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Mastectomy (sentinel node or nodes removed - no cancer in nodes) in 2000. Concurrent medical conditions included Herpes NOS (Patient took Acyclovir to suppress herpes.) and Sleep disorder NOS (Patient took Lorazepam 1mg half a pill to help with sleep.). Concomitant products included ACYCLOVIR [ACICLOVIR] for Herpes NOS, LORAZEPAM for Sleep disorder NOS.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tiredness). On 07-Feb-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tiredness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-378306, MOD-2021-378678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Details of medical history was updated.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: notice small red raised area which has been very itchy; notice small red raised area which has been very itchy; had soreness at the injection site with touch after receiving the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had soreness at the injection site with touch after receiving the booster dose), VACCINATION SITE ERYTHEMA (notice small red raised area which has been very itchy) and VACCINATION SITE PRURITUS (notice small red raised area which has been very itchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 012L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (had soreness at the injection site with touch after receiving the booster dose). On 06-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (notice small red raised area which has been very itchy) and VACCINATION SITE PRURITUS (notice small red raised area which has been very itchy). At the time of the report, VACCINATION SITE PAIN (had soreness at the injection site with touch after receiving the booster dose), VACCINATION SITE ERYTHEMA (notice small red raised area which has been very itchy) and VACCINATION SITE PRURITUS (notice small red raised area which has been very itchy) outcome was unknown.            No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm; a little tiredness; 42 days between 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (a little tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 days between 1st and 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Mastectomy (sentinel node or nodes removed - no cancer in nodes) in 2000. Concurrent medical conditions included Sleep disorder NOS (Took Half a pill Lorazepam to help with sleep) and Herpes NOS (Took Acyclovir to suppress herpes.). Concomitant products included ACYCLOVIR [ACICLOVIR] for Herpes NOS, LORAZEPAM for Sleep disorder NOS.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (a little tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 days between 1st and 2nd dose). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 days between 1st and 2nd dose) had resolved. On 21-Mar-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (a little tiredness) had resolved.            No treatment information was provided by the reporter.   This case was linked to MOD-2021-378670 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Details of medical history was updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Some pretty significant side effects; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (Some pretty significant side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some pretty significant side effects). At the time of the report, VACCINATION COMPLICATION (Some pretty significant side effects) 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 concomitant medications were provided by the reporter. No treatment information was provided by the reporter It was reported that the patient did not get the second dose and wanted to get a 1/2 dose instead.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (ill last week), upper abdominal pain (bad stomachache) and headache(s) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (ill last week), upper abdominal pain (bad stomachache) and headache(s). At the time of the report, illness (ill last week), upper abdominal pain (bad stomachache) and headache(s) outcome: unknown. The patient was ill and had a bad stomachache last week (in Nov 2021). She also had headaches. The patient stated she was trying to get her booster shot. Concomitant medications and treatment information not provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After the vial puncture time limit; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the vial puncture time limit) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the vial puncture time limit). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the vial puncture time limit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vial was initially punctured on 14-SEP-2021 at 10:00 AM. Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-378312 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes Zosters Shingles (Acute); This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Herpes Zosters Shingles (Acute)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced HERPES ZOSTER (Herpes Zosters Shingles (Acute)). At the time of the report, HERPES ZOSTER (Herpes Zosters Shingles (Acute)) 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 details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 12-hours post puncture; 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 (Dose administered after 12-hours post puncture) 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 08-Nov-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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12-hours post puncture). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12-hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist stated a vial that was open on Friday 05 Nov 2021 given on 08 Nov 2021 to a patient.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Vaccination complication
Clinical narrative: had the flu symptoms on vaccine 2; was out for about 4 days on vaccine 2; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (had the flu symptoms on vaccine 2) and VACCINATION COMPLICATION (was out for about 4 days on vaccine 2) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Artery dissection (dissected celiac artery) in 2020 and Cardiac arrest (9 years ago she experienced heart attack). Concurrent medical conditions included Heart disease, unspecified.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (had the flu symptoms on vaccine 2) and VACCINATION COMPLICATION (was out for about 4 days on vaccine 2). At the time of the report, INFLUENZA (had the flu symptoms on vaccine 2) and VACCINATION COMPLICATION (was out for about 4 days on vaccine 2) outcome was unknown.            Concomitant medicine included heart medications No treatment information were reported by the reporter   This case was linked to MOD-2021-377079, MOD-2021-378958 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Vaccination complication
Clinical narrative: had the flu symptoms on vaccine 1; and was out for about 4 days on vaccine 1; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (had the flu symptoms on vaccine 1) and VACCINATION COMPLICATION (and was out for about 4 days on vaccine 1) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (9 Years ago.) and Artery dissection (dissected celiac artery.) in 2020. Concurrent medical conditions included Heart disease, unspecified.    On 05-Feb-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 INFLUENZA (had the flu symptoms on vaccine 1) and VACCINATION COMPLICATION (and was out for about 4 days on vaccine 1). At the time of the report, INFLUENZA (had the flu symptoms on vaccine 1) and VACCINATION COMPLICATION (and was out for about 4 days on vaccine 1) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs included heart medications. Treatment medications were not provided.  It was reported that the patient did not have rash with dose 1.   This case was linked to MOD-2021-377079, MOD-2021-378957 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm was a bit sore by the injection spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm was a bit sore by the injection spot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (right arm was a bit sore by the injection spot). In February 2021, VACCINATION SITE PAIN (right arm was a bit sore by the injection spot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-379265, MOD-2021-378255 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling, Vaccination site warmth
Clinical narrative: Swelling; Warmth to deltoid; swollen axillary lymph nodes to the same arm; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (Swelling), VACCINATION SITE WARMTH (Warmth to deltoid) and LYMPHADENOPATHY (swollen axillary lymph nodes to the same arm) 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 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), VACCINATION SITE WARMTH (Warmth to deltoid) and LYMPHADENOPATHY (swollen axillary lymph nodes to the same arm). At the time of the report, SWELLING (Swelling), VACCINATION SITE WARMTH (Warmth to deltoid) and LYMPHADENOPATHY (swollen axillary lymph nodes to the same arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: She can only lift her arm part way up without discomfort/when she raises her arm up by her ear at midlevel it feels like it starts pulling, it is not painful but is very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (She can only lift her arm part way up without discomfort/when she raises her arm up by her ear at midlevel it feels like it starts pulling, it is not painful but is very uncomfortable) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced LIMB DISCOMFORT (She can only lift her arm part way up without discomfort/when she raises her arm up by her ear at midlevel it feels like it starts pulling, it is not painful but is very uncomfortable). At the time of the report, LIMB DISCOMFORT (She can only lift her arm part way up without discomfort/when she raises her arm up by her ear at midlevel it feels like it starts pulling, it is not painful but is very uncomfortable) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-379259, MOD-2021-378255 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: It was the second 0.25mL dose that they've had in 4 weeks; 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 ACCIDENTAL OVERDOSE (It was the second 0.25mL dose that they've had in 4 weeks) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (It was the second 0.25mL dose that they've had in 4 weeks). At the time of the report, ACCIDENTAL OVERDOSE (It was the second 0.25mL dose that they've had in 4 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment medications were reported.  The couple really wanted to get the Flu shot but got booster second 0.25ml dose within 4 weeks.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Palpitations
Clinical narrative: Upper chest pain; stronger and faster heartbeat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Upper chest pain) and PALPITATIONS (stronger and faster heartbeat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced CHEST PAIN (Upper chest pain) and PALPITATIONS (stronger and faster heartbeat). At the time of the report, CHEST PAIN (Upper chest pain) and PALPITATIONS (stronger and faster heartbeat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Heart rate: fast (High) stronger and faster heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported.  It was reported that the patient had experienced stronger heartbeat which come and goes. It went away after  while on 06-Nov-2021 and came back on 07-Nov-2021.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Neck pain, Vaccination site pain
Clinical narrative: pain in the back of my neck; chills; pain in the arm; headache; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm), HEADACHE (headache) and NAUSEA (nauseated) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021 at 9:00 PM, the patient experienced NECK PAIN (pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm), HEADACHE (headache) and NAUSEA (nauseated). At the time of the report, NECK PAIN (pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm), HEADACHE (headache) and NAUSEA (nauseated) had resolved.            It was reported that all the symptoms lasted for about 4 to 5 hours.  Advil were reported as a treatment medication used for unspecified/unknown indication. Concomitant information were included diabetes medication, asthma medication, cholesterol medication,  blood pressure medication.   This case was linked to MOD-2021-379422, MOD-2021-379419 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Myalgia
Clinical narrative: feeling of tiredness; hot flushes; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flushes), PAIN (body aches), CHILLS (chills) and FATIGUE (feeling of tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Nov-2021, the patient experienced HOT FLUSH (hot flushes), PAIN (body aches) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (feeling of tiredness). At the time of the report, HOT FLUSH (hot flushes), PAIN (body aches), CHILLS (chills) and FATIGUE (feeling of tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low-grade fever around 100; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade fever around 100) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low-grade fever around 100). At the time of the report, PYREXIA (low-grade fever around 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) low-grade fever around 100.         No concomitant medications were reported. Treatment medications were not provided by the reporter.  Patient had the booster shot on Thursday.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (minor reaction to 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (minor reaction to 1st dose). At the time of the report, vaccination complication (minor reaction to 1st dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-379973 (patient link).
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump underneath his arm, Lump started to get bigger in the last few days; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump underneath his arm, Lump started to get bigger in the last few days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AXILLARY MASS (Lump underneath his arm, Lump started to get bigger in the last few days). At the time of the report, AXILLARY MASS (Lump underneath his arm, Lump started to get bigger in the last few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   This case was linked to MOD-2021-381136 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and MYALGIA (body aches) 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 PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, PYREXIA (Fever) and MYALGIA (body aches) 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 and medication information provided.  No treatment information provided
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021 at 4:57 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received on 10-NOV-2021 contains no new Significant information.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling sensation; Numbness in his hand and fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in his hand and fingers) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in his hand and fingers). At the time of the report, PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in his hand and fingers) outcome was unknown.            No concomitant medication was provided. No treatment information was provided. It was reported that, over the weekend had some numbness in his hand and fingers,like a tingling sensation. It's the same arm where the lump was started to get bigger in the last few days too. Patient was reporting side effects of her daughters husband.  This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, unexpected events of paraesthesia and hypoaesthesia. The events occurred  1 day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-380332 (Patient Link).; Sender's Comments: This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, unexpected events of paraesthesia and hypoaesthesia. The events occurred  1 day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Bad vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Bad vertigo) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039821A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Nov-2021, the patient experienced VERTIGO (Bad vertigo) (seriousness criterion hospitalization). The patient was hospitalized from sometime in November 2021 to sometime in November 2021 due to VERTIGO. At the time of the report, VERTIGO (Bad vertigo) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  Company Comment: This case concerns a 83-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of vertigo. The event occurred 2 days after the third dose of mRNA-1273 Moderna vaccine (booster dose). The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 83-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of vertigo. The event occurred 2 days after the third dose of mRNA-1273 Moderna vaccine (booster dose). The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Same problem/continue to have diarrheal now into 9 months; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Same problem/continue to have diarrheal now into 9 months) in a 74-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 DIARRHOEA (Same problem/continue to have diarrheal now into 9 months). At the time of the report, DIARRHOEA (Same problem/continue to have diarrheal now into 9 months) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided It was reported that women in her mid to late 70s had the same problem after receiving booster dose. Treatment medications were not provided.   This case was linked to MOD-2021-356678, MOD-2021-355994, MOD-2021-355923 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: the rash was on just her arm yesterday and today she woke up and it's on her torso and legs, it's like spreading was reported as worsened.; the rash was on just her arm yesterday and today she woke up and it's on her torso and legs, it's like spreading was reported as worsened.; This is a spontaneous report from a contactable consumer (patient).  A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration in left arm around 5pm on 26Jul2021 (at the age of 26-years-old) as dose 1, single for covid-19 immunization. The patient medical history (including any illness at time of vaccination) was none. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines were administered on same date of the Pfizer Suspect. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jul2021, the patient reported the rash was on just her arm yesterday and today (28Jul2021) she woke up and it was on her torso and legs, it was like spreading and was reported as worsened. Patient stated the rash started on 27Jul2021 mid-day around the afternoon was when she started noticing it and stated that it was getting worse. Patient was asking what she can take, she did not get a rash right where they gave it but, on the side where she got the shot. Patient was asking if she still can get the second dose of the Pfizer Covid-19 vaccine. There were no relevant tests. It was reported that the adverse event did not require any visit to emergency room or physician office. The clinical outcome of the events was not recovered at the time of the report.  Follow-up attempts completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema
Clinical narrative: Swollen above the skin; little redness around the injection site; This is a spontaneous report received from a contactable consumer or other non-health care professional (Patient's mother). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186), via an unknown route of administration, administered in Arm Left on 26Jul2021 (at the age of 12-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0282) via an unknown route of administration, administered in Arm left on 30Jun2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. Patient received vaccination facility in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Caller stated that she is the mother of a 13 year old male who received his second dose of the Pfizer Covid 19 vaccine. He started to have a little redness around the injection site yesterday on 27Jul2021 and then today she states that it is red and swollen above the skin on 28Jul2021. She would like to know if this is considered normal or if she should seek. She wanted to see if that is normal and should she take him to hospital. The outcome of the events was reported as unknown.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Pharyngeal swelling
Clinical narrative: My throat started to swell; Swallowing became difficult. I had to force myself hard to swallow; my voice started to get tight.; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: fa7485) via an unspecified route of administration in Arm Left on 29Jul2021 11:15 (age at vaccination: 54-years-old) as  single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, drug penicillin allergies , thyroid disorder. The patient previously took cefdinir and ciprofloxacin and experienced known allergy. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hydrocodone bitartrate, paracetamol (NORCO) taken for an unspecified indication, start and stop date were not reported. On 29Jul2021 20:45, patient experienced my throat started to swell and swallowing became difficult. I had to force myself hard to swallow and my voice started to get tight. I took two Antihistamines and was getting ready to call EMT, but it started to loosen up after 15 min. The clinical outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.