chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced TREMOR (Tremors). At the time of the report, TREMOR (Tremors) had not resolved.            Patient saw his doctor but was not diagnosed with anything yet. He takes concomitant medication that did not want to disclose. No treatment information was provided. Patient would like to have a face to face meeting with someone.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Peripheral swelling
Clinical narrative: Swelling of the arm; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), CHILLS (Chills) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had an ER ride and hospital visit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an ER ride and hospital visit) 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 26-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 VACCINATION COMPLICATION (Had an ER ride and hospital visit). At the time of the report, VACCINATION COMPLICATION (Had an ER ride and hospital visit) outcome was unknown.            No other medications were provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: some heat coming off the area of injection; I have a large red spot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (some heat coming off the area of injection) and VACCINATION SITE ERYTHEMA (I have a large red spot) 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 14-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced VACCINATION SITE WARMTH (some heat coming off the area of injection) and VACCINATION SITE ERYTHEMA (I have a large red spot). At the time of the report, VACCINATION SITE WARMTH (some heat coming off the area of injection) and VACCINATION SITE ERYTHEMA (I have a large red spot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Still feel off after a week/just not right yet; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Still feel off after a week/just not right yet) 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 FEELING ABNORMAL (Still feel off after a week/just not right yet). At the time of the report, FEELING ABNORMAL (Still feel off after a week/just not right yet) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Transplant patient received half dose for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Transplant patient received half dose for 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Transplant. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Transplant patient received half dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Transplant patient received half dose for 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Myalgia, Pain
Clinical narrative: did not feel good; lethargic; achy; body aches/achy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good), LETHARGY (lethargic), PAIN (achy) and MYALGIA (body aches/achy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced MALAISE (did not feel good), LETHARGY (lethargic), PAIN (achy) and MYALGIA (body aches/achy). At the time of the report, MALAISE (did not feel good), LETHARGY (lethargic), PAIN (achy) and MYALGIA (body aches/achy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.  Events were lasted for 21/2 days.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Non-significant follow-up: No new information was added.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Feeling abnormal
Clinical narrative: Unable to get out of bed; Brain fog; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Unable to get out of bed), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue) in a 100-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced BEDRIDDEN (Unable to get out of bed), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue). At the time of the report, BEDRIDDEN (Unable to get out of bed) and FATIGUE (Fatigue) had not resolved and FEELING ABNORMAL (Brain fog) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Feeling abnormal, Inflammation
Clinical narrative: Inflammation in upper body and hip; Burning; Tingling; Pain in upper body and hip; Feeling terrible; Muscle pain; Pain in upper body and hip; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip) and FEELING ABNORMAL (Feeling terrible) in a 49-year-old male 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 Fatty liver, Arthritis and High cholesterol.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip), FEELING ABNORMAL (Feeling terrible), MYALGIA (Muscle pain), ARTHRALGIA (Pain in upper body and hip), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip), MYALGIA (Muscle pain), ARTHRALGIA (Pain in upper body and hip) and ARTHRALGIA (Joint pain) outcome was unknown and FEELING ABNORMAL (Feeling terrible), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Inflammation in upper body and hip; Burning; Tingling; Pain in upper body and hip; Feeling terrible; Muscle pain; Pain in upper body and hip; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip) and FEELING ABNORMAL (Feeling terrible) in a 49-year-old male 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 Fatty liver, Arthritis and High cholesterol.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip), FEELING ABNORMAL (Feeling terrible), MYALGIA (Muscle pain), ARTHRALGIA (Pain in upper body and hip), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip), MYALGIA (Muscle pain), ARTHRALGIA (Pain in upper body and hip) and ARTHRALGIA (Joint pain) outcome was unknown and FEELING ABNORMAL (Feeling terrible), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received beyond 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Broken leg and Surgery (The patient had 8 surgeries due to broken left leg before 1st dose) since an unknown date. Concurrent medical conditions included Diabetes (The patient reported a history of being diabetic) and Wheelchair user (The patient is confined to wheelchair).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days) had resolved.            No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-416046 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Gait disturbance, Inflammation, Laboratory test, Movement disorder
Clinical narrative: Uterus fibroids; Vaginal bleeding; Soreness in arms and legs that never went away; Couldn't walk, shower get in and out of her car; Had trouble with basic movement; Bad belly pain around belly button area/Belly pain on and off for about week; Inflammation in back of both legs and knee area; This spontaneous case was reported by a consumer and describes the occurrence of UTERINE LEIOMYOMA (Uterus fibroids), VAGINAL HAEMORRHAGE (Vaginal bleeding), ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week), PAIN IN EXTREMITY (Soreness in arms and legs that never went away) and GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INFLAMMATION (Inflammation in back of both legs and knee area). On 24-Jun-2021, the patient experienced ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week). In August 2021, the patient experienced PAIN IN EXTREMITY (Soreness in arms and legs that never went away), GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) and MOVEMENT DISORDER (Had trouble with basic movement). On an unknown date, the patient experienced UTERINE LEIOMYOMA (Uterus fibroids) and VAGINAL HAEMORRHAGE (Vaginal bleeding). The patient was treated with PREDNISONE on 12-Oct-2021 for Adverse event, at an unspecified dose and frequency and Surgery (DNC done on 30JUL2021) for Uterine leiomyoma. At the time of the report, UTERINE LEIOMYOMA (Uterus fibroids), VAGINAL HAEMORRHAGE (Vaginal bleeding), ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week), PAIN IN EXTREMITY (Soreness in arms and legs that never went away) and GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) outcome was unknown, INFLAMMATION (Inflammation in back of both legs and knee area) was resolving and MOVEMENT DISORDER (Had trouble with basic movement) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: abnormal (abnormal) Uterus fibroids were found.         No other medications were provided.  The patient went to GYN but they said she was anomaly and found no issues. The patient started taking Prednisone on 12OCT2021 and started feeling a lot of better. It relieved the inflammation.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Uterine leiomyoma, Vaginal haemorrhage
Clinical narrative: Uterus fibroids; Vaginal bleeding; Soreness in arms and legs that never went away; Couldn't walk, shower get in and out of her car; Had trouble with basic movement; Bad belly pain around belly button area/Belly pain on and off for about week; Inflammation in back of both legs and knee area; This spontaneous case was reported by a consumer and describes the occurrence of UTERINE LEIOMYOMA (Uterus fibroids), VAGINAL HAEMORRHAGE (Vaginal bleeding), ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week), PAIN IN EXTREMITY (Soreness in arms and legs that never went away) and GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INFLAMMATION (Inflammation in back of both legs and knee area). On 24-Jun-2021, the patient experienced ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week). In August 2021, the patient experienced PAIN IN EXTREMITY (Soreness in arms and legs that never went away), GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) and MOVEMENT DISORDER (Had trouble with basic movement). On an unknown date, the patient experienced UTERINE LEIOMYOMA (Uterus fibroids) and VAGINAL HAEMORRHAGE (Vaginal bleeding). The patient was treated with PREDNISONE on 12-Oct-2021 for Adverse event, at an unspecified dose and frequency and Surgery (DNC done on 30JUL2021) for Uterine leiomyoma. At the time of the report, UTERINE LEIOMYOMA (Uterus fibroids), VAGINAL HAEMORRHAGE (Vaginal bleeding), ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week), PAIN IN EXTREMITY (Soreness in arms and legs that never went away) and GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) outcome was unknown, INFLAMMATION (Inflammation in back of both legs and knee area) was resolving and MOVEMENT DISORDER (Had trouble with basic movement) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: abnormal (abnormal) Uterus fibroids were found.         No other medications were provided.  The patient went to GYN but they said she was anomaly and found no issues. The patient started taking Prednisone on 12OCT2021 and started feeling a lot of better. It relieved the inflammation.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). The patient was treated with OMALIZUMAB (XOLAIR) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) outcome was unknown.            No concomitant medication details was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Received half dose Moderna  Booster instead of the first dose; Received half dose Moderna  Booster instead of the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 13-Dec-2021, the patient experienced UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose). On 13-Dec-2021, UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick since receiving her Moderna Covid-19 vaccine booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick since receiving her Moderna Covid-19 vaccine booster dose.) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (felt sick since receiving her Moderna Covid-19 vaccine booster dose.). At the time of the report, MALAISE (felt sick since receiving her Moderna Covid-19 vaccine booster dose.) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes swelled afterwards, (Under both arms and groin area); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swelled afterwards, (Under both arms and groin area)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swelled afterwards, (Under both arms and groin area)). At the time of the report, LYMPHADENOPATHY (Lymph nodes swelled afterwards, (Under both arms and groin area)) had not resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient reported that booster got two months ago and experienced lymph nodes swelled afterwards.(under both arms and groin area). Still having this issue 60 days later.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: had an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (had an adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (had an adverse event). At the time of the report, ADVERSE EVENT (had an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines) 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 URTICARIA (she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines). At the time of the report, URTICARIA (she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines) 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No Concomitant medicines were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were received.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) 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 PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.  No treatment medications were not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Pharmacist reports that they administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home. Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM and they administered the vaccine from 10Dec2021-13Dec2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling, Vaccination site erythema
Clinical narrative: Looked like an allergic reaction; localized swelling at the injection site; localized redness at the injection site; This is a spontaneous report received from a contactable reporter (pharmacist) from Medical Information Team.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, solution for injection in pre-filled syringe, lot number DR0570, expiration date 28Feb2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "recovered", described as "looked like an allergic reaction"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "localized swelling at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered", described as "localized redness at the injection site". Therapeutic measures were taken as a result of drug hypersensitivity, vaccination site swelling, vaccination site erythema - cleared up with cream and hydrocortisone.  Additional Information: The pharmacist reported that there were 2 patients who had these very similar adverse reactions to Prevnar-13. The pharmacist expressed concern since the product came from the same lot number.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957359 same reporter/drug/event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Looked like an allergic reaction; localized swelling, redness, at the injection site; localized swelling, redness, at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: DR0570, Expiration Date: 28Feb2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "recovered", described as "Looked like an allergic reaction"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "localized swelling, redness, at the injection site". Therapeutic measures were taken as a result of hypersensitivity, vaccination site swelling, vaccination site erythema.   Additional information: The pharmacist reported that there were 2 patients (Age and Genders not available to Caller) who had "very similar adverse reactions" to pneumococcal 13-val conj vac (dipht crm197 protein). The pharmacist stated it "looked like an allergic reaction", both patients had "localized swelling, redness, at the injection site". Both patients cleared up with cream and hydrocortisone. The pharmacist expressed concern since this came from the same lot number. Since both patients had the same localized reaction "redness, swelling, and pain as well" from the same lot number, the pharmacist asked if there are any other type of report from this lot number of similar issues or the adverse reaction rate per lot number.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100956498 Same Reporter/Drug/AE, Different Patient
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Sinusitis
Clinical narrative: severe arm pain; reoccurring sinusitis; This is a spontaneous report received from a contactable reporter (physician).  An female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, solution for injection in pre-filled syringe, lot number unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "severe arm pain"; SINUSITIS (non-serious), outcome "unknown", described as "reoccurring sinusitis".  Additional Information: The patient was under "65" (no units).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: Fever of 101-103 starting day 1 after injection; extreme headache; pain scale of 7-10/10; vomiting; lethargy; malaise; muscle weakness; fatigue; dyspnea; loss of appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0181) , administered in arm left, administration date 04Aug2021 12:00 at the age of 48 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Penicilin" (unspecified if ongoing), notes: Known allergies: penicilin. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Fever of 101-103 starting day 1 after injection"; HEADACHE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "extreme headache"; PAIN (non-serious) with onset 05Aug2021, outcome "not recovered", described as "pain scale of 7-10/10"; VOMITING (non-serious) with onset 05Aug2021, outcome "not recovered", described as "vomiting"; LETHARGY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "lethargy"; MALAISE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "malaise"; MUSCULAR WEAKNESS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "muscle weakness"; FATIGUE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "fatigue"; DYSPNOEA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "dyspnea"; DECREASED APPETITE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "loss of appetite". The events "fever of 101-103 starting day 1 after injection", "extreme headache", "pain scale of 7-10/10", "vomiting", "lethargy", "malaise", "muscle weakness", "fatigue", "dyspnea" and "loss of appetite" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, pain, vomiting, lethargy, malaise, muscular weakness, fatigue, dyspnoea, decreased appetite.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Muscular weakness, Pain, Pain assessment
Clinical narrative: Fever of 101-103 starting day 1 after injection; extreme headache; pain scale of 7-10/10; vomiting; lethargy; malaise; muscle weakness; fatigue; dyspnea; loss of appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0181) , administered in arm left, administration date 04Aug2021 12:00 at the age of 48 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Penicilin" (unspecified if ongoing), notes: Known allergies: penicilin. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Fever of 101-103 starting day 1 after injection"; HEADACHE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "extreme headache"; PAIN (non-serious) with onset 05Aug2021, outcome "not recovered", described as "pain scale of 7-10/10"; VOMITING (non-serious) with onset 05Aug2021, outcome "not recovered", described as "vomiting"; LETHARGY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "lethargy"; MALAISE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "malaise"; MUSCULAR WEAKNESS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "muscle weakness"; FATIGUE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "fatigue"; DYSPNOEA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "dyspnea"; DECREASED APPETITE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "loss of appetite". The events "fever of 101-103 starting day 1 after injection", "extreme headache", "pain scale of 7-10/10", "vomiting", "lethargy", "malaise", "muscle weakness", "fatigue", "dyspnea" and "loss of appetite" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, pain, vomiting, lethargy, malaise, muscular weakness, fatigue, dyspnoea, decreased appetite.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Fever of 101-103 starting day 1 after injection; extreme headache; pain scale of 7-10/10; vomiting; lethargy; malaise; muscle weakness; fatigue; dyspnea; loss of appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0181) , administered in arm left, administration date 04Aug2021 12:00 at the age of 48 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Penicilin" (unspecified if ongoing), notes: Known allergies: penicilin. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Fever of 101-103 starting day 1 after injection"; HEADACHE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "extreme headache"; PAIN (non-serious) with onset 05Aug2021, outcome "not recovered", described as "pain scale of 7-10/10"; VOMITING (non-serious) with onset 05Aug2021, outcome "not recovered", described as "vomiting"; LETHARGY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "lethargy"; MALAISE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "malaise"; MUSCULAR WEAKNESS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "muscle weakness"; FATIGUE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "fatigue"; DYSPNOEA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "dyspnea"; DECREASED APPETITE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "loss of appetite". The events "fever of 101-103 starting day 1 after injection", "extreme headache", "pain scale of 7-10/10", "vomiting", "lethargy", "malaise", "muscle weakness", "fatigue", "dyspnea" and "loss of appetite" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, pain, vomiting, lethargy, malaise, muscular weakness, fatigue, dyspnoea, decreased appetite.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Patient had a fever of 99.8 degrees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP and Other HCP). The reporter is the parent.  A 16-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Patient had a fever of 99.8 degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's mother reported that patient received COVID-19 Vaccine and she had symptoms. She stated that patient had a fever of 99.8 degrees.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: Allergies; Hives; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset Mar2021, outcome "unknown", described as "Allergies"; URTICARIA (non-serious) with onset Mar2021, outcome "unknown", described as "Hives".  Additional information: Caller asking to speak with (withheld) and talking about setting up a checkup. Caller said he's done with the 1st dose of the vaccine on 12Mar2021 and the 2nd dose on 31Mar2021. Caller mentioned allergies and hives. Tried to confirm the reason for the call but the caller is unclear and hard to understand. Advised to call a facility or hospital if he's trying to set up an appointment for a checkup. Unable to gather demographics and unable to transfer. Unable to provide the PMI phone number. Created manual AE form.  No follow-up attempts are possible. No further information is expected.