chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: Develop Tonsillitis after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (Develop Tonsillitis after receiving the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONSILLITIS (Develop Tonsillitis after receiving the vaccine). At the time of the report, TONSILLITIS (Develop Tonsillitis after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Antibiotics used as a Treatment medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received on 05-JUN-2021, patient denied conset to Followup and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information is requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Hotness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), FEELING HOT (Hotness), HEADACHE (Headache) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN (Body aches), FEELING HOT (Hotness), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Body aches), FEELING HOT (Hotness), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included medication for high blood pressure.   Treatment for events included Paracetamol and Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm is swollen where injected; Arm is warm and red; arm is warm and red; A spontaneous report was received from a consumer concerning a 49-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site swelling, arm was warm and red.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L208) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the injection site swelling, arm is warm and erythema.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events injection site swelling, arm is warm and red were unknown.; Reporter's Comments: This case concerns a 49-year-old female patient who experienced the non-serious expected events of Injection site swelling, Injection site erythema and Injection site warmth. The events occurred on an unknown date after receiving their first of two planned doses of mRNA-1273 (Lot 025L208) intramuscularly in the arm for prophylaxis of COVID-19 infection. Treatment information is not provided. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events of are considered possibly related to the product.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: pyrexia; weakness; Tiredness; Muscle pain; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (weakness), FATIGUE (Tiredness), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (pyrexia) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-Jan-2021, the patient experienced ASTHENIA (weakness), FATIGUE (Tiredness), MYALGIA (Muscle pain) and HEADACHE (Headache). On an unknown date, the patient experienced PYREXIA (pyrexia). At the time of the report, ASTHENIA (weakness), FATIGUE (Tiredness), MYALGIA (Muscle pain) and HEADACHE (Headache) was resolving and PYREXIA (pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.  No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 2 swollen, painful, lymph nodes in neck; A spontaneous report was received from a consumer who was 32-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed 2 swollen, painful, lymph nodes in neck and a couple more lymph node, visibly swollen under the clavicle.  No medical history was provided. No relevant concomitant medications were reported.  On 05 Jan 2021, approximately seven days prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient developed 2 swollen, painful, lymph nodes in neck on the same side of the vaccination.  On 12 Jan 2021, the patient noticed a couple more lymph node, visibly swollen under the clavicle. Treatment for the events included paracetamol and ibuprofen which did not help much to manage the pain.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 2 swollen, painful, lymph nodes in neck and a couple more lymph node, visibly swollen under the clavicle was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Heart rate is elevated to about 110-120; Shaking; Fever; Chills; Vomiting; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Heart rate is elevated to about 110-120), TREMOR (Shaking), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 27-Jan-2021, the patient experienced HEART RATE INCREASED (Heart rate is elevated to about 110-120), TREMOR (Shaking), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, HEART RATE INCREASED (Heart rate is elevated to about 110-120), TREMOR (Shaking), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol and ibuprofen. Action taken with mRNA-123 is not applicable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Heart rate is elevated to about 110-120; Shaking; Fever; Chills; Vomiting; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Heart rate is elevated to about 110-120), TREMOR (Shaking), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 27-Jan-2021, the patient experienced HEART RATE INCREASED (Heart rate is elevated to about 110-120), TREMOR (Shaking), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, HEART RATE INCREASED (Heart rate is elevated to about 110-120), TREMOR (Shaking), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol and ibuprofen. Action taken with mRNA-123 is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: pain in back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in back) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced BACK PAIN (pain in back). At the time of the report, BACK PAIN (pain in back) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No relevant concomitant medications were reported. No treatment information was provided.  Reporter did not allow further contact  Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of back pain, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site coldness, Pain, Vaccination site induration, Vaccination site swelling
Clinical narrative: pain; cool to touch; redness moved down to the wrist; it was hot; red and hard; site swelled to like a golf ball size; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: The follow up received contain email address of the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: pain; cool to touch; redness moved down to the wrist; it was hot; red and hard; site swelled to like a golf ball size; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: The follow up received contain email address of the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: vaccination site pruritus; Feverish; Soreness in her arm; Chills; Pain at the injection site; Redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (vaccination site pruritus), PYREXIA (Feverish), MYALGIA (Soreness in her arm), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included AMOXICILLIN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus), PYREXIA (Feverish), MYALGIA (Soreness in her arm), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (vaccination site pruritus), PYREXIA (Feverish), MYALGIA (Soreness in her arm), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: vaccination site pruritus; Feverish; Soreness in her arm; Chills; Pain at the injection site; Redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (vaccination site pruritus), PYREXIA (Feverish), MYALGIA (Soreness in her arm), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included AMOXICILLIN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus), PYREXIA (Feverish), MYALGIA (Soreness in her arm), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (vaccination site pruritus), PYREXIA (Feverish), MYALGIA (Soreness in her arm), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling at the injection arm; Redness at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a non-health professional and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).   On 27-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Aug-2020 and the estimated date of delivery was 28-May-2021. On 27-Jan-2021 at 11:00 AM, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2020, Ultrasound scan: confirm heart beat. On 05-Jan-2021, Ultrasound scan: (normal) anatomy scan.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   18-SEP-2020 was reported as Date of positive pregnancy test. 04-SEP-2021 was reported as Estimated date of conception. There was no maternal history of subfertility There was no complications or acute illnesses during this pregnancy to date. No family history of congenital anomalies/genetic disease. No patient's chronic or long-standing health conditions No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Upon internal review on 20-Jul-2021, patient, products, events, analysis and regulatory reports tabs were updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Headache, Hypertension, Illness
Clinical narrative: cellulitis; itch at the injection site; red, raised and warm spot; ears ringing; body aches; Blood pressure was extremely high; feel ill; arm has a throbbing sensation; swelling in  lymph nodes under the armpit area; nausea; chills; low grade temperature; Severe  headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing) and PAIN (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache) outcome was unknown. off and on wet sensation    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 154/95 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medication for the events, antibiotic and oral steroids. Later on, when the conditions magnified several doses of IBU and Tylenol were also taken.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: cellulitis; itch at the injection site; red, raised and warm spot; ears ringing; body aches; Blood pressure was extremely high; feel ill; arm has a throbbing sensation; swelling in  lymph nodes under the armpit area; nausea; chills; low grade temperature; Severe  headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing) and PAIN (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache) outcome was unknown. off and on wet sensation    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 154/95 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medication for the events, antibiotic and oral steroids. Later on, when the conditions magnified several doses of IBU and Tylenol were also taken.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site cellulitis
Clinical narrative: cellulitis; itch at the injection site; red, raised and warm spot; ears ringing; body aches; Blood pressure was extremely high; feel ill; arm has a throbbing sensation; swelling in  lymph nodes under the armpit area; nausea; chills; low grade temperature; Severe  headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing) and PAIN (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache) outcome was unknown. off and on wet sensation    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 154/95 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medication for the events, antibiotic and oral steroids. Later on, when the conditions magnified several doses of IBU and Tylenol were also taken.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unnown) for COVID-19 vaccination.     Concomitant products included VALACICLOVIR HCL from 20-Jan-2021 to an unknown date for Herpes infection.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Jan-2021, the patient experienced DRUG INTERACTION (took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak). At the time of the report, DRUG INTERACTION (took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Injection site urticaria, Rash erythematous, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: still red; itching on injection site.; cluster hives 2" wide on injection site; rash on injection site; A litte sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (still red), VACCINATION SITE PRURITUS (itching on injection site.), INJECTION SITE URTICARIA (cluster hives 2" wide on injection site), VACCINATION SITE PAIN (A litte sore arm) and VACCINATION SITE RASH (rash on injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (A litte sore arm). On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching on injection site.), INJECTION SITE URTICARIA (cluster hives 2" wide on injection site) and VACCINATION SITE RASH (rash on injection site). On 19-Jan-2021, the patient experienced RASH ERYTHEMATOUS (still red). At the time of the report, RASH ERYTHEMATOUS (still red), VACCINATION SITE PRURITUS (itching on injection site.), INJECTION SITE URTICARIA (cluster hives 2" wide on injection site), VACCINATION SITE PAIN (A litte sore arm) and VACCINATION SITE RASH (rash on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information and no relevant concominant medications were reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Lacrimation increased, Pruritus
Clinical narrative: Feels like I had a shot of novocaine on upper lip; Feels like a bad allergy; I started itching-eyes, back and mouth.; eyes watery; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pruritus, increased lacrimation, oral hypoesthesia and hypersensitivity.    The patient's medical history included heart disease, sulfonamide allergy, kidney disfunction and vocal cord paralysis. Concomitant medications included carvedilol, ramipril, simvastatin, pantoprazole, Norco, duloxetine, aspirin-81.      On 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 63L5C20A) in the left arm for prophylaxis of COVID-19 infection.    On 19-Jan-2021, the patient experienced pruritus, increased lacrimation, and hypersensitivity. On 20-Jan-2021, the patient experienced oral hypoesthesia.   No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the events (pruritus, increased lacrimation, oral hypoesthesia and hypersensitivity) was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Hives on the arm; Sore at the site of injection; Red at the site of injection; Itchiness at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (Hives on the arm), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives on the arm), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (Hives on the arm), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Additional information received: Updated event outcome from not recovered to recovered for all reported events. Patient had declined further follow-up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: A spontaneous report was received from a consumer concerning a 76 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced fatigue, chills.   The patient's medical history and concomitant medication were not reported.  On 11Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscularly for prophylaxis of COVID-19 infection.  On 12Jan2021, the patient experienced fatigue and chills. No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events fatigue, chills were unknown.  The consumer assessed the event fatigue and chills were not reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was sore at injection site; Injection site turned red; Injection site swollen; The temperature is up at injection site; Injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The temperature is up at injection site), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE PAIN (Arm was sore at injection site), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (Injection site swollen) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus since 24-Jan-2002, Breast cancer since 2011 and Hypertension since 2008. Concomitant products included LOSARTAN from 02-Oct-2008 to an unknown date for Blood pressure high, TAMOXIFEN from 22-Feb-2011 to an unknown date for Breast cancer, SIMVASTATIN from 12-Jan-2001 to an unknown date for Cholesterol, METFORMIN from 20-Jan-2002 to an unknown date for Diabetes, OMEPRAZOLE from 23-Jan-2002 to an unknown date for Stomach ulcer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (The temperature is up at injection site), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (Injection site swollen). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (The temperature is up at injection site), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE PAIN (Arm was sore at injection site), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (Injection site swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received and updated patient demographics, medical history, concomitant medications and outcome of the events.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: two patients presenting adverse effects 10-14 days post 1st dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (two patients presenting adverse effects 10-14 days post 1st dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (two patients presenting adverse effects 10-14 days post 1st dose). At the time of the report, VACCINATION COMPLICATION (two patients presenting adverse effects 10-14 days post 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Mobility decreased, Vaccination site pain
Clinical narrative: difficulty raising her arms/difficulty turning to the right when sleeping; right shoulder is inflamed; Felt soreness of injection site; pain on right shoulder radiating down to her arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (difficulty raising her arms/difficulty turning to the right when sleeping), INFLAMMATION (right shoulder is inflamed), VACCINATION SITE PAIN (Felt soreness of injection site) and ARTHRALGIA (pain on right shoulder radiating down to her arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MOBILITY DECREASED (difficulty raising her arms/difficulty turning to the right when sleeping), INFLAMMATION (right shoulder is inflamed) and ARTHRALGIA (pain on right shoulder radiating down to her arm). 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Felt soreness of injection site). At the time of the report, MOBILITY DECREASED (difficulty raising her arms/difficulty turning to the right when sleeping), INFLAMMATION (right shoulder is inflamed), VACCINATION SITE PAIN (Felt soreness of injection site) and ARTHRALGIA (pain on right shoulder radiating down to her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site bruising, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Vaccination site pain; Pain at injection site and bruise; itchy; Nodule; Redness; feeling swollen; discoloration of skin; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (feeling swollen), VACCINATION SITE PRURITUS (itchy), ERYTHEMA (Redness) and VACCINATION SITE INDURATION (Nodule) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Jan-2021, the patient experienced VACCINATION SITE SWELLING (feeling swollen), VACCINATION SITE PRURITUS (itchy), ERYTHEMA (Redness), VACCINATION SITE INDURATION (Nodule) and SKIN DISCOLOURATION (discoloration of skin). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE BRUISING (BRUISE). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (feeling swollen), SKIN DISCOLOURATION (discoloration of skin), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE BRUISING (BRUISE) outcome was unknown and VACCINATION SITE PRURITUS (itchy), ERYTHEMA (Redness) and VACCINATION SITE INDURATION (Nodule) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information provided as antipyretics, antihistamine, cold therapy and heat therapy.; Sender's Comments: very limited information regarding these events has been provided at this time. Further information has bene requested
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site pain; Pain at injection site and bruise; itchy; Nodule; Redness; feeling swollen; discoloration of skin; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (feeling swollen), VACCINATION SITE PRURITUS (itchy), ERYTHEMA (Redness) and VACCINATION SITE INDURATION (Nodule) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Jan-2021, the patient experienced VACCINATION SITE SWELLING (feeling swollen), VACCINATION SITE PRURITUS (itchy), ERYTHEMA (Redness), VACCINATION SITE INDURATION (Nodule) and SKIN DISCOLOURATION (discoloration of skin). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE BRUISING (BRUISE). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (feeling swollen), SKIN DISCOLOURATION (discoloration of skin), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE BRUISING (BRUISE) outcome was unknown and VACCINATION SITE PRURITUS (itchy), ERYTHEMA (Redness) and VACCINATION SITE INDURATION (Nodule) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information provided as antipyretics, antihistamine, cold therapy and heat therapy.; Sender's Comments: very limited information regarding these events has been provided at this time. Further information has bene requested