chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Lingering leg muscle issues; Leg pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Lingering leg muscle issues) and PAIN IN EXTREMITY (Leg 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 MUSCLE SPASMS (Lingering leg muscle issues) and PAIN IN EXTREMITY (Leg pain). At the time of the report, MUSCLE SPASMS (Lingering leg muscle issues) and PAIN IN EXTREMITY (Leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medication was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tenderness
Clinical narrative: slight pain; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (slight pain) and TENDERNESS (tenderness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (slight pain) and TENDERNESS (tenderness). At the time of the report, PAIN (slight pain) and TENDERNESS (tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain from the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (pain from the vaccine) 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 No adverse reaction.    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 VACCINATION SITE PAIN (pain from the vaccine). At the time of the report, VACCINATION SITE PAIN (pain from the vaccine) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose on day 30 after the expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time). On 25-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose on day 30 after the expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose on day 30 after the expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) 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 drug details were reported.  No treatment details were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Muscle twitching, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: twitching movement belowher right eye; Sharp pain belowher right eye; stiffness at the injection site; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching movement belowher right eye), EYE PAIN (Sharp pain belowher right eye), MUSCULOSKELETAL STIFFNESS (stiffness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021 at 12:00 PM, the patient experienced MUSCLE TWITCHING (twitching movement belowher right eye), EYE PAIN (Sharp pain belowher right eye), MUSCULOSKELETAL STIFFNESS (stiffness at the injection site) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, MUSCLE TWITCHING (twitching movement belowher right eye) and EYE PAIN (Sharp pain belowher right eye) had not resolved and MUSCULOSKELETAL STIFFNESS (stiffness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant follow-up: Reporter contact information updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose on day 30 after the expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash papular, Skin exfoliation, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy horribly; Red spots; Scaly; Injection site itchy; Injection site is red; Injection site swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified since 2010 and Blood pressure high since 2010. Concomitant products included IRBESARTAN from 2019 to an unknown date, HYDRALAZINE from 2020 to an unknown date, ROSUVASTATIN, AMLODIPINE from 2018 to an unknown date, CARVEDILOL from 2019 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASA from 2010 to an unknown date for an unknown indication.    On 04-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021 at 11:00 PM, the patient experienced PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen) to be not related.    Treatment information was not provided.  There were 25- 30 red itchy swelling spots that are pealing on the knees, ankles, a couple on up the leg, on his Rt Hip, Left upper shoulder, wrists on top. The injection site is red and swollen, itchy.   This case was linked to MOD-2021-271504 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information received contains updated patient details, new concurrent conditions (heart disease and high BP), new event (injection site itchy, Injection site swollen, Injection site rash) added, events (Itchy horribly, Red spots and Scaly) outcome updated to not recovered from unknown and causality updated from not provided to not related.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itchy horribly; Red spots; Scaly; Injection site itchy; Injection site is red; Injection site swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified since 2010 and Blood pressure high since 2010. Concomitant products included IRBESARTAN from 2019 to an unknown date, HYDRALAZINE from 2020 to an unknown date, ROSUVASTATIN, AMLODIPINE from 2018 to an unknown date, CARVEDILOL from 2019 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASA from 2010 to an unknown date for an unknown indication.    On 04-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021 at 11:00 PM, the patient experienced PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen) to be not related.    Treatment information was not provided.  There were 25- 30 red itchy swelling spots that are pealing on the knees, ankles, a couple on up the leg, on his Rt Hip, Left upper shoulder, wrists on top. The injection site is red and swollen, itchy.   This case was linked to MOD-2021-271504 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information received contains updated patient details, new concurrent conditions (heart disease and high BP), new event (injection site itchy, Injection site swollen, Injection site rash) added, events (Itchy horribly, Red spots and Scaly) outcome updated to not recovered from unknown and causality updated from not provided to not related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test
Clinical narrative: flu like sypmtoms; tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID) and INFLUENZA LIKE ILLNESS (flu like sypmtoms) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included ANASTROZOLE (ARIMIDEX) for Breast cancer.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced COVID-19 (tested positive for COVID). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like sypmtoms). At the time of the report, COVID-19 (tested positive for COVID) and INFLUENZA LIKE ILLNESS (flu like sypmtoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Non-significant follow up- Reporter info. updated
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive second dose of the Moderna COVID-19 vaccine, first dose was received in March 2021.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine, first dose was received in March 2021.) 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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine, first dose was received in March 2021.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine, first dose was received in March 2021.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the first dose in Mar-2021.  No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes side effects from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes side effects from 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes side effects from the vaccine). At the time of the report, LYMPHADENOPATHY (lymph nodes side effects from the vaccine) 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.   The concomitant medication was not reported.  Patient mentions how he has been doing research online and read about how women get false alarm due to lymph nodes side effects from the vaccine and how it affected mammograms.  The treatment information was not  provided.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Interchanged JNJ & Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchanged JNJ & Moderna Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 INTERCHANGE OF VACCINE PRODUCTS (Interchanged JNJ & Moderna Vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchanged JNJ & Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Illness, Myalgia, Product dose omission issue
Clinical narrative: bad metal taste in her mouth; got really sick; headache; very sore arm; got really sick at hospital for a while and decided not to take the; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bad metal taste in her mouth), ILLNESS (got really sick), HEADACHE (headache), MYALGIA (very sore arm) and PRODUCT DOSE OMISSION ISSUE (got really sick at hospital for a while and decided not to take the) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (bad metal taste in her mouth), ILLNESS (got really sick), HEADACHE (headache), MYALGIA (very sore arm) and PRODUCT DOSE OMISSION ISSUE (got really sick at hospital for a while and decided not to take the). At the time of the report, DYSGEUSIA (bad metal taste in her mouth), ILLNESS (got really sick) and HEADACHE (headache) outcome was unknown and MYALGIA (very sore arm) and PRODUCT DOSE OMISSION ISSUE (got really sick at hospital for a while and decided not to take the) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Discomfort, Erythema, Feeling hot, Muscle rigidity
Clinical narrative: itchy; "knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide; "a little red"; "a little bruise"; more uncomfortable; "kinda hot"; really tight; injection site is swollen; started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), SWELLING ("knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide), ERYTHEMA ("a little red"), CONTUSION ("a little bruise") and DISCOMFORT (more uncomfortable) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Heart disease, unspecified.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced PAIN (started to hurt). On 23-Jul-2021, the patient experienced PRURITUS (itchy), SWELLING ("knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide), ERYTHEMA ("a little red"), CONTUSION ("a little bruise"), DISCOMFORT (more uncomfortable), FEELING HOT ("kinda hot"), MUSCLE RIGIDITY (really tight) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, PRURITUS (itchy), SWELLING ("knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide), ERYTHEMA ("a little red"), CONTUSION ("a little bruise"), DISCOMFORT (more uncomfortable), PAIN (started to hurt), FEELING HOT ("kinda hot"), MUSCLE RIGIDITY (really tight) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.            Concomitant medication includes medication for heart, high blood pressure and blood thinners. Patient has not taken any medication to treat, but stated that she might take antihistamine and ibuprofen since it started to hurt. The pharmacist gave patient an ice pack to apply.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling, Vaccination site swelling
Clinical narrative: itchy; "knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide; "a little red"; "a little bruise"; more uncomfortable; "kinda hot"; really tight; injection site is swollen; started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), SWELLING ("knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide), ERYTHEMA ("a little red"), CONTUSION ("a little bruise") and DISCOMFORT (more uncomfortable) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Heart disease, unspecified.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced PAIN (started to hurt). On 23-Jul-2021, the patient experienced PRURITUS (itchy), SWELLING ("knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide), ERYTHEMA ("a little red"), CONTUSION ("a little bruise"), DISCOMFORT (more uncomfortable), FEELING HOT ("kinda hot"), MUSCLE RIGIDITY (really tight) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, PRURITUS (itchy), SWELLING ("knot" is getting bigger/The size of knot is swelling like a size of "koose" and is now 4 and 1/2 or 5 inches long, and 2 inches wide), ERYTHEMA ("a little red"), CONTUSION ("a little bruise"), DISCOMFORT (more uncomfortable), PAIN (started to hurt), FEELING HOT ("kinda hot"), MUSCLE RIGIDITY (really tight) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.            Concomitant medication includes medication for heart, high blood pressure and blood thinners. Patient has not taken any medication to treat, but stated that she might take antihistamine and ibuprofen since it started to hurt. The pharmacist gave patient an ice pack to apply.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: have not been able to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (have not been able to get the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not been able to get the second dose). In March 2021, PRODUCT DOSE OMISSION ISSUE (have not been able to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (Headaches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever) and HEADACHE (Headaches) outcome was unknown.            No concomitant information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: What is the longest time possible an allergic reaction can take to occur?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (What is the longest time possible an allergic reaction can take to occur?) 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 ALLERGY TO VACCINE (What is the longest time possible an allergic reaction can take to occur?). At the time of the report, ALLERGY TO VACCINE (What is the longest time possible an allergic reaction can take to occur?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Diarrhea; a lot of pain in her arm; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (a lot of pain in her arm), NAUSEA (Nausea) and PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (a lot of pain in her arm), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (a lot of pain in her arm), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: tested for Covid antibodies.The result was negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (tested for Covid antibodies.The result was negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia. Concomitant products included VENETOCLAX for Chronic lymphocytic leukaemia.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (tested for Covid antibodies.The result was negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (tested for Covid antibodies.The result was negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Influenza like illness
Clinical narrative: 2 weeks after had flu like symptoms; Delayed reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (2 weeks after had flu like symptoms) and ADVERSE REACTION (Delayed reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    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 INFLUENZA LIKE ILLNESS (2 weeks after had flu like symptoms) and ADVERSE REACTION (Delayed reaction). At the time of the report, INFLUENZA LIKE ILLNESS (2 weeks after had flu like symptoms) and ADVERSE REACTION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.  No lab data has been provided by the reporter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site was tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was tender to touch) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION SITE PAIN (Injection site was tender to touch). On 02-Jul-2021, VACCINATION SITE PAIN (Injection site was tender to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given. The patient informed that injection site was tender to touch at night until the next morning. Treatment information was not provided.   This case was linked to MOD-2021-271724 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants and treatment medications were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site discomfort, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: a little pinkish; slightly uncomfortable; warm; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (a little pinkish), VACCINATION SITE DISCOMFORT (slightly uncomfortable), VACCINATION SITE WARMTH (warm) and VACCINATION SITE PRURITUS (itchy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (a little pinkish), VACCINATION SITE DISCOMFORT (slightly uncomfortable), VACCINATION SITE WARMTH (warm) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE DISCOLOURATION (a little pinkish), VACCINATION SITE DISCOMFORT (slightly uncomfortable), VACCINATION SITE WARMTH (warm) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.            Concomitant medications included everyday multivitamins and blood pressure medication.  Treatment details included Alcohol and itchy cream for itching.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Shot om 3/22/2021. For various reasons I delayed and had second shot today; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Shot om 3/22/2021. For various reasons I delayed and had second shot today) 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Shot om 3/22/2021. For various reasons I delayed and had second shot today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Shot om 3/22/2021. For various reasons I delayed and had second shot today) had resolved.            Concomitant medications were not provided. Treatment information was not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Vaccination site movement impairment
Clinical narrative: Could barely move arm in the morning; Felt like she was about to pass out; Felt dizzy; Felt weak/had no energy; Area is real hot; Swelling at injection site/swollen/Knot at injection site; Pain at injection site; Rash forming at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could barely move arm in the morning), FEELING ABNORMAL (Felt like she was about to pass out), DIZZINESS (Felt dizzy), ASTHENIA (Felt weak/had no energy) and VACCINATION SITE WARMTH (Area is real hot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (in 2010 for which she was on chemotherapy and radiation). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could barely move arm in the morning), FEELING ABNORMAL (Felt like she was about to pass out), DIZZINESS (Felt dizzy), ASTHENIA (Felt weak/had no energy), VACCINATION SITE WARMTH (Area is real hot), VACCINATION SITE SWELLING (Swelling at injection site/swollen/Knot at injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE RASH (Rash forming at injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could barely move arm in the morning), FEELING ABNORMAL (Felt like she was about to pass out), DIZZINESS (Felt dizzy), ASTHENIA (Felt weak/had no energy), VACCINATION SITE WARMTH (Area is real hot), VACCINATION SITE SWELLING (Swelling at injection site/swollen/Knot at injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE RASH (Rash forming at injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on tramadol and flexeril, but hasn't taken tramadol and flexeril in a while.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Could barely move arm in the morning; Felt like she was about to pass out; Felt dizzy; Felt weak/had no energy; Area is real hot; Swelling at injection site/swollen/Knot at injection site; Pain at injection site; Rash forming at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could barely move arm in the morning), FEELING ABNORMAL (Felt like she was about to pass out), DIZZINESS (Felt dizzy), ASTHENIA (Felt weak/had no energy) and VACCINATION SITE WARMTH (Area is real hot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (in 2010 for which she was on chemotherapy and radiation). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could barely move arm in the morning), FEELING ABNORMAL (Felt like she was about to pass out), DIZZINESS (Felt dizzy), ASTHENIA (Felt weak/had no energy), VACCINATION SITE WARMTH (Area is real hot), VACCINATION SITE SWELLING (Swelling at injection site/swollen/Knot at injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE RASH (Rash forming at injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could barely move arm in the morning), FEELING ABNORMAL (Felt like she was about to pass out), DIZZINESS (Felt dizzy), ASTHENIA (Felt weak/had no energy), VACCINATION SITE WARMTH (Area is real hot), VACCINATION SITE SWELLING (Swelling at injection site/swollen/Knot at injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE RASH (Rash forming at injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on tramadol and flexeril, but hasn't taken tramadol and flexeril in a while.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm to touch; 2 inch redness around the area of the injection; Chills really bad; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), CHILLS (Chills really bad), PYREXIA (pyrexia) and VACCINATION SITE ERYTHEMA (2 inch redness around the area of the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced CHILLS (Chills really bad) and PYREXIA (pyrexia). On 29-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (2 inch redness around the area of the injection). On 28-Jul-2021, PYREXIA (pyrexia) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), CHILLS (Chills really bad) and VACCINATION SITE ERYTHEMA (2 inch redness around the area of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Body temperature: high (High) Temperature: 100.5F.     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 medication was mentioned. No treatment medication was mentioned.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, Renal pain, Vaccination site pain
Clinical narrative: kidney pain like she has a bladder infection; has pain in the injected arm that feels like someone used it as a punching bag; lung pain like she smoked a whole lot of cigarettes; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes), RENAL PAIN (kidney pain like she has a bladder infection) and VACCINATION SITE PAIN (has pain in the injected arm that feels like someone used it as a punching bag) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes) and VACCINATION SITE PAIN (has pain in the injected arm that feels like someone used it as a punching bag). On 30-Jul-2021, the patient experienced RENAL PAIN (kidney pain like she has a bladder infection). At the time of the report, PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes), RENAL PAIN (kidney pain like she has a bladder infection) and VACCINATION SITE PAIN (has pain in the injected arm that feels like someone used it as a punching bag) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by Reporter.  No treatment information provided by Reporter.