chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lip swelling, Pruritus
Clinical narrative: Skin is very itchy; Eyes are very itchy; Swelling around the lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling around the lip), PRURITUS (Skin is very itchy) and EYE PRURITUS (Eyes are very itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 038H20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for Bone disorder (NOS).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swelling around the lip). On 15-Nov-2021, the patient experienced PRURITUS (Skin is very itchy) and EYE PRURITUS (Eyes are very itchy). At the time of the report, LIP SWELLING (Swelling around the lip), PRURITUS (Skin is very itchy) and EYE PRURITUS (Eyes are very itchy) outcome was unknown.            Treatment information was not provided.  Patient takes Fosamax for the bones, once a week. Patient agreed to be contacted for a follow-up. Patient did not have a reaction to the first two doses of the vaccine, and has no known allergies.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection arm), PYREXIA (High fever (102.5F)), CHILLS (Chills) and HEADACHE (Strong headaches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection arm), PYREXIA (High fever (102.5F)), CHILLS (Chills) and HEADACHE (Strong headaches). At the time of the report, VACCINATION SITE PAIN (Pain in the injection arm), PYREXIA (High fever (102.5F)), CHILLS (Chills) and HEADACHE (Strong headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: high (High) high fever (102.5 F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered after exposure to room temperature >24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours). On 11-Nov-2021, PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP reported that 1 vial of the Moderna vaccine was placed at room temperature at 9 am on 10-Nov-2021, left at room temperature overnight, and then, 24 hours later, on 11-Nov-2021 9am, 1 booster dose was administered and, after an additional 6 hours, at 3pm 11Nov2021, 2 doses were administered from the same vial as booster doses. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Vaccination complication
Clinical narrative: Armpits are swollen; Today is the first day she is not running fever; Has been having bad side effects for 3 days; 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 VACCINATION COMPLICATION (Has been having bad side effects for 3 days), PERIPHERAL SWELLING (Armpits are swollen) and PYREXIA (Today is the first day she is not running fever) 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 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Has been having bad side effects for 3 days), PERIPHERAL SWELLING (Armpits are swollen) and PYREXIA (Today is the first day she is not running fever). On 15-Nov-2021, PYREXIA (Today is the first day she is not running fever) had resolved. At the time of the report, VACCINATION COMPLICATION (Has been having bad side effects for 3 days) had resolved and PERIPHERAL SWELLING (Armpits are swollen) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized itching; Generalized hives; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Generalized itching) and URTICARIA (Generalized hives) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 012A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PRURITUS (Generalized itching) and URTICARIA (Generalized hives). At the time of the report, PRURITUS (Generalized itching) and URTICARIA (Generalized hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were given.  Patient was trying to find out whether hives are possible reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received included non significant information. On 17-Nov-2021: Follow up received included patient demographics, vaccine details, concomitant medication and events start dates.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Feel tired), NAUSEA (Nauseated) and PYREXIA (Temp 99.1) 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 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced FATIGUE (Feel tired), NAUSEA (Nauseated) and PYREXIA (Temp 99.1). At the time of the report, FATIGUE (Feel tired), NAUSEA (Nauseated) and PYREXIA (Temp 99.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 99.1 (High) Temp 99.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: really sick, pretty sick; had severe aches; cold; fever; chills; 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 ILLNESS (really sick, pretty sick), PAIN (had severe aches), NASOPHARYNGITIS (cold), PYREXIA (fever) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick, pretty sick), PAIN (had severe aches), NASOPHARYNGITIS (cold), PYREXIA (fever) and CHILLS (chills). At the time of the report, ILLNESS (really sick, pretty sick), PAIN (had severe aches), NASOPHARYNGITIS (cold), PYREXIA (fever) and CHILLS (chills) had not resolved.            No Concomitant use were reported  Patient got really sick, had severe aches, fever and cold chills. Has been like this for 3 days and was not getting better.  No Treatment were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired booster dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired booster dose). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (receiving expired booster dose) had resolved.            No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up document received contains no new information. On 15-Nov-2021: Non-Significant Follow up- Reporter's mail Id and Address updated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding after 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     No medical history for patient was reported.  Concomitant products included TRAZODONE from 01-Jan-2019 to an unknown date for Insomnia.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding after 2nd dose). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding after 2nd dose) had resolved.            No treatment medication was reported.   This case was linked to MOD-2021-386812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contains event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 expired doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that  4 patients received an expired vaccine. It was reported that vials were transported in a cold container and remained cold the entire time while being transported.   This case was linked to MOD-2021-387476, MOD-2021-387484 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Number of patients and gender confirmed and additional information received. On 15-Nov-2021: No new information.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; patient also stated that she had common side effects like fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (patient also stated that she had common side effects like fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 011J20A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE from 01-Jan-2019 to an unknown date for Insomnia.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (patient also stated that she had common side effects like fatigue). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) had resolved and FATIGUE (patient also stated that she had common side effects like fatigue) outcome was unknown.            Treatment medications were not provided.  It was reported that patient has no history of COVID-19.  Irregular vaginal bleeding within 24 hours of receiving the mRNA vaccine.  Light to medium bleeding, lasting only 1-2 days.     This case was linked to MOD-2021-386798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received includes Patient information (race, ethnicity, height, weight, pregnancy status), concomitant medications and outcome of event updated
Sex: U
Vaccine: COVID19
Symptoms: Gingival pain
Clinical narrative: sorness in the gums / sensitve gum; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of GINGIVAL PAIN (sorness in the gums / sensitve gum) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (sorness in the gums / sensitve gum). At the time of the report, GINGIVAL PAIN (sorness in the gums / sensitve gum) 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 concomitants and treatment drugs are provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Induration, Lip swelling, Rash pruritic, Swelling
Clinical narrative: under her chin was hard & swollen; under her chin was hard & swollen; she was itching here & there/random itching spots/was itchy & bumpy from the waist down; right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together; her upper lip was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (her upper lip was swollen), INDURATION (under her chin was hard & swollen), RASH PRURITIC (she was itching here & there/random itching spots/was itchy & bumpy from the waist down), EYE SWELLING (right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together) and SWELLING (under her chin was hard & swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 030L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (her upper lip was swollen). On 14-Nov-2021, the patient experienced RASH PRURITIC (she was itching here & there/random itching spots/was itchy & bumpy from the waist down) and EYE SWELLING (right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together). On 15-Nov-2021, the patient experienced INDURATION (under her chin was hard & swollen). 15-Nov-2021, the patient experienced SWELLING (under her chin was hard & swollen). On 13-Nov-2021, LIP SWELLING (her upper lip was swollen) had resolved. At the time of the report, INDURATION (under her chin was hard & swollen) had not resolved and RASH PRURITIC (she was itching here & there/random itching spots/was itchy & bumpy from the waist down), EYE SWELLING (right eye was swollen again but not as much/eye swelling again but not as bad/right eye was swollen together) and SWELLING (under her chin was hard & swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Feeding disorder, Feeling abnormal, Impaired work ability, Insomnia
Clinical narrative: started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.; red big  knot on their left side hip; pain on the right side of their leg; swelled up to their buttocks; not been able to go to work; feel so bad; cannot stand on their leg for too long.; not been able to eat; not been able to go to work, eat or sleep for 6 days.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks) and IMPAIRED WORK ABILITY (not been able to go to work) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE, CELECOXIB (CELEBREX) and PREGABALIN (LYRICA) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks), IMPAIRED WORK ABILITY (not been able to go to work), FEELING ABNORMAL (feel so bad), DYSSTASIA (cannot stand on their leg for too long.), FEEDING DISORDER (not been able to eat) and INSOMNIA (not been able to go to work, eat or sleep for 6 days.). At the time of the report, SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks), IMPAIRED WORK ABILITY (not been able to go to work), FEELING ABNORMAL (feel so bad), DYSSTASIA (cannot stand on their leg for too long.), FEEDING DISORDER (not been able to eat) and INSOMNIA (not been able to go to work, eat or sleep for 6 days.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications reported. No treatment reported
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Swelling, Swelling face
Clinical narrative: started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.; red big  knot on their left side hip; pain on the right side of their leg; swelled up to their buttocks; not been able to go to work; feel so bad; cannot stand on their leg for too long.; not been able to eat; not been able to go to work, eat or sleep for 6 days.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks) and IMPAIRED WORK ABILITY (not been able to go to work) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE, CELECOXIB (CELEBREX) and PREGABALIN (LYRICA) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks), IMPAIRED WORK ABILITY (not been able to go to work), FEELING ABNORMAL (feel so bad), DYSSTASIA (cannot stand on their leg for too long.), FEEDING DISORDER (not been able to eat) and INSOMNIA (not been able to go to work, eat or sleep for 6 days.). At the time of the report, SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks), IMPAIRED WORK ABILITY (not been able to go to work), FEELING ABNORMAL (feel so bad), DYSSTASIA (cannot stand on their leg for too long.), FEEDING DISORDER (not been able to eat) and INSOMNIA (not been able to go to work, eat or sleep for 6 days.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications reported. No treatment reported
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain
Clinical narrative: stomach hurt like there is a lot of pressure and she have abdominal pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurt like there is a lot of pressure and she have abdominal pain) and BACK PAIN (Back pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson for her covid19. Past adverse reactions to the above products included No adverse event with Johnson and Johnson for her covid19.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurt like there is a lot of pressure and she have abdominal pain) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach hurt like there is a lot of pressure and she have abdominal pain) and BACK PAIN (Back pain) outcome was unknown.            NO Concomitant drug reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching) 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 PRURITUS (itching). At the time of the report, PRURITUS (itching) 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 did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in jaw
Clinical narrative: Neck pain; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and PAIN IN JAW (Jaw pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D3) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NECK PAIN (Neck pain) and PAIN IN JAW (Jaw pain). At the time of the report, NECK PAIN (Neck pain) and PAIN IN JAW (Jaw pain) outcome was unknown.            No treatment information was reported. The patient stated that he was worried that his first dose was invalid because he had no reaction at all and there was a power outage at the vaccine site due to a grid power loss in his state at the time of 1st dose.  The lot no for first dose was provided as CR7M20A CR may not be correct.   This case was linked to MOD-2021-386949 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired dose administered to patient; patient first 2 dose were of pfizer and 3rd dose of moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient first 2 dose were of pfizer and 3rd dose of moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1sd dose and 2nd dose). Past adverse reactions to the above products included No adverse reaction with Pfizer.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient first 2 dose were of pfizer and 3rd dose of moderna). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient first 2 dose were of pfizer and 3rd dose of moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up document contains no new information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Couldn't get out of bed because of dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Couldn't get out of bed because of dizziness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 016M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Couldn't get out of bed because of dizziness). At the time of the report, DIZZINESS (Couldn't get out of bed because of dizziness) had not resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypokinesia, Peripheral swelling, Skin warm
Clinical narrative: it is hot, like a fever; can't move it/she could not move it until this morning; arm is red; arm is swollen/it is big and round as the palm of her hand; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (it is hot, like a fever), HYPOKINESIA (can't move it/she could not move it until this morning), ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen/it is big and round as the palm of her hand) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 026A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN WARM (it is hot, like a fever), HYPOKINESIA (can't move it/she could not move it until this morning), ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen/it is big and round as the palm of her hand). At the time of the report, SKIN WARM (it is hot, like a fever), HYPOKINESIA (can't move it/she could not move it until this morning), ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen/it is big and round as the palm of her hand) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment: Put ice on it.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Pyrexia
Clinical narrative: really sick, pretty sick; had severe aches, pains; fever; Cold chills; 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 ILLNESS (really sick, pretty sick), PAIN (had severe aches, pains), PYREXIA (fever) and CHILLS (Cold chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick, pretty sick), PAIN (had severe aches, pains), PYREXIA (fever) and CHILLS (Cold chills). At the time of the report, ILLNESS (really sick, pretty sick), PAIN (had severe aches, pains), PYREXIA (fever) and CHILLS (Cold chills) had resolved.            No concomitant and treatment information were reported by the reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling
Clinical narrative: Swollen lymph nodes in arm pits; Breast swell; Breast pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Breast swell), BREAST PAIN (Breast pain) and LYMPHADENOPATHY (Swollen lymph nodes in arm pits) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced BREAST SWELLING (Breast swell), BREAST PAIN (Breast pain) and LYMPHADENOPATHY (Swollen lymph nodes in arm pits). At the time of the report, BREAST SWELLING (Breast swell), BREAST PAIN (Breast pain) and LYMPHADENOPATHY (Swollen lymph nodes in arm pits) had not resolved.            Patient does not take concomitant medication.  Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: After 1st dose, she noticed her fingers were tingling on and off.; When I was driving car, my hands went numb.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After 1st dose, she noticed her fingers were tingling on and off.) and HYPOAESTHESIA (When I was driving car, my hands went numb.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (After 1st dose, she noticed her fingers were tingling on and off.) and HYPOAESTHESIA (When I was driving car, my hands went numb.). At the time of the report, PARAESTHESIA (After 1st dose, she noticed her fingers were tingling on and off.) and HYPOAESTHESIA (When I was driving car, my hands went numb.) 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.   Treatment to the events given as hot bath.   This case was linked to MOD-2021-386892, MOD-2021-386893 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Body temperature, Myalgia, Oxygen saturation
Clinical narrative: I am sick on my stomach; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155 (High) 155. On an unknown date, Body temperature: 100.6 (High) 100.6 and 103.6 (High) 103.6. On an unknown date, Oxygen saturation: 80.93 (Low) 80.93.         No concomitant product information was provided.   This case was linked to MOD-2021-042608 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I am sick on my stomach; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155 (High) 155. On an unknown date, Body temperature: 100.6 (High) 100.6 and 103.6 (High) 103.6. On an unknown date, Oxygen saturation: 80.93 (Low) 80.93.         No concomitant product information was provided.   This case was linked to MOD-2021-042608 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Treatment: given Hot bath.   This case was linked to MOD-2021-386875, MOD-2021-386893 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vertigo
Clinical narrative: Starting next day after booster, she noticed that her fingers of hands and foot are tingling/she feels tingling and numbness every day; Going numb/she feels tingling and numbness every day; has been having vertigo that started next day after taking booster dose.; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Starting next day after booster, she noticed that her fingers of hands and foot are tingling/she feels tingling and numbness every day), HYPOAESTHESIA (Going numb/she feels tingling and numbness every day) and VERTIGO (has been having vertigo that started next day after taking booster dose.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PARAESTHESIA (Starting next day after booster, she noticed that her fingers of hands and foot are tingling/she feels tingling and numbness every day), HYPOAESTHESIA (Going numb/she feels tingling and numbness every day) and VERTIGO (has been having vertigo that started next day after taking booster dose.). At the time of the report, PARAESTHESIA (Starting next day after booster, she noticed that her fingers of hands and foot are tingling/she feels tingling and numbness every day), HYPOAESTHESIA (Going numb/she feels tingling and numbness every day) and VERTIGO (has been having vertigo that started next day after taking booster dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had reported his treatment with Hot Bath.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-386892, MOD-2021-386875 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pruritus, Vaccination complication
Clinical narrative: believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae; like burning ice; sort of itchiness; there's something going around her skin or something.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae), BURNING SENSATION (like burning ice), PRURITUS (sort of itchiness) and VACCINATION COMPLICATION (there's something going around her skin or something.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 036521A and 071F211A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae), BURNING SENSATION (like burning ice), PRURITUS (sort of itchiness) and VACCINATION COMPLICATION (there's something going around her skin or something.). At the time of the report, HERPES ZOSTER (believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae), BURNING SENSATION (like burning ice), PRURITUS (sort of itchiness) and VACCINATION COMPLICATION (there's something going around her skin or something.) outcome was unknown.            No Concomitants were reported. No treatment drugs were reported.   This case was linked to MOD-2021-386953, MOD-2021-386572 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Facial swelling). At the time of the report, SWELLING FACE (Facial swelling) outcome was unknown.        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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced RASH (Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs)). At the time of the report, RASH (Having rashes all over the body (It started in my face, around my ears and neck. Now it is on my arms, stomach and legs)) outcome was unknown.            No concomitant medication were reported.  Patient stated having rashes all over the body. It started on face, around ears and neck. Now it is on arms, stomach and legs. The symptoms started about a week ago. The patient took pain pills only.