chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchiness on the palms of his hands; rash developing on his neck and chest/rash around his waist.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on the palms of his hands) and RASH (rash developing on his neck and chest/rash around his waist.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itchiness on the palms of his hands). 27-Feb-2021, the patient experienced RASH (rash developing on his neck and chest/rash around his waist.). At the time of the report, PRURITUS (itchiness on the palms of his hands) and RASH (rash developing on his neck and chest/rash around his waist.) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Reporter stated that the patient takes lots of medications but someone takes care of them for him. Patient self treated the events using cortisone cream with mild relief but  stated that itchiness comes back.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received the first shot of the Moderna Covid vaccine; A spontaneous report was received from a pharmacist regarding a 16 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)/Product administered to patient of inappropriate age.  No adverse event was reported after the administration of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient who was 16 year old received the first shot.  Treatment information was not applicable.  Action taken with mRNA-1273 was unknown.  The outcome of the event, product administered to patient of inappropriate age, was resolved.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 012M20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Headache
Clinical narrative: lost taste and smell; lost taste and smell; fever; chills with teeth chattering/chills; headache; exhausted; body aches; terrible night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (terrible night sweats), AGEUSIA (lost taste and smell), ANOSMIA (lost taste and smell), PYREXIA (fever) and CHILLS (chills with teeth chattering/chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (lost taste and smell.) in March 2020.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced NIGHT SWEATS (terrible night sweats), PYREXIA (fever), HEADACHE (headache), FATIGUE (exhausted) and MYALGIA (body aches). 28-Feb-2021, the patient experienced CHILLS (chills with teeth chattering/chills). On an unknown date, the patient experienced AGEUSIA (lost taste and smell) and ANOSMIA (lost taste and smell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (terrible night sweats), AGEUSIA (lost taste and smell), ANOSMIA (lost taste and smell), PYREXIA (fever), CHILLS (chills with teeth chattering/chills), HEADACHE (headache), FATIGUE (exhausted) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive. In July 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concominant medications were provided. Treatment information also included heat pads and corn bags.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30 Jun 2021 included no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: lost taste and smell; lost taste and smell; fever; chills with teeth chattering/chills; headache; exhausted; body aches; terrible night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (terrible night sweats), AGEUSIA (lost taste and smell), ANOSMIA (lost taste and smell), PYREXIA (fever) and CHILLS (chills with teeth chattering/chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (lost taste and smell.) in March 2020.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced NIGHT SWEATS (terrible night sweats), PYREXIA (fever), HEADACHE (headache), FATIGUE (exhausted) and MYALGIA (body aches). 28-Feb-2021, the patient experienced CHILLS (chills with teeth chattering/chills). On an unknown date, the patient experienced AGEUSIA (lost taste and smell) and ANOSMIA (lost taste and smell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (terrible night sweats), AGEUSIA (lost taste and smell), ANOSMIA (lost taste and smell), PYREXIA (fever), CHILLS (chills with teeth chattering/chills), HEADACHE (headache), FATIGUE (exhausted) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive. In July 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concominant medications were provided. Treatment information also included heat pads and corn bags.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30 Jun 2021 included no new information.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot. 6" x 3" inches; Rash full arm to elbow; Pain at injection left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot. 6" x 3" inches), VACCINATION SITE RASH (Rash full arm to elbow) and VACCINATION SITE PAIN (Pain at injection left) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection left). On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot. 6" x 3" inches) and VACCINATION SITE RASH (Rash full arm to elbow). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form; CORTISONE at a dose of 1 dosage form; TRIAMCINOLONE at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 02-Mar-2021, VACCINATION SITE PAIN (Pain at injection left) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot. 6" x 3" inches) and VACCINATION SITE RASH (Rash full arm to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information also included ice.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme abnormal
Clinical narrative: liver enzymes were not good; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME ABNORMAL (liver enzymes were not good) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Kidney disorder. Concomitant products included INSULIN ASPART (NOVOLOG), LOSARTAN and ATORVASTATIN for an unknown indication.    On 06-Mar-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME ABNORMAL (liver enzymes were not good). At the time of the report, HEPATIC ENZYME ABNORMAL (liver enzymes were not good) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A spontaneous report, was received from a Non Health Professional, concerning an unknown age of patient with unknown gender age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and patients got their injections from a vial that has experienced a temperature excursion (Incorrect product storage). The patient's medical history, concomitant history, lab data was not provided by the reporter. On unknown date,  the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient got their injections from a vial that  has experienced a temperature excursion (Incorrect product storage). The Action taken with the second dose of mRNA-1273 in response to the event was not reported. The  outcome of the events were considered as recovered.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot #028L20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: a lot of people had flu like symptoms; chills; fever of 100; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (a lot of people had flu like symptoms), CHILLS (chills) and PYREXIA (fever of 100) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (a lot of people had flu like symptoms), CHILLS (chills) and PYREXIA (fever of 100). At the time of the report, INFLUENZA LIKE ILLNESS (a lot of people had flu like symptoms), CHILLS (chills) and PYREXIA (fever of 100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-029671, MOD-2021-038923, MOD-2021-038840 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-029671:REporter's first injection MOD-2021-038923:Reporter's second injection MOD-2021-038840:Reporter's friend
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 24-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-038277 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated Patient demographics, and outcome of the event; Sender's Comments:  MOD-2021-038277:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Vaccination site erythema; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 26-Feb-2021, VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) and Statin drugs for an unknown indication.   On 07-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 09-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient has not gotten second vaccine by day 35 from date of first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first 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.    On 28-Jan-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Balance disorder, Dizziness, Hypoaesthesia
Clinical narrative: pain across the back and shoulders; pain across the back and shoulders; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire). On an unknown date, the patient experienced BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders). At the time of the report, PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain across the back and shoulders; pain across the back and shoulders; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire). On an unknown date, the patient experienced BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders). At the time of the report, PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Rash
Clinical narrative: rash on right hand; blisters look like they are gonna open; red places on nose; red places on hand; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red places on nose), ERYTHEMA (red places on hand), BLISTER (blisters look like they are gonna open) and RASH (rash on right hand) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (red places on hand). On 05-Mar-2021, the patient experienced ERYTHEMA (red places on nose) and BLISTER (blisters look like they are gonna open). On 09-Mar-2021, the patient experienced RASH (rash on right hand). At the time of the report, ERYTHEMA (red places on nose), ERYTHEMA (red places on hand), BLISTER (blisters look like they are gonna open) and RASH (rash on right hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-138794 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: concomitant medications updated, event updated, product information updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gait disturbance, Headache, Ill-defined disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), CHILLS (chills), PYREXIA (low grade fever) and VOMITING (throwing up dark yellow and it tasted terrible). On 28-Feb-2021, the patient experienced ASTHENIA (felt weak) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (low grade fever), VOMITING (throwing up dark yellow and it tasted terrible) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), CHILLS (chills), PYREXIA (low grade fever) and VOMITING (throwing up dark yellow and it tasted terrible). On 28-Feb-2021, the patient experienced ASTHENIA (felt weak) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (low grade fever), VOMITING (throwing up dark yellow and it tasted terrible) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Received second dose of vaccine subcutaneously; A spontaneous report was received from a nurse concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it was noted that she received second dose of vaccine subcutaneously/ Incorrect route of product administration.  Medical history or concomitant product use was not reported.  On 08 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 08 Mar 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: 010M20A) subcutaneously in the left arm. It was reported that the injection was given on the tender surface of the skin, not muscle. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable since the patient took her second dose already.  The outcome of the event was resolved on 08 Mar 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 012L20A with no associated AEs.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Slight headaches; Fever of 100; Chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever of 100), CHILLS (Chills) and HEADACHE (Slight headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus, LOSARTAN for Hypertension, PANCRELIPASE (ZENPEP) for Pancreas disorder.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever of 100) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Slight headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever of 100), CHILLS (Chills) and HEADACHE (Slight headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included advil.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: overall itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (overall itch) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BENZONATATE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (overall itch). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date at a dose of 1 dosage form. On 27-Feb-2021, PRURITUS (overall itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: nausea; tired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and FATIGUE (tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 immunisation.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced NAUSEA (nausea) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea) and FATIGUE (tired) was resolving.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache
Clinical narrative: diarrhea; upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) outcome was unknown.            Concomitant medications was reported cholesterol medication. No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medications.  Treatment medications included shingles vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: experienced severe headache; soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (experienced severe headache) and VACCINATION SITE PAIN (soreness at the site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEADACHE (experienced severe headache) and VACCINATION SITE PAIN (soreness at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced severe headache) and VACCINATION SITE PAIN (soreness at the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Pain in extremity, Vomiting
Clinical narrative: Vomiting; little bit of a sore arm; had no appetite; diarrhea; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea), FATIGUE (exhausted) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Hypersensitive syndrome and Blood pressure high.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea) and FATIGUE (exhausted). On an unknown date, the patient experienced VOMITING (Vomiting). The patient was treated with DOMPERIDONE (MOTILIUM [DOMPERIDONE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea), FATIGUE (exhausted) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were low dose high blood pressure medication.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pain in extremity
Clinical narrative: Breastfeeding mother; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included birth control.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Insomnia, Myalgia, Pain in extremity
Clinical narrative: one minute she felt okay and then she felt bad again; hurting; rash on her arm; fells like fever on it; hurting arm; 101 °F fever; couldn't sleep; itching on arm; SORE MUSCLE; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), PRURITUS (itching on arm), SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm) and FEELING ABNORMAL (one minute she felt okay and then she felt bad again) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (couldn't sleep), PRURITUS (itching on arm), MYALGIA (SORE MUSCLE) and MYALGIA (body aches). On 07-Mar-2021, the patient experienced SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm), DISCOMFORT (hurting), RASH (rash on her arm) and PYREXIA (101 °F fever). On an unknown date, the patient experienced FEELING ABNORMAL (one minute she felt okay and then she felt bad again). At the time of the report, INSOMNIA (couldn't sleep), PRURITUS (itching on arm), SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm), FEELING ABNORMAL (one minute she felt okay and then she felt bad again), DISCOMFORT (hurting), RASH (rash on her arm), MYALGIA (SORE MUSCLE), MYALGIA (body aches) and PYREXIA (101 °F fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment :Cortisone
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin temperature
Clinical narrative: one minute she felt okay and then she felt bad again; hurting; rash on her arm; fells like fever on it; hurting arm; 101 °F fever; couldn't sleep; itching on arm; SORE MUSCLE; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), PRURITUS (itching on arm), SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm) and FEELING ABNORMAL (one minute she felt okay and then she felt bad again) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (couldn't sleep), PRURITUS (itching on arm), MYALGIA (SORE MUSCLE) and MYALGIA (body aches). On 07-Mar-2021, the patient experienced SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm), DISCOMFORT (hurting), RASH (rash on her arm) and PYREXIA (101 °F fever). On an unknown date, the patient experienced FEELING ABNORMAL (one minute she felt okay and then she felt bad again). At the time of the report, INSOMNIA (couldn't sleep), PRURITUS (itching on arm), SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm), FEELING ABNORMAL (one minute she felt okay and then she felt bad again), DISCOMFORT (hurting), RASH (rash on her arm), MYALGIA (SORE MUSCLE), MYALGIA (body aches) and PYREXIA (101 °F fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment :Cortisone
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) 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 FATIGUE (fatigued). At the time of the report, FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (a rash on the arm which was itchy) and HEADACHE (more headaches than usual) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (a rash on the arm which was itchy) and HEADACHE (more headaches than usual). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (a rash on the arm which was itchy) and HEADACHE (more headaches than usual) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: moderate to sever pain in middle of his back; pain in the thigh and knee; fatigue; mild chills; mild nausea; Moderate muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills) and NAUSEA (mild nausea) in a 77-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 information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills), NAUSEA (mild nausea) and MYALGIA (Moderate muscle aches). At the time of the report, BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills), NAUSEA (mild nausea) and MYALGIA (Moderate muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications include OTC AspirinExtra strength tylenol and advil
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: moderate to sever pain in middle of his back; pain in the thigh and knee; fatigue; mild chills; mild nausea; Moderate muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills) and NAUSEA (mild nausea) in a 77-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 information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills), NAUSEA (mild nausea) and MYALGIA (Moderate muscle aches). At the time of the report, BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills), NAUSEA (mild nausea) and MYALGIA (Moderate muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications include OTC AspirinExtra strength tylenol and advil
Sex: F
Vaccine: COVID19
Symptoms: Acne, Rash, Skin discolouration
Clinical narrative: small blood spots on her face; a knot or pimple on her left jaw line; rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (small blood spots on her face), ACNE (a knot or pimple on her left jaw line) and RASH (rash on left arm) 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 23-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 SKIN DISCOLOURATION (small blood spots on her face), ACNE (a knot or pimple on her left jaw line) and RASH (rash on left arm). At the time of the report, SKIN DISCOLOURATION (small blood spots on her face), ACNE (a knot or pimple on her left jaw line) and RASH (rash on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Slept all day; Extremely Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept all day) and FATIGUE (Extremely Tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Extremely Tired). On 07-Mar-2021, the patient experienced HYPERSOMNIA (Slept all day). On 07-Mar-2021, HYPERSOMNIA (Slept all day) and FATIGUE (Extremely Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.