chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021) in a 35-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 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021). On 05-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Patient states that she received her first Moderna vaccine in what she thinks was January but possibly February of 2021.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: ask people if they lost their hair after getting the vaccine they tell her that hey have; 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 ALOPECIA (ask people if they lost their hair after getting the vaccine they tell her that hey have) 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 ALOPECIA (ask people if they lost their hair after getting the vaccine they tell her that hey have). At the time of the report, ALOPECIA (ask people if they lost their hair after getting the vaccine they tell her that hey have) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No Treatment informations were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Non-significant Follow-up -NNI On 05-Oct-2021: Follow up received on 06-Oct-2021 contained No New Information.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was pretty sick for the first two shots; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was pretty sick for the first two shots) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was pretty sick for the first two shots). At the time of the report, ILLNESS (I was pretty sick for the first two shots) outcome was unknown.            Concomitant medication was not reported.  Treatment information was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash; Little rash on their lower right arm; It is itching so bad/ they started itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash), VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site) and VACCINATION SITE RASH (Little rash on their lower right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site). On 23-Sep-2021, the patient experienced RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash) and VACCINATION SITE RASH (Little rash on their lower right arm). At the time of the report, RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash), VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site) and VACCINATION SITE RASH (Little rash on their lower right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad") in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD in July 1968. Concomitant products included TIMOLOL for Glaucoma.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad"). At the time of the report, VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient reported that it felt better.   This case was linked to MOD-2021-339295 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Patients race, ethnicity, Relevant medical history, concomitant medications, Event outcome and event assessment updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine; Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot) 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 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot). At the time of the report, COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 04-Oct-2021: Non-significant follow-up: Reporters email address updated; Sender's Comments: This case concerns a female patient, age unknown with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (event onset date unknown). The rechallenge was not applicable since only information about first dose was disclosed. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling at the injection site after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site after second vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site after second vaccine). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site after second vaccine) outcome was unknown.            Concomitant medications were not reported. treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given last 30 Sept; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given last 30 Sept) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given last 30 Sept). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given last 30 Sept) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Added drug start date and updated event verbatim.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Pyrexia
Clinical narrative: Swelling in her hands; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Lethargy, Lymphadenopathy, Vaccination site pain
Clinical narrative: sore in his left arm which moved to his right breast; underneath arm lymph nodes are swollen; sore in his left arm; severe joint pain; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), BREAST PAIN (sore in his left arm which moved to his right breast), ARTHRALGIA (severe joint pain), LYMPHADENOPATHY (underneath arm lymph nodes are swollen) and VACCINATION SITE PAIN (sore in his left arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (believed he already had COVID 2 1/2 months ago.).    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced LETHARGY (lethargic) and ARTHRALGIA (severe joint pain). On 01-Oct-2021, the patient experienced BREAST PAIN (sore in his left arm which moved to his right breast), LYMPHADENOPATHY (underneath arm lymph nodes are swollen) and VACCINATION SITE PAIN (sore in his left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), BREAST PAIN (sore in his left arm which moved to his right breast), ARTHRALGIA (severe joint pain), LYMPHADENOPATHY (underneath arm lymph nodes are swollen) and VACCINATION SITE PAIN (sore in his left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported not being on any medications prior to getting vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Therapeutic response unexpected
Clinical narrative: Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again; Hadaches every now and then; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047b21a and 041b21a) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Always had psoriasis in her neck for 4 years) and Herpes infection (Used to get herpes in her lips or on her gluteus).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-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 THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then) outcome was unknown.            No concomitant medication were reported. It was reported that 3 days after receiving the vaccine her underlying burning diminished and the psoriasis disappeared.Patient also stated that sometimes she used to get herpes in her lips or on her gluteus and after vaccination she didn't had another episode of herpes again.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Inappropriate schedule of product administration, Movement disorder
Clinical narrative: Can not really move; Lack of energy; Tired/ fatigue; Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021) and FATIGUE (Tired/ fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021). On an unknown date, the patient experienced MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy) and FATIGUE (Tired/ fatigue). On 13-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021) had resolved. At the time of the report, MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy) and FATIGUE (Tired/ fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. Pharmacist reports that the patient reported after the second dose,he has been experiencing tired, fatigue, lack of energy, and was unable to move.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia, Vaccination site erythema
Clinical narrative: Fever of 100.5-100.7 Deg. F; Swollen axillary adenopathy that is 5cm; Redness of injection site of 4cm.; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever of 100.5-100.7 Deg. F), LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PYREXIA (Fever of 100.5-100.7 Deg. F), LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Oct-2021, PYREXIA (Fever of 100.5-100.7 Deg. F) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 100.5-100.7 (High) 100.5-100.7 Deg. F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Feeding disorder, Feeling abnormal, Feeling of body temperature change, Mobility decreased
Clinical narrative: a little clammy; I slept  all day probably for about 18 hours; l was hot and cold; I couldn't eat; couldn't get up; felt like I am going to fall down; A little nauseated; pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm), COLD SWEAT (a little clammy), SOMNOLENCE (I slept  all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold) and FEEDING DISORDER (I couldn't eat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm). On 02-Oct-2021, the patient experienced SOMNOLENCE (I slept  all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold), FEEDING DISORDER (I couldn't eat), MOBILITY DECREASED (couldn't get up ), FEELING ABNORMAL (felt like I am going to fall down) and NAUSEA (A little nauseated). On 03-Oct-2021, the patient experienced COLD SWEAT (a little clammy). The patient was treated with IBUPROFEN for Adverse event, at a dose of 2 Tab every six hours. At the time of the report, PAIN IN EXTREMITY (pain in my arm) and COLD SWEAT (a little clammy) had not resolved and SOMNOLENCE (I slept  all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold), FEEDING DISORDER (I couldn't eat), MOBILITY DECREASED (couldn't get up ), FEELING ABNORMAL (felt like I am going to fall down) and NAUSEA (A little nauseated) was resolving.            Concomitant medication information was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Somnolence
Clinical narrative: a little clammy; I slept  all day probably for about 18 hours; l was hot and cold; I couldn't eat; couldn't get up; felt like I am going to fall down; A little nauseated; pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm), COLD SWEAT (a little clammy), SOMNOLENCE (I slept  all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold) and FEEDING DISORDER (I couldn't eat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm). On 02-Oct-2021, the patient experienced SOMNOLENCE (I slept  all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold), FEEDING DISORDER (I couldn't eat), MOBILITY DECREASED (couldn't get up ), FEELING ABNORMAL (felt like I am going to fall down) and NAUSEA (A little nauseated). On 03-Oct-2021, the patient experienced COLD SWEAT (a little clammy). The patient was treated with IBUPROFEN for Adverse event, at a dose of 2 Tab every six hours. At the time of the report, PAIN IN EXTREMITY (pain in my arm) and COLD SWEAT (a little clammy) had not resolved and SOMNOLENCE (I slept  all day probably for about 18 hours), FEELING OF BODY TEMPERATURE CHANGE (l was hot and cold), FEEDING DISORDER (I couldn't eat), MOBILITY DECREASED (couldn't get up ), FEELING ABNORMAL (felt like I am going to fall down) and NAUSEA (A little nauseated) was resolving.            Concomitant medication information was not provided by the reporter.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Muscle spasms, Paraesthesia, Product administered to patient of inappropriate age
Clinical narrative: Both feet are a little numb; Numbness in middle right toe; Cramping in left foot; Tingling (numbness) in his right foot; 16 year old given vaccine; Patient received second dose 36 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingling (numbness) in his right foot), HYPOAESTHESIA (Numbness in middle right toe), MUSCLE SPASMS (Cramping in left foot), HYPOAESTHESIA (Both feet are a little numb) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 36 days after the first dose). On 15-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Tingling (numbness) in his right foot). On 19-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness in middle right toe) and MUSCLE SPASMS (Cramping in left foot). On 22-Aug-2021, the patient experienced HYPOAESTHESIA (Both feet are a little numb). On 13-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 36 days after the first dose) had resolved. On 25-Aug-2021, PARAESTHESIA (Tingling (numbness) in his right foot), HYPOAESTHESIA (Numbness in middle right toe), MUSCLE SPASMS (Cramping in left foot) and HYPOAESTHESIA (Both feet are a little numb) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Tingling in his right foot started on 15-AUG-2021. On  19-AUG-2021 reported numbness in middle right toe and cramping in left foot. On 22-AUG-2021, both feet are a little numb.  Patient race is On 25-AUG-2021 reported no numbness or any other symptoms.  No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-280894 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Myalgia
Clinical narrative: welt at the injection site; big red circle at the injection site; itching at the injection site; hives at injection site; arm being kind of sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (welt at the injection site), MYALGIA (arm being kind of sore), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes, SIMVASTATIN, VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and FISH OIL for an unknown indication.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced MYALGIA (arm being kind of sore). On 27-Sep-2021, the patient experienced INJECTION SITE URTICARIA (welt at the injection site), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE URTICARIA (welt at the injection site), MYALGIA (arm being kind of sore), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient reported that she won't get the second shot. Patient also reported that  she has an appointment with her doctor on 16October2021. treatment medication include antibiotic,vaseline
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Shoulder injury related to vaccine administration, Vaccination site pain, Vaccination site swelling
Clinical narrative: my shoulder, the joint is really hurting/ my neck and behind my back hurts; I have extra pain/ patient states all this is on the left arm were the vaccine was administrated; swelling around the injection site, the shoulder joint; a bad administration of the vaccine; 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 SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (my shoulder, the joint is really hurting/ my neck and behind my back hurts), VACCINATION SITE PAIN (I have extra pain/ patient states all this is on the left arm were the vaccine was administrated), VACCINATION SITE SWELLING (swelling around the injection site, the shoulder joint) and PRODUCT ADMINISTRATION ERROR (a bad administration of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (a bad administration of the vaccine). On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (my shoulder, the joint is really hurting/ my neck and behind my back hurts), VACCINATION SITE PAIN (I have extra pain/ patient states all this is on the left arm were the vaccine was administrated) and VACCINATION SITE SWELLING (swelling around the injection site, the shoulder joint). On 25-Sep-2021, PRODUCT ADMINISTRATION ERROR (a bad administration of the vaccine) had resolved. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (my shoulder, the joint is really hurting/ my neck and behind my back hurts), VACCINATION SITE PAIN (I have extra pain/ patient states all this is on the left arm were the vaccine was administrated) and VACCINATION SITE SWELLING (swelling around the injection site, the shoulder joint) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: sick for about a week/ felt crappy for longer like almost a month; arms hurt; flu-like symptoms; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sick for about a week/ felt crappy for longer like almost a month), PAIN IN EXTREMITY (arms hurt), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024172OA and 028L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (sick for about a week/ felt crappy for longer like almost a month), PAIN IN EXTREMITY (arms hurt), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (sick for about a week/ felt crappy for longer like almost a month), PAIN IN EXTREMITY (arms hurt), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were not reported.  She is nervous about taking the booster vaccine and will discuss with her Oncologist  No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: TCR was received on 6-OCT-2021 and contains significant information: address, age , current condition , events ,were added.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: Body aches; Covid toes( feet hurting, red/purple coloration); Covid toes( feet hurting, red/purple coloration); Low energy/fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Post-traumatic stress disorder. Concomitant products included TRAZODONE for Post-traumatic stress disorder.    On 27-Apr-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 (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  Patient reported that she was experiencing an intense rash in the scalp that is causing hair loss and it got worse since last two months. She also reported that her Dermatologist thinks this is dermatitis or psoriasis and prescribed, whit Clobetasol (steroid medication), propionate shampoo and a ciclopirox shampoo.   This case was linked to MOD-2021-339457 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Myalgia, Pyrexia
Clinical narrative: Unsteady on feet; Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills). On 20-Sep-2021, GAIT DISTURBANCE (Unsteady on feet), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient took appointment on 8 Oct 2021 to take second dose and said that no rash was experienced as a side effect.  treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Removed event Rash.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Eye irritation, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Almost debilitating; Inappropriate schedule of vaccine administered; EYE TWITCHING; OCCASIONAL STRONG HEARTBEAT; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), EYE IRRITATION (EYE TWITCHING), HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT), ASTHENIA (Almost debilitating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 048F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Amoxicillin, Amoxicillin, Pseudoephedrine and Caffeine. Past adverse reactions to the above products included Abdominal discomfort with Amoxicillin; Heart racing with Caffeine and Pseudoephedrine; and Vomiting with Amoxicillin. Concurrent medical conditions included Drug allergy (Augmentin), Heart racing and Ear infection (Bacterial , Fungal Ear infections.) in December 2020. Concomitant products included L-METHYLFOLATE from 15-Jun-2021 to an unknown date for Anxiety.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ANXIETY (Anxiety). On 22-Sep-2021, the patient experienced EYE IRRITATION (EYE TWITCHING) and HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT). On an unknown date, the patient experienced ASTHENIA (Almost debilitating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ANXIETY (Anxiety), EYE IRRITATION (EYE TWITCHING), HEART RATE INCREASED (OCCASIONAL STRONG HEARTBEAT) and ASTHENIA (Almost debilitating) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had anxiety on a daily basis as that happend once thirty years ago due to OTC pseudophedrine, Afrin use and caffeine. Lasted a few weeks and also happend a second time  a couple weeks after flu vaccine several years ago and lasted 2- 3 weeks.  Treatment information does not provided.   This case was linked to MOD-2021-291669 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (administration of an expired dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 048F21A) for COVID-19 immunization. No medical history reported. On Oct 3, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 3, 2021, patient administered expired product (administration of an expired dose). On Oct 3, 2021, administered expired product (administration of an expired dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated the dose administered after 30-day use by date or after manufacturer date of expiry. Storage details provide by reporter included: Date the vial was initially stored in the refrigerator: Sep 1, 2021 with a use by date of Oct 1, 2021. This case linked to MOD-2021-339392 (patient link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Oropharyngeal discomfort, Rhinorrhoea, Sinusitis
Clinical narrative: runny nose; sinus issues; throat discomfort; weakness in her arms; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-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 RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache). At the time of the report, RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold
Clinical narrative: Coldness; Joints being painful/It comes and goes, knees feel painful, and elbows; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-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 FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows). At the time of the report, FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Next day arm sore at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Penicillin allergy (Severe itching on back) since 1957 and Sulfonamide allergy (Itching) since 2003.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache). At the time of the report, VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient partial date of birth was reported as the year 1942.  No concomitant medications were provided. No treatment information was provided by the reporter.   This case was linked to MOD-2021-016765 (Patient Link).