chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Haematoma
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (Hematoma on bicep from shoulder to elbow), BURNING SENSATION (Burning Sensation) and ARTHRALGIA (Soreness in shoulder) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 014M20A) for COVID-19 vaccination.   The patient's past medical history included Surgery (Patient had a surgery on that shoulder 4yrs ago never had any problem with that shoulder since then). Previously administered products included for an unreported indication: FLU VACCINE VII (have taken flu shots on either shoulder for over 20 years.). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced BURNING SENSATION (Burning Sensation) and ARTHRALGIA (Soreness in shoulder). On 09-Mar-2021, the patient experienced HAEMATOMA (Hematoma on bicep from shoulder to elbow). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, HAEMATOMA (Hematoma on bicep from shoulder to elbow), BURNING SENSATION (Burning Sensation) and ARTHRALGIA (Soreness in shoulder) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Patient initals were updated from P-P to D-S.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Ear pain, Laryngitis, Product dose omission issue
Clinical narrative: has not received 2nd shot of moderna vaccine; earache; laryngitis; body feels real bloated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received 2nd shot of moderna vaccine), EAR PAIN (earache), LARYNGITIS (laryngitis) and ABDOMINAL DISTENSION (body feels real bloated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received 2nd shot of moderna vaccine), EAR PAIN (earache), LARYNGITIS (laryngitis) and ABDOMINAL DISTENSION (body feels real bloated). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received 2nd shot of moderna vaccine) had resolved and EAR PAIN (earache), LARYNGITIS (laryngitis) and ABDOMINAL DISTENSION (body feels real bloated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was also taking antibiotics prescribed by her doctor and does not know if her side effects are caused by antibiotics or the vaccine. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How I can report side effects after 1st shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 02-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (How I can report side effects after 1st shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How I can report side effects after 1st shot). At the time of the report, VACCINATION COMPLICATION (How I can report side effects after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       AE submitted via text - "How I can report side effects after 1st shot" Consumer answered "Yes" when the chatbot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Very painful joint pain in shoulder/Very painful joint pain in elbow; 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 ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) 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 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 an unknown date, the patient experienced ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow). At the time of the report, ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) outcome was unknown.            No concomitant medications was reported by the reporter.  No treatment medications was  provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose for moderna vaccine was scheduled for May 24 I missed it; 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 PRODUCT DOSE OMISSION ISSUE (second dose for moderna vaccine was scheduled for May 24 I missed it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose for moderna vaccine was scheduled for May 24 I missed it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose for moderna vaccine was scheduled for May 24 I missed it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to toxic agent
Clinical narrative: caught poison ivy; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO TOXIC AGENT (caught poison ivy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced EXPOSURE TO TOXIC AGENT (caught poison ivy). At the time of the report, EXPOSURE TO TOXIC AGENT (caught poison ivy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.  Treatment medications information were not provided.  Patient had exposed to poison ivy on 21 May21 and was diagnosed on 24may21.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 3 months overdue formy second moderna vaccinatioon; 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 PRODUCT DOSE OMISSION ISSUE (3 months overdue formy second moderna vaccinatioon) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (3 months overdue formy second moderna vaccinatioon). At the time of the report, PRODUCT DOSE OMISSION ISSUE (3 months overdue formy second moderna vaccinatioon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included steroids.   No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Last 4 weeks I have lost my sense of taste; 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 AGEUSIA (Last 4 weeks I have lost my sense of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Last 4 weeks I have lost my sense of taste). At the time of the report, AGEUSIA (Last 4 weeks I have lost my sense of taste) outcome was unknown.            Concomitant medication not provided. Patient reported to have changed medication with the time span of the vaccine.  Patient reported his last dose date was 08 March. Treatment information not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Vaccination site erythema
Clinical narrative: Left arm got swollen; Left arm got red; General fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm got swollen), VACCINATION SITE ERYTHEMA (Left arm got red) and FATIGUE (General fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm got red) and FATIGUE (General fatigue). On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Left arm got swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (Left arm got swollen), VACCINATION SITE ERYTHEMA (Left arm got red) and FATIGUE (General fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication provided was Dietary Supplements.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever after Second Shot; 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 PYREXIA (Fever after Second Shot   ) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after Second Shot   ). At the time of the report, PYREXIA (Fever after Second Shot   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting after second medera shot; 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 VOMITING (vomiting after second medera shot) 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 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 an unknown date, the patient experienced VOMITING (vomiting after second medera shot). At the time of the report, VOMITING (vomiting after second medera shot) outcome was unknown.            No concomitant medications provided.  No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Dizziness
Clinical narrative: Dizziness; Confusion; 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 DIZZINESS (Dizziness) and CONFUSIONAL STATE (Confusion) 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 DIZZINESS (Dizziness) and CONFUSIONAL STATE (Confusion). At the time of the report, DIZZINESS (Dizziness) and CONFUSIONAL STATE (Confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications details was provided. No treatment drug details was included.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Unable to sleep; Stiff neck; Pain at the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep), MUSCULOSKELETAL STIFFNESS (Stiff neck) and VACCINATION SITE PAIN (Pain at the injection site (left arm)) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00CD21A and 21721A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INSOMNIA (Unable to sleep), MUSCULOSKELETAL STIFFNESS (Stiff neck) and VACCINATION SITE PAIN (Pain at the injection site (left arm)). At the time of the report, INSOMNIA (Unable to sleep), MUSCULOSKELETAL STIFFNESS (Stiff neck) and VACCINATION SITE PAIN (Pain at the injection site (left arm)) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Concomitant products included Blood pressure pill and Anticholesterol pill for an unknown indication Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101.9; 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 PYREXIA (Fever of 101.9) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101.9). At the time of the report, PYREXIA (Fever of 101.9) outcome was unknown.            Treatment medication was unknown
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Gout
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of gout (within 36 hours) and gait inability (she couldn't walk/she cant do anything) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included diabetes. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced gout (within 36 hours) and gait inability (she couldn't walk/she cant do anything). At the time of the report, gout (within 36 hours) and gait inability (she couldn't walk/she cant do anything) outcome: unknown. No concomitant medications reported. Treatment information provided: a pill.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I have a fever today; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (I have a fever today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PYREXIA (I have a fever today). At the time of the report, PYREXIA (I have a fever today) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: diarrhea; nausea; 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 DIARRHOEA (diarrhea) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 103.8.; 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 PYREXIA (Fever 103.8.) 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) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever 103.8.). At the time of the report, PYREXIA (Fever 103.8.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Some bruising after my first dose away from the infection site near some spider veins in my leg; This spontaneous case was reported by a patient and describes the occurrence of CONTUSION (Some bruising after my first dose away from the infection site near some spider veins in my leg) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Some bruising after my first dose away from the infection site near some spider veins in my leg). At the time of the report, CONTUSION (Some bruising after my first dose away from the infection site near some spider veins in my leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not received.  Treatment medications were not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Gait disturbance, Lacrimation increased, Pain in extremity
Clinical narrative: sinus drainage; watery eyes; little sore arm; inability to walk or balance; inability to walk or balance; total joint paint thought out the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes), PAIN IN EXTREMITY (little sore arm), GAIT DISTURBANCE (inability to walk or balance) and BALANCE DISORDER (inability to walk or balance) in a 76-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes), PAIN IN EXTREMITY (little sore arm), GAIT DISTURBANCE (inability to walk or balance), BALANCE DISORDER (inability to walk or balance) and ARTHRALGIA (total joint paint thought out the body). The patient was treated with HYDROXYCHLOROQUINE at a dose of UNK dosage form. At the time of the report, SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes) and PAIN IN EXTREMITY (little sore arm) outcome was unknown and GAIT DISTURBANCE (inability to walk or balance), BALANCE DISORDER (inability to walk or balance) and ARTHRALGIA (total joint paint thought out the body) had not resolved.            No concomitant medications was provided by the reporter. Treatment included steroid was noted.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information received captured patient demographics, product, events and treatment drugs updated.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus drainage; watery eyes; little sore arm; inability to walk or balance; inability to walk or balance; total joint paint thought out the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes), PAIN IN EXTREMITY (little sore arm), GAIT DISTURBANCE (inability to walk or balance) and BALANCE DISORDER (inability to walk or balance) in a 76-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes), PAIN IN EXTREMITY (little sore arm), GAIT DISTURBANCE (inability to walk or balance), BALANCE DISORDER (inability to walk or balance) and ARTHRALGIA (total joint paint thought out the body). The patient was treated with HYDROXYCHLOROQUINE at a dose of UNK dosage form. At the time of the report, SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes) and PAIN IN EXTREMITY (little sore arm) outcome was unknown and GAIT DISTURBANCE (inability to walk or balance), BALANCE DISORDER (inability to walk or balance) and ARTHRALGIA (total joint paint thought out the body) had not resolved.            No concomitant medications was provided by the reporter. Treatment included steroid was noted.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information received captured patient demographics, product, events and treatment drugs updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Pyrexia, Swelling face, Vaccination site erythema
Clinical narrative: chin became red and swollen; pain in their eyes and between the eyes; in the left arm itched; redness of 8cm by 2cm in size in the left arm; the left arm hurt; high fever of up to over 103°F; bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (chin became red and swollen), EYE PAIN (pain in their eyes and between the eyes), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm) and VACCINATION SITE PAIN (the left arm hurt) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced SWELLING FACE (chin became red and swollen), EYE PAIN (pain in their eyes and between the eyes), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm), VACCINATION SITE PAIN (the left arm hurt), PYREXIA (high fever of up to over 103°F) and HEADACHE (bad headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Jun-2021, EYE PAIN (pain in their eyes and between the eyes), PYREXIA (high fever of up to over 103°F) and HEADACHE (bad headaches) had resolved. At the time of the report, SWELLING FACE (chin became red and swollen), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm) and VACCINATION SITE PAIN (the left arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided As reported patient used cortisone for the arm only the following day after vaccination and fomentations (compresses) for the arm.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: chin became red and swollen; pain in their eyes and between the eyes; in the left arm itched; redness of 8cm by 2cm in size in the left arm; the left arm hurt; high fever of up to over 103°F; bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (chin became red and swollen), EYE PAIN (pain in their eyes and between the eyes), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm) and VACCINATION SITE PAIN (the left arm hurt) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced SWELLING FACE (chin became red and swollen), EYE PAIN (pain in their eyes and between the eyes), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm), VACCINATION SITE PAIN (the left arm hurt), PYREXIA (high fever of up to over 103°F) and HEADACHE (bad headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Jun-2021, EYE PAIN (pain in their eyes and between the eyes), PYREXIA (high fever of up to over 103°F) and HEADACHE (bad headaches) had resolved. At the time of the report, SWELLING FACE (chin became red and swollen), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm) and VACCINATION SITE PAIN (the left arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided As reported patient used cortisone for the arm only the following day after vaccination and fomentations (compresses) for the arm.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: face dry; arm hurt a little; face stiff/ tight; face tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (face tingling), DRY SKIN (face dry), MYALGIA (arm hurt a little) and MUSCULOSKELETAL STIFFNESS (face stiff/ tight) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FOLIC ACID, LEVOTHYROXINE, DIGOXIN, RIVAROXABAN (XARELTO) and METHOTREXATE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced PARAESTHESIA (face tingling) and MUSCULOSKELETAL STIFFNESS (face stiff/ tight). On an unknown date, the patient experienced DRY SKIN (face dry) and MYALGIA (arm hurt a little). At the time of the report, PARAESTHESIA (face tingling), DRY SKIN (face dry), MYALGIA (arm hurt a little) and MUSCULOSKELETAL STIFFNESS (face stiff/ tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient reported an event hair/ back of head feels funny outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: I'm still feeling very tired doing the simplest tasks; Some nausea/I was also nauseous; I had a terrible headache until early afternoon today; Dizzy; Getting chills; Fevered; 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 FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy) and CHILLS (Getting chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy), CHILLS (Getting chills) and PYREXIA (Fevered). At the time of the report, FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy), CHILLS (Getting chills) and PYREXIA (Fevered) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I'm still feeling very tired doing the simplest tasks; Some nausea/I was also nauseous; I had a terrible headache until early afternoon today; Dizzy; Getting chills; Fevered; 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 FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy) and CHILLS (Getting chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy), CHILLS (Getting chills) and PYREXIA (Fevered). At the time of the report, FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy), CHILLS (Getting chills) and PYREXIA (Fevered) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: The top of her arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The top of her arm is swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (The top of her arm is swollen). At the time of the report, VACCINATION SITE SWELLING (The top of her arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Vaccination site pruritus, Vaccination site swelling, Vomiting
Clinical narrative: some swelling at the shot site; be itchy; i started having chills this afternoon; vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (some swelling at the shot site), VACCINATION SITE PRURITUS (be itchy), CHILLS (i started having chills this afternoon) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced CHILLS (i started having chills this afternoon) and VOMITING (vomiting). On an unknown date, the patient experienced VACCINATION SITE SWELLING (some swelling at the shot site) and VACCINATION SITE PRURITUS (be itchy). At the time of the report, VACCINATION SITE SWELLING (some swelling at the shot site), VACCINATION SITE PRURITUS (be itchy), CHILLS (i started having chills this afternoon) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Pain is so severe; Joints are aching/ Shoulders ache/ Knees ache/ Hips ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain is so severe) and ARTHRALGIA (Joints are aching/ Shoulders ache/ Knees ache/ Hips ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced PAIN (Pain is so severe) and ARTHRALGIA (Joints are aching/ Shoulders ache/ Knees ache/ Hips ache). The patient was treated with MORPHINE for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Pain is so severe) and ARTHRALGIA (Joints are aching/ Shoulders ache/ Knees ache/ Hips ache) outcome was unknown.            Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: very server night cramps in both legs after a very light workout that afternoon; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (very server night cramps in both legs after a very light workout that afternoon) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MUSCLE SPASMS (very server night cramps in both legs after a very light workout that afternoon). At the time of the report, MUSCLE SPASMS (very server night cramps in both legs after a very light workout that afternoon) outcome was unknown.            Concomitant medication details were not reported.  Treatment details were not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Hypoaesthesia, Hypoaesthesia oral, Myalgia
Clinical narrative: given total of 1.65 ml instead of 0.5ml; tingling on her mouth; feeling tingling ears/Cheeks; feeling of numbness mouth; feeling of numbness ears/Cheeks; pain; chills; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (given total of 1.65 ml instead of 0.5ml), PARAESTHESIA ORAL (tingling on her mouth), PARAESTHESIA (feeling tingling ears/Cheeks), HYPOAESTHESIA ORAL (feeling of numbness mouth) and HYPOAESTHESIA (feeling of numbness ears/Cheeks) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Drug allergy (Sulfa), Penicillin allergy and Drug allergy (Emgality). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRETIC), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and AZELASTINE for Allergy, NADOLOL, TOPIRAMATE (TOPAMAX), UBROGEPANT (UBRELVY) and SUMATRIPTAN for Migraine.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1.65 ml. On 19-May-2021, the patient experienced ACCIDENTAL OVERDOSE (given total of 1.65 ml instead of 0.5ml), PARAESTHESIA ORAL (tingling on her mouth), PARAESTHESIA (feeling tingling ears/Cheeks), HYPOAESTHESIA ORAL (feeling of numbness mouth), HYPOAESTHESIA (feeling of numbness ears/Cheeks), PAIN (pain), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Ache, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, ACCIDENTAL OVERDOSE (given total of 1.65 ml instead of 0.5ml), PARAESTHESIA ORAL (tingling on her mouth), PARAESTHESIA (feeling tingling ears/Cheeks), HYPOAESTHESIA ORAL (feeling of numbness mouth), HYPOAESTHESIA (feeling of numbness ears/Cheeks), PAIN (pain), CHILLS (chills) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: given total of 1.65 ml instead of 0.5ml; tingling on her mouth; feeling tingling ears/Cheeks; feeling of numbness mouth; feeling of numbness ears/Cheeks; pain; chills; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (given total of 1.65 ml instead of 0.5ml), PARAESTHESIA ORAL (tingling on her mouth), PARAESTHESIA (feeling tingling ears/Cheeks), HYPOAESTHESIA ORAL (feeling of numbness mouth) and HYPOAESTHESIA (feeling of numbness ears/Cheeks) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Drug allergy (Sulfa), Penicillin allergy and Drug allergy (Emgality). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRETIC), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and AZELASTINE for Allergy, NADOLOL, TOPIRAMATE (TOPAMAX), UBROGEPANT (UBRELVY) and SUMATRIPTAN for Migraine.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1.65 ml. On 19-May-2021, the patient experienced ACCIDENTAL OVERDOSE (given total of 1.65 ml instead of 0.5ml), PARAESTHESIA ORAL (tingling on her mouth), PARAESTHESIA (feeling tingling ears/Cheeks), HYPOAESTHESIA ORAL (feeling of numbness mouth), HYPOAESTHESIA (feeling of numbness ears/Cheeks), PAIN (pain), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Ache, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, ACCIDENTAL OVERDOSE (given total of 1.65 ml instead of 0.5ml), PARAESTHESIA ORAL (tingling on her mouth), PARAESTHESIA (feeling tingling ears/Cheeks), HYPOAESTHESIA ORAL (feeling of numbness mouth), HYPOAESTHESIA (feeling of numbness ears/Cheeks), PAIN (pain), CHILLS (chills) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Jun-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Neck mass
Clinical narrative: No energy since the 2nd dose/weak; Tired since the 2nd dose; Bigger knot on side of neck after 2nd dose; ache and pain; headache; a pain in the left side of the neck; temperature is 99.3 degrees; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (No energy since the 2nd dose/weak), FATIGUE (Tired since the 2nd dose), NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain), HEADACHE (headache), NECK PAIN (a pain in the left side of the neck) and PYREXIA (temperature is 99.3 degrees). On an unknown date, the patient experienced ASTHENIA (No energy since the 2nd dose/weak) and FATIGUE (Tired since the 2nd dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, ASTHENIA (No energy since the 2nd dose/weak), FATIGUE (Tired since the 2nd dose), NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain), HEADACHE (headache), NECK PAIN (a pain in the left side of the neck) and PYREXIA (temperature is 99.3 degrees) outcome was unknown.            Concomitant medications were not reported.   This case was linked to MOD-2021-049400 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Due to system limitation IRD captured as latest present in system 02-JUN-21 instead of backdated IRD of 17-APR-21.