chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: Sweating profusely; Felt off; Headachy; Tired; Feverish; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy) and FATIGUE (Tired) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy), FATIGUE (Tired) and PYREXIA (Feverish). At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy), FATIGUE (Tired) and PYREXIA (Feverish) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. Treatment for the events included ibuprofen
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sweating profusely; Felt off; Headachy; Tired; Feverish; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy) and FATIGUE (Tired) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy), FATIGUE (Tired) and PYREXIA (Feverish). At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy), FATIGUE (Tired) and PYREXIA (Feverish) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. Treatment for the events included ibuprofen
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Miliaria, Pain, Pain in extremity, Pruritus
Clinical narrative: Pain in arm; Body aches; Prickly; Itching; Skin reaction; Burning red rash on chest and back; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MILIARIA (Prickly), PRURITUS (Itching) and SKIN REACTION (Skin reaction) in a 34-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.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MILIARIA (Prickly), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH ERYTHEMATOUS (Burning red rash on chest and back), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MILIARIA (Prickly), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH ERYTHEMATOUS (Burning red rash on chest and back), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-061007 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Skin reaction
Clinical narrative: Pain in arm; Body aches; Prickly; Itching; Skin reaction; Burning red rash on chest and back; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MILIARIA (Prickly), PRURITUS (Itching) and SKIN REACTION (Skin reaction) in a 34-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.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MILIARIA (Prickly), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH ERYTHEMATOUS (Burning red rash on chest and back), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MILIARIA (Prickly), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH ERYTHEMATOUS (Burning red rash on chest and back), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-061007 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain, Tenderness
Clinical narrative: sore; tender; upset stomach; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), TENDERNESS (tender), ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (sore), TENDERNESS (tender), ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea). At the time of the report, PAIN (sore), TENDERNESS (tender), ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-060494 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: itchy left arm; swollen left arm; lump on her left arm; left arm a little sore, sore left arm; red left arm; headache; achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache), PAIN (achiness) and VACCINATION SITE PRURITUS (itchy left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache) and PAIN (achiness). On 28-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE SWELLING (swollen left arm) and VACCINATION SITE MASS (lump on her left arm). At the time of the report, VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache), PAIN (achiness), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE SWELLING (swollen left arm) and VACCINATION SITE MASS (lump on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy left arm; swollen left arm; lump on her left arm; left arm a little sore, sore left arm; red left arm; headache; achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache), PAIN (achiness) and VACCINATION SITE PRURITUS (itchy left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache) and PAIN (achiness). On 28-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE SWELLING (swollen left arm) and VACCINATION SITE MASS (lump on her left arm). At the time of the report, VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache), PAIN (achiness), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE SWELLING (swollen left arm) and VACCINATION SITE MASS (lump on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine leaked out during administration and patient did not get full 0.5 ml; Vaccine leaked out from syringe during administration; 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 UNDERDOSE (Vaccine leaked out during administration and patient did not get full 0.5 ml) and DEVICE CONNECTION ISSUE (Vaccine leaked out from syringe during administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced UNDERDOSE (Vaccine leaked out during administration and patient did not get full 0.5 ml) and DEVICE CONNECTION ISSUE (Vaccine leaked out from syringe during administration). On 29-Mar-2021, UNDERDOSE (Vaccine leaked out during administration and patient did not get full 0.5 ml) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (Vaccine leaked out from syringe during administration) 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 relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) 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 EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Concomitant medications was not provided.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: my son received his 2nd dose earlier than the recommended window; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my son received his 2nd dose earlier than the recommended window) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029L20A) for COVID-19 immunisation.     No medical history provided.  Concomitant products included ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my son received his 2nd dose earlier than the recommended window). On 29-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my son received his 2nd dose earlier than the recommended window) had resolved.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information reported.   This case was linked to MOD-2021-061031 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received on 07-JUL-2021 ,event outcome updated and declined consent for follow up.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed Shingles after the initial dose; 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 HERPES ZOSTER (developed Shingles after the initial dose) 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 HERPES ZOSTER (developed Shingles after the initial dose). At the time of the report, HERPES ZOSTER (developed Shingles after the initial dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Loss of personal independence in daily activities, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; terribly ill/so very sick; couldn't function; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (terribly ill/so very sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't function) and SARS-COV-2 TEST POSITIVE (tested positive for Covid) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Relevant medical history not reported.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ILLNESS (terribly ill/so very sick) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't function). On 10-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid). At the time of the report, ILLNESS (terribly ill/so very sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't function) and SARS-COV-2 TEST POSITIVE (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, COVID-19: Positive.         Concomitant medication use was not reported.  Treatment information was not reported.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, SARS-CoV-2 test
Clinical narrative: very dizzy; very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy) and FATIGUE (very tired) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (tested positive for COVID-19) on 10-Mar-2021.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (very dizzy) and FATIGUE (very tired). At the time of the report, DIZZINESS (very dizzy) and FATIGUE (very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.         This case was linked to MOD-2021-061051 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching at the injection site; Injection site swelling; redness at the injection site; Vaccination site pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (Vaccination site pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 immunisation.     No Medical History information was reported.    On 10-Mar-2021 at 12:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (Vaccination site pain) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: The follow-up was received on 14-MAY-2021.  Patient demographics, Product route of administration, was updated. New event was added.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) 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 EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided. Treatment information was not available.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt really tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (felt really tired). At the time of the report, FATIGUE (felt really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-064570 (E2B Linked Report).; Sender's Comments:  MOD21-064570:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Euphoric mood, Frequent bowel movements
Clinical narrative: multiple slightly softer bowel movements; next morning felt supercharged; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (multiple slightly softer bowel movements) and EUPHORIC MOOD (next morning felt supercharged) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (multiple slightly softer bowel movements) and EUPHORIC MOOD (next morning felt supercharged). At the time of the report, FREQUENT BOWEL MOVEMENTS (multiple slightly softer bowel movements) and EUPHORIC MOOD (next morning felt supercharged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of NAUSEA (Nausea) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included ALPRAZOLAM (XANAX SR), ATORVASTATIN CALCIUM (LIPTOR [ATORVASTATIN CALCIUM]) and VITAMINS NOS for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) 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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site left arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (pain at injection site left arm). At the time of the report, INJECTION SITE PAIN (pain at injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) 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 concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Myalgia, Pain
Clinical narrative: painful to walk and stand; painful to walk and stand; level of pain has stayed the same since it began; joint and muscle pain; joint and muscle pain; joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments; 2 days after vaccine sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (2 days after vaccine sore arm), GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began) and ARTHRALGIA (joint and muscle pain) in a 65-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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (2 days after vaccine sore arm). On 10-Mar-2021, the patient experienced GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and ARTHRALGIA (joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments). On 05-Mar-2021, PAIN IN EXTREMITY (2 days after vaccine sore arm) had resolved. At the time of the report, GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and ARTHRALGIA (joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. treatment medicine include Ibuprofen but not too often since it causes stomach issues for him.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: painful to walk and stand; painful to walk and stand; level of pain has stayed the same since it began; joint and muscle pain; joint and muscle pain; joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments; 2 days after vaccine sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (2 days after vaccine sore arm), GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began) and ARTHRALGIA (joint and muscle pain) in a 65-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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (2 days after vaccine sore arm). On 10-Mar-2021, the patient experienced GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and ARTHRALGIA (joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments). On 05-Mar-2021, PAIN IN EXTREMITY (2 days after vaccine sore arm) had resolved. At the time of the report, GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and ARTHRALGIA (joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. treatment medicine include Ibuprofen but not too often since it causes stomach issues for him.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gingival bleeding, Oral fungal infection, Oral pain, Oropharyngeal discomfort
Clinical narrative: Yeast infection of the mouth; Gum bleeding; Throat discomfort; Feeling abnormal; Mouth pain; Feeling strange; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GINGIVAL BLEEDING (Gum bleeding), OROPHARYNGEAL DISCOMFORT (Throat discomfort), FEELING ABNORMAL (Feeling abnormal), ORAL PAIN (Mouth pain ) and FEELING ABNORMAL (Feeling strange) in a 50-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.     The patient's past medical history included Tonsillectomy. Concomitant products included LEVONORGESTREL (MIRENA), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MONTELUKAST SODIUM (SINGULAIR) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced GINGIVAL BLEEDING (Gum bleeding), OROPHARYNGEAL DISCOMFORT (Throat discomfort), FEELING ABNORMAL (Feeling abnormal), ORAL PAIN (Mouth pain ) and FEELING ABNORMAL (Feeling strange). On an unknown date, the patient experienced ORAL FUNGAL INFECTION (Yeast infection of the mouth). The patient was treated with FLUCONAZOLE (DIFLUCAN) for Yeast infection of the mouth, at a dose of 1 dosage form. On 26-Mar-2021, GINGIVAL BLEEDING (Gum bleeding) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (Throat discomfort), FEELING ABNORMAL (Feeling abnormal), ORAL PAIN (Mouth pain ), FEELING ABNORMAL (Feeling strange) and ORAL FUNGAL INFECTION (Yeast infection of the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included gargle salt water.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: significant follow-up received on 19-Apr-2021, appended in the case on 27-Apr-2021.Event reported by the reporter with Diflucan treatment information.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) 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 EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.Treatment details were nor provided.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling and redness at the injection  site (left deltoid); redness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (swelling and redness at the injection  site (left deltoid)) and VACCINATION SITE ERYTHEMA (redness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling and redness at the injection  site (left deltoid)) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE SWELLING (swelling and redness at the injection  site (left deltoid)) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Rash, Rash pruritic
Clinical narrative: Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"; Felt extra tired ,has been sleeping a lot; Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"; Headache; Felt extra tired ,has been sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"), HYPERSOMNIA (Felt extra tired ,has been sleeping a lot), RASH (Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"), HEADACHE (Headache) and FATIGUE (Felt extra tired ,has been sleeping a lot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-Mar-2021, the patient experienced RASH PRURITIC (Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"), HYPERSOMNIA (Felt extra tired ,has been sleeping a lot), RASH (Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"), HEADACHE (Headache) and FATIGUE (Felt extra tired ,has been sleeping a lot). At the time of the report, RASH PRURITIC (Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"), HYPERSOMNIA (Felt extra tired ,has been sleeping a lot), RASH (Breaking out with a rash that is still breaking out, it is on her hands, arms, one leg ¨for now¨, as the caller mentioned, chest, face, "it is itching pretty bad"), HEADACHE (Headache) and FATIGUE (Felt extra tired ,has been sleeping a lot) outcome was unknown.            Concomitant medicines include allergy pills, pills for depression, stomach pills, muscle relaxer. Treatment include Benadryl.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: A few chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (A few chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced CHILLS (A few chills). At the time of the report, CHILLS (A few chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included arthritis medication and high blood pressure medication. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 and does not contain any new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch on the injection site; Itching on the injection site; Swelling on the injection site; Pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch on the injection site), VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE PAIN (Pain on the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), METOPROLOL and ATORVASTATIN for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch on the injection site), VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE PAIN (Pain on the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch on the injection site), VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE PAIN (Pain on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: Neck and back pain; Neck and back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck and back pain) and BACK PAIN (Neck and back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck and back pain) and BACK PAIN (Neck and back pain). On 28-Mar-2021, NECK PAIN (Neck and back pain) and BACK PAIN (Neck and back pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported. Treatment information was not provided. Patient does not want to take the second shot due to the side effects she experienced with the first shot. She also confirmed with her  HCP about it.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021 contains non-significant information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Facial discomfort, Feeling abnormal, Hypokinesia, Limb discomfort
Clinical narrative: Diarrhea; It felt like a neurological issue.; It felt like a neurological issue.; Right now, the only problem is that the muscle occasionally locks up; can't lift my arm without maneuvering it to try to get it to loosen up.; my arm started to ache; I Felt ill; Nausea; pulling sensation on face,lip, and leg; pulling sensation on face,lip, and leg; pulling sensation on face,lip, and leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm started to ache), MALAISE (I Felt ill), DIARRHEA (Diarrhea), FACIAL DISCOMFORT (pulling sensation on face,lip, and leg) and ORAL DISCOMFORT (pulling sensation on face,lip, and leg) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced MALAISE (I Felt ill), FACIAL DISCOMFORT (pulling sensation on face,lip, and leg), ORAL DISCOMFORT (pulling sensation on face,lip, and leg), LIMB DISCOMFORT (pulling sensation on face,lip, and leg) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm started to ache), DIARRHEA (Diarrhea), NEUROLOGICAL SYMPTOM (It felt like a neurological issue.), FEELING ABNORMAL (It felt like a neurological issue.), MUSCLE DISCOMFORT (Right now, the only problem is that the muscle occasionally locks up) and HYPOKINESIA (can't lift my arm without maneuvering it to try to get it to loosen up.). At the time of the report, PAIN IN EXTREMITY (my arm started to ache), MALAISE (I Felt ill), DIARRHEA (Diarrhea), FACIAL DISCOMFORT (pulling sensation on face,lip, and leg), ORAL DISCOMFORT (pulling sensation on face,lip, and leg), LIMB DISCOMFORT (pulling sensation on face,lip, and leg), NEUROLOGICAL SYMPTOM (It felt like a neurological issue.), FEELING ABNORMAL (It felt like a neurological issue.), MUSCLE DISCOMFORT (Right now, the only problem is that the muscle occasionally locks up), HYPOKINESIA (can't lift my arm without maneuvering it to try to get it to loosen up.) and NAUSEA (Nausea) was resolving.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-061044 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Updated Patient's AE outcome details, New events added, Patient also provided details about her husband's AE outcome.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.