chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Fatigue, Headache, Tinnitus
Clinical narrative: ringing in her ears; aphasia; sever fatigue; headaches; A Spontaneous report was received from the nurse  concerning 51 year old female patient who received the second dose of moderna's COVID-19 vaccine(mRNA -1273) and experienced aphasia, sever fatigue, headaches and buzzing/ringing in her ears.  The patient medical history  and concomitant medications were not provided.  On 03-FEB-2021, prior to onset of events the patient received two doses of mRNA (Batch no: 004M220A)vaccine for prophylaxis of COVID-19 infection.  After receiving the second dose,  she had neurological symptoms. She has buzzing or ringing in her ears  and aphasia, severe fatigue. She cannot work for more than 4 hours and she had continous headaches. The ringing gets worse when she gets tired.  Two neurologist have put the patient on concision protocol for two weeks  Action taken with mRNA response to the events was not reported.  The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Fatigue and headache are consistent with the product known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling, Vaccination site warmth
Clinical narrative: hot to the touch; swollen on her left arm; patch on her left arm; tired; sore arm/arm hurts when she lifts it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it), VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm), FATIGUE (tired) and ERYTHEMA (patch on her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it) and FATIGUE (tired). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm) and ERYTHEMA (patch on her left arm). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 200 milligram. On 07-Mar-2021, FATIGUE (tired) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it), VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm) and ERYTHEMA (patch on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As a treatment patient applied a Cold Rag.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No new information.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Genital discomfort, Headache, Pyrexia
Clinical narrative: Penis tingled/vibrated; Headache; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of GENITAL DISCOMFORT (Penis tingled/vibrated), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 dosage form. On 17-Mar-2021, the patient experienced GENITAL DISCOMFORT (Penis tingled/vibrated), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 17-Mar-2021, GENITAL DISCOMFORT (Penis tingled/vibrated) had resolved. On 18-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received on 07-MAY-2021, no new information On 15-Jun-2021: Non significant follow up received on 15-JUN-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm is swelling a little bit; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore). At the time of the report, PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Erythema, Feeling hot, Headache
Clinical narrative: Itching; Arm swollen; Hot to the touch; Redness has an extension of 4 inches; Redness at the injection site; Stomach pain; Itching all over the body; Pain in the upper part of the back; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching) and PERIPHERAL SWELLING (Arm swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back) and HEADACHE (Headaches). On 16-Mar-2021, the patient experienced PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Back pain, at an unspecified dose and frequency and IBUPROFEN for Back pain and Headache, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches), HEADACHE (Headaches) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: Itching; Arm swollen; Hot to the touch; Redness has an extension of 4 inches; Redness at the injection site; Stomach pain; Itching all over the body; Pain in the upper part of the back; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching) and PERIPHERAL SWELLING (Arm swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back) and HEADACHE (Headaches). On 16-Mar-2021, the patient experienced PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Back pain, at an unspecified dose and frequency and IBUPROFEN for Back pain and Headache, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches), HEADACHE (Headaches) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: some of the vaccine leaked out of patient's arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (some of the vaccine leaked out of patient's arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (some of the vaccine leaked out of patient's arm). At the time of the report, UNDERDOSE (some of the vaccine leaked out of patient's arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: diarrhea; felt like flu; achy arm; chills; little fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like flu), PAIN IN EXTREMITY (achy arm), CHILLS (chills) and PYREXIA (little fever) 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 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 DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like flu), PAIN IN EXTREMITY (achy arm), CHILLS (chills) and PYREXIA (little fever). At the time of the report, DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like flu), PAIN IN EXTREMITY (achy arm), CHILLS (chills) and PYREXIA (little fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant and treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information was reported.  Upon internal review on 24-May-2021, the age was corrected to unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2OA) for COVID-19 vaccination.     The patient's past medical history included Chest discomfort, AFib on 09-Sep-2020 and COVID-19. Concurrent medical conditions included Shellfish allergy (Patient is allergic shrimp). Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL, LISINOPRIL and VITAMIN D NOS for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2020, SARS-CoV-2 test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-028450 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Mass, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site) and NAUSEA (Nauseous) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 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 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site), NAUSEA (Nauseous), HEADACHE (headache), CHILLS (chills), VACCINATION SITE SWELLING (lump and hardness to injection site), MYALGIA (body ache) and PYREXIA (mild fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 17-Mar-2021, NAUSEA (Nauseous), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (mild fever) had resolved. On 18-Mar-2021, PALPITATIONS (heart racing) had resolved. At the time of the report, VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), VACCINATION SITE WARMTH (very hot at injection site), CHILLS (chills) and VACCINATION SITE SWELLING (lump and hardness to injection site) outcome was unknown.            No concomitant medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site) and NAUSEA (Nauseous) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 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 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site), NAUSEA (Nauseous), HEADACHE (headache), CHILLS (chills), VACCINATION SITE SWELLING (lump and hardness to injection site), MYALGIA (body ache) and PYREXIA (mild fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 17-Mar-2021, NAUSEA (Nauseous), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (mild fever) had resolved. On 18-Mar-2021, PALPITATIONS (heart racing) had resolved. At the time of the report, VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), VACCINATION SITE WARMTH (very hot at injection site), CHILLS (chills) and VACCINATION SITE SWELLING (lump and hardness to injection site) outcome was unknown.            No concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest; redness on arm/ red spots on arms and legs and body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest) and ERYTHEMA (redness on arm/ red spots on arms and legs and body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 immunisation.     Concurrent medical conditions included Allergy (Seasonal allergies) and UTI on 11-Mar-2021. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID), LOSARTAN, ATORVASTATIN, METOPROLOL and CALCIUM for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (redness on arm/ red spots on arms and legs and body). On an unknown date, the patient experienced PRURITUS (delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest). At the time of the report, PRURITUS (delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest) and ERYTHEMA (redness on arm/ red spots on arms and legs and body) outcome was unknown.            Took generic allergy pills for treatment.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Patient demography, medical history and concomitant drugs were added
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pyrexia
Clinical narrative: Face redness; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 UNK. On 12-Mar-2021, ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.            Upon internal review on 24-May-2021, the age was corrected to unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site pain
Clinical narrative: possible invalid dose; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and INCORRECT DOSE ADMINISTERED (possible invalid dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 18-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (possible invalid dose). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown and INCORRECT DOSE ADMINISTERED (possible invalid dose) had resolved. Not Provided          No concomitant medication were provided No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-050279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-050279:crosslinked for Dose 2
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their second dose of the Moderna vaccine 8 days prior to the 28 days; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) 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 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient received the second does 8 day prior to 28 days.   This case was linked to US-MODERNATX, INC.-MOD-2021-098304 (E2B Linked Report). This case was linked to MOD-2021-050287 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-may-2021 contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098304:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Possible invalid dose/extra of the vaccine from the syringe; She felt her arm was wet after dose; A spontaneous report  was received from a consumer concerning a 24-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt her arm was wet after dose/ exposure via skin contact and administered the dose said that was extra of the vaccine from the syringe and that he overfilled the syringe/ inappropriate dose of vaccine administered  The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 18 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The patient stated that she felt her arm wet after the dose, as the pharmacist administered the dose that was extra (overfilled the syringe).  Treatment details were not reported.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events felt her arm was wet after dose/ exposure via skin contact and administered the dose said that was extra of the vaccine from the syringe and that he overfilled the syringe/ inappropriate dose of vaccine administered were considered as unknown.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact for mRNA-1273 with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-050266:crosslinked for Dose 1
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their second dose of the Moderna vaccine 8 days prior to the 28 days; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history provided.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-098304 (E2B Linked Report). This case was linked to MOD-2021-050270 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs. US-MODERNATX, INC.-MOD-2021-098304:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Nausea, Pain in extremity
Clinical narrative: About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; dizziness; About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; her head was cloudy; soreness in her arm; her head was cloudy soreness in her arm and nausea; A spontaneous report was received from consumer concerning a 63-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, about 3 or 4 min after she got the shot she starting feeling hot like she was fainting and dizziness, her head was cloudy, soreness in her arm and nausea and soreness in her arm.  The patient's past medical history included Cancer since an unknown date. Concomitant products included metoclopramide, olaparib, metoprolol and laxatives.   On 17-Mar-2021, the patient received first of the two planned doses of mRNA-1273 (lot number: 048a21a) intramuscularly for the prophylaxis of COVID-19 infection.  Patient reported that about 3 or 4 min after she got the shot she started feeling hot like she was fainting and dizziness which lasted for a long time (1hs or 2 hours). She felt her head was cloudy, soreness in her arm and nausea and then she slept for 3 hours. At the time of report, patient was experiencing soreness in her arm.  Treatment medication included none.  No lab tests were mentioned.  The event syncope was considered as serious with criteria of important medical event.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event soreness in her arm was considered not resolved and all other events were resolved on 18 Mar 2021.; Reporter'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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; dizziness; About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; her head was cloudy; soreness in her arm; her head was cloudy soreness in her arm and nausea; A spontaneous report was received from consumer concerning a 63-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, about 3 or 4 min after she got the shot she starting feeling hot like she was fainting and dizziness, her head was cloudy, soreness in her arm and nausea and soreness in her arm.  The patient's past medical history included Cancer since an unknown date. Concomitant products included metoclopramide, olaparib, metoprolol and laxatives.   On 17-Mar-2021, the patient received first of the two planned doses of mRNA-1273 (lot number: 048a21a) intramuscularly for the prophylaxis of COVID-19 infection.  Patient reported that about 3 or 4 min after she got the shot she started feeling hot like she was fainting and dizziness which lasted for a long time (1hs or 2 hours). She felt her head was cloudy, soreness in her arm and nausea and then she slept for 3 hours. At the time of report, patient was experiencing soreness in her arm.  Treatment medication included none.  No lab tests were mentioned.  The event syncope was considered as serious with criteria of important medical event.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event soreness in her arm was considered not resolved and all other events were resolved on 18 Mar 2021.; Reporter'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.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine). At the time of the report, OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: Dizzy; Loopy; Body aches; Running a low grade fever; Woke up 2:30 am with chills; Muscle aches; Joint ache; Feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever) and CHILLS (Woke up 2:30 am with chills) 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 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.6 f (Borderline) 99.6 F.         Concomitant product used was not provided by the reporter.   Treatment information was not provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pain, Pyrexia
Clinical narrative: Dizzy; Loopy; Body aches; Running a low grade fever; Woke up 2:30 am with chills; Muscle aches; Joint ache; Feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever) and CHILLS (Woke up 2:30 am with chills) 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 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.6 f (Borderline) 99.6 F.         Concomitant product used was not provided by the reporter.   Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhoea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhoea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIARRHOEA (diarrhoea). On 17-Mar-2021, DIARRHOEA (diarrhoea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.     Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (went away after about 10 days) in August 2020.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea). On 17-Mar-2021, FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter Treatment information was not provided by the reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Feeling abnormal, Feeling hot, Pain
Clinical narrative: felt horrible; arm hot; achy; stayed in bed all day; chills; low grade fever; she wouldn't track (her eyes were fluttering); face got white; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt horrible) and FEELING HOT (arm hot) in a 65-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 COVID-19 in November 2020. Concurrent medical conditions included Headache.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white) and PAIN IN EXTREMITY (arm hurt). On 27-Feb-2021, the patient experienced FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever). On 26-Feb-2021, PHOTOPSIA (she wouldn't track (her eyes were fluttering)) and PALLOR (face got white) had resolved. On 27-Feb-2021, PAIN IN EXTREMITY (arm hurt) had resolved. On 28-Feb-2021, FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient used ice on hurt arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Photopsia, Pyrexia
Clinical narrative: felt horrible; arm hot; achy; stayed in bed all day; chills; low grade fever; she wouldn't track (her eyes were fluttering); face got white; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt horrible) and FEELING HOT (arm hot) in a 65-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 COVID-19 in November 2020. Concurrent medical conditions included Headache.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white) and PAIN IN EXTREMITY (arm hurt). On 27-Feb-2021, the patient experienced FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever). On 26-Feb-2021, PHOTOPSIA (she wouldn't track (her eyes were fluttering)) and PALLOR (face got white) had resolved. On 27-Feb-2021, PAIN IN EXTREMITY (arm hurt) had resolved. On 28-Feb-2021, FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient used ice on hurt arm.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site pain
Clinical narrative: Arm discomfort at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm discomfort at the site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm discomfort at the site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm discomfort at the site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 103 (High) 103 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-034872 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: serious chest pressure pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (serious chest pressure pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHEST PAIN (serious chest pressure pain). On 09-Mar-2021, CHEST PAIN (serious chest pressure pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has stents. No treatment was reported.  The second night after the first dose around 7p patient had serious chest pressure pain. This lasted for 2-3 nights. He did inform his doctor.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; injection site redness; injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling). At the time of the report, INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) 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.   Concomitant medication history not provided by reporter.   Treatment information is not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: The follow up received on 24-May-2021 contain no new information.