chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Myalgia, Pruritus, Rhinorrhoea
Clinical narrative: has eczema; itches; fatigue; chills; slight pain at the injection site; muscle ache; headache; some sniffles; gets winded; anxiety; gastrointestinal (GI) issues; diarrhea; abdominal distress; abdominal cramping; hard to focus; slight confusion; forgetful; thinking Tuesday was Thursday; taking a shower takes a lot out of him; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (gastrointestinal (GI) issues), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (abdominal distress), ABDOMINAL PAIN (abdominal cramping) and DISTURBANCE IN ATTENTION (hard to focus) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Gastrointestinal disorder.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (taking a shower takes a lot out of him). On 08-May-2021, the patient experienced GASTROINTESTINAL DISORDER (gastrointestinal (GI) issues), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (abdominal distress), ABDOMINAL PAIN (abdominal cramping), DISTURBANCE IN ATTENTION (hard to focus), CONFUSIONAL STATE (slight confusion), MEMORY IMPAIRMENT (forgetful; thinking Tuesday was Thursday), RHINORRHOEA (some sniffles), DYSPNOEA (gets winded), ANXIETY (anxiety), FATIGUE (fatigue), CHILLS (chills), INJECTION SITE PAIN (slight pain at the injection site), MYALGIA (muscle ache) and HEADACHE (headache). On an unknown date, the patient experienced ECZEMA (has eczema) and PRURITUS (itches). At the time of the report, GASTROINTESTINAL DISORDER (gastrointestinal (GI) issues), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (abdominal distress), ABDOMINAL PAIN (abdominal cramping), DISTURBANCE IN ATTENTION (hard to focus), CONFUSIONAL STATE (slight confusion), MEMORY IMPAIRMENT (forgetful; thinking Tuesday was Thursday), ECZEMA (has eczema), RHINORRHOEA (some sniffles), DYSPNOEA (gets winded), ANXIETY (anxiety), ASTHENIA (taking a shower takes a lot out of him), PRURITUS (itches), FATIGUE (fatigue), CHILLS (chills), INJECTION SITE PAIN (slight pain at the injection site), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient went to the hospital ER, tested negative for COVID-19 and had normal bloodwork. Treatment information not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. Concomitant medications were not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary mass
Clinical narrative: MRI after first dose, 5mm growth on lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY MASS (MRI after first dose, 5mm growth on lungs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY MASS (MRI after first dose, 5mm growth on lungs). At the time of the report, PULMONARY MASS (MRI after first dose, 5mm growth on lungs) had not resolved.            No treatment information was provided.  Action taken with the mRNA-1273 in response to the event is not applicable.   This case was linked to MOD-2021-138893 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Product administered to patient of inappropriate age
Clinical narrative: typical sore arm; 17yr old got the 1st shot of Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old got the 1st shot of Vaccine) and ARTHRALGIA (typical sore arm) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old got the 1st shot of Vaccine). On an unknown date, the patient experienced ARTHRALGIA (typical sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old got the 1st shot of Vaccine) and ARTHRALGIA (typical sore arm) outcome was unknown.            No treatment or concomitant products reported Action taken with mRNA-1273 in response to the drug was not applicable. Patient was experienced no adverse effects from either dose other than the typical sore arm.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: follow up received and  Added contact information for the patient's Medical Doctor and her Registered Nurse to our records On 21-Jun-2021: Follow up received Provides significant information patient demographics ( patient Initial, Race, Ethnic group, Height, Weight) added Second dose information, batch number for first dose were added. event typical sore arm was added. On 18-Jul-2021: NNI FU - No new information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported . treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-138859 (E2B Linked Report); Sender's Comments:  MODERNATX, INC.-MOD-2021-138859:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Pyrexia, Vomiting
Clinical narrative: Weak; Loss of appetite; Fever; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), VOMITING (Vomiting) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced ASTHENIA (Weak), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), VOMITING (Vomiting) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 09-JUL-2021 contains no newinformation.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Vaccination site pain, Vaccination site rash
Clinical narrative: arm hurting on the injection site; rash to injection site; body aches; my left arm started killing me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurting on the injection site), VACCINATION SITE RASH (rash to injection site), PAIN (body aches) and LIMB DISCOMFORT (my left arm started killing me) in a 91-year-old male patient 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 PAIN (arm hurting on the injection site), VACCINATION SITE RASH (rash to injection site), PAIN (body aches) and LIMB DISCOMFORT (my left arm started killing me). At the time of the report, VACCINATION SITE PAIN (arm hurting on the injection site), VACCINATION SITE RASH (rash to injection site), PAIN (body aches) and LIMB DISCOMFORT (my left arm started killing me) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported. patent took Moderna Covid-19 injection in March.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Pruritus, Rash
Clinical narrative: Contact Dermatitis; Itching on the rash; Rash on right forearm /Rash on left forearm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Contact Dermatitis), PRURITUS (Itching on the rash) and RASH (Rash on right forearm /Rash on left forearm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DERMATITIS CONTACT (Contact Dermatitis), PRURITUS (Itching on the rash) and RASH (Rash on right forearm /Rash on left forearm). The patient was treated with ALOE VERA (ALOE DERMA) for Rash, at an unspecified dose and frequency. At the time of the report, DERMATITIS CONTACT (Contact Dermatitis) and PRURITUS (Itching on the rash) had not resolved and RASH (Rash on right forearm /Rash on left forearm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. patient has Contact Dermatitis, and wanted to put her on steroids but patient gets upset stomach with steroids medication and do not want to take them.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Limb discomfort, Myalgia, SARS-CoV-2 antibody test
Clinical narrative: Body was hot; Body was hot and red; Left arm started killing me; Experienced the same symptoms as if he had Covid-19; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19 in November 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Clot blood.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches). On 23-Apr-2021, FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Patient had COVID antibodies in his blood before Moderna-Covidin-19 injection was administered on 21 Apr 2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had taken prednisone, antibiotics, acetaminophen and  acetylsalicylic acid since Nov 2020 due to Corona virus infection, but had been discontinued. No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Body was hot; Body was hot and red; Left arm started killing me; Experienced the same symptoms as if he had Covid-19; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19 in November 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Clot blood.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches). On 23-Apr-2021, FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Patient had COVID antibodies in his blood before Moderna-Covidin-19 injection was administered on 21 Apr 2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had taken prednisone, antibiotics, acetaminophen and  acetylsalicylic acid since Nov 2020 due to Corona virus infection, but had been discontinued. No treatment information was provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash to injection site; Pain to injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain to injection site) and VACCINATION SITE RASH (Rash to injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Pain to injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash to injection site). At the time of the report, VACCINATION SITE PAIN (Pain to injection site) and VACCINATION SITE RASH (Rash to injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-091323, MOD21-091332 (E2B Linked Report).; Sender's Comments:  MOD21-091323:Crosslink MOD21-091332:Crosslink
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches for 3-4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches for 3-4 days). At the time of the report, HEADACHE (headaches for 3-4 days) outcome was unknown.            Treatment information not given, concomitant medications were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered, Wrong product administered
Clinical narrative: exposure via skin contact; patient only received half or less than half of her dose/more than half of the dose leaked out; Administered pfizer instead of moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE VIA SKIN CONTACT (exposure via skin contact), INCORRECT DOSE ADMINISTERED (patient only received half or less than half of her dose/more than half of the dose leaked out) and WRONG PRODUCT ADMINISTERED (Administered pfizer instead of moderna) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-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 08-May-2021, the patient experienced EXPOSURE VIA SKIN CONTACT (exposure via skin contact), INCORRECT DOSE ADMINISTERED (patient only received half or less than half of her dose/more than half of the dose leaked out) and WRONG PRODUCT ADMINISTERED (Administered pfizer instead of moderna). On 08-May-2021, EXPOSURE VIA SKIN CONTACT (exposure via skin contact), INCORRECT DOSE ADMINISTERED (patient only received half or less than half of her dose/more than half of the dose leaked out) and WRONG PRODUCT ADMINISTERED (Administered pfizer instead of moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was provided.  Treatment information was not provided.  The Clinical Manager could not provide the name of the facility where the dose was administered nor any other details. The Clinical Manager asked if the patient should have her second dose repeated and if repeated, did it matter that several days had already passed since the patient received her second dose. Consent received to be contacted by Safety. Consent to receive the information in writing.  Company comment: This report refers to a case of an underdose, syringe leak and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.  The follow up had received and reporter said that the patient took the Pfizer vaccine but not the moderna.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  This report refers to a case of an underdose, syringe leak and exposure via skin contact for mRNA-1273 (lot no unknown) with no associated AEs reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: The follow up document received.Pt. said they took Pfizer vaccine, not moderna.; Sender's Comments: This report refers to a case of an underdose, syringe leak and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Myalgia, Pyrexia
Clinical narrative: Hot, cold, things like that; Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot, cold, things like that), MYALGIA (Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy) and PYREXIA (Slight fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN (UNITOR) for Thyroid disorder NOS.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot, cold, things like that), MYALGIA (Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at a dose of 1 dosage form. On 17-May-2021, MYALGIA (Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot, cold, things like that) and PYREXIA (Slight fever) had resolved.            Action taken with mRNA-1273 in response to the events were not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Myalgia, Nausea, Pain
Clinical narrative: worsening symptoms; continued soreness and pain on the arm; numbness on the arm; Feverish; nausea; pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;; soreness in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN (soreness in the arm), HYPOAESTHESIA (numbness on the arm), VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;), PYREXIA (Feverish) and NAUSEA (nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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 medical history reported.). Concomitant products included ASCORBIC ACID, BIOTIN, TOCOPHERYL ACETATE (BIOTIN GUMMY) for an unknown indication.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (soreness in the arm). 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;). On 29-Apr-2021, the patient experienced PYREXIA (Feverish) and NAUSEA (nausea). On 12-May-2021, the patient experienced HYPOAESTHESIA (numbness on the arm). On an unknown date, the patient experienced CONDITION AGGRAVATED (worsening symptoms) and MYALGIA (continued soreness and pain on the arm). The patient was treated with IBUPROFEN for Pain, at a dose of 800 milligram three times a day. At the time of the report, PAIN (soreness in the arm), HYPOAESTHESIA (numbness on the arm), VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;), PYREXIA (Feverish), NAUSEA (nausea), CONDITION AGGRAVATED (worsening symptoms) and MYALGIA (continued soreness and pain on the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-138849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up document uploaded on 21-MAY-2021, Events updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: worsening symptoms; continued soreness and pain on the arm; numbness on the arm; Feverish; nausea; pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;; soreness in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN (soreness in the arm), HYPOAESTHESIA (numbness on the arm), VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;), PYREXIA (Feverish) and NAUSEA (nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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 medical history reported.). Concomitant products included ASCORBIC ACID, BIOTIN, TOCOPHERYL ACETATE (BIOTIN GUMMY) for an unknown indication.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (soreness in the arm). 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;). On 29-Apr-2021, the patient experienced PYREXIA (Feverish) and NAUSEA (nausea). On 12-May-2021, the patient experienced HYPOAESTHESIA (numbness on the arm). On an unknown date, the patient experienced CONDITION AGGRAVATED (worsening symptoms) and MYALGIA (continued soreness and pain on the arm). The patient was treated with IBUPROFEN for Pain, at a dose of 800 milligram three times a day. At the time of the report, PAIN (soreness in the arm), HYPOAESTHESIA (numbness on the arm), VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;), PYREXIA (Feverish), NAUSEA (nausea), CONDITION AGGRAVATED (worsening symptoms) and MYALGIA (continued soreness and pain on the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-138849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up document uploaded on 21-MAY-2021, Events updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Pyrexia
Clinical narrative: Hard to swallow as she feels like it's kind a  lumpy; Fever; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Hard to swallow as she feels like it's kind a  lumpy), PYREXIA (Fever) and FATIGUE (Tiredness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DYSPHAGIA (Hard to swallow as she feels like it's kind a  lumpy), PYREXIA (Fever) and FATIGUE (Tiredness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 17-May-2021, PYREXIA (Fever) and FATIGUE (Tiredness) had resolved. At the time of the report, DYSPHAGIA (Hard to swallow as she feels like it's kind a  lumpy) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events were not applicable. No treatment information provided by the reporter.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Feeling hot, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received the second one on day 34), PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), FEELING HOT (He had to wear heavy winter blankets, after that he got really hot) and BURNING SENSATION (he was still burning) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) 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 LEVOTHYROXINE, NIFEDIPINE, METOPROLOL, ATORVASTATIN, HYDRALAZINE, OXYCODONE, ZOLPIDEM and FUROSEMIDE for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced OFF LABEL USE (Received the second one on day 34), PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), CHILLS (chills) and HEADACHE (Headache). On 04-Jul-2021, the patient experienced FEELING HOT (He had to wear heavy winter blankets, after that he got really hot), BURNING SENSATION (he was still burning) and CHILLS (Patient got chills, the chills lasted all day. He had to wear heavy winter blankets). On 17-Feb-2021, OFF LABEL USE (Received the second one on day 34) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), FEELING HOT (He had to wear heavy winter blankets, after that he got really hot), BURNING SENSATION (he was still burning), CHILLS (chills), HEADACHE (Headache) and CHILLS (Patient got chills, the chills lasted all day. He had to wear heavy winter blankets) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Heart rate: 90-99 (Inconclusive) Heartbeat was up to 90-99 per minute. The patient was still experiencing adverse effects from the vaccine. It was reported that the effects happen four to five times a week. Treatment information was not provided. This case was linked to MOD-2021-023382 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow-up was received. Events added.; Sender's Comments:  MOD-2021-023382:Dose 1 case
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Off label use, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received the second one on day 34), PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), FEELING HOT (He had to wear heavy winter blankets, after that he got really hot) and BURNING SENSATION (he was still burning) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) 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 LEVOTHYROXINE, NIFEDIPINE, METOPROLOL, ATORVASTATIN, HYDRALAZINE, OXYCODONE, ZOLPIDEM and FUROSEMIDE for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced OFF LABEL USE (Received the second one on day 34), PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), CHILLS (chills) and HEADACHE (Headache). On 04-Jul-2021, the patient experienced FEELING HOT (He had to wear heavy winter blankets, after that he got really hot), BURNING SENSATION (he was still burning) and CHILLS (Patient got chills, the chills lasted all day. He had to wear heavy winter blankets). On 17-Feb-2021, OFF LABEL USE (Received the second one on day 34) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), FEELING HOT (He had to wear heavy winter blankets, after that he got really hot), BURNING SENSATION (he was still burning), CHILLS (chills), HEADACHE (Headache) and CHILLS (Patient got chills, the chills lasted all day. He had to wear heavy winter blankets) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Heart rate: 90-99 (Inconclusive) Heartbeat was up to 90-99 per minute. The patient was still experiencing adverse effects from the vaccine. It was reported that the effects happen four to five times a week. Treatment information was not provided. This case was linked to MOD-2021-023382 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow-up was received. Events added.; Sender's Comments:  MOD-2021-023382:Dose 1 case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Tingling and numbness on left hand; Tingling and numbness on left hand; Pain inside both legs similar to a electric shock; Headache; Light headiness,dizziness; Flush; Pain in left arm,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headiness,dizziness), FLUSHING (Flush), PAIN IN EXTREMITY (Pain in left arm,), PARAESTHESIA (Tingling and numbness on left hand) and HYPOAESTHESIA (Tingling and numbness on left hand) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (Light headiness,dizziness), FLUSHING (Flush) and PAIN IN EXTREMITY (Pain in left arm,). On 29-Apr-2021, the patient experienced PARAESTHESIA (Tingling and numbness on left hand), HYPOAESTHESIA (Tingling and numbness on left hand), PAIN IN EXTREMITY (Pain inside both legs similar to a electric shock) and HEADACHE (Headache). At the time of the report, DIZZINESS (Light headiness,dizziness), FLUSHING (Flush), PAIN IN EXTREMITY (Pain in left arm,), PARAESTHESIA (Tingling and numbness on left hand), HYPOAESTHESIA (Tingling and numbness on left hand), PAIN IN EXTREMITY (Pain inside both legs similar to a electric shock) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.  Patient reported that Her HCP said it was okay to receive the second shot but she is worried that she should not take the second dose.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling and numbness on left hand; Tingling and numbness on left hand; Pain inside both legs similar to a electric shock; Headache; Light headiness,dizziness; Flush; Pain in left arm,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headiness,dizziness), FLUSHING (Flush), PAIN IN EXTREMITY (Pain in left arm,), PARAESTHESIA (Tingling and numbness on left hand) and HYPOAESTHESIA (Tingling and numbness on left hand) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (Light headiness,dizziness), FLUSHING (Flush) and PAIN IN EXTREMITY (Pain in left arm,). On 29-Apr-2021, the patient experienced PARAESTHESIA (Tingling and numbness on left hand), HYPOAESTHESIA (Tingling and numbness on left hand), PAIN IN EXTREMITY (Pain inside both legs similar to a electric shock) and HEADACHE (Headache). At the time of the report, DIZZINESS (Light headiness,dizziness), FLUSHING (Flush), PAIN IN EXTREMITY (Pain in left arm,), PARAESTHESIA (Tingling and numbness on left hand), HYPOAESTHESIA (Tingling and numbness on left hand), PAIN IN EXTREMITY (Pain inside both legs similar to a electric shock) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.  Patient reported that Her HCP said it was okay to receive the second shot but she is worried that she should not take the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: first dose, felt like heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (first dose, felt like heart was racing) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 immunisation.     Concurrent medical conditions included Caffeine allergy (stays away from these because makes heart race) and Drug allergy (stays away from these because makes heart race).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PALPITATIONS (first dose, felt like heart was racing). The patient was treated with MAGNESIUM for Heart racing, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (first dose, felt like heart was racing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were by reporter.   This case was linked to MOD21-091252 (E2B Linked Report). This case was linked to MOD-2021-139361 (Patient Link).; Sender's Comments:  MOD21-091252:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Illness, Influenza like illness, Myalgia
Clinical narrative: Metallic taste in mouth; Headache; flu like symptoms; achy body; kind of sick; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (achy body) and ILLNESS (kind of sick) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Atrial fibrillation medication for Product used for unknown indication, Thyroid medication for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (achy body) and ILLNESS (kind of sick). At the time of the report, DYSGEUSIA (Metallic taste in mouth), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (achy body) and ILLNESS (kind of sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-139311 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient receive a dose of the Pfizer vaccine and one dose of Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient receive a dose of the Pfizer vaccine and one dose of Moderna Covid-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient receive a dose of the Pfizer vaccine and one dose of Moderna Covid-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient receive a dose of the Pfizer vaccine and one dose of Moderna Covid-19 vaccine) had resolved. Not Provided      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.   It was reported that Patient took Pfizer vaccine in Feb 2021 but did not inform Pharmacist  No concomitant details were provided No treatment details were provided
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21) for COVID-19 vaccination.     No Medical History information was reported.     On 11-Mar-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) 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 relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-074028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow received on 17-Jun-2021, patient demographics, reporter information and vaccine information updated.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: gout flare; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout flare) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 UNK. On an unknown date, the patient experienced GOUT (gout flare). The patient was treated with INDOMETHACIN [INDOMETACIN] for Pain, at an unspecified dose and frequency. At the time of the report, GOUT (gout flare) had not resolved.            no concomitant medications information were provided   This case was linked to MOD-2021-044348 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: injection site swelled slightly; tingling confined to my chin and the bottom of my face; Headache; severe pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling confined to my chin and the bottom of my face), HEADACHE (Headache), INJECTION SITE PAIN (severe pain at the injection site) and INJECTION SITE SWELLING (injection site swelled slightly) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C14C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-May-2021 at 12:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced PARAESTHESIA (tingling confined to my chin and the bottom of my face), HEADACHE (Headache) and INJECTION SITE PAIN (severe pain at the injection site). On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site swelled slightly). On 08-Apr-2021, PARAESTHESIA (tingling confined to my chin and the bottom of my face) and HEADACHE (Headache) had resolved. On 09-May-2021, INJECTION SITE PAIN (severe pain at the injection site) had resolved. At the time of the report, INJECTION SITE SWELLING (injection site swelled slightly) 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.   This case was linked to MOD-2021-068481 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a non-health professional and describes the occurrence of TINNITUS (Tinnitus) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome reported as Unknown