chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymph node pain, Lymphadenitis, Lymphadenopathy
Clinical narrative: lymph node is painful; lymph node size increased; rash all around the injection site; injection site, hot to touch.; huge lymph node, in the same arm of the injection; dizziness; throwing out; super tiredness; injection arm soreness (right arm); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VOMITING (throwing out), FATIGUE (super tiredness), PAIN IN EXTREMITY (injection arm soreness (right arm)) and LYMPHADENOPATHY (huge lymph node, in the same arm of the injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (dizziness), VOMITING (throwing out), FATIGUE (super tiredness) and PAIN IN EXTREMITY (injection arm soreness (right arm)). On 30-Apr-2021, the patient experienced LYMPHADENOPATHY (huge lymph node, in the same arm of the injection). On 02-May-2021, the patient experienced LYMPH NODE PAIN (lymph node is painful), LYMPHADENITIS (lymph node size increased), VACCINATION SITE RASH (rash all around the injection site) and VACCINATION SITE WARMTH (injection site, hot to touch.). At the time of the report, DIZZINESS (dizziness), VOMITING (throwing out), FATIGUE (super tiredness), PAIN IN EXTREMITY (injection arm soreness (right arm)), LYMPHADENOPATHY (huge lymph node, in the same arm of the injection), LYMPH NODE PAIN (lymph node is painful), LYMPHADENITIS (lymph node size increased), VACCINATION SITE RASH (rash all around the injection site) and VACCINATION SITE WARMTH (injection site, hot to touch.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash, Vaccination site warmth, Vomiting
Clinical narrative: lymph node is painful; lymph node size increased; rash all around the injection site; injection site, hot to touch.; huge lymph node, in the same arm of the injection; dizziness; throwing out; super tiredness; injection arm soreness (right arm); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VOMITING (throwing out), FATIGUE (super tiredness), PAIN IN EXTREMITY (injection arm soreness (right arm)) and LYMPHADENOPATHY (huge lymph node, in the same arm of the injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (dizziness), VOMITING (throwing out), FATIGUE (super tiredness) and PAIN IN EXTREMITY (injection arm soreness (right arm)). On 30-Apr-2021, the patient experienced LYMPHADENOPATHY (huge lymph node, in the same arm of the injection). On 02-May-2021, the patient experienced LYMPH NODE PAIN (lymph node is painful), LYMPHADENITIS (lymph node size increased), VACCINATION SITE RASH (rash all around the injection site) and VACCINATION SITE WARMTH (injection site, hot to touch.). At the time of the report, DIZZINESS (dizziness), VOMITING (throwing out), FATIGUE (super tiredness), PAIN IN EXTREMITY (injection arm soreness (right arm)), LYMPHADENOPATHY (huge lymph node, in the same arm of the injection), LYMPH NODE PAIN (lymph node is painful), LYMPHADENITIS (lymph node size increased), VACCINATION SITE RASH (rash all around the injection site) and VACCINATION SITE WARMTH (injection site, hot to touch.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash down her arm; swollen vaccination site; rash around Vaccination site; headache; tired; Itching vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash down her arm), VACCINATION SITE PRURITUS (Itching vaccination site), HEADACHE (headache), FATIGUE (tired) and VACCINATION SITE SWELLING (swollen vaccination site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching vaccination site). On 24-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tired). On 01-May-2021, the patient experienced RASH (rash down her arm), VACCINATION SITE SWELLING (swollen vaccination site) and VACCINATION SITE RASH (rash around Vaccination site). At the time of the report, RASH (rash down her arm), VACCINATION SITE PRURITUS (Itching vaccination site), HEADACHE (headache), FATIGUE (tired), VACCINATION SITE SWELLING (swollen vaccination site) and VACCINATION SITE RASH (rash around Vaccination site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: rash down her arm; swollen vaccination site; rash around Vaccination site; headache; tired; Itching vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash down her arm), VACCINATION SITE PRURITUS (Itching vaccination site), HEADACHE (headache), FATIGUE (tired) and VACCINATION SITE SWELLING (swollen vaccination site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching vaccination site). On 24-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tired). On 01-May-2021, the patient experienced RASH (rash down her arm), VACCINATION SITE SWELLING (swollen vaccination site) and VACCINATION SITE RASH (rash around Vaccination site). At the time of the report, RASH (rash down her arm), VACCINATION SITE PRURITUS (Itching vaccination site), HEADACHE (headache), FATIGUE (tired), VACCINATION SITE SWELLING (swollen vaccination site) and VACCINATION SITE RASH (rash around Vaccination site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 HEART RATE IRREGULAR (Irregular heartbeat). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Started with her menstrual period 10 days before her regular cycle; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Started with her menstrual period 10 days before her regular cycle) in a 35-year-old female patient who received mRNA-1273 (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced POLYMENORRHOEA (Started with her menstrual period 10 days before her regular cycle). At the time of the report, POLYMENORRHOEA (Started with her menstrual period 10 days before her regular cycle) outcome was unknown.            The patient's cycle is consistent with 28 days for about 15 years and she believes is a potential adverse event.   Treatment information not provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nasal congestion
Clinical narrative: congestion that has not gone away; little light headiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little light headiness) and NASAL CONGESTION (congestion that has not gone away) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (little light headiness). On 25-Apr-2021, the patient experienced NASAL CONGESTION (congestion that has not gone away). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, DIZZINESS (little light headiness) outcome was unknown and NASAL CONGESTION (congestion that has not gone away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching less; injection site itched like crazy; injection site swelled up; injection site is bright red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching less), VACCINATION SITE PRURITUS (injection site itched like crazy), VACCINATION SITE SWELLING (injection site swelled up) and VACCINATION SITE ERYTHEMA (injection site is bright red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LOVASTATIN for an unknown indication.    On 20-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 VACCINATION SITE PRURITUS (injection site itched like crazy), VACCINATION SITE SWELLING (injection site swelled up) and VACCINATION SITE ERYTHEMA (injection site is bright red). On 01-May-2021, the patient experienced PRURITUS (Itching less). At the time of the report, PRURITUS (Itching less), VACCINATION SITE SWELLING (injection site swelled up) and VACCINATION SITE ERYTHEMA (injection site is bright red) outcome was unknown and VACCINATION SITE PRURITUS (injection site itched like crazy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient applied cortisone.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site that radiated down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site that radiated down to elbow) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site that radiated down to elbow). On 22-Apr-2021, VACCINATION SITE PAIN (pain at injection site that radiated down to elbow) had resolved.            Action taken with mRNA-1273 in response to the events were not applicable.  Treatment information not reported. No concomitant medications reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site pain and injection site erythema (2 inch red circle around injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003C21A) for COVID-19 immunization. No medical history reported. On Apr 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 30, 2021, patient experienced injection site pain and injection site erythema (2 inch red circle around injection site). At the time of the report, injection site pain and injection site erythema (2 inch red circle around injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication, treatment information or causality assessments provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Migraine, Paraesthesia, Pruritus
Clinical narrative: hard to swallow; migraine on left side of my forehead; felt tingly in finger; voice was horse; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt tingly in finger), MIGRAINE (migraine on left side of my forehead), DYSPHAGIA (hard to swallow), DYSPHONIA (voice was horse) and PRURITUS (itchy arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin and Clindamycin).    On 16-Apr-2021 at 1:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PARAESTHESIA (felt tingly in finger), DYSPHONIA (voice was horse) and PRURITUS (itchy arm). On 28-Apr-2021 at 5:00 PM, the patient experienced MIGRAINE (migraine on left side of my forehead). On 28-Apr-2021 at 7:00 PM, the patient experienced DYSPHAGIA (hard to swallow). On 28-Apr-2021, PARAESTHESIA (felt tingly in finger) and PRURITUS (itchy arm) had resolved. On 28-Apr-2021 at 6:00 PM, MIGRAINE (migraine on left side of my forehead) had resolved. On 28-Apr-2021 at 8:00 PM, DYSPHAGIA (hard to swallow) had resolved. At the time of the report, DYSPHONIA (voice was horse) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Some of the vaccine went dribbled down arm; too much leakage as if syringe leaked; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Some of the vaccine went dribbled down arm) and SYRINGE ISSUE (too much leakage as if syringe leaked) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C03C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced UNDERDOSE (Some of the vaccine went dribbled down arm) and SYRINGE ISSUE (too much leakage as if syringe leaked). On 30-Apr-2021, UNDERDOSE (Some of the vaccine went dribbled down arm) and SYRINGE ISSUE (too much leakage as if syringe leaked) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. 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   This case was linked to MOD-2021-191547 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-Apr-2021 contains no new information On 29-May-2021: Follow-up information received on 29-May-2021 and contains no new information On 31-May-2021: Follow-up information received on 31-May-2021 and contains non-significant information
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-100840 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Mild headache, which occurs when she bends down; nausea; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache, which occurs when she bends down), NAUSEA (nausea) and PYREXIA (low grade fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (Mild headache, which occurs when she bends down), NAUSEA (nausea) and PYREXIA (low grade fever). At the time of the report, HEADACHE (Mild headache, which occurs when she bends down), NAUSEA (nausea) and PYREXIA (low grade fever) outcome was unknown.        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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling hot, Induration, Malaise
Clinical narrative: arm hurting; arm red; sick; weird feeling- arm; arm itching; arm warm, hot; (hard pocket) that is leaking out maybe pus- arm; hard pocket- arm; arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting) and ERYTHEMA (arm red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PROGESTERONE;ESTROGENS for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm) and PERIPHERAL SWELLING (arm swollen). On 28-Apr-2021, the patient experienced FEELING HOT (arm warm, hot). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), ERYTHEMA (arm red), MALAISE (sick), FEELING ABNORMAL (weird feeling- arm) and PRURITUS (arm itching). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), ERYTHEMA (arm red), FEELING HOT (arm warm, hot), MALAISE (sick), FEELING ABNORMAL (weird feeling- arm) and PRURITUS (arm itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-100798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional adverse events. On 07-Jul-2021: Outcome recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Purulent discharge
Clinical narrative: arm hurting; arm red; sick; weird feeling- arm; arm itching; arm warm, hot; (hard pocket) that is leaking out maybe pus- arm; hard pocket- arm; arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting) and ERYTHEMA (arm red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PROGESTERONE;ESTROGENS for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm) and PERIPHERAL SWELLING (arm swollen). On 28-Apr-2021, the patient experienced FEELING HOT (arm warm, hot). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), ERYTHEMA (arm red), MALAISE (sick), FEELING ABNORMAL (weird feeling- arm) and PRURITUS (arm itching). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), ERYTHEMA (arm red), FEELING HOT (arm warm, hot), MALAISE (sick), FEELING ABNORMAL (weird feeling- arm) and PRURITUS (arm itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-100798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional adverse events. On 07-Jul-2021: Outcome recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain on his arm). At the time of the report, PAIN IN EXTREMITY (pain on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.   Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity ("it feels like something in my left arm is being stretched at; it hurts"), pain descending to elbow and arm rash in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 044B21A) for COVID-19 immunization. No medical history reported. On Apr 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient experienced pain in extremity ("it feels like something in my left arm is being stretched at; it hurts"). On Apr 28, 2021, patient experienced arm rash. On Apr 29, 2021, patient experienced pain descending to elbow. On Apr 28, 2021, arm rash resolved. At the time of the report, pain in extremity ("it feels like something in my left arm is being stretched at; it hurts") and pain descending to elbow resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: round red itchy circle; round red itchy circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (round red itchy circle) and VACCINATION SITE ERYTHEMA (round red itchy circle) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (round red itchy circle) and VACCINATION SITE ERYTHEMA (round red itchy circle). At the time of the report, VACCINATION SITE PRURITUS (round red itchy circle) and VACCINATION SITE ERYTHEMA (round red itchy circle) had not resolved.        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: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site pruritus
Clinical narrative: itching around injection site; felt like the needle didn't enter her muscle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching around injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like the needle didn't enter her muscle) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary hypertension.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching around injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like the needle didn't enter her muscle). At the time of the report, INJECTION SITE PRURITUS (itching around injection site) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like the needle didn't enter her muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 antibody test: positive (Positive) Showed antibodies.. In March 2021, SARS-CoV-2 antibody test: negative (Negative) No Antibodies. On an unknown date, Heart rate: 55 (Low) dropped down to 55 and 30 (Low) further to 30.. On an unknown date, Lymphocyte count: low (Low) low lymphocytes. On an unknown date, nucleic antibody test negative.  No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-100843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Lab data was updated.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Kind of sweaty but they sweat a lot.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Kind of sweaty but they sweat a lot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HYPERHIDROSIS (Kind of sweaty but they sweat a lot.). At the time of the report, HYPERHIDROSIS (Kind of sweaty but they sweat a lot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Patient had her second dose in May with no adverse reactions.Updated outcome of event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Dry mouth, Eyelid ptosis
Clinical narrative: eyes looked droopy; felt weak; couldn't hold her arms; stomach hurt; dry mouth; extreme fatigue; pain on her joints; she was so weak, so she hit her head ,she has severe headache; vomiting; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt) and DRY MOUTH (dry mouth) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016T21A) 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 METHADONE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt), DRY MOUTH (dry mouth), FATIGUE (extreme fatigue), ARTHRALGIA (pain on her joints), HEADACHE (she was so weak, so she hit her head ,she has severe headache), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt), DRY MOUTH (dry mouth), FATIGUE (extreme fatigue) and HEADACHE (she was so weak, so she hit her head ,she has severe headache) outcome was unknown and ARTHRALGIA (pain on her joints), VOMITING (vomiting) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medicines for her sarcastic episodes.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Nausea, Vomiting
Clinical narrative: eyes looked droopy; felt weak; couldn't hold her arms; stomach hurt; dry mouth; extreme fatigue; pain on her joints; she was so weak, so she hit her head ,she has severe headache; vomiting; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt) and DRY MOUTH (dry mouth) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016T21A) 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 METHADONE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt), DRY MOUTH (dry mouth), FATIGUE (extreme fatigue), ARTHRALGIA (pain on her joints), HEADACHE (she was so weak, so she hit her head ,she has severe headache), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt), DRY MOUTH (dry mouth), FATIGUE (extreme fatigue) and HEADACHE (she was so weak, so she hit her head ,she has severe headache) outcome was unknown and ARTHRALGIA (pain on her joints), VOMITING (vomiting) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medicines for her sarcastic episodes.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a consumer describes the occurrence of COVID-19 symptoms and minor fatigue in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. Concomitant products included Metoprolol succinate for an unknown indication. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 11, 2021, patient experienced COVID-19 symptoms. On an unknown date, patient had minor fatigue. At the time of the report, COVID-19 symptoms outcome: unknown; and minor fatigue: not resolved. Diagnostic results: On Apr 13, 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment information included Advil. The patient had minor fatigue as of Apr 30, 2021 and no more symptoms. Sender's comments: Based on the current available information, the mechanism of action of mRNA-1237 vaccine and the etiology of COVID-19, the event of COVID-19 is assessed as unlikely related. The event of fatigue is in consistence with the symptoms of COVID-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Itching on her left arm only; Rash on her left arm only; My arm was red at the injection site; My arm was hot at the injection site; my arm was hard-like at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (My arm was red at the injection site), VACCINATION SITE WARMTH (My arm was hot at the injection site), VACCINATION SITE INDURATION (my arm was hard-like at the injection site), VACCINATION SITE PRURITUS (Itching on her left arm only) and VACCINATION SITE RASH (Rash on her left arm only) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Sensitive skin. Concomitant products included OXYCODONE for Neck pain, METFORMIN, LISINOPRIL, ESTROGENS CONJUGATED (PREMARIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) 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 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (My arm was red at the injection site), VACCINATION SITE WARMTH (My arm was hot at the injection site) and VACCINATION SITE INDURATION (my arm was hard-like at the injection site). On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on her left arm only) and VACCINATION SITE RASH (Rash on her left arm only). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2021 for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (My arm was red at the injection site), VACCINATION SITE WARMTH (My arm was hot at the injection site), VACCINATION SITE INDURATION (my arm was hard-like at the injection site), VACCINATION SITE PRURITUS (Itching on her left arm only) and VACCINATION SITE RASH (Rash on her left arm only) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101509 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received the 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine) had resolved.        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.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Decreased appetite, Fatigue
Clinical narrative: loss of smell for a week; loss of taste for a week gone; no appetite; no strength; tired since she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell for a week), AGEUSIA (loss of taste for a week gone), DECREASED APPETITE (no appetite), ASTHENIA (no strength) and FATIGUE (tired since she got the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Past medical history  was provided.     On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss of smell for a week), AGEUSIA (loss of taste for a week gone), DECREASED APPETITE (no appetite), ASTHENIA (no strength) and FATIGUE (tired since she got the vaccine). At the time of the report, ANOSMIA (loss of smell for a week), AGEUSIA (loss of taste for a week gone), DECREASED APPETITE (no appetite), ASTHENIA (no strength) and FATIGUE (tired since she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was provided
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Erythema
Clinical narrative: Redness on scalp; Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on scalp) and ALOPECIA (Hair loss) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (Redness on scalp) and ALOPECIA (Hair loss). At the time of the report, ERYTHEMA (Redness on scalp) and ALOPECIA (Hair loss) outcome was unknown.            Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: whole body was experiencing muscle and joint pain.; whole body was experiencing muscle and joint pain.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (whole body was experiencing muscle and joint pain.) and ARTHRALGIA (whole body was experiencing muscle and joint pain.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 096B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MYALGIA (whole body was experiencing muscle and joint pain.) and ARTHRALGIA (whole body was experiencing muscle and joint pain.). At the time of the report, MYALGIA (whole body was experiencing muscle and joint pain.) and ARTHRALGIA (whole body was experiencing muscle and joint pain.) outcome was unknown.        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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Hyperhidrosis, Illness, Pain in extremity
Clinical narrative: Extreme sinus congestion; Cough; Got sick; Fatigue; Slept half the day away; Night sweats where she was sweating through everything she was wearing and the sheets; Slight sore arm; low grade temp around 100 but never went higher than that; So fatigued could not even drive/got so fatigued had to lay down; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PAIN IN EXTREMITY (Slight sore arm), SINUS CONGESTION (Extreme sinus congestion) and COUGH (Cough) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PAIN IN EXTREMITY (Slight sore arm) and PYREXIA (low grade temp around 100 but never went higher than that). 28-Apr-2021, the patient experienced FATIGUE (So fatigued could not even drive/got so fatigued had to lay down). On 02-Jun-2021, the patient experienced SINUS CONGESTION (Extreme sinus congestion), COUGH (Cough), ILLNESS (Got sick) and FATIGUE (Fatigue). On 29-Apr-2021, SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PYREXIA (low grade temp around 100 but never went higher than that) and FATIGUE (So fatigued could not even drive/got so fatigued had to lay down) had resolved. At the time of the report, PAIN IN EXTREMITY (Slight sore arm) had resolved and SINUS CONGESTION (Extreme sinus congestion), COUGH (Cough), ILLNESS (Got sick) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up information received included additional events and lab data.