chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under 18 years old was vaccinated with first dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old was vaccinated with first dose of Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old was vaccinated with first dose of Moderna vaccine). On 20-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old was vaccinated with first dose of Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated adverse events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: arm got red and splotchy; itched real bad; hot and burning when touched; hot and burning when touched; covid arm; spot moved down to elbow; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ERYTHEMA (arm got red and splotchy), PRURITUS (itched real bad), FEELING HOT (hot and burning when touched) and BURNING SENSATION (hot and burning when touched) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ERYTHEMA (arm got red and splotchy), PRURITUS (itched real bad), FEELING HOT (hot and burning when touched), BURNING SENSATION (hot and burning when touched), VACCINATION SITE REACTION (covid arm) and RASH MACULAR (spot moved down to elbow). At the time of the report, PAIN IN EXTREMITY (arm was sore) had resolved and ERYTHEMA (arm got red and splotchy), PRURITUS (itched real bad), FEELING HOT (hot and burning when touched), BURNING SENSATION (hot and burning when touched), VACCINATION SITE REACTION (covid arm) and RASH MACULAR (spot moved down to elbow) outcome was unknown. Not Provided      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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site reaction
Clinical narrative: arm got red and splotchy; itched real bad; hot and burning when touched; hot and burning when touched; covid arm; spot moved down to elbow; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ERYTHEMA (arm got red and splotchy), PRURITUS (itched real bad), FEELING HOT (hot and burning when touched) and BURNING SENSATION (hot and burning when touched) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ERYTHEMA (arm got red and splotchy), PRURITUS (itched real bad), FEELING HOT (hot and burning when touched), BURNING SENSATION (hot and burning when touched), VACCINATION SITE REACTION (covid arm) and RASH MACULAR (spot moved down to elbow). At the time of the report, PAIN IN EXTREMITY (arm was sore) had resolved and ERYTHEMA (arm got red and splotchy), PRURITUS (itched real bad), FEELING HOT (hot and burning when touched), BURNING SENSATION (hot and burning when touched), VACCINATION SITE REACTION (covid arm) and RASH MACULAR (spot moved down to elbow) outcome was unknown. Not Provided      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: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: waking in the middle of the night because his hands feel like they have fallen asleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (waking in the middle of the night because his hands feel like they have fallen asleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPOAESTHESIA (waking in the middle of the night because his hands feel like they have fallen asleep). At the time of the report, HYPOAESTHESIA (waking in the middle of the night because his hands feel like they have fallen asleep) outcome was unknown. Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hiccups, Muscle spasms, Muscle tightness, Neck pain
Clinical narrative: pain has been has been keeping her up; right arm is bothering her; pain in the lower part of her neck down her back from the crook in the neck; hurting when she moves; tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it; Right arm feels warm/right arm feels feverish; developed hiccups all day, after the second shot; injected arm swoll up a little bit; slight fever; developed a crook in her neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (developed a crook in her neck), PAIN IN EXTREMITY (right arm is bothering her), NECK PAIN (pain in the lower part of her neck down her back from the crook in the neck), PAIN (hurting when she moves) and MUSCLE TIGHTNESS (tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided ).    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MUSCLE SPASMS (developed a crook in her neck), HICCUPS (developed hiccups all day, after the second shot), VACCINATION SITE SWELLING (injected arm swoll up a little bit) and PYREXIA (slight fever). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm is bothering her), NECK PAIN (pain in the lower part of her neck down her back from the crook in the neck), PAIN (hurting when she moves), MUSCLE TIGHTNESS (tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it) and FEELING HOT (Right arm feels warm/right arm feels feverish). On an unknown date, the patient experienced SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (pain has been has been keeping her up). At the time of the report, MUSCLE SPASMS (developed a crook in her neck), PAIN IN EXTREMITY (right arm is bothering her), NECK PAIN (pain in the lower part of her neck down her back from the crook in the neck), PAIN (hurting when she moves), MUSCLE TIGHTNESS (tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it), FEELING HOT (Right arm feels warm/right arm feels feverish), SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (pain has been has been keeping her up), HICCUPS (developed hiccups all day, after the second shot), VACCINATION SITE SWELLING (injected arm swoll up a little bit) and PYREXIA (slight fever) outcome was unknown.            This case was linked to MOD-2021-054661 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder due to a general medical condition, Vaccination site swelling
Clinical narrative: pain has been has been keeping her up; right arm is bothering her; pain in the lower part of her neck down her back from the crook in the neck; hurting when she moves; tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it; Right arm feels warm/right arm feels feverish; developed hiccups all day, after the second shot; injected arm swoll up a little bit; slight fever; developed a crook in her neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (developed a crook in her neck), PAIN IN EXTREMITY (right arm is bothering her), NECK PAIN (pain in the lower part of her neck down her back from the crook in the neck), PAIN (hurting when she moves) and MUSCLE TIGHTNESS (tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided ).    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MUSCLE SPASMS (developed a crook in her neck), HICCUPS (developed hiccups all day, after the second shot), VACCINATION SITE SWELLING (injected arm swoll up a little bit) and PYREXIA (slight fever). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm is bothering her), NECK PAIN (pain in the lower part of her neck down her back from the crook in the neck), PAIN (hurting when she moves), MUSCLE TIGHTNESS (tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it) and FEELING HOT (Right arm feels warm/right arm feels feverish). On an unknown date, the patient experienced SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (pain has been has been keeping her up). At the time of the report, MUSCLE SPASMS (developed a crook in her neck), PAIN IN EXTREMITY (right arm is bothering her), NECK PAIN (pain in the lower part of her neck down her back from the crook in the neck), PAIN (hurting when she moves), MUSCLE TIGHTNESS (tight muscles/skin feels different like something is going on with the muscle itself/it feels "rubbery" when she moves it), FEELING HOT (Right arm feels warm/right arm feels feverish), SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (pain has been has been keeping her up), HICCUPS (developed hiccups all day, after the second shot), VACCINATION SITE SWELLING (injected arm swoll up a little bit) and PYREXIA (slight fever) outcome was unknown.            This case was linked to MOD-2021-054661 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Vaccination site pruritus, Vaccination site rash
Clinical narrative: feels burning when something brushes against it; It is itchy when it is touched; rash about 2 inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (feels burning when something brushes against it), VACCINATION SITE PRURITUS (It is itchy when it is touched) and VACCINATION SITE RASH (rash about 2 inches at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced SKIN BURNING SENSATION (feels burning when something brushes against it), VACCINATION SITE PRURITUS (It is itchy when it is touched) and VACCINATION SITE RASH (rash about 2 inches at the injection site). At the time of the report, SKIN BURNING SENSATION (feels burning when something brushes against it), VACCINATION SITE PRURITUS (It is itchy when it is touched) and VACCINATION SITE RASH (rash about 2 inches at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants products were reported. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy left hand, itchy left ankle and itchy left neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy left hand, itchy left ankle and itchy left neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (itchy left hand, itchy left ankle and itchy left neck). At the time of the report, PRURITUS (itchy left hand, itchy left ankle and itchy left neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. The patient went to visit his doctor and was prescribed a medication (unspecified).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: arm became sore; soft ball size swelling; warm to the touch; red all around the area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm became sore), SWELLING (soft ball size swelling), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE ERYTHEMA (red all around the area) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm became sore), SWELLING (soft ball size swelling), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE ERYTHEMA (red all around the area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Manual therapy (ice) for Pain in extremity; Manual therapy (ice) for Swelling; Manual therapy (ice) for Vaccination site warmth and Manual therapy (ice) for Vaccination site erythema. At the time of the report, PAIN IN EXTREMITY (arm became sore), SWELLING (soft ball size swelling), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE ERYTHEMA (red all around the area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain
Clinical narrative: Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Loss of smell in January 2021 and Loss of taste in January 2021. Concomitant products included MINOXIDIL, CARBIDOPA, LEVODOPA (SINEMET), PROPRANOLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), COENZYME Q10 [UBIDECARENONE], VITAMIN D [VITAMIN D NOS] and DENOSUMAB (PROLIA) from 02-Dec-2020 to an unknown date for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Mar-2021, PAIN (Soreness) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: over 100 (Inconclusive) fever over 100.     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.   In Dec. 2021, patient was sick and had some of the COVID-19 symptoms.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Vaccination site haemorrhage
Clinical narrative: Sore Arm; Corn Size Bruise; Bleeding Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Corn Size Bruise), VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site) and PAIN IN EXTREMITY (Sore Arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CONTUSION (Corn Size Bruise) and VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 21-Mar-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, CONTUSION (Corn Size Bruise) had not resolved and VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Feeling bad; Heart rate raised; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), HEART RATE INCREASED (Heart rate raised), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to some food) and Drug allergy (Allergic to some medicines). Concomitant products included HYOSCYAMINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling bad), HEART RATE INCREASED (Heart rate raised), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad), HEART RATE INCREASED (Heart rate raised), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: headache; weakness - I don't have by strength back; dizziness; very thirsty; Foggy brain and felt bad call day; extreme chills; severe muscle pain; fever; nausea; diarrhea; sweating; woke me up at night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea) and HYPERHIDROSIS (sweating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea). On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy brain and felt bad call day). On 23-Mar-2021, the patient experienced ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness) and THIRST (very thirsty). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; WATER at an unspecified dose and frequency and ELECTROLYTE SOLUTIONS [ELECTROLYTES NOS] at an unspecified dose and frequency. On 21-Mar-2021, SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea), THIRST (very thirsty) and HEADACHE (headache) outcome was unknown and HYPERHIDROSIS (sweating) had resolved.            No Concomitant medications was reported
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Pyrexia
Clinical narrative: headache; weakness - I don't have by strength back; dizziness; very thirsty; Foggy brain and felt bad call day; extreme chills; severe muscle pain; fever; nausea; diarrhea; sweating; woke me up at night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea) and HYPERHIDROSIS (sweating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea). On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy brain and felt bad call day). On 23-Mar-2021, the patient experienced ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness) and THIRST (very thirsty). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; WATER at an unspecified dose and frequency and ELECTROLYTE SOLUTIONS [ELECTROLYTES NOS] at an unspecified dose and frequency. On 21-Mar-2021, SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea), THIRST (very thirsty) and HEADACHE (headache) outcome was unknown and HYPERHIDROSIS (sweating) had resolved.            No Concomitant medications was reported
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Thirst
Clinical narrative: headache; weakness - I don't have by strength back; dizziness; very thirsty; Foggy brain and felt bad call day; extreme chills; severe muscle pain; fever; nausea; diarrhea; sweating; woke me up at night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea) and HYPERHIDROSIS (sweating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea). On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy brain and felt bad call day). On 23-Mar-2021, the patient experienced ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness) and THIRST (very thirsty). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; WATER at an unspecified dose and frequency and ELECTROLYTE SOLUTIONS [ELECTROLYTES NOS] at an unspecified dose and frequency. On 21-Mar-2021, SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea), THIRST (very thirsty) and HEADACHE (headache) outcome was unknown and HYPERHIDROSIS (sweating) had resolved.            No Concomitant medications was reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right leg Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right leg Pain) in a 62-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right leg Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Right leg Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: A record high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (A record high blood pressure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPERTENSION (A record high blood pressure). At the time of the report, HYPERTENSION (A record high blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were provided. Patient had received  beta blockers treatment.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness/whooziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness/whooziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness/whooziness). At the time of the report, DIZZINESS (Lightheadedness/whooziness) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension
Clinical narrative: Elevated blood pressure both systolic and diastolic; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Elevated blood pressure both systolic and diastolic) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Bleaches & cleansers sensitivity and Allergic reaction to drug. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) for Allergy.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERTENSION (Elevated blood pressure both systolic and diastolic). At the time of the report, HYPERTENSION (Elevated blood pressure both systolic and diastolic) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: increased (High) slight elevation in pulse. On 17-Mar-2021, Blood pressure measurement: 168/89 (High) high. On 23-Mar-2021, Blood pressure measurement: 120/75 (normal) normal. On an unknown date, Blood pressure measurement: 122/79 (normal) normal and 167/85 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received contains significant information - Updated patient demographics, Allergic conditions, Concomitant medication, Outcome provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: sore arm, tender at injection site; sore arm, tender at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, tender at injection site) and VACCINATION SITE PAIN (sore arm, tender at injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Patient's medical history included No Adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm, tender at injection site) and VACCINATION SITE PAIN (sore arm, tender at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm, tender at injection site) and VACCINATION SITE PAIN (sore arm, tender at injection site) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-054855, MOD-2021-054651, MOD-2021-054855 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea
Clinical narrative: light headedness; nausea; severe headache; muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (light headedness), NAUSEA (nausea), HEADACHE (severe headache) and MYALGIA (muscle aches) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (light headedness), NAUSEA (nausea), HEADACHE (severe headache) and MYALGIA (muscle aches). At the time of the report, DIZZINESS (light headedness), NAUSEA (nausea), HEADACHE (severe headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinusitis; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinusitis) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Fibrillation, Angioma (angiomas of head.) and Splenectomy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SINUSITIS (sinusitis). At the time of the report, SINUSITIS (sinusitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: fast heart rate; arm numbness; tingling; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart rate), HYPOAESTHESIA (arm numbness) and PARAESTHESIA (tingling) 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 21-Mar-2021, 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 INCREASED (fast heart rate), HYPOAESTHESIA (arm numbness) and PARAESTHESIA (tingling). At the time of the report, HEART RATE INCREASED (fast heart rate), HYPOAESTHESIA (arm numbness) and PARAESTHESIA (tingling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high High.     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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Papule, Vaccination site erythema
Clinical narrative: slight headache; hot to the touch; little tiny bumps on my upper right chest near my armpit; nausea; tender; The injection site was swollen about the size of a baseball; pain in my ankles; The injection site had a red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), PAPULE (little tiny bumps on my upper right chest near my armpit), NAUSEA (nausea), VACCINATION SITE PAIN (tender) and VACCINATION SITE SWELLING (The injection site was swollen about the size of a baseball) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PAPULE (little tiny bumps on my upper right chest near my armpit), NAUSEA (nausea), VACCINATION SITE PAIN (tender), VACCINATION SITE SWELLING (The injection site was swollen about the size of a baseball), ARTHRALGIA (pain in my ankles) and VACCINATION SITE ERYTHEMA (The injection site had a red mark). On 22-Mar-2021, the patient experienced HEADACHE (slight headache). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), PAPULE (little tiny bumps on my upper right chest near my armpit), NAUSEA (nausea), VACCINATION SITE PAIN (tender), VACCINATION SITE SWELLING (The injection site was swollen about the size of a baseball), ARTHRALGIA (pain in my ankles), VACCINATION SITE ERYTHEMA (The injection site had a red mark) and HEADACHE (slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated outcome for all events as recovered/resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: slight headache; hot to the touch; little tiny bumps on my upper right chest near my armpit; nausea; tender; The injection site was swollen about the size of a baseball; pain in my ankles; The injection site had a red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), PAPULE (little tiny bumps on my upper right chest near my armpit), NAUSEA (nausea), VACCINATION SITE PAIN (tender) and VACCINATION SITE SWELLING (The injection site was swollen about the size of a baseball) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PAPULE (little tiny bumps on my upper right chest near my armpit), NAUSEA (nausea), VACCINATION SITE PAIN (tender), VACCINATION SITE SWELLING (The injection site was swollen about the size of a baseball), ARTHRALGIA (pain in my ankles) and VACCINATION SITE ERYTHEMA (The injection site had a red mark). On 22-Mar-2021, the patient experienced HEADACHE (slight headache). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), PAPULE (little tiny bumps on my upper right chest near my armpit), NAUSEA (nausea), VACCINATION SITE PAIN (tender), VACCINATION SITE SWELLING (The injection site was swollen about the size of a baseball), ARTHRALGIA (pain in my ankles), VACCINATION SITE ERYTHEMA (The injection site had a red mark) and HEADACHE (slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated outcome for all events as recovered/resolved.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fatigue; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection in November 2020.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills only; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills only) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CHILLS (chills only). At the time of the report, CHILLS (chills only) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided   This case was linked to MOD-2021-054634 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue, Pyrexia
Clinical narrative: Couldn't get a schedule for her second dose, more than 42 days have passed; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Couldn't get a schedule for her second dose, more than 42 days have passed), MYALGIA (Body aches) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMLODIPINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Couldn't get a schedule for her second dose, more than 42 days have passed), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Couldn't get a schedule for her second dose, more than 42 days have passed), MYALGIA (Body aches) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 contains updated event outcome.