chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: lost appetite; very thirsty; increase urination; 102 fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesteremia.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue). At the time of the report, DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 102 (Inconclusive) 102 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medications included unspecified high blood pressure and cholesterol medication.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased, Hypertension
Clinical narrative: Flushing of the face; Rapid heart beat; Elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, AMLODIPINE, PHENYTOIN (DILANTIN [PHENYTOIN]) and LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included BENADRYL.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: severe dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (severe dizziness). On 14-Feb-2021, DIZZINESS (severe dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (severe dizziness). On 14-Feb-2021, DIZZINESS (severe dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tongue dry
Clinical narrative: Itching from head to toe; Her tongue was very dry about 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (Itching from head to toe). On an unknown date, the patient experienced TONGUE DRY (Her tongue was very dry about 20 minutes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (Itching from head to toe). On an unknown date, the patient experienced TONGUE DRY (Her tongue was very dry about 20 minutes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Test) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced COVID-19 (COVID-19 Test). At the time of the report, COVID-19 (COVID-19 Test) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: felt hot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING HOT (felt hot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Feb-2021, the patient experienced FEELING HOT (felt hot). On 20-Feb-2021, FEELING HOT (felt hot) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Pain in extremity, Pruritus, Vaccination site swelling
Clinical narrative: Red; Swollen; Itchy; Arm Hurt; Shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurt), ARTHRALGIA (Shoulder hurt), INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurt) and ARTHRALGIA (Shoulder hurt). On 22-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy). At the time of the report, PAIN IN EXTREMITY (Arm Hurt), ARTHRALGIA (Shoulder hurt), INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm to touch; Redness 2 and 1/2 inch around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3-jun -2021 does not contain any new information. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3-jun -2021 does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Fatigue, Gait inability, Headache
Clinical narrative: Immediate redness, then swelling, raised local area that became hot to touch, by that night I was running fever, had headache, nausea, overall fatigue, body ache, glands in neck seemed swollen... these symptoms lasted for 5 days.  After the 5 days when fever broke, my legs felt weak and started to have spasms that locked my legs into stretched out position. My legs became painful, starting with mostly on the right, but then both.  By the next week I started to lose use of my legs and I ended up in a wheelchair because unable to walk.   It is now in August and I am no longer in a wheelchair and although I am about to walk some, I still have difficulty and must rest a lot or I am unable to take normal steps, the legs still cause a lot of pain, but even that is improving.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: Immediate redness, then swelling, raised local area that became hot to touch, by that night I was running fever, had headache, nausea, overall fatigue, body ache, glands in neck seemed swollen... these symptoms lasted for 5 days.  After the 5 days when fever broke, my legs felt weak and started to have spasms that locked my legs into stretched out position. My legs became painful, starting with mostly on the right, but then both.  By the next week I started to lose use of my legs and I ended up in a wheelchair because unable to walk.   It is now in August and I am no longer in a wheelchair and although I am about to walk some, I still have difficulty and must rest a lot or I am unable to take normal steps, the legs still cause a lot of pain, but even that is improving.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Immediate redness, then swelling, raised local area that became hot to touch, by that night I was running fever, had headache, nausea, overall fatigue, body ache, glands in neck seemed swollen... these symptoms lasted for 5 days.  After the 5 days when fever broke, my legs felt weak and started to have spasms that locked my legs into stretched out position. My legs became painful, starting with mostly on the right, but then both.  By the next week I started to lose use of my legs and I ended up in a wheelchair because unable to walk.   It is now in August and I am no longer in a wheelchair and although I am about to walk some, I still have difficulty and must rest a lot or I am unable to take normal steps, the legs still cause a lot of pain, but even that is improving.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Wheelchair user, X-ray
Clinical narrative: Immediate redness, then swelling, raised local area that became hot to touch, by that night I was running fever, had headache, nausea, overall fatigue, body ache, glands in neck seemed swollen... these symptoms lasted for 5 days.  After the 5 days when fever broke, my legs felt weak and started to have spasms that locked my legs into stretched out position. My legs became painful, starting with mostly on the right, but then both.  By the next week I started to lose use of my legs and I ended up in a wheelchair because unable to walk.   It is now in August and I am no longer in a wheelchair and although I am about to walk some, I still have difficulty and must rest a lot or I am unable to take normal steps, the legs still cause a lot of pain, but even that is improving.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Soreness, redness, swelling at injection site. Dizziness, fatigue, headache. I slept, took Advil.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Soreness, redness, swelling at injection site. Dizziness, fatigue, headache. I slept, took Advil.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Vaccination site induration, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: hands and feet also were cold/ had chills; "COVID arm" around the injection site.; hardness at that site and swelling; COVID arm" around the injection site., big donut sized raised hives; COVID arm" around the injection site., big donut sized raised hives and rash; hardness at that site and swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives) and VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) 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.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling). At the time of the report, FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling) 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
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: hands and feet also were cold/ had chills; "COVID arm" around the injection site.; hardness at that site and swelling; COVID arm" around the injection site., big donut sized raised hives; COVID arm" around the injection site., big donut sized raised hives and rash; hardness at that site and swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives) and VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) 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.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling). At the time of the report, FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling) 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
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Skin abrasion
Clinical narrative: Scrapes on left leg; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ABRASION (Scrapes on left leg) in a 92-year-old female 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).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced SKIN ABRASION (Scrapes on left leg). At the time of the report, SKIN ABRASION (Scrapes on left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) 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 reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over her body). At the time of the report, RASH (rash all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over her body). At the time of the report, RASH (rash all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Insomnia, Pain in extremity, Pruritus
Clinical narrative: itches frequently; Not able to sleep; Shingles rash; Severe back pain; Shingles on her left side; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and BACK PAIN (Severe back pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 11-Feb-2021, the patient experienced HERPES ZOSTER (Shingles on her left side) and BACK PAIN (Severe back pain). On 01-Mar-2021, the patient experienced RASH (Shingles rash). On an unknown date, the patient experienced PRURITUS (itches frequently) and INSOMNIA (Not able to sleep). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Rash on face, at a dose of UNK dosage form; PREDNISONE at a dose of UNK dosage form and GABAPENTIN for Pain, at a dose of UNK dosage form. On 13-Mar-2021, BACK PAIN (Severe back pain) outcome was unknown. At the time of the report, HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and RASH (Shingles rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received .Patient's demographic details, Treatment product as Gabapentin, New event Severe back pain, Rash and Insomnia were added. Outcome of Shingles event added. Causality of Shingles event was added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: itches frequently; Not able to sleep; Shingles rash; Severe back pain; Shingles on her left side; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and BACK PAIN (Severe back pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 11-Feb-2021, the patient experienced HERPES ZOSTER (Shingles on her left side) and BACK PAIN (Severe back pain). On 01-Mar-2021, the patient experienced RASH (Shingles rash). On an unknown date, the patient experienced PRURITUS (itches frequently) and INSOMNIA (Not able to sleep). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Rash on face, at a dose of UNK dosage form; PREDNISONE at a dose of UNK dosage form and GABAPENTIN for Pain, at a dose of UNK dosage form. On 13-Mar-2021, BACK PAIN (Severe back pain) outcome was unknown. At the time of the report, HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and RASH (Shingles rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received .Patient's demographic details, Treatment product as Gabapentin, New event Severe back pain, Rash and Insomnia were added. Outcome of Shingles event added. Causality of Shingles event was added.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Potential side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Potential side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Potential side effects). At the time of the report, ADVERSE REACTION (Potential side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: excessive sleeping; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-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 HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired). At the time of the report, HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-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 HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired). At the time of the report, HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Horrible reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Horrible reaction to the vaccine) 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) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (Horrible reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (Horrible reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Cold. Concomitant products included LISINOPRIL for Blood pressure management, RIVAROXABAN (XARELTO) for Circulating anticoagulant, AMLODIPINE BESILATE (NORVASC) for an unknown indication.   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) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information includes nebulizer oxygen and different meds.  Treatment medication information  was not provided  by the reporter.  Patient was loss of taste and smell after first shot of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow Up document received on 15-jul-2021 contains Significant  information of patient identifiers , concomitant medication. On 23-Jul-2021: follow up received contain no new information
Sex: M
Vaccine: COVID19
Symptoms: Blood count, Blood count abnormal, Haemoglobin, Red blood cell count
Clinical narrative: my hematology blood count is higher than it has normally been; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Polycythemia since an unknown date.   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, 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 BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been). At the time of the report, BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: High. On an unknown date, Haemoglobin: High. On an unknown date, Red blood cell count: High.         No relevant concomitant medications were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Polycythemia since an unknown date.   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, 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 BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been). At the time of the report, BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: High. On an unknown date, Haemoglobin: High. On an unknown date, Red blood cell count: High.         No relevant concomitant medications were reported.   No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular, Vaccination site pruritus
Clinical narrative: small bumps, like little rashes; Itching all over the body; Itching at the injection site; Rashes all over the body, especially ankles and behind knees; This spontaneous case was reported by a nurse and describes the occurrence of RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 15 milligram. On 15-Feb-2021, RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-021656 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash pruritic
Clinical narrative: tingling in right arm; itchy; breakout on neck; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in right arm), PRURITUS (itchy) and RASH PRURITIC (breakout on neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Victoza, ) and Drug allergy (Byetta).    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 PARAESTHESIA (tingling in right arm), PRURITUS (itchy) and RASH PRURITIC (breakout on neck). At the time of the report, PARAESTHESIA (tingling in right arm), PRURITUS (itchy) and RASH PRURITIC (breakout on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR form received on 14 JUL 2021: Declined for follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Pain
Clinical narrative: Chest pain; Weak; Aching; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ASTHENIA (Weak) and PAIN (Aching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Dialysis on 03-Feb-2021. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN ), ATORVASTATIN, ISOSORBIDE, LEVOTHYROXINE, NIFEDIPINE, ALBUTEROL [SALBUTAMOL], CALCIUM CHLORIDE DIHYDRATE, GLUCOSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE (DIALYTE), CITALOPRAM and APIXABAN (ELIQUIS) for an unknown indication.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced CHEST PAIN (Chest pain), ASTHENIA (Weak) and PAIN (Aching). On 03-Feb-2021, CHEST PAIN (Chest pain) had resolved. At the time of the report, ASTHENIA (Weak) and PAIN (Aching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Consumer did not have an email address and never saw a HCP after receiving the vaccine. It was reported that patient  feels fine now and would rather not have any more follow up
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling abnormal, Headache, Nasal congestion
Clinical narrative: Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19; Stuffy nose; Chilled; Headache; Fever; Started feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Started feeling bad), CHILLS (Chilled) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 20-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021 at 8:00 AM, the patient experienced FEELING ABNORMAL (Started feeling bad). On an unknown date, the patient experienced COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19), NASAL CONGESTION (Stuffy nose), CHILLS (Chilled), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19) and CHILLS (Chilled) outcome was unknown and NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Started feeling bad), HEADACHE (Headache) and PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) positive COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up document was received on 14-07-2021 and it included patient details(age, weight, height, email), allergic drug and batch number of dose 1 COVID-19 vaccine new events and outcome were added.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19; Stuffy nose; Chilled; Headache; Fever; Started feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Started feeling bad), CHILLS (Chilled) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 20-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021 at 8:00 AM, the patient experienced FEELING ABNORMAL (Started feeling bad). On an unknown date, the patient experienced COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19), NASAL CONGESTION (Stuffy nose), CHILLS (Chilled), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19) and CHILLS (Chilled) outcome was unknown and NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Started feeling bad), HEADACHE (Headache) and PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) positive COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up document was received on 14-07-2021 and it included patient details(age, weight, height, email), allergic drug and batch number of dose 1 COVID-19 vaccine new events and outcome were added.