chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Milia, Rash pustular, Squamous cell carcinoma
Clinical narrative: Positive for squamous cell carcinoma; Pustular rash; Colloid milia; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of SQUAMOUS CELL CARCINOMA (Positive for squamous cell carcinoma) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SQUAMOUS CELL CARCINOMA (Positive for squamous cell carcinoma) (seriousness criterion medically significant). an unknown date, the patient experienced RASH PUSTULAR (Pustular rash) and MILIA (Colloid milia). At the time of the report, SQUAMOUS CELL CARCINOMA (Positive for squamous cell carcinoma), RASH PUSTULAR (Pustular rash) and MILIA (Colloid milia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: positive (Positive) Conducted three biopsies on patient and it was positive for squamous cell carcinoma..     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.  Treatment information was not provided.  Company comment: 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Coronavirus test, Hypoxia, Pyrexia
Clinical narrative: COVID virus test positive; low oxygen; weakness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (low oxygen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPOXIA (low oxygen) (seriousness criterion medically significant), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPOXIA (low oxygen), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Coronavirus test: positive (Positive) Tested positive for COVID-19 and. On 15-Apr-2021, Coronavirus test negative (Negative) Tested negative for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient, immediately after the vaccination experienced low oxygen, fever, chills, and weakness and these symptoms lasted for 13 days.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The causality for positive COVID-19 test is unlikely.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test false positive
Clinical narrative: COVID virus test positive; low oxygen; weakness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (low oxygen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPOXIA (low oxygen) (seriousness criterion medically significant), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPOXIA (low oxygen), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Coronavirus test: positive (Positive) Tested positive for COVID-19 and. On 15-Apr-2021, Coronavirus test negative (Negative) Tested negative for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient, immediately after the vaccination experienced low oxygen, fever, chills, and weakness and these symptoms lasted for 13 days.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The causality for positive COVID-19 test is unlikely.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Loss of consciousness
Clinical narrative: Feels dizzy while walking; Can not get up; Bad chills in night and Teeth chattering; Passed out for couple of hours; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for couple of hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dysautonomia, Neurocardiogenic syncope and Orthostatic hypotension.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for couple of hours) (seriousness criterion medically significant) and CHILLS (Bad chills in night and Teeth chattering). On 21-Apr-2021, the patient experienced DIZZINESS (Feels dizzy while walking) and ASTHENIA (Can not get up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for couple of hours) and DIZZINESS (Feels dizzy while walking) had not resolved and ASTHENIA (Can not get up) and CHILLS (Bad chills in night and Teeth chattering) outcome was unknown.            There was no treatment information provided.  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. However, her concurrent medical conditions of Dysautonomia, Neurocardiogenic syncope and Orthostatic hypotension are cofounders.; 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. However, her concurrent medical conditions of Dysautonomia, Neurocardiogenic syncope and Orthostatic hypotension are cofounders.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Myalgia, Rash, Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash spread to face, arm and neck; Diagnosed with Cellulitis; "fever" at site of injection; Rash at site of injection; Muscle aches; Redness at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash spread to face, arm and neck) and CELLULITIS (Diagnosed with Cellulitis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Anxiety, Blood pressure high, Fibromyalgia and Pain.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH ("fever" at site of injection), VACCINATION SITE RASH (Rash at site of injection), MYALGIA (Muscle aches) and VACCINATION SITE ERYTHEMA (Redness at site of injection). On 20-Apr-2021, the patient experienced RASH (Rash spread to face, arm and neck) (seriousness criterion medically significant) and CELLULITIS (Diagnosed with Cellulitis) (seriousness criterion medically significant). At the time of the report, RASH (Rash spread to face, arm and neck) and CELLULITIS (Diagnosed with Cellulitis) had not resolved and VACCINATION SITE WARMTH ("fever" at site of injection), VACCINATION SITE RASH (Rash at site of injection), MYALGIA (Muscle aches) and VACCINATION SITE ERYTHEMA (Redness at site of injection) outcome was unknown.            Concomitant medications included anti-anxiety medications, high blood pressure medications, fibromyalgia medications and pain medications.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment included Keflex, Tylenol, Ibuprofen.  Company comment: This case concerns a 65-year-old female with a serious unexpected event of rash and cellulitis, nonserious unexpected vaccination site warmth, and expected myalgia, vaccination site rash, vaccination site erythema. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 65-year-old female with a serious unexpected event of rash and cellulitis, nonserious unexpected vaccination site warmth, and expected myalgia, vaccination site rash, vaccination site erythema. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Rash spread to face, arm and neck; Diagnosed with Cellulitis; "fever" at site of injection; Rash at site of injection; Muscle aches; Redness at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash spread to face, arm and neck) and CELLULITIS (Diagnosed with Cellulitis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Anxiety, Blood pressure high, Fibromyalgia and Pain.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH ("fever" at site of injection), VACCINATION SITE RASH (Rash at site of injection), MYALGIA (Muscle aches) and VACCINATION SITE ERYTHEMA (Redness at site of injection). On 20-Apr-2021, the patient experienced RASH (Rash spread to face, arm and neck) (seriousness criterion medically significant) and CELLULITIS (Diagnosed with Cellulitis) (seriousness criterion medically significant). At the time of the report, RASH (Rash spread to face, arm and neck) and CELLULITIS (Diagnosed with Cellulitis) had not resolved and VACCINATION SITE WARMTH ("fever" at site of injection), VACCINATION SITE RASH (Rash at site of injection), MYALGIA (Muscle aches) and VACCINATION SITE ERYTHEMA (Redness at site of injection) outcome was unknown.            Concomitant medications included anti-anxiety medications, high blood pressure medications, fibromyalgia medications and pain medications.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment included Keflex, Tylenol, Ibuprofen.  Company comment: This case concerns a 65-year-old female with a serious unexpected event of rash and cellulitis, nonserious unexpected vaccination site warmth, and expected myalgia, vaccination site rash, vaccination site erythema. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 65-year-old female with a serious unexpected event of rash and cellulitis, nonserious unexpected vaccination site warmth, and expected myalgia, vaccination site rash, vaccination site erythema. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Limb mass
Clinical narrative: experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side; lost of sight after taking moderna vaccine; huge lump on arms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side), BLINDNESS (lost of sight after taking moderna vaccine) and LIMB MASS (huge lump on arms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side) (seriousness criterion hospitalization), BLINDNESS (lost of sight after taking moderna vaccine) (seriousness criterion hospitalization) and LIMB MASS (huge lump on arms) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to BLINDNESS, CEREBROVASCULAR ACCIDENT and LIMB MASS. At the time of the report, CEREBROVASCULAR ACCIDENT (experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side), BLINDNESS (lost of sight after taking moderna vaccine) and LIMB MASS (huge lump on arms) 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 reported.  No treatment information provided.; 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. However, Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Feeling hot, Glaucoma, Influenza like illness, Weight increased
Clinical narrative: feeling hot; flu-like symptoms; weight gain; tiredness; glaucoma; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GLAUCOMA (glaucoma) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. In February 2021, the patient experienced GLAUCOMA (glaucoma) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING HOT (feeling hot), INFLUENZA LIKE ILLNESS (flu-like symptoms), WEIGHT INCREASED (weight gain) and FATIGUE (tiredness). At the time of the report, GLAUCOMA (glaucoma), FEELING HOT (feeling hot) and WEIGHT INCREASED (weight gain) was resolving and INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In Feb 2021 patient was diagnosed with glaucoma. She was feeling flu like symptoms and tired. In the last few months as of 19 Mar 2021 she had been feeling very hot and gained some weight. It was unknown if she was enrolled in a COVID 19 vaccine trial. Patient received 1st dose COVID 19 vaccine manufactured by Moderna.  Company Comment 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Generalised tonic-clonic seizure, Migraine, Myalgia
Clinical narrative: two grand mal seizures; migraine; under skull feels like it itches; persistent cough; body aches; chills; pain at vaccination site; extreme n/v; extreme n/v; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), CARBAMAZEPINE (TEGRETOL), TRAZODONE and POTASSIUM GLUCONATE for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) (seriousness criterion medically significant), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain at vaccination site), NAUSEA (extreme n/v) and VOMITING (extreme n/v). On 20-Apr-2021, VACCINATION SITE PAIN (pain at vaccination site) had resolved. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), NAUSEA (extreme n/v) and VOMITING (extreme n/v) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication: Norco 10mg, Zofran 8mg, Tylenol, Motrin.  Company comment: 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .; 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Vaccination site pain, Vomiting
Clinical narrative: two grand mal seizures; migraine; under skull feels like it itches; persistent cough; body aches; chills; pain at vaccination site; extreme n/v; extreme n/v; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), CARBAMAZEPINE (TEGRETOL), TRAZODONE and POTASSIUM GLUCONATE for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) (seriousness criterion medically significant), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain at vaccination site), NAUSEA (extreme n/v) and VOMITING (extreme n/v). On 20-Apr-2021, VACCINATION SITE PAIN (pain at vaccination site) had resolved. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), NAUSEA (extreme n/v) and VOMITING (extreme n/v) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication: Norco 10mg, Zofran 8mg, Tylenol, Motrin.  Company comment: 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .; 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anaphylactic reaction, Arthralgia, Dizziness, Dyspnoea
Clinical narrative: Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate irregular, Nausea, Orthostatic hypotension, Pain
Clinical narrative: Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Erythema, Feeling abnormal, Myalgia, Skin burning sensation
Clinical narrative: eyeball filled with blood; Blotchy red skin felt like sunburn; burning skin; felt like she weighed a thousand pounds; sore all over,; This spontaneous case was reported by a non-health professional and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood) in a 70-year-old female patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood) (seriousness criteria medically significant), ERYTHEMA (Blotchy red skin felt like sunburn), SKIN BURNING SENSATION (burning skin), FEELING ABNORMAL (felt like she weighed a thousand pounds) and MYALGIA (sore all over,). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood), ERYTHEMA (Blotchy red skin felt like sunburn), SKIN BURNING SENSATION (burning skin), FEELING ABNORMAL (felt like she weighed a thousand pounds) and MYALGIA (sore all over,) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Reporter did not allow further contact; 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.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest X-ray, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: Flutter in the heart; Heart Rate Increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (Flutter in the heart) in a 19-year-old female patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CARDIAC FLUTTER (Flutter in the heart) (seriousness criterion medically significant) and HEART RATE INCREASED (Heart Rate Increased). On 29-Mar-2021, CARDIAC FLUTTER (Flutter in the heart) and HEART RATE INCREASED (Heart Rate Increased) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Chest X-ray: normal (normal) Normal. On 26-Mar-2021, Electrocardiogram: normal (normal) Normal. On 26-Mar-2021, Heart rate: 106 (abnormal) 106 bpm. On 29-Mar-2021, Heart rate: normal (normal) Normal. The action taken with mRNA-1273 (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Reportedly, the patient's second dose is scheduled for 23-Apr-2021.   Reporter did not allow further contact; Sender's Comments: This case concerns a 19-year-old female with a serious unexpected event of cardiac flutter, and nonserious unexpected heart rate. Event onset the same day as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy after second vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy after second vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's Palsy after second vaccine) (seriousness criteria hospitalization and medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy after second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Off label use, Wound infection
Clinical narrative: Right Ankle Fracture; Wound Infection from a Right Ankle Fracture; Delayed Second Vaccine (Not received yet); This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Right Ankle Fracture) and WOUND INFECTION (Wound Infection from a Right Ankle Fracture) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 30-Mar-2021, the patient experienced ANKLE FRACTURE (Right Ankle Fracture) (seriousness criteria hospitalization and medically significant) and WOUND INFECTION (Wound Infection from a Right Ankle Fracture) (seriousness criteria hospitalization and medically significant). On 22-Apr-2021, the patient experienced OFF LABEL USE (Delayed Second Vaccine (Not received yet)). The patient was hospitalized on 30-Mar-2021 due to ANKLE FRACTURE and WOUND INFECTION. At the time of the report, ANKLE FRACTURE (Right Ankle Fracture), WOUND INFECTION (Wound Infection from a Right Ankle Fracture) and OFF LABEL USE (Delayed Second Vaccine (Not received yet)) 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.   The Hospital did not have Moderna Vaccine and they refused to allow the Nursing home to send someone to the hospital to vaccinate her. Agent provided the case# and instructed the caller to update Moderna, If and when the patient is vaccinated with the second dose, the date and the lot# for both doses of Moderna COVID-19 Vaccine.  Company comment: Based on the current available information, and not knowing the circumstances that resulted in the ankle injury, a causal relationship with the events cannot be excluded.; Sender's Comments: Based on the current available information, and not knowing the circumstances that resulted in the ankle injury, a causal relationship with the events cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out in his car; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out in his car) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out in his car) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 08-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out in his car) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-085853 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Gait disturbance, Magnetic resonance imaging, Movement disorder
Clinical narrative: stroke; trouble walking; Difficulty getting out of bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On 19-Feb-2021, the patient experienced MOVEMENT DISORDER (Difficulty getting out of bed). On an unknown date, the patient experienced GAIT DISTURBANCE (trouble walking). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident; Rehabilitation therapy for Movement disorder and Rehabilitation therapy for Gait disturbance. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), MOVEMENT DISORDER (Difficulty getting out of bed) and GAIT DISTURBANCE (trouble walking) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown unknown. In 2021, Magnetic resonance imaging: abnormal Abnormal.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  The patient got worse so was sent for MRI was done and showed something. The patient stated the stroke has affected his right side and has trouble walking. He was in the hospital for 3 days. He then went back for rehab hospital and there for about a week. He is now home and doing out patient rehab.  No concomitant medications were reported.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Pyrexia
Clinical narrative: Passed out; Sweaty; Slightly feverish; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045A21A) 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) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Sweaty) and PYREXIA (Slightly feverish). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Sweaty) and PYREXIA (Slightly feverish) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant medications were not reported.   Description: The patient felt sweaty and slightly feverish all night on 21 April 2021. When he got up to urinate he actually passed out (medically significant) and was on the floor for a few seconds. Later last night, on the same day, he went to drink some water, and passed out again for a few seconds. The patient did not seek any medical attention, and stated that he felt fine now.  No treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Idiopathic thrombocytopenic purpura; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-Jan-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       One day after the patient's first dose, the patient woke up with bruises on the arms and legs, and had blisters that bled inside mouth. The patient was admitted to an unspecified hospital on 19Jan2021 with a severe case of idiopathic thrombocytopenic purpura. Concomitant and treatment information not provided  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dysuria, Neurosis, Product dose omission issue
Clinical narrative: Neurosis; Chest pain; kidney disease-Trouble urinating; Caller missed second vaccine appointment; Anxiety; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROSIS (Neurosis), CHEST PAIN (Chest pain) and DYSURIA (kidney disease-Trouble urinating) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disorder and Cancer.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced NEUROSIS (Neurosis) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DYSURIA (kidney disease-Trouble urinating) (seriousness criterion hospitalization) and ANXIETY (Anxiety). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller missed second vaccine appointment). The patient was hospitalized on 06-Apr-2021 due to CHEST PAIN, DYSURIA and NEUROSIS. At the time of the report, NEUROSIS (Neurosis), CHEST PAIN (Chest pain), DYSURIA (kidney disease-Trouble urinating), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Caller missed second vaccine appointment) 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.   Treatment for the events was not provided.  Company Comment: This report refers to a case of Product dose omission issue for mRNA-1273, lot # 026A219  with associated Adverse Events of Neurosis,Chest pain ,Dysuria, and Anxiety. 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: This report refers to a case of Product dose omission issue for mRNA-1273, lot # 026A219  with associated Adverse Events of Neurosis,Chest pain ,Dysuria, and Anxiety.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Platelet count, Vaginal haemorrhage
Clinical narrative: two weeks later, began to have heavy vaginal bleeding; red spots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (two weeks later, began to have heavy vaginal bleeding) and PETECHIAE (red spots) 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 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VAGINAL HAEMORRHAGE (two weeks later, began to have heavy vaginal bleeding) (seriousness criteria hospitalization and medically significant). January 2021, the patient experienced PETECHIAE (red spots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 days due to PETECHIAE and VAGINAL HAEMORRHAGE. At the time of the report, VAGINAL HAEMORRHAGE (two weeks later, began to have heavy vaginal bleeding) and PETECHIAE (red spots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Platelet count: 0 (Low) Obstetrician ordered blood work, and the platelet count was 0.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  Treatment for the events included platelet transfusions, immunoglobulins and steroids.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information could not be requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information could not be requested.