chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild soreness at the site; 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 VACCINATION SITE PAIN (mild soreness at the site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication.    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 VACCINATION SITE PAIN (mild soreness at the site). At the time of the report, VACCINATION SITE PAIN (mild soreness at the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Bursitis, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Bursitis; acute case of bronchitis and laryngitis; Frozen shoulder in non vaccinated arm; Severe brain fog; Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia; Dizziness; Dizziness Vertigo; Six days after each vaccine I experienced exhaustion I slept for two days; Headache; body ache; Fatigue extreme; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Dizziness Vertigo), FEELING ABNORMAL (Severe brain fog), BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), DIZZINESS (Dizziness) and BURSITIS (Bursitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D NOS, MAGNESIUM, FISH OIL, ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VERTIGO (Dizziness Vertigo), DIZZINESS (Dizziness), FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days), HEADACHE (Headache), MYALGIA (body ache) and FATIGUE (Fatigue extreme). On an unknown date, the patient experienced FEELING ABNORMAL (Severe brain fog), BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), BURSITIS (Bursitis), LARYNGITIS (acute case of bronchitis and laryngitis) and PERIARTHRITIS (Frozen shoulder in non vaccinated arm). On 17-Feb-2021, VERTIGO (Dizziness Vertigo), DIZZINESS (Dizziness), FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days), HEADACHE (Headache) and MYALGIA (body ache) had resolved. At the time of the report, FEELING ABNORMAL (Severe brain fog) had resolved, BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), BURSITIS (Bursitis), LARYNGITIS (acute case of bronchitis and laryngitis) and PERIARTHRITIS (Frozen shoulder in non vaccinated arm) outcome was unknown and FATIGUE (Fatigue extreme) was resolving.            No treatment medication were provided by the reporter   This case was linked to MOD-2021-289558 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Laryngitis, Myalgia, Periarthritis, Vertigo
Clinical narrative: Bursitis; acute case of bronchitis and laryngitis; Frozen shoulder in non vaccinated arm; Severe brain fog; Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia; Dizziness; Dizziness Vertigo; Six days after each vaccine I experienced exhaustion I slept for two days; Headache; body ache; Fatigue extreme; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Dizziness Vertigo), FEELING ABNORMAL (Severe brain fog), BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), DIZZINESS (Dizziness) and BURSITIS (Bursitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D NOS, MAGNESIUM, FISH OIL, ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VERTIGO (Dizziness Vertigo), DIZZINESS (Dizziness), FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days), HEADACHE (Headache), MYALGIA (body ache) and FATIGUE (Fatigue extreme). On an unknown date, the patient experienced FEELING ABNORMAL (Severe brain fog), BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), BURSITIS (Bursitis), LARYNGITIS (acute case of bronchitis and laryngitis) and PERIARTHRITIS (Frozen shoulder in non vaccinated arm). On 17-Feb-2021, VERTIGO (Dizziness Vertigo), DIZZINESS (Dizziness), FATIGUE (Six days after each vaccine I experienced exhaustion I slept for two days), HEADACHE (Headache) and MYALGIA (body ache) had resolved. At the time of the report, FEELING ABNORMAL (Severe brain fog) had resolved, BRONCHITIS (Recently developed an acute case of bronchitis I was never sick before being treated for walking pneumonia), BURSITIS (Bursitis), LARYNGITIS (acute case of bronchitis and laryngitis) and PERIARTHRITIS (Frozen shoulder in non vaccinated arm) outcome was unknown and FATIGUE (Fatigue extreme) was resolving.            No treatment medication were provided by the reporter   This case was linked to MOD-2021-289558 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: it has made a couple of people really sick; 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 ILLNESS (it has made a couple of people really sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ILLNESS (it has made a couple of people really sick). At the time of the report, ILLNESS (it has made a couple of people really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-276849 (Patient Link).
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently gave a 1st Moderna dose to a 13 year old today; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently gave a 1st Moderna dose to a 13 year old today) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently gave a 1st Moderna dose to a 13 year old today). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently gave a 1st Moderna dose to a 13 year old today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Body pain; Run a low fever; Vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting). At the time of the report, PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Fatigue, Feeling of body temperature change, Headache, Malaise
Clinical narrative: didn't actually have a fever but went between cold and warm; her arm was hurting; she wasn't feeling great; neuropathic side effects; electrical tingling shock that goes up in her feet and sometimes into her leg; her nerves spazzing out; it's really painful; electrical tingling shock that goes up in her feet and sometimes into her leg; a headache which was described as "not a severe one, a minor one"; more tired than usual; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), NEURALGIA (neuropathic side effects) and ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Bipolar disorder and Social anxiety disorder.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), NEURALGIA (neuropathic side effects), ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg), MUSCLE SPASMS (her nerves spazzing out), PAIN (it's really painful), PARAESTHESIA (electrical tingling shock that goes up in her feet and sometimes into her leg), HEADACHE (a headache which was described as "not a severe one, a minor one") and FATIGUE (more tired than usual). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), HEADACHE (a headache which was described as "not a severe one, a minor one") and FATIGUE (more tired than usual) had resolved and NEURALGIA (neuropathic side effects), ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg), MUSCLE SPASMS (her nerves spazzing out), PAIN (it's really painful) and PARAESTHESIA (electrical tingling shock that goes up in her feet and sometimes into her leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported by reporter It was reported that the caller did not know the name of medications of the top of her head. Patient's physician stated that she would be fine to receive the second dose and patient had a physical examination scheduled in a few weeks
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: didn't actually have a fever but went between cold and warm; her arm was hurting; she wasn't feeling great; neuropathic side effects; electrical tingling shock that goes up in her feet and sometimes into her leg; her nerves spazzing out; it's really painful; electrical tingling shock that goes up in her feet and sometimes into her leg; a headache which was described as "not a severe one, a minor one"; more tired than usual; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), NEURALGIA (neuropathic side effects) and ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Bipolar disorder and Social anxiety disorder.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), NEURALGIA (neuropathic side effects), ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg), MUSCLE SPASMS (her nerves spazzing out), PAIN (it's really painful), PARAESTHESIA (electrical tingling shock that goes up in her feet and sometimes into her leg), HEADACHE (a headache which was described as "not a severe one, a minor one") and FATIGUE (more tired than usual). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (didn't actually have a fever but went between cold and warm), PAIN IN EXTREMITY (her arm was hurting), MALAISE (she wasn't feeling great), HEADACHE (a headache which was described as "not a severe one, a minor one") and FATIGUE (more tired than usual) had resolved and NEURALGIA (neuropathic side effects), ELECTRIC SHOCK SENSATION (electrical tingling shock that goes up in her feet and sometimes into her leg), MUSCLE SPASMS (her nerves spazzing out), PAIN (it's really painful) and PARAESTHESIA (electrical tingling shock that goes up in her feet and sometimes into her leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported by reporter It was reported that the caller did not know the name of medications of the top of her head. Patient's physician stated that she would be fine to receive the second dose and patient had a physical examination scheduled in a few weeks
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided.     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 MYALGIA (Very sore arm). At the time of the report, MYALGIA (Very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment Medications were provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Myalgia, Tremor
Clinical narrative: some tremor; was in bed for for 7 to 10 days; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (some tremor), BEDRIDDEN (was in bed for for 7 to 10 days) and MYALGIA (muscle soreness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (some tremor), BEDRIDDEN (was in bed for for 7 to 10 days) and MYALGIA (muscle soreness). At the time of the report, TREMOR (some tremor), BEDRIDDEN (was in bed for for 7 to 10 days) and MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.   This case was linked to MOD-2021-290104 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced DIARRHEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Dizzy; arm hurt; 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 DIZZINESS (Dizzy) and PAIN IN EXTREMITY (arm hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy) and PAIN IN EXTREMITY (arm hurt). At the time of the report, DIZZINESS (Dizzy) and PAIN IN EXTREMITY (arm hurt) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   No concomitant drugs were provided.   No treatment drugs were provided
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue) and PARAESTHESIA (tingling) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN CALCIUM (CRESTOR) and HYDROCHLOROTHIAZIDE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue), PARAESTHESIA (tingling) and HEADACHE (headaches for six weeks). At the time of the report, BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue), PARAESTHESIA (tingling) and HEADACHE (headaches for six weeks) had not resolved. The patient had CAT scans, blood tests and an MRI while also feeling tingling at the tip and top of his tongue. He claimed that his health care provider could not determine the cause and was not sure how to treat him. Treatment information was not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue) and PARAESTHESIA (tingling) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN CALCIUM (CRESTOR) and HYDROCHLOROTHIAZIDE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue), PARAESTHESIA (tingling) and HEADACHE (headaches for six weeks). At the time of the report, BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue), PARAESTHESIA (tingling) and HEADACHE (headaches for six weeks) had not resolved. The patient had CAT scans, blood tests and an MRI while also feeling tingling at the tip and top of his tongue. He claimed that his health care provider could not determine the cause and was not sure how to treat him. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was also not reported.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only received one moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Dyspepsia, Headache, Hypoaesthesia, Vaccination site erythema
Clinical narrative: Numbness in arm and hand of the right side; Experiencing anxiety; Digestion issues; Itching of injection site; Redness of injection site; Swelling of injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in arm and hand of the right side), ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues), VACCINATION SITE PRURITUS (Itching of injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in arm and hand of the right side), ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues), VACCINATION SITE PRURITUS (Itching of injection site), VACCINATION SITE ERYTHEMA (Redness of injection site), VACCINATION SITE SWELLING (Swelling of injection site) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Numbness in arm and hand of the right side), VACCINATION SITE PRURITUS (Itching of injection site), VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE SWELLING (Swelling of injection site) outcome was unknown and ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues) and HEADACHE (Headache) had not resolved. Not Provided          Concomitant medications were not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-260290 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Numbness in arm and hand of the right side; Experiencing anxiety; Digestion issues; Itching of injection site; Redness of injection site; Swelling of injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in arm and hand of the right side), ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues), VACCINATION SITE PRURITUS (Itching of injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in arm and hand of the right side), ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues), VACCINATION SITE PRURITUS (Itching of injection site), VACCINATION SITE ERYTHEMA (Redness of injection site), VACCINATION SITE SWELLING (Swelling of injection site) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Numbness in arm and hand of the right side), VACCINATION SITE PRURITUS (Itching of injection site), VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE SWELLING (Swelling of injection site) outcome was unknown and ANXIETY (Experiencing anxiety), DYSPEPSIA (Digestion issues) and HEADACHE (Headache) had not resolved. Not Provided          Concomitant medications were not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-260290 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose). On 17-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Patient takes some medication but nothing long term.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Pain in extremity
Clinical narrative: Mild soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild soreness of the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Mild soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Mild soreness of the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood glucose: high (High) Higher than normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Tremor, Vaccination complication
Clinical narrative: Hands trembling uncontrollable; All the side effects; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Hands trembling uncontrollable), VACCINATION COMPLICATION (All the side effects) and HEADACHE (Headaches) 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 COVID-19 in February 2021. Concurrent medical conditions included Lung scarring and Aortic aneurysm enlargement.  In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Hands trembling uncontrollable), VACCINATION COMPLICATION (All the side effects) and HEADACHE (Headaches). At the time of the report, TREMOR (Hands trembling uncontrollable) and HEADACHE (Headaches) had not resolved and VACCINATION COMPLICATION (All the side effects) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Relevant concomitant medications were not provided.  Treatment medication was not provided.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-290627, MOD-2021-291235 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having side effects that are 300% worse than the first two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having side effects that are 300% worse than the first two) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reporter.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having side effects that are 300% worse than the first two). At the time of the report, VACCINATION COMPLICATION (having side effects that are 300% worse than the first two) outcome was unknown.            It was reported that the patient received the booster dose and had adverse events.  No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: Had vivid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Had vivid symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (Had vivid symptoms). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Had vivid symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 12-year-old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12-year-old patient) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12-year-old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12-year-old patient) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient aged almost 13 years
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 031M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided. patient stated that he got a mole treatment for cancer on his nose
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: breathing is worse than it has ever been since getting the vaccine/breathing has been compromised; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing is worse than it has ever been since getting the vaccine/breathing has been compromised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathing is worse than it has ever been since getting the vaccine/breathing has been compromised). At the time of the report, DYSPNOEA (breathing is worse than it has ever been since getting the vaccine/breathing has been compromised) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Vaccination site pain
Clinical narrative: left arm was hurting, where I got the shot; body aches; headaches; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headaches), MYALGIA (muscle pain) and VACCINATION SITE PAIN (left arm was hurting, where I got the shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (body aches), HEADACHE (headaches) and MYALGIA (muscle pain). On 17-Aug-2021, the patient experienced VACCINATION SITE PAIN (left arm was hurting, where I got the shot). At the time of the report, PAIN (body aches), HEADACHE (headaches), MYALGIA (muscle pain) and VACCINATION SITE PAIN (left arm was hurting, where I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  On 16-Aug-2021, the symptoms started a little, but it started again on 17-Aug-2021 after work.  No treatment information was provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Dizziness, Fatigue, Gait disturbance
Clinical narrative: dizzy; could not walk without holding to an object; felt the need to relax and little tired; headachy; muscle aches; chills; little tired; patient received third shot within minutes of receiving second shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot) and HEADACHE (headachy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL and ROSUVASTATIN 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 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot). On an unknown date, the patient experienced DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), HEADACHE (headachy), MYALGIA (muscle aches), CHILLS (chills) and FATIGUE (little tired). On 26-Feb-2021, ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot) had resolved. At the time of the report, DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), HEADACHE (headachy), MYALGIA (muscle aches) and CHILLS (chills) was resolving and FATIGUE (little tired) outcome was unknown.            No treatment medication was reported by patient.  Within a few minutes of receiving second shot, patient received a third shot of the Moderna vaccine. Patient said this was a confusion made by the nurse. Right away, he didn't experience any symptoms. However, when his night shift started, patient felt headachy, dizzy, had muscle aches, chills, could not walk without holding to an object, and felt the need to relax. His shift ended at 7 o'clock in the morning, and when he went to bed and woke up around noon, he felt much better. Patient felt a little tired, but nothing compared to what he experienced before.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Restlessness
Clinical narrative: dizzy; could not walk without holding to an object; felt the need to relax and little tired; headachy; muscle aches; chills; little tired; patient received third shot within minutes of receiving second shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot) and HEADACHE (headachy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL and ROSUVASTATIN 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 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot). On an unknown date, the patient experienced DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), HEADACHE (headachy), MYALGIA (muscle aches), CHILLS (chills) and FATIGUE (little tired). On 26-Feb-2021, ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot) had resolved. At the time of the report, DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), HEADACHE (headachy), MYALGIA (muscle aches) and CHILLS (chills) was resolving and FATIGUE (little tired) outcome was unknown.            No treatment medication was reported by patient.  Within a few minutes of receiving second shot, patient received a third shot of the Moderna vaccine. Patient said this was a confusion made by the nurse. Right away, he didn't experience any symptoms. However, when his night shift started, patient felt headachy, dizzy, had muscle aches, chills, could not walk without holding to an object, and felt the need to relax. His shift ended at 7 o'clock in the morning, and when he went to bed and woke up around noon, he felt much better. Patient felt a little tired, but nothing compared to what he experienced before.