chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Oral herpes, Pyrexia
Clinical narrative: mouth broke out with cold sores; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (mouth broke out with cold sores), CHILLS (chills) and PYREXIA (fever) 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 ORAL HERPES (mouth broke out with cold sores), CHILLS (chills) and PYREXIA (fever). At the time of the report, ORAL HERPES (mouth broke out with cold sores), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.; 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: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Body ache; 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 PYREXIA (Fever) and MYALGIA (Body ache) 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 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 PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up information on received and does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feel 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 MALAISE (Feel 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 MALAISE (Feel sick). At the time of the report, MALAISE (Feel sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Laryngeal discomfort, Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COUGH (started coughing), LARYNGEAL DISCOMFORT (woke up with congestion  centered at my larynx), DYSPHONIA (am very hoarse) and MYALGIA (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 information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (sore arm). On 29-May-2021, the patient experienced COUGH (started coughing), LARYNGEAL DISCOMFORT (woke up with congestion  centered at my larynx) and DYSPHONIA (am very hoarse). On 28-May-2021, MYALGIA (sore arm) had resolved. At the time of the report, COUGH (started coughing), LARYNGEAL DISCOMFORT (woke up with congestion  centered at my larynx) and DYSPHONIA (am very hoarse) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patien got  first Moderna shot about 6 weeks ago. Turned up for second shot but a thunderstorm forced it all to shut down. APH has not contacted me to re-schedule.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Product dose omission issue
Clinical narrative: was dizzy; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (was dizzy) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced DIZZINESS (was dizzy) and PRODUCT DOSE OMISSION ISSUE (Missed dose). On 25-May-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. At the time of the report, DIZZINESS (was dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Patient stated that he is under medications but not specified.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; 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 TINNITUS (tinnitus) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.            No Concomitants are provided. No Treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills after the 2nd dose of vaccine; fever of 101after the 2nd  dose of vaccine; 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 CHILLS (chills after the 2nd dose of vaccine) and PYREXIA (fever of 101after the 2nd  dose of vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills after the 2nd dose of vaccine) and PYREXIA (fever of 101after the 2nd  dose of vaccine). At the time of the report, CHILLS (chills after the 2nd dose of vaccine) and PYREXIA (fever of 101after the 2nd  dose of vaccine) outcome was unknown.            Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) 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 17-May-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Dizziness; Headaches; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches) 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 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 DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I currently took first dose 38 days ago; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I currently took first dose 38 days ago) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I currently took first dose 38 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I currently took first dose 38 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Muscle pain; 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 CHILLS (Chills) and MYALGIA (Muscle pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Muscle pain). At the time of the report, CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Depression, Eating disorder
Clinical narrative: Depression has worsened since 2nd vaccine; Not eating as much/Noeating very li; 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 DEPRESSION (Depression has worsened since 2nd vaccine) and EATING DISORDER (Not eating as much/Noeating very li) 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 DEPRESSION (Depression has worsened since 2nd vaccine) and EATING DISORDER (Not eating as much/Noeating very li). At the time of the report, DEPRESSION (Depression has worsened since 2nd vaccine) and EATING DISORDER (Not eating as much/Noeating very li) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination complication
Clinical narrative: very tired; not possible to act normal; a severe side effect; 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 FATIGUE (very tired), FEELING ABNORMAL (not possible to act normal) and VACCINATION COMPLICATION (a severe side effect) 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 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 FATIGUE (very tired), FEELING ABNORMAL (not possible to act normal) and VACCINATION COMPLICATION (a severe side effect). At the time of the report, FATIGUE (very tired), FEELING ABNORMAL (not possible to act normal) and VACCINATION COMPLICATION (a severe side effect) outcome was unknown.  No concomitant and treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: tingling down arm and into thumb; It's becoming debilitating; numbness down arm and into thumb; 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 PARAESTHESIA (tingling down arm and into thumb), ASTHENIA (It's becoming debilitating) and HYPOAESTHESIA (numbness down arm and into thumb) 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 29-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling down arm and into thumb), ASTHENIA (It's becoming debilitating) and HYPOAESTHESIA (numbness down arm and into thumb). At the time of the report, PARAESTHESIA (tingling down arm and into thumb), ASTHENIA (It's becoming debilitating) and HYPOAESTHESIA (numbness down arm and into thumb) outcome was unknown.            No treatment medication were provided. No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Pyrexia
Clinical narrative: Shortness of breath; Profuse sweating at night; Fever; 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 DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profuse sweating at night) and PYREXIA (Fever) 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 DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profuse sweating at night) and PYREXIA (Fever). At the time of the report, DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profuse sweating at night) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Onychoclasis
Clinical narrative: Brittle nails; brain fog; lack of appetite; exhaustion; 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 ONYCHOCLASIS (Brittle nails), FEELING ABNORMAL (brain fog), DECREASED APPETITE (lack of appetite) and FATIGUE (exhaustion) 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 ONYCHOCLASIS (Brittle nails), FEELING ABNORMAL (brain fog), DECREASED APPETITE (lack of appetite) and FATIGUE (exhaustion). At the time of the report, ONYCHOCLASIS (Brittle nails), FEELING ABNORMAL (brain fog), DECREASED APPETITE (lack of appetite) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants was not reported.  No treatment medication was reported.  Patient had experienced  brittle nails, exhaustion, brain fog, lack of appetite.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; 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 (dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   No treatment was reported for the events.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under the age of 18 received the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the age of 18 received the Moderna Covid-19 vaccine) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the age of 18 received the Moderna Covid-19 vaccine). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the age of 18 received the Moderna Covid-19 vaccine) had resolved. Not applicable      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 treatment medication was provided. No concomitant medication was perform. Additional information was provided that reporter had forgotten that Pfizer was the only product given for under age people. she had mistakenly given the suspect drug instead of Pfizer Covid-19 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain
Clinical narrative: I cannot move them without difficulty; I have been having severe pain in my shoulders and my neck; I have been having severe pain in my shoulders and my neck; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I cannot move them without difficulty), NECK PAIN (I have been having severe pain in my shoulders and my neck) and ARTHRALGIA (I have been having severe pain in my shoulders and my neck) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (I cannot move them without difficulty), NECK PAIN (I have been having severe pain in my shoulders and my neck) and ARTHRALGIA (I have been having severe pain in my shoulders and my neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (I cannot move them without difficulty), NECK PAIN (I have been having severe pain in my shoulders and my neck) and ARTHRALGIA (I have been having severe pain in my shoulders and my neck) outcome was unknown.            Concomitant medications were not provide. Treatment medication were not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Therapeutic response unexpected
Clinical narrative: when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better; I still have depression; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better) and DEPRESSION (I still have depression) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Back pain. Concurrent medical conditions included Depression, Anxiety and Hypertension. Concomitant products included LORAZEPAM for Anxiety, AMLODIPINE for Blood pressure high, BUPROPION and DESVENLAFAXINE for Depression.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better) and DEPRESSION (I still have depression). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better) and DEPRESSION (I still have depression) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient takes medications routinely for her depression and anxiety, but not for the pain in her back. There were five people in her family and two killed themselves. She has suffered with depression all her life. She would take the anxiety medication and go outside and feel better, but after waking up from sleep in the morning, the mental pain would come back. She had visited a psychiatrist, but she doesn't go to that psychiatrist anymore. Her primary care physician prescribed her with depression medications.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: Shortness of breath; dizzy; my balance ain't great anymore when I walk; so I haven't been able to drive for two days; 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 DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), BALANCE DISORDER (my balance ain't great anymore when I walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (so I haven't been able to drive for two days) 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 DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), BALANCE DISORDER (my balance ain't great anymore when I walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (so I haven't been able to drive for two days). At the time of the report, DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), BALANCE DISORDER (my balance ain't great anymore when I walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (so I haven't been able to drive for two days) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Arm reaction after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Arm reaction after the first vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Arm reaction after the first vaccination). At the time of the report, VACCINATION COMPLICATION (Arm reaction after the first vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-190727 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (soar throat) 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 OROPHARYNGEAL PAIN (soar throat). At the time of the report, OROPHARYNGEAL PAIN (soar throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant therapy included oxygen. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little sore). At the time of the report, PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment details were provided. Follow-up received on 04-JUN-2021 included no new information   This case was linked to MOD-2021-029198, MOD-2021-029198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Possible NNI
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy; Hives on legs/ on back/ on scalp of head/ on butt; 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 PRURITUS (Itchy) and URTICARIA (Hives on legs/ on back/ on scalp of head/ on butt) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy) and URTICARIA (Hives on legs/ on back/ on scalp of head/ on butt). At the time of the report, PRURITUS (Itchy) and URTICARIA (Hives on legs/ on back/ on scalp of head/ on butt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Product dose omission issue
Clinical narrative: did not complete vaccine series; negative reaction - 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not complete vaccine series) and ADVERSE REACTION (negative reaction - 1st dose) 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 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 (did not complete vaccine series) and ADVERSE REACTION (negative reaction - 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not complete vaccine series) and ADVERSE REACTION (negative reaction - 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pharyngitis streptococcal
Clinical narrative: Not feeling well after the 2nd dose; Bad sore throat (strep) after the 2nd dose; 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 MALAISE (Not feeling well after the 2nd dose) and PHARYNGITIS STREPTOCOCCAL (Bad sore throat (strep) after the 2nd dose) in a 36-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well after the 2nd dose) and PHARYNGITIS STREPTOCOCCAL (Bad sore throat (strep) after the 2nd dose). At the time of the report, MALAISE (Not feeling well after the 2nd dose) and PHARYNGITIS STREPTOCOCCAL (Bad sore throat (strep) after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: have been suffering with a very bad back ache; 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 BACK PAIN (have been suffering with a very bad back ache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (have been suffering with a very bad back ache). At the time of the report, BACK PAIN (have been suffering with a very bad back ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Headache, Illness
Clinical narrative: ill; severe flu-like symptoms; fever; chills; body aches; headache; nasal congestion; chest congestion; sneezing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion) and SNEEZING (sneezing) 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.     The patient's past medical history included No adverse event.   On 05-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion), SNEEZING (sneezing), COUGH (coughing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion), SNEEZING (sneezing), COUGH (coughing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            Concomitant products were not provided. Treatment products were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nasal congestion, Pyrexia, Sneezing
Clinical narrative: ill; severe flu-like symptoms; fever; chills; body aches; headache; nasal congestion; chest congestion; sneezing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion) and SNEEZING (sneezing) 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.     The patient's past medical history included No adverse event.   On 05-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion), SNEEZING (sneezing), COUGH (coughing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion), SNEEZING (sneezing), COUGH (coughing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            Concomitant products were not provided. Treatment products were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Why is my arm still puffy and red at injection spot; my arm still has a big red area; 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 ERYTHEMA (my arm still has a big red area) and VACCINATION SITE SWELLING (Why is my arm still puffy and red at injection spot) 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 VACCINATION SITE ERYTHEMA (my arm still has a big red area) and VACCINATION SITE SWELLING (Why is my arm still puffy and red at injection spot). At the time of the report, VACCINATION SITE ERYTHEMA (my arm still has a big red area) and VACCINATION SITE SWELLING (Why is my arm still puffy and red at injection spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Urticaria
Clinical narrative: I had a severe hives; sudden dizziness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I had a severe hives) and DIZZINESS (sudden dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (I had a severe hives) and DIZZINESS (sudden dizziness). At the time of the report, URTICARIA (I had a severe hives) and DIZZINESS (sudden dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching; Red; 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 PRURITUS (Itching) and ERYTHEMA (Red) 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 PRURITUS (Itching) and ERYTHEMA (Red). At the time of the report, PRURITUS (Itching) and ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Sore arm; Warm at injection site; Stiff; Sore arm; Swollen; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm at injection site), MUSCULOSKELETAL STIFFNESS (Stiff), the first episode of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE SWELLING (Swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Lyme disease, Blood pressure high and Diabetes.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced VACCINATION SITE WARMTH (Warm at injection site), MUSCULOSKELETAL STIFFNESS (Stiff), the first episode of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red at the injection site). On an unknown date, the patient experienced the second episode of PAIN IN EXTREMITY (Sore arm). At the time of the report, last episode of PAIN IN EXTREMITY (Sore arm) had resolved and VACCINATION SITE WARMTH (Warm at injection site), MUSCULOSKELETAL STIFFNESS (Stiff), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngitis
Clinical narrative: Pharyngitis after the 2nd dose; Sore throat after the 2nd dose; 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 PHARYNGITIS (Pharyngitis after the 2nd dose) and OROPHARYNGEAL PAIN (Sore throat after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     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 30-May-2021, the patient experienced PHARYNGITIS (Pharyngitis after the 2nd dose) and OROPHARYNGEAL PAIN (Sore throat after the 2nd dose). At the time of the report, PHARYNGITIS (Pharyngitis after the 2nd dose) and OROPHARYNGEAL PAIN (Sore throat after the 2nd dose) outcome was unknown.            Patient is wants to know, whether its safe to take antibiotic orelox for 5days No treatment and concomitant medications were provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I'm very 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 (I'm very 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I'm very sick). At the time of the report, ILLNESS (I'm very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Can I use steroids to treat my side effects; 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 COMPLICATION (Can I use steroids to treat my side effects) 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 VACCINATION COMPLICATION (Can I use steroids to treat my side effects). At the time of the report, VACCINATION COMPLICATION (Can I use steroids to treat my side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia
Clinical narrative: Not able to run because of knee pain; Not able to run because of knee pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Not able to run because of knee pain) and ARTHRALGIA (Not able to run because of knee pain) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 025B21A) for COVID-19 immunisation.     Concurrent medical conditions included Arthritis (Patient had a history of arthritis joint.).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-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 HYPOKINESIA (Not able to run because of knee pain) and ARTHRALGIA (Not able to run because of knee pain). At the time of the report, HYPOKINESIA (Not able to run because of knee pain) and ARTHRALGIA (Not able to run because of knee pain) outcome was unknown.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Patient was a known avid runner. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-191152 (Patient Link).