chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received a 100-mcg dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received a 100-mcg dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ACCIDENTAL OVERDOSE (received a 100-mcg dose). At the time of the report, ACCIDENTAL OVERDOSE (received a 100-mcg dose) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac operation
Clinical narrative: Open heart surgery eight weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC OPERATION (Open heart surgery eight weeks ago) 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 05-Feb-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 CARDIAC OPERATION (Open heart surgery eight weeks ago). At the time of the report, CARDIAC OPERATION (Open heart surgery eight weeks ago) outcome was unknown.            wondering if the vaccination is still effective because it is now been seven months since the second shot. Concomitant medication use was unknown Treatment information was unknown
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles
Clinical narrative: They got something flipped up the heart.; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (They got something flipped up the heart.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRASYSTOLES (They got something flipped up the heart.). At the time of the report, EXTRASYSTOLES (They got something flipped up the heart.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pyrexia, Vaccination site pain
Clinical narrative: His symptoms felt more like the flu than anything else; Fever; Chills; felt like crap; area where he received the shot was hot to the touch; little painful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 092D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE WARMTH (area where he received the shot was hot to the touch) and VACCINATION SITE PAIN (little painful). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (felt like crap), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at a dose of 1 dosage form. On 04-Aug-2021, FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (little painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: His symptoms felt more like the flu than anything else; Fever; Chills; felt like crap; area where he received the shot was hot to the touch; little painful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 092D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE WARMTH (area where he received the shot was hot to the touch) and VACCINATION SITE PAIN (little painful). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (felt like crap), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at a dose of 1 dosage form. On 04-Aug-2021, FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (little painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Soreness throughout her entire body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness throughout her entire body) and HEADACHE (Headache) 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 PAIN (Soreness throughout her entire body) and HEADACHE (Headache). At the time of the report, PAIN (Soreness throughout her entire body) and HEADACHE (Headache) had not resolved.            No concomitant medications were reported by reporter. No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Crying, Diarrhoea, Self-injurious ideation
Clinical narrative: So weak; Watery stools; Crying uncontrollably; Suicidal thoughts; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts) 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 ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts). At the time of the report, ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts) outcome was unknown.            No concomitant medications were reported. No treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I am very tired almost all the time; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I am very tired almost all the time) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 FATIGUE (I am very tired almost all the time). At the time of the report, FATIGUE (I am very tired almost all the time) outcome was unknown.            concomitant and treatment drugs were not provided
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like 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 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 INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medications reported.  No treatment information was reported by reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Hypoaesthesia, Migraine, Muscular weakness, Ophthalmic migraine
Clinical narrative: Pretty bad spine pain; Migraine; Leg numbness; Leg weakness; Ocular migraines; Seeing shapesand has difficulty seeing; Muscle weakness; Could not get up; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness) and OPHTHALMIC MIGRAINE (Ocular migraines) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (CUTAQUIG), ATENOLOL, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), AMITRIPTYLINE, DIAZEPAM and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication.    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 SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting). At the time of the report, SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting) outcome was unknown.            Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Visual impairment, Vomiting
Clinical narrative: Pretty bad spine pain; Migraine; Leg numbness; Leg weakness; Ocular migraines; Seeing shapesand has difficulty seeing; Muscle weakness; Could not get up; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness) and OPHTHALMIC MIGRAINE (Ocular migraines) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (CUTAQUIG), ATENOLOL, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), AMITRIPTYLINE, DIAZEPAM and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication.    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 SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting). At the time of the report, SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting) outcome was unknown.            Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Syncope
Clinical narrative: Blood pressure issues; Fainting; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) 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 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and BLOOD PRESSURE ABNORMAL (Blood pressure issues). At the time of the report, SYNCOPE (Fainting) and BLOOD PRESSURE ABNORMAL (Blood pressure issues) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) abnormal.         Concomitant product use was not provider by the reporter.  Treatment information was not provided.  Company comment: Very limited information regarding these events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information is not expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: General body pain; body aches/ muscle aches and pains; headache; fatigue; chills; Fever; Vaccination site reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever). At the time of the report, MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported. The patient reported "I have COVID arm. Delayed reaction".
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site reaction
Clinical narrative: General body pain; body aches/ muscle aches and pains; headache; fatigue; chills; Fever; Vaccination site reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever). At the time of the report, MALAISE ("I am hurting all over"), MYALGIA (body aches/ muscle aches and pains), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported. The patient reported "I have COVID arm. Delayed reaction".
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to the virus; 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 Exposed to Covid19 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 Exposed to Covid19. At the time of the report, EXPOSURE TO SARS-COV-2 Exposed to Covid19 outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; She's been throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VOMITING (She's been throwing up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ZINC for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VOMITING (She's been throwing up). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VOMITING (She's been throwing up) outcome was unknown.            Concomitant medications include Blood pressure medicines.  Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over body) 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 RASH (Rash all over body). At the time of the report, RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication is not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired doses to some patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment product information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Headache, Injection site erythema
Clinical narrative: adverse reaction; injection site had turned red after 1st dose; headache after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (for 10 years ). Concomitant products included TIMOLOL for Glaucoma, ATORVASTATIN CALCIUM, ZOLPIDEM and LATANOPROST for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose). At the time of the report, ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information reported as Denlafaxine (substitute drug).  Unknown treatment medication was reported for nausea.   This case was linked to MOD-2021-313718, MOD21-140857, MOD-2021-313629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up contains significant information, reporter information added, Patient information and medical history information added, Product information added, Concomitant medication information added, Adverse event added.
Sex: U
Vaccine: COVID19
Symptoms: Acne pustular, Rash
Clinical narrative: Multiple large puss filled pimples on upper body area; Skin rashes; This spontaneous case was reported by a consumer and describes the occurrence of ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes) 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 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes). At the time of the report, ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were provided by the reporter.  No Treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chest pain, Chills, Myalgia
Clinical narrative: Pain in my chest/slight chest pain on the left side; Experiencing side effects; night sweating; increase in feelings of arthritis in our arthritic areas; joint pain; aching everywhere; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHEST PAIN (Pain in my chest/slight chest pain on the left side) had resolved and VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            It was reported that patient received the Booster dose of Moderna and experienced  chest pain that came  for five seconds and then departed  for period as long as fifteen minutes.  Concomitant medications were not reported.  Treatment information was  not provided.   This case was linked to MOD-2021-316965, MOD-2021-317608 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up document received contained: Updated reporter details- Phone number; Dose number; Additional events; Outcome of event- From unknown to recovered;
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Vaccination complication
Clinical narrative: Pain in my chest/slight chest pain on the left side; Experiencing side effects; night sweating; increase in feelings of arthritis in our arthritic areas; joint pain; aching everywhere; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in my chest/slight chest pain on the left side), VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHEST PAIN (Pain in my chest/slight chest pain on the left side) had resolved and VACCINATION COMPLICATION (Experiencing side effects), NIGHT SWEATS (night sweating), ARTHRITIS (increase in feelings of arthritis in our arthritic areas), ARTHRALGIA (joint pain), MYALGIA (aching everywhere), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            It was reported that patient received the Booster dose of Moderna and experienced  chest pain that came  for five seconds and then departed  for period as long as fifteen minutes.  Concomitant medications were not reported.  Treatment information was  not provided.   This case was linked to MOD-2021-316965, MOD-2021-317608 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up document received contained: Updated reporter details- Phone number; Dose number; Additional events; Outcome of event- From unknown to recovered;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Alopecia, Asthenia, Fatigue, Fluid retention
Clinical narrative: Retaining fluid; Affecting my legs/circulation in legs; Fatigued; Less than 35 days since first dose; Losing hair; Still fatigued with no energy; Lost my taste; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Losing hair), AGEUSIA (Lost my taste), FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs) and ASTHENIA (Still fatigued with no energy  ) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Arthritic-like pain, LOSARTAN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AGEUSIA (Lost my taste). In May 2021, the patient experienced ASTHENIA (Still fatigued with no energy  ). In July 2021, the patient experienced ALOPECIA (Losing hair). On an unknown date, the patient experienced FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs), FATIGUE (Fatigued) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 35 days since first dose). The patient was treated with HYDROCHLOROTHIAZIDE on 14-Jul-2021 for Adverse event, at a dose of UNK, one time dose. At the time of the report, ALOPECIA (Losing hair), AGEUSIA (Lost my taste), FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs) and ASTHENIA (Still fatigued with no energy  ) outcome was unknown, FATIGUE (Fatigued) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 35 days since first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated he did not experienced any adverse events after first dose of Moderna vaccine which was done on 12-MAR-2021  On 03-SEP-2021 patient had undergone some bloodwork which results were not yet disclosed.  On 14-SEP-2021 his primary care provider ordered for ultrasound of legs.  Reporter also mentioned that after taking Hydrochlorothiazide 12.5mg/1day but it did not work.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor peripheral circulation
Clinical narrative: Retaining fluid; Affecting my legs/circulation in legs; Fatigued; Less than 35 days since first dose; Losing hair; Still fatigued with no energy; Lost my taste; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Losing hair), AGEUSIA (Lost my taste), FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs) and ASTHENIA (Still fatigued with no energy  ) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Arthritic-like pain, LOSARTAN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AGEUSIA (Lost my taste). In May 2021, the patient experienced ASTHENIA (Still fatigued with no energy  ). In July 2021, the patient experienced ALOPECIA (Losing hair). On an unknown date, the patient experienced FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs), FATIGUE (Fatigued) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 35 days since first dose). The patient was treated with HYDROCHLOROTHIAZIDE on 14-Jul-2021 for Adverse event, at a dose of UNK, one time dose. At the time of the report, ALOPECIA (Losing hair), AGEUSIA (Lost my taste), FLUID RETENTION (Retaining fluid), POOR PERIPHERAL CIRCULATION (Affecting my legs/circulation in legs) and ASTHENIA (Still fatigued with no energy  ) outcome was unknown, FATIGUE (Fatigued) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 35 days since first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated he did not experienced any adverse events after first dose of Moderna vaccine which was done on 12-MAR-2021  On 03-SEP-2021 patient had undergone some bloodwork which results were not yet disclosed.  On 14-SEP-2021 his primary care provider ordered for ultrasound of legs.  Reporter also mentioned that after taking Hydrochlorothiazide 12.5mg/1day but it did not work.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (body aches) 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 HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, HEADACHE (headaches) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's consent to follow-up was given.  Concomitant product use was not provided.  Treatment product information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a side effect.). At the time of the report, VACCINATION COMPLICATION (What are side effects after the third dose/had received the Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Inappropriate schedule of product administration, Myalgia
Clinical narrative: left arm is swollen; it's hot to touch; a slight or very light sore throat; 2nd dose on 4Mar2021; left arm is pretty sore; a little fatigue; low grade fever at 99.5; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021) and MYALGIA (left arm is pretty sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05RE21A, 029A20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-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 PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021), MYALGIA (left arm is pretty sore), FATIGUE (a little fatigue) and PYREXIA (low grade fever at 99.5). At the time of the report, PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), MYALGIA (left arm is pretty sore) and FATIGUE (a little fatigue) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021) and PYREXIA (low grade fever at 99.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) Patient had low grade fever this morning at 99.5..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient not sure if he's immunocompromised Concomitant medications was not provided by the reporter Treatment Patient put ice on it and didn't take any other treatments 2-3 hours after, his temperature became normal.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling, Pyrexia
Clinical narrative: left arm is swollen; it's hot to touch; a slight or very light sore throat; 2nd dose on 4Mar2021; left arm is pretty sore; a little fatigue; low grade fever at 99.5; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021) and MYALGIA (left arm is pretty sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05RE21A, 029A20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-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 PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021), MYALGIA (left arm is pretty sore), FATIGUE (a little fatigue) and PYREXIA (low grade fever at 99.5). At the time of the report, PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), MYALGIA (left arm is pretty sore) and FATIGUE (a little fatigue) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021) and PYREXIA (low grade fever at 99.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) Patient had low grade fever this morning at 99.5..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient not sure if he's immunocompromised Concomitant medications was not provided by the reporter Treatment Patient put ice on it and didn't take any other treatments 2-3 hours after, his temperature became normal.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contract covid between doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contract covid between doses) 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 COVID-19 (Contract covid between doses). At the time of the report, COVID-19 (Contract covid between doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by reporter Treatment provided was Antibody IV infusion.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat; Stuffiness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffiness) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffiness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffiness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Vaccination site discomfort, Vaccination site pain, Vaccination site pruritus
Clinical narrative: continuous discomfort on her left arm; big rash 8 inches in length and 3-4 inches width; itching; hot; tender; sweaty; hot/She stated she woke up feeling hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PAIN (tender) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (tender), HYPERHIDROSIS (sweaty) and FEELING HOT (hot/She stated she woke up feeling hot). At the time of the report, VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (tender), HYPERHIDROSIS (sweaty) and FEELING HOT (hot/She stated she woke up feeling hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was mentioned. Treatment medication includes Benadryl and Cortisone cream.