chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Malaise, Muscle spasms
Clinical narrative: Bones in his arm hurts; His legs clamp up at night; Having vision issues; No energy; not feeling well since getting the 2nd shot; Bones in his knee hurts; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy) and MALAISE (not feeling well since getting the 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy), MALAISE (not feeling well since getting the 2nd shot) and ARTHRALGIA (Bones in his knee hurts). At the time of the report, BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy), MALAISE (not feeling well since getting the 2nd shot) and ARTHRALGIA (Bones in his knee hurts) had not resolved.            Concomitant medication includes unspecified pain medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-237349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contains significant information - added event(feeling unwell) and updated event outcome as not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Bones in his arm hurts; His legs clamp up at night; Having vision issues; No energy; not feeling well since getting the 2nd shot; Bones in his knee hurts; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy) and MALAISE (not feeling well since getting the 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy), MALAISE (not feeling well since getting the 2nd shot) and ARTHRALGIA (Bones in his knee hurts). At the time of the report, BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy), MALAISE (not feeling well since getting the 2nd shot) and ARTHRALGIA (Bones in his knee hurts) had not resolved.            Concomitant medication includes unspecified pain medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-237349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contains significant information - added event(feeling unwell) and updated event outcome as not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Flushing, Headache, Heart rate increased
Clinical narrative: Arm swelling followed by diffuse red warm areas.  Headache. Rigors late evening the vaccine was given. Rapid heartbeat late evening the vaccine was given, Fever for 24 hours.  Facial flushing and swelling 24 hrs after vaccine (still present after 48 hours.)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Swelling face
Clinical narrative: Arm swelling followed by diffuse red warm areas.  Headache. Rigors late evening the vaccine was given. Rapid heartbeat late evening the vaccine was given, Fever for 24 hours.  Facial flushing and swelling 24 hrs after vaccine (still present after 48 hours.)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from the syringe that was withdrawn the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Insomnia, pain in arm
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nasopharyngitis, Product dose omission issue
Clinical narrative: More than 35 days after the first dose without receiving the second dose; She was sick; had a cold; she got tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (She was sick), NASOPHARYNGITIS (had a cold) and FATIGUE (she got tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Kidney disorder (She has kidney problems since 1 year).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (she got tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (She was sick) and NASOPHARYNGITIS (had a cold). On 23-Mar-2021, FATIGUE (she got tired) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (She was sick) and NASOPHARYNGITIS (had a cold) outcome was unknown.        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.   Patient stated that she was sick and could not assist to the second dose. She stated that she had a cold which she usually has as she has COPD, and she has many conditions and it was horrible for her to go out of her house.  She stated that she may have a surgery on Monday, or maybe not.  Patient reported that she takes 16 concomitant medications for her conditions. No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Skin papilloma, Visual impairment
Clinical narrative: The wart over his eye on his eyelid, which had started to impede vision, started to slough off; Wart over his eye on his eyelid; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Wart (Large wart on his wrist/upper hand which had been present for years).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid). At the time of the report, VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient also had a large wart on his wrist/upper hand which had been present for years that at this point has almost disappeared.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: Cyst/mass around her pancreas region after second dose; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CYST (Cyst/mass around her pancreas region after second dose) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 CYST (Cyst/mass around her pancreas region after second dose). At the time of the report, CYST (Cyst/mass around her pancreas region after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up added and updated patient contact details(Email and Fax).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose was scheduled for 22May2021. Patient missed the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use
Clinical narrative: This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In January 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021). At the time of the report, OFF LABEL USE (This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Vertigo
Clinical narrative: experienced vertigo; tightness on the chest; 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 VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot in September 2020.    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 VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest). At the time of the report, VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest) 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: forgot to get the second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: arm was sore; arm had a rash was red and itchy; arm had a rash, was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was provided.     In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red). In 2021, PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of Vaccine more than 6 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Vaccine more than 6 weeks ago) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Vaccine more than 6 weeks ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Vaccine more than 6 weeks ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by the reporter.  No treatment details were provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: around the injection site  It is hard; around the injection site  It is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (around the injection site  It is hard) and VACCINATION SITE ERYTHEMA (around the injection site  It is 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (around the injection site  It is hard) and VACCINATION SITE ERYTHEMA (around the injection site  It is red). At the time of the report, VACCINATION SITE INDURATION (around the injection site  It is hard) and VACCINATION SITE ERYTHEMA (around the injection site  It is red) outcome was unknown.            Concomitant medications details not available. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of ageusia (I received my second Moderna vaccine in April, since then I have lost my sense of taste. Have you had this reported before?) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. April 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. April 2021, patient had ageusia (I received my second Moderna vaccine in April, since then I have lost my sense of taste. Have you had this reported before?). At the time of the report, ageusia (I received my second Moderna vaccine in April, since then I have lost my sense of taste. Have you had this reported before?) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: second dose scheduled 25 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (second dose scheduled 25 days after first dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (second dose scheduled 25 days after first dose). At the time of the report, OFF LABEL USE (second dose scheduled 25 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information reported.  No treatment medication information given.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: experiencing intense stomach pains and cramps 4 days post my second vaccine.; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (experiencing intense stomach pains and cramps 4 days post my second 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (experiencing intense stomach pains and cramps 4 days post my second vaccine.). At the time of the report, ABDOMINAL PAIN UPPER (experiencing intense stomach pains and cramps 4 days post my second vaccine.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: suffering from early satiety with no other symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jun-2021 and was forwarded to Moderna on 27-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL DISTENSION (suffering from early satiety with no other 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.   In April 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISTENSION (suffering from early satiety with no other symptoms). At the time of the report, ABDOMINAL DISTENSION (suffering from early satiety with no other symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and it contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were reported. no treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (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 (experienced a side effect). At the time of the report, VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: 10 people who are having/had the same side effects as his; 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 (10 people who are having/had the same side effects as his) 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 (10 people who are having/had the same side effects as his). At the time of the report, VACCINATION COMPLICATION (10 people who are having/had the same side effects as his) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient who had previously called to report his side effects, stated that he knew up to 10 people who are having/had the same side effects as his. Patient was not specific with the people he knows who are having side effects.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was nor provided No lab data was provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Tight feeling in my chest; Hurts to breath deeply; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight feeling in my chest) and DYSPNOEA (Hurts to breath deeply) 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 CHEST DISCOMFORT (Tight feeling in my chest) and DYSPNOEA (Hurts to breath deeply). At the time of the report, CHEST DISCOMFORT (Tight feeling in my chest) and DYSPNOEA (Hurts to breath deeply) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: Is feel head pressure a side effect; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Is feel head pressure 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Is feel head pressure a side effect). At the time of the report, HEAD DISCOMFORT (Is feel head pressure a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) outcome was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Fatigue, Influenza like illness, Myalgia
Clinical narrative: After second dose had severe flu-like symptoms; runny nose; sneezing; diarrhea; dehydration; body and joint pain; low-grade fever; severe fatigue; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After second dose had severe flu-like symptoms), RHINORRHOEA (runny nose), SNEEZING (sneezing), DIARRHOEA (diarrhea) and DEHYDRATION (dehydration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever. Concurrent medical conditions included Bee sting hypersensitivity (hives and illness due to bee stings.), Asthma and Anxiety depression. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) for Birth control, ESCITALOPRAM for Depression.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (After second dose had severe flu-like symptoms), RHINORRHEA (runny nose), SNEEZING (sneezing), DIARRHOEA (diarrhea), DEHYDRATION (dehydration), MYALGIA (body and joint pain), PYREXIA (low-grade fever) and FATIGUE (severe fatigue). On 22-Apr-2021, INFLUENZA LIKE ILLNESS (After second dose had severe flu-like symptoms), RHINORRHOEA (runny nose), SNEEZING (sneezing), DIARRHOEA (diarrhea) and MYALGIA (body and joint pain) had resolved and DEHYDRATION (dehydration), PYREXIA (low-grade fever) and FATIGUE (severe fatigue) outcome was unknown.            No treatment information was provided by the reporter.   This case was linked to MOD-2021-062917 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: After second dose had severe flu-like symptoms; runny nose; sneezing; diarrhea; dehydration; body and joint pain; low-grade fever; severe fatigue; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After second dose had severe flu-like symptoms), RHINORRHOEA (runny nose), SNEEZING (sneezing), DIARRHOEA (diarrhea) and DEHYDRATION (dehydration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever. Concurrent medical conditions included Bee sting hypersensitivity (hives and illness due to bee stings.), Asthma and Anxiety depression. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) for Birth control, ESCITALOPRAM for Depression.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (After second dose had severe flu-like symptoms), RHINORRHEA (runny nose), SNEEZING (sneezing), DIARRHOEA (diarrhea), DEHYDRATION (dehydration), MYALGIA (body and joint pain), PYREXIA (low-grade fever) and FATIGUE (severe fatigue). On 22-Apr-2021, INFLUENZA LIKE ILLNESS (After second dose had severe flu-like symptoms), RHINORRHOEA (runny nose), SNEEZING (sneezing), DIARRHOEA (diarrhea) and MYALGIA (body and joint pain) had resolved and DEHYDRATION (dehydration), PYREXIA (low-grade fever) and FATIGUE (severe fatigue) outcome was unknown.            No treatment information was provided by the reporter.   This case was linked to MOD-2021-062917 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rash on chest and back; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on chest and back) 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 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 RASH (rash on chest and back) and PYREXIA (Fever). At the time of the report, RASH (rash on chest and back) outcome was unknown and PYREXIA (Fever) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: sore like the flue; i feel hot feverish; Aches; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (sore like the flue), PYREXIA (i feel hot feverish), MYALGIA (Aches) and FATIGUE (Tired) 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 INFLUENZA LIKE ILLNESS (sore like the flue), PYREXIA (i feel hot feverish), MYALGIA (Aches) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (sore like the flue), PYREXIA (i feel hot feverish), MYALGIA (Aches) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Moderna vaccine was administered beyond the appointment due date; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine was administered beyond the appointment due date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine was administered beyond the appointment due date). On 27-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine was administered beyond the appointment due date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received: only email address was added. No newother information was updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round) 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 LYMPHADENOPATHY (swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information available. No Treatment medication information provided by the Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Vestibular neuronitis; ringing in the ears; myalgia; fever 102.9; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR NEURONITIS (Vestibular neuronitis), TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR NEURONITIS (Vestibular neuronitis). an unknown date, the patient experienced TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, VESTIBULAR NEURONITIS (Vestibular neuronitis), TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.9 (High) High.         No Concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Vestibular neuronitis
Clinical narrative: Vestibular neuronitis; ringing in the ears; myalgia; fever 102.9; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR NEURONITIS (Vestibular neuronitis), TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR NEURONITIS (Vestibular neuronitis). an unknown date, the patient experienced TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, VESTIBULAR NEURONITIS (Vestibular neuronitis), TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.9 (High) High.         No Concomitant and treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Paraesthesia, Tinnitus
Clinical narrative: she felt really dizzy; her face felt funny; her ears were ringing; her legs tingling; she felt tired that evening; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she felt really dizzy), FEELING ABNORMAL (her face felt funny), TINNITUS (her ears were ringing), PARAESTHESIA (her legs tingling) and FATIGUE (she felt tired that evening) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (she felt really dizzy), FEELING ABNORMAL (her face felt funny), TINNITUS (her ears were ringing), PARAESTHESIA (her legs tingling) and FATIGUE (she felt tired that evening). On 04-Mar-2021, DIZZINESS (she felt really dizzy), FEELING ABNORMAL (her face felt funny), TINNITUS (her ears were ringing), PARAESTHESIA (her legs tingling) and FATIGUE (she felt tired that evening) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-237418 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the vaccine). At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.