chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Glands are swollen; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Glands are swollen) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Glands are swollen) and HEADACHE (Headache). At the time of the report, LYMPHADENOPATHY (Glands are swollen) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: arm is red where i got my shot; Med Info Agent:  My arm is red where i got my shot. It has spread. Should i be worried about
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) 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 ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Started early menstrual cycle after receiving vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of MENSTRUAL DISORDER (Started early menstrual cycle after receiving vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced MENSTRUAL DISORDER (Started early menstrual cycle after receiving vaccine). At the time of the report, MENSTRUAL DISORDER (Started early menstrual cycle after receiving vaccine) 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.   Concomitant medication include birth control pills.  No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site scab
Clinical narrative: Red spot that turned into scab; Red spot after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SCAB (Red spot that turned into scab) and VACCINATION SITE ERYTHEMA (Red spot after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAB (Red spot that turned into scab) and VACCINATION SITE ERYTHEMA (Red spot after vaccination). At the time of the report, VACCINATION SITE SCAB (Red spot that turned into scab) and VACCINATION SITE ERYTHEMA (Red spot after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication provided.  No treatment information provided.   Reporter did not allow further contact
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: thawed upon arrival on 09Apr2021, vials were stored in the refrigerator upon shipment arrival; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (thawed upon arrival on 09Apr2021, vials were stored in the refrigerator upon shipment arrival) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 STORAGE ERROR (thawed upon arrival on 09Apr2021, vials were stored in the refrigerator upon shipment arrival). At the time of the report, PRODUCT STORAGE ERROR (thawed upon arrival on 09Apr2021, vials were stored in the refrigerator upon shipment arrival) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-163779 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-163779:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: second vaccine causes arm pain more than one month later; 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 PAIN IN EXTREMITY (second vaccine causes arm pain more than one month later) 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 PAIN IN EXTREMITY (second vaccine causes arm pain more than one month later). At the time of the report, PAIN IN EXTREMITY (second vaccine causes arm pain more than one month later) outcome was unknown.            No concomitant medications reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; 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 RHINORRHOEA (Runny nose) 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 RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No Treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 100.4; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.4) 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 PYREXIA (Fever 100.4). At the time of the report, PYREXIA (Fever 100.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.4 (High) Fever 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse event; This spontaneous case was reported by a patient and describes the occurrence of NO ADVERSE EVENT (no adverse event) 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 NO ADVERSE EVENT (no adverse event). At the time of the report, NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant medication provided. No treatment medication provided. The patient mentioned is it safe to take vitamins, ibuprofen, and unknown medication after the second vaccine for side effects.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash, Vaccination site pain
Clinical narrative: full body rash in the upper half of my body; sore left injection site arm; Flu like symptom; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptom), RASH (full body rash in the upper half of my body) and VACCINATION SITE PAIN (sore left injection site arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptom) and VACCINATION SITE PAIN (sore left injection site arm). On 21-May-2021, the patient experienced RASH (full body rash in the upper half of my body). The patient was treated with DIPHENHYDRAMINE at a dose of 1 dosage form. On 15-May-2021, INFLUENZA LIKE ILLNESS (Flu like symptom) and VACCINATION SITE PAIN (sore left injection site arm) had resolved. At the time of the report, RASH (full body rash in the upper half of my body) outcome was unknown.            No treatment information provided.   This case was linked to MOD-2021-163733 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: bring down my period blood; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (bring down my period blood) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (bring down my period blood). At the time of the report, MENSTRUAL DISORDER (bring down my period blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid positive after the Moderna Covid vaccine was applied; 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 COVID-19 (Covid positive after the Moderna Covid vaccine was applied) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid positive after the Moderna Covid vaccine was applied). At the time of the report, COVID-19 (Covid positive after the Moderna Covid vaccine was applied) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        The question is if I should apply the second dose on the scheduled date or if I should change it for being positive for COVID after the first dose.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: have cold sore; 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 ORAL HERPES (have cold sore) 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 ORAL HERPES (have cold sore). At the time of the report, ORAL HERPES (have cold sore) outcome was unknown.            The patient treatment data was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Vaccination site pain
Clinical narrative: On a scale of 1 to 10 it was a 6-7/ the arm was not useful; significant pain in my arm almost immediately after the shot and lasting about 3 days approximately; Within the first night there was mild chills that lasted for about an hour.; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (On a scale of 1 to 10 it was a 6-7/ the arm was not useful), VACCINATION SITE PAIN (significant pain in my arm almost immediately after the shot and lasting about 3 days approximately) and CHILLS (Within the first night there was mild chills that lasted for about an hour.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (On a scale of 1 to 10 it was a 6-7/ the arm was not useful), VACCINATION SITE PAIN (significant pain in my arm almost immediately after the shot and lasting about 3 days approximately) and CHILLS (Within the first night there was mild chills that lasted for about an hour.). At the time of the report, MOBILITY DECREASED (On a scale of 1 to 10 it was a 6-7/ the arm was not useful), VACCINATION SITE PAIN (significant pain in my arm almost immediately after the shot and lasting about 3 days approximately) and CHILLS (Within the first night there was mild chills that lasted for about an hour.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-163778 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: My injection site is still swollen; My injection site is still red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (My injection site is still swollen) and VACCINATION SITE ERYTHEMA (My injection site is still red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (My injection site is still swollen) and VACCINATION SITE ERYTHEMA (My injection site is still red). At the time of the report, VACCINATION SITE SWELLING (My injection site is still swollen) and VACCINATION SITE ERYTHEMA (My injection site is still red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Hi! Ingot my second shot on Friday. My injection site is still swollen and red. Is this normal or should I call my PCP?
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: second Moderna COVID-19 vaccine at this time: 28May2021; experienced soreness after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna COVID-19 vaccine at this time: 28May2021) and PAIN (experienced soreness after first dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 049C21A) for COVID-19 vaccination.     Concomitant products included TRAMADOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna COVID-19 vaccine at this time: 28May2021) and PAIN (experienced soreness after first dose). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna COVID-19 vaccine at this time: 28May2021) had resolved. At the time of the report, PAIN (experienced soreness after first dose) outcome was unknown.            Concomitant drug included blood pressure medication and cholesterol medication.  Treatment medication was not reported.  Company Comment: This report refers to a case of inappropriate schedule of Product administration for mRNA-1273, lot # 045A21A with an AE. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-277233 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received and contains non-significant information. On 05-Aug-2021: In follow-up information 2nd dose detail has been updated  & AE- terminology has been updated as "dose omission issue"(Patient has not received second dose of Moderna COVID-19  vaccine after 42 days) to "inappropriate schedule of vaccine administration" (second Moderna COVID-19 vaccine at this time: 28May2021 ).; Sender's Comments: This report refers to a case of inappropriate schedule of Product administration for mRNA-1273, lot # 045A21A with an AE. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Skin discolouration
Clinical narrative: I have black and blue marks and sore spots all over after second Moderna shot; I have black and blue marks and sore spots all over after second Moderna shot; 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 SKIN DISCOLOURATION (I have black and blue marks and sore spots all over after second Moderna shot) and PAIN (I have black and blue marks and sore spots all over after second Moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (I have black and blue marks and sore spots all over after second Moderna shot) and PAIN (I have black and blue marks and sore spots all over after second Moderna shot). At the time of the report, SKIN DISCOLOURATION (I have black and blue marks and sore spots all over after second Moderna shot) and PAIN (I have black and blue marks and sore spots all over after second Moderna shot) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: Report a side effect; Body is hurting; 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 (Report a side effect) and MYALGIA (Body is hurting) 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 (Report a side effect) and MYALGIA (Body is hurting). At the time of the report, VACCINATION COMPLICATION (Report a side effect) and MYALGIA (Body is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   The reporter submitted AE via text.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product dose omission issue
Clinical narrative: haven't got their second dose; lymph nodes swollen every where in their body; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes swollen every where in their body) and PRODUCT DOSE OMISSION ISSUE (haven't got their second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Anxiety and Depression.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (lymph nodes swollen every where in their body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (haven't got their second dose). At the time of the report, LYMPHADENOPATHY (lymph nodes swollen every where in their body) and PRODUCT DOSE OMISSION ISSUE (haven't got their second dose) 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.   Concomitant medication history not provided. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Testicular pain, Vascular pain
Clinical narrative: slight chest pain; testicular vascular pain; testicular vascular pain; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (slight chest pain), TESTICULAR PAIN (testicular vascular pain), VASCULAR PAIN (testicular vascular pain) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 CHEST PAIN (slight chest pain), TESTICULAR PAIN (testicular vascular pain), VASCULAR PAIN (testicular vascular pain) and MYALGIA (body aches). At the time of the report, CHEST PAIN (slight chest pain), TESTICULAR PAIN (testicular vascular pain), VASCULAR PAIN (testicular vascular pain) and MYALGIA (body aches) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccination) was not applicable  Treatment information was not provided  Concomitant product use was not provided by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tremor
Clinical narrative: Numbness in hands; Tremors in arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands) and TREMOR (Tremors in arms) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in hands) and TREMOR (Tremors in arms). At the time of the report, HYPOAESTHESIA (Numbness in hands) and TREMOR (Tremors in arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No allergies, current illness, lab data and medical history was reported by patient.  No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient went to PCP and had may test done with no answers.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion, Oropharyngeal pain, Pain in extremity
Clinical narrative: Arm hurt a little bit; Tired and fatigued; Low-grade fever; Sneezing; Coughing; Phlegm and muscus, described as post-nasal drip; Sore throat; Blowing the runny nose; Little bit of congestion; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little bit), SNEEZING (Sneezing), COUGH (Coughing), UPPER-AIRWAY COUGH SYNDROME (Phlegm and muscus, described as post-nasal drip) and OROPHARYNGEAL PAIN (Sore throat) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Arthritis, MULTIVITAMIN [VITAMINS NOS], VITAMIN A NOS, COLECALCIFEROL (VITAMIN D3) and CALCIUM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced SNEEZING (Sneezing), COUGH (Coughing), UPPER-AIRWAY COUGH SYNDROME (Phlegm and muscus, described as post-nasal drip), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Blowing the runny nose), NASAL CONGESTION (Little bit of congestion) and PYREXIA (Low-grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt a little bit) and FATIGUE (Tired and fatigued). At the time of the report, PAIN IN EXTREMITY (Arm hurt a little bit), SNEEZING (Sneezing), COUGH (Coughing), UPPER-AIRWAY COUGH SYNDROME (Phlegm and muscus, described as post-nasal drip), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Blowing the runny nose), NASAL CONGESTION (Little bit of congestion), FATIGUE (Tired and fatigued) and PYREXIA (Low-grade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographic details updated.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sneezing, Upper-airway cough syndrome
Clinical narrative: Arm hurt a little bit; Tired and fatigued; Low-grade fever; Sneezing; Coughing; Phlegm and muscus, described as post-nasal drip; Sore throat; Blowing the runny nose; Little bit of congestion; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little bit), SNEEZING (Sneezing), COUGH (Coughing), UPPER-AIRWAY COUGH SYNDROME (Phlegm and muscus, described as post-nasal drip) and OROPHARYNGEAL PAIN (Sore throat) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Arthritis, MULTIVITAMIN [VITAMINS NOS], VITAMIN A NOS, COLECALCIFEROL (VITAMIN D3) and CALCIUM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced SNEEZING (Sneezing), COUGH (Coughing), UPPER-AIRWAY COUGH SYNDROME (Phlegm and muscus, described as post-nasal drip), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Blowing the runny nose), NASAL CONGESTION (Little bit of congestion) and PYREXIA (Low-grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt a little bit) and FATIGUE (Tired and fatigued). At the time of the report, PAIN IN EXTREMITY (Arm hurt a little bit), SNEEZING (Sneezing), COUGH (Coughing), UPPER-AIRWAY COUGH SYNDROME (Phlegm and muscus, described as post-nasal drip), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Blowing the runny nose), NASAL CONGESTION (Little bit of congestion), FATIGUE (Tired and fatigued) and PYREXIA (Low-grade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographic details updated.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Iritis, Migraine, Vaccination site pain
Clinical narrative: iritis; painful headache like a migraine; soreness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of IRITIS (iritis), MIGRAINE (painful headache like a migraine) and VACCINATION SITE PAIN (soreness in the injection arm) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Collagen-vascular disease. Concomitant products included Retro Vials for HIV for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced MIGRAINE (painful headache like a migraine) and VACCINATION SITE PAIN (soreness in the injection arm). On 21-May-2021, the patient experienced IRITIS (iritis). The patient was treated with PREDNISONE (drop) for Light sensitivity to eye and Eye redness, at an unspecified dose and frequency. At the time of the report, IRITIS (iritis), MIGRAINE (painful headache like a migraine) and VACCINATION SITE PAIN (soreness in the injection arm) outcome was unknown.            Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Ever since patient received the vaccine patient have been getting hives; 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 URTICARIA (Ever since patient received the vaccine patient have been getting hives) 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 URTICARIA (Ever since patient received the vaccine patient have been getting hives). At the time of the report, URTICARIA (Ever since patient received the vaccine patient have been getting hives) 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. Treatment information was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Nipple pain
Clinical narrative: Tender nipples; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (Tender nipples) 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 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced NIPPLE PAIN (Tender nipples). At the time of the report, NIPPLE PAIN (Tender nipples) had not resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Palpitations
Clinical narrative: felt little dizzy; little bit heart palliation for around 60 mins and then was alright.; After 1 dose soreness was gone in 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt little dizzy), PALPITATIONS (little bit heart palliation for around 60 mins and then was alright.) and MYALGIA (After 1 dose soreness was gone in 3-4 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, Vitamin D and LOVASTATIN.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (felt little dizzy), PALPITATIONS (little bit heart palliation for around 60 mins and then was alright.) and MYALGIA (After 1 dose soreness was gone in 3-4 days). On 14-Apr-2021, DIZZINESS (felt little dizzy) and PALPITATIONS (little bit heart palliation for around 60 mins and then was alright.) had resolved. On 18-Apr-2021, MYALGIA (After 1 dose soreness was gone in 3-4 days) 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.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: fever; aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (aches) and HEADACHE (headache) 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 PYREXIA (fever), MYALGIA (aches) and HEADACHE (headache). At the time of the report, PYREXIA (fever), MYALGIA (aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were provided
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Product dose omission issue
Clinical narrative: missed the second dose; shingles; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HERPES ZOSTER (shingles) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HERPES ZOSTER (shingles). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) had resolved and HERPES ZOSTER (shingles) 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.   No concomitant medication reported. No treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: My hair is falling out, Hair loss started maybe a week after first shot; 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 ALOPECIA (My hair is falling out, Hair loss started maybe a week after first shot) 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 ALOPECIA (My hair is falling out, Hair loss started maybe a week after first shot). At the time of the report, ALOPECIA (My hair is falling out, Hair loss started maybe a week after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were provided.  Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Hypokinesia
Clinical narrative: did not feel well; sick to my stomach; I couldn't function/had to stay in bed for a while; I had diarrhea for 3 to 4 days; chills; felt nauseated; I had really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), ABDOMINAL DISCOMFORT (sick to my stomach), HYPOKINESIA (I couldn't function/had to stay in bed for a while), DIARRHOEA (I had diarrhea for 3 to 4 days) and CHILLS (chills) in a female 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 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced MALAISE (did not feel well), ABDOMINAL DISCOMFORT (sick to my stomach), HYPOKINESIA (I couldn't function/had to stay in bed for a while), DIARRHOEA (I had diarrhea for 3 to 4 days), CHILLS (chills), NAUSEA (felt nauseated) and HEADACHE (I had really bad headache). On 24-May-2021, MALAISE (did not feel well), ABDOMINAL DISCOMFORT (sick to my stomach), HYPOKINESIA (I couldn't function/had to stay in bed for a while), DIARRHOEA (I had diarrhea for 3 to 4 days), CHILLS (chills), NAUSEA (felt nauseated) and HEADACHE (I had really bad headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Advil before getting the 2nd dose of vaccine on 06-MAY-2021. Over-the-counter gas relief for stomach problems since the patient got the 2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: did not feel well; sick to my stomach; I couldn't function/had to stay in bed for a while; I had diarrhea for 3 to 4 days; chills; felt nauseated; I had really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), ABDOMINAL DISCOMFORT (sick to my stomach), HYPOKINESIA (I couldn't function/had to stay in bed for a while), DIARRHOEA (I had diarrhea for 3 to 4 days) and CHILLS (chills) in a female 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 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced MALAISE (did not feel well), ABDOMINAL DISCOMFORT (sick to my stomach), HYPOKINESIA (I couldn't function/had to stay in bed for a while), DIARRHOEA (I had diarrhea for 3 to 4 days), CHILLS (chills), NAUSEA (felt nauseated) and HEADACHE (I had really bad headache). On 24-May-2021, MALAISE (did not feel well), ABDOMINAL DISCOMFORT (sick to my stomach), HYPOKINESIA (I couldn't function/had to stay in bed for a while), DIARRHOEA (I had diarrhea for 3 to 4 days), CHILLS (chills), NAUSEA (felt nauseated) and HEADACHE (I had really bad headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Advil before getting the 2nd dose of vaccine on 06-MAY-2021. Over-the-counter gas relief for stomach problems since the patient got the 2nd dose
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Insomnia, Lethargy
Clinical narrative: pain immediately upon the shot; unable to sleep through the night; temperature of 103F; lethargic; dry heaved; severe chills -Shivering; really tired; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic) and RETCHING (dry heaved) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for an unknown indication.   On 15-Apr-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 PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic), RETCHING (dry heaved), CHILLS (severe chills -Shivering), FATIGUE (really tired) and MYALGIA (Body aches). At the time of the report, PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic), RETCHING (dry heaved), CHILLS (severe chills -Shivering), FATIGUE (really tired) and MYALGIA (Body aches) outcome was unknown.            The patient's medical history was not provided.  patient lab test data not reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Retching
Clinical narrative: pain immediately upon the shot; unable to sleep through the night; temperature of 103F; lethargic; dry heaved; severe chills -Shivering; really tired; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic) and RETCHING (dry heaved) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for an unknown indication.   On 15-Apr-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 PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic), RETCHING (dry heaved), CHILLS (severe chills -Shivering), FATIGUE (really tired) and MYALGIA (Body aches). At the time of the report, PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic), RETCHING (dry heaved), CHILLS (severe chills -Shivering), FATIGUE (really tired) and MYALGIA (Body aches) outcome was unknown.            The patient's medical history was not provided.  patient lab test data not reported. Treatment information was not provided.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine used; Second dose was improperly stored; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Second dose was improperly stored) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (Second dose was improperly stored). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT STORAGE ERROR (Second dose was improperly stored) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided.   This case was linked to MOD-2021-163363, MOD-2021-163751, MOD-2021-163459, MOD-2021-163974, MOD-2021-163302 (E2B Linked Report).; Sender's Comments:  MOD-2021-163363:Same reporter MOD-2021-163751:Same reporter MOD-2021-163459:Same reporter MOD-2021-163974:Same reporter MOD-2021-163302:Same reporter