chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster. Is there any chance the booster can cause Covid-19) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster.  Is there any chance the booster can cause Covid-19). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster.  Is there any chance the booster can cause Covid-19) had resolved. Concomitant medications were not provided.Treatment medication was not provided. Patient had two doses of Pfizer vaccine and received the Moderna booster dose two weeks ago.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Received 3rd dose, not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received 3rd dose, not immunocompromised) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information  was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received 3rd dose, not immunocompromised). At the time of the report, OFF LABEL USE (Received 3rd dose, not immunocompromised) had resolved.            Concomitant medications included chronic hormones as the patient was a transgender.  The treatment information was  not provided.  It was reported that patient received the third shot of vaccine  from a pharmacy and then scheduled her for a  fourth shot on 09-Sep-2021. She didn't  present her initial vaccination card upon receiving the third dose, and stated that  she did not qualify as immunocompromised.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: allergy reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergy reaction) 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 ALLERGY TO VACCINE (allergy reaction). At the time of the report, ALLERGY TO VACCINE (allergy reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist reporting that 12 doses were given within the 12 hour time limit from time of first puncture from 3 refrigerated vials, but the 3 vials had been refrigerated for 31 & 32 days.  Concomitant product use was not provided.  Treatment product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant Follow-up received on 07-Sep-2021. Reporter's Salutation, fax number and phone number were updated. Patient Initials, Patient's notes were changed. Batch/lot number for suspect product was added. Action taken, Re-challenge and De-challenge of suspect product were updated. Outcome of event was updated. Product event details were updated. Narrative from the source was added
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of employment
Clinical narrative: he returned to work with the vaccination card he was told You no longer work here; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-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 LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here). At the time of the report, LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here) outcome was unknown.       Concomitant medication was not provided Treatment information was not reported. It was reported that, Consumer had called to find out if there was something wrong with the Moderna vaccine. Patient was fully vaccinated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Erythema, Injection site erythema, Limb discomfort
Clinical narrative: arm feels worse; Redness/armpit is red; Swelling; arm became red around injection site/upper arm was red; itchy; Settling in armpit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red) and PRURITUS (itchy) in a 76-year-old female patient 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills) outcome was unknown.        No concomitant medications were reported. Ice were reported as treatment medication.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: arm feels worse; Redness/armpit is red; Swelling; arm became red around injection site/upper arm was red; itchy; Settling in armpit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red) and PRURITUS (itchy) in a 76-year-old female patient 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills) outcome was unknown.        No concomitant medications were reported. Ice were reported as treatment medication.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: On going migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (On going migraine) 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 MIGRAINE (On going migraine). At the time of the report, MIGRAINE (On going migraine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter Treatment information was not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Just began methotrexate therapy 25 MG per week for arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis) 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, 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 ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis). The patient was treated with METHOTREXATE for Arthritis, at a dose of 25 mg,per week. At the time of the report, ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient stated that she vaccinated with both series of moderna Covid shots 6 months ago. she just began methotrexate therapy 25 MG per week for arthritis.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drooping shoulder syndrome, Hypoaesthesia, Mobility decreased, Paraesthesia, Periarthritis
Clinical narrative: Frozen shoulder; Problem moving her arm behind her head; Neurological symptoms/Numbness in the face / Numbness in the arm; Pins and needles; Drooping; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-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 PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping). The patient was treated with ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for Numbness, at an unspecified dose and frequency and STEROIDS for Frozen shoulder, at an unspecified dose and frequency. At the time of the report, PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-311359.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness and swelling on her arm; Soreness and swelling on her arm; body aches, pain and her body hurt; Muscle pain/Body ache/ pain / body hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt) 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 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt). At the time of the report, PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications reported.  No treatment information was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.   This case was linked to MOD-2021-310807.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) 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 COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: other positive (Positive) tested positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I have been having trouble catching my breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I have been having trouble catching my breath) 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.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSPNOEA (I have been having trouble catching my breath). At the time of the report, DYSPNOEA (I have been having trouble catching my breath) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: stomach is off; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            No Concomitant information was reported. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included VALSARTAN for Blood pressure, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Reflux gastritis, VITAMINS NOS, POTASSIUM CHLORIDE, COLECALCIFEROL (D3), CLONIDINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL-D) and DILTIAZEM for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking a medicine to help digestion and another medicine to help gut be more normal.   This case was linked to MOD-2021-311012 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not return for their 2nd dose after 28 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Pain in extremity, Peripheral swelling
Clinical narrative: Acid reflux; Having really bad pain at that time; hand got swollen, like under arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand got swollen, like under arm), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PAIN IN EXTREMITY (Having really bad pain at that time) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251321A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event.    On 07-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 PERIPHERAL SWELLING (hand got swollen, like under arm). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PAIN IN EXTREMITY (Having really bad pain at that time). At the time of the report, PERIPHERAL SWELLING (hand got swollen, like under arm) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) outcome was unknown and PAIN IN EXTREMITY (Having really bad pain at that time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.   This case was linked to MOD-2021-311791 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Gastrooesophageal reflux disease, Limb discomfort, Peripheral swelling
Clinical narrative: this is happening only on my left arm/something is there in my underarm; side effects; acid reflux; hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow), LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm), ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251214 and 0251321A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow). On an unknown date, the patient experienced LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm), ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow) had not resolved, LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm) had resolved and ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow), LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm) and ADVERSE REACTION (side effects) to be related. No further causality assessment was provided for GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux).    No concomitant medication was reported. No treatment medication was reported however, patient had taken Motrin for 2 days post the first dose at the time.   This case was linked to MOD-2021-311729 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: struggled to use it afterward due to soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (struggled to use it afterward due to soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (struggled to use it afterward due to soreness). At the time of the report, MYALGIA (struggled to use it afterward due to soreness) 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.   concomitant medication was not provided.  Patient requested to be vaccinated in his good arm and struggled to use it afterward due to soreness.  He was wondering if his second dose can be given IM in his gluteal muscle.  treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Hypoaesthesia eye, Paraesthesia, Trismus
Clinical narrative: Chest pain; back pain; left eye numbness; tingling feeling at left side of the jaw; jaw keeps locking up; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), BACK PAIN (back pain), HYPOAESTHESIA EYE (left eye numbness), PARAESTHESIA (tingling feeling at left side of the jaw) and TRISMUS (jaw keeps locking up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced CHEST PAIN (Chest pain), BACK PAIN (back pain), HYPOAESTHESIA EYE (left eye numbness), PARAESTHESIA (tingling feeling at left side of the jaw) and TRISMUS (jaw keeps locking up). At the time of the report, CHEST PAIN (Chest pain), BACK PAIN (back pain), HYPOAESTHESIA EYE (left eye numbness), PARAESTHESIA (tingling feeling at left side of the jaw) and TRISMUS (jaw keeps locking up) outcome was unknown.            Reportedly, Patient was advised to consult the doctor for further assessment. Consent for follow up was affirmative.  Patient had not visited Healthcare Professional  Concomitant product use was not provided.  Treatment product information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles
Clinical narrative: They got something flipped up the heart; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (They got something flipped up the heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRASYSTOLES (They got something flipped up the heart). At the time of the report, EXTRASYSTOLES (They got something flipped up the heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Had an exhausting 24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Had an exhausting 24 hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Had an exhausting 24 hours). On 01-Sep-2021, FATIGUE (Had an exhausting 24 hours) had resolved. Not Provided          No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.   This case was linked to MOD-2021-304655 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Influenza like illness, Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain). At the time of the report, INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain) had resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were provided by reporter. The rash finally stopped after taking an antibiotic.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer recurrent
Clinical narrative: Her breast cancer come back after being cancer free for 11 years; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) (seriousness criterion medically significant). At the time of the report, BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) 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.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Inappropriate schedule of product administration
Clinical narrative: she lost her balance and fell down; Fell down; More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021); This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (she lost her balance and fell down), FALL (Fell down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BALANCE DISORDER (she lost her balance and fell down), FALL (Fell down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)). On 07-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)) had resolved. At the time of the report, BALANCE DISORDER (she lost her balance and fell down) and FALL (Fell down) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Illness, Nausea, Product dose omission issue
Clinical narrative: I had diarrhea nausea and vomiting; I was sick for approximately 4 days; I had diarrhea nausea and vomiting; I had diarrhea nausea and vomiting; Fever and major fatigue and tiredness; Fever and major fatigue and tiredness; Arm was red and painful; Arm was red and painful; patient did not receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting) and PYREXIA (Fever and major fatigue and tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and GLIMEPIRIDE (AMARYL) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting), PYREXIA (Fever and major fatigue and tiredness), FATIGUE (Fever and major fatigue and tiredness), VACCINATION SITE ERYTHEMA (Arm was red and painful), VACCINATION SITE PAIN (Arm was red and painful) and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting), PYREXIA (Fever and major fatigue and tiredness), FATIGUE (Fever and major fatigue and tiredness), VACCINATION SITE ERYTHEMA (Arm was red and painful) and VACCINATION SITE PAIN (Arm was red and painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vomiting
Clinical narrative: I had diarrhea nausea and vomiting; I was sick for approximately 4 days; I had diarrhea nausea and vomiting; I had diarrhea nausea and vomiting; Fever and major fatigue and tiredness; Fever and major fatigue and tiredness; Arm was red and painful; Arm was red and painful; patient did not receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting) and PYREXIA (Fever and major fatigue and tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and GLIMEPIRIDE (AMARYL) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting), PYREXIA (Fever and major fatigue and tiredness), FATIGUE (Fever and major fatigue and tiredness), VACCINATION SITE ERYTHEMA (Arm was red and painful), VACCINATION SITE PAIN (Arm was red and painful) and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting), PYREXIA (Fever and major fatigue and tiredness), FATIGUE (Fever and major fatigue and tiredness), VACCINATION SITE ERYTHEMA (Arm was red and painful) and VACCINATION SITE PAIN (Arm was red and painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Product dose omission issue
Clinical narrative: When I went for 2nd dose  Medical Facility), my blood pressure was  higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot; my blood pressure was higher than they preferred; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (When I went for 2nd dose ( Medical Facility), my blood pressure was  higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot) and BLOOD PRESSURE INCREASED (my blood pressure was higher than they preferred) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (When I went for 2nd dose  (Medical Facility), my blood pressure was  higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot) and BLOOD PRESSURE INCREASED (my blood pressure was higher than they preferred). At the time of the report, PRODUCT DOSE OMISSION ISSUE (When I went for 2nd dose (Medical Facility), my blood pressure was  higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot) had resolved and BLOOD PRESSURE INCREASED (my blood pressure was higher than they preferred) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I started having side effects one week after 3rd dose of Moderna; 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 (I started having side effects one week after 3rd dose of Moderna) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna). At the time of the report, VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported.  Patient took immunosuppressive drugs.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Renal disorder
Clinical narrative: Kidneys problem; Heart problem; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Kidneys problem) and CARDIAC DISORDER (Heart problem) 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 RENAL DISORDER (Kidneys problem) and CARDIAC DISORDER (Heart problem). At the time of the report, RENAL DISORDER (Kidneys problem) and CARDIAC DISORDER (Heart problem) 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 medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Fatigue
Clinical narrative: lost taste; fatigued; 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 AGEUSIA (lost taste) and FATIGUE (fatigued) 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 August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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 AGEUSIA (lost taste) and FATIGUE (fatigued). At the time of the report, AGEUSIA (lost taste) and FATIGUE (fatigued) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects ) 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 VACCINATION COMPLICATION (Side effects ). At the time of the report, VACCINATION COMPLICATION (Side effects ) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: >35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No Treatment medication was provided.