chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site pain
Clinical narrative: Received her booster dose of the Moderna Covid-19 vaccine; her injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her injection site arm was sore) and EXTRA DOSE ADMINISTERED (Received her booster dose of the Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 001B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE PAIN (her injection site arm was sore). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received her booster dose of the Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (her injection site arm was sore) and EXTRA DOSE ADMINISTERED (Received her booster dose of the Moderna Covid-19 vaccine) outcome was unknown.            Patient Date of Birth was mentioned as 13May (declined yr) Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-291045.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Erythema, Influenza like illness, Malaise
Clinical narrative: Arm was swollen to the elbow; Began to itch again,itching; Redness/swelling/lumpiness began to wrap around her arm to her armpit; Arm hurt; Migraine; Vertigo; Dizziness; Flu like; Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site; Just didn't feel good,Very sick and went to bed; Arm was red; Nausea; Achy Muscle and joints; (Right arm) was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt) and MIGRAINE (Migraine) in a 78-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.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore). On 24-Mar-2021, PERIPHERAL SWELLING (Arm was swollen to the elbow), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore) had resolved. At the time of the report, PRURITUS (Began to itch again,itching) and SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit) had not resolved.            The Treatment history was not reported. Patient's all of the symptoms went away again after 7-8 days except for the itching and redness/swelling of her arm. Patient feeled about 70%.   This case was linked to MOD-2021-290851, MOD-2021-291781 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was swollen to the elbow; Began to itch again,itching; Redness/swelling/lumpiness began to wrap around her arm to her armpit; Arm hurt; Migraine; Vertigo; Dizziness; Flu like; Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site; Just didn't feel good,Very sick and went to bed; Arm was red; Nausea; Achy Muscle and joints; (Right arm) was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt) and MIGRAINE (Migraine) in a 78-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.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore). On 24-Mar-2021, PERIPHERAL SWELLING (Arm was swollen to the elbow), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore) had resolved. At the time of the report, PRURITUS (Began to itch again,itching) and SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit) had not resolved.            The Treatment history was not reported. Patient's all of the symptoms went away again after 7-8 days except for the itching and redness/swelling of her arm. Patient feeled about 70%.   This case was linked to MOD-2021-290851, MOD-2021-291781 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin mass, Vaccination site mass, Vertigo
Clinical narrative: Arm was swollen to the elbow; Began to itch again,itching; Redness/swelling/lumpiness began to wrap around her arm to her armpit; Arm hurt; Migraine; Vertigo; Dizziness; Flu like; Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site; Just didn't feel good,Very sick and went to bed; Arm was red; Nausea; Achy Muscle and joints; (Right arm) was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt) and MIGRAINE (Migraine) in a 78-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.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore). On 24-Mar-2021, PERIPHERAL SWELLING (Arm was swollen to the elbow), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore) had resolved. At the time of the report, PRURITUS (Began to itch again,itching) and SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit) had not resolved.            The Treatment history was not reported. Patient's all of the symptoms went away again after 7-8 days except for the itching and redness/swelling of her arm. Patient feeled about 70%.   This case was linked to MOD-2021-290851, MOD-2021-291781 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I contract covid around two weeks after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I contract covid around two weeks after the 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 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 (I contract covid around two weeks after the first dose). At the time of the report, COVID-19 (I contract covid around two weeks after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment mediations were provided. Patient would like to know if patient contract covid around two weeks after the first dose, how long do patient have to wait for the second dose.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache after the second shot; Pain all over body after the second shot; Low Grade Fever after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the second shot), MYALGIA (Pain all over body after the second shot) and PYREXIA (Low Grade Fever after the second shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Amputee (Left leg above knee).   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (Headache after the second shot), MYALGIA (Pain all over body after the second shot) and PYREXIA (Low Grade Fever after the second shot). On 18-Aug-2021, HEADACHE (Headache after the second shot), MYALGIA (Pain all over body after the second shot) and PYREXIA (Low Grade Fever after the second shot) had resolved.            No Concomitant Medications were provided. No Treatment Medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose on 2March2021 and did not get his second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose on 2March2021 and did not get his second dose) 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 02-Mar-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 (first dose on 2March2021 and did not get his second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose on 2March2021 and did not get his second dose) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product was not provided by the reporter.  Treatment information was not provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administration interrupted
Clinical narrative: Patient waited to get the second dose; Left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurt) and PRODUCT ADMINISTRATION INTERRUPTED (Patient waited to get the second dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 15-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 PAIN IN EXTREMITY (Left arm hurt) and PRODUCT ADMINISTRATION INTERRUPTED (Patient waited to get the second dose). At the time of the report, PAIN IN EXTREMITY (Left arm hurt) and PRODUCT ADMINISTRATION INTERRUPTED (Patient waited to get the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  The patient reported that the reason behind a large gap between the first dose and the second dose was due to she had no facility close to her that supplied the Moderna vaccine.  No treatment information was provided.   This case was linked to MOD-2021-291331 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment product information was not provided. Concomitant product use was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick/Horribly ill; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick/Horribly ill) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick/Horribly ill). At the time of the report, ILLNESS (Sick/Horribly ill) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever 100F; Tired; A day in bed; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (A day in bed), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever 100F) and FATIGUE (Tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced BEDRIDDEN (A day in bed). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever 100F) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 17-Aug-2021, BEDRIDDEN (A day in bed) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever 100F) and FATIGUE (Tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100f (High) 100F.         Concomitant product use was not provided by the reporter.  On 18 Aug 2021, the patient was feeling fine but not 100 percent.   This case was linked to MOD-2021-290368, MOD-2021-290627 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: sore arm; Lots of energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Lots of energy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Lots of energy). At the time of the report, PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Lots of energy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       She stated that her side effects were good because she could do some garden work.  No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-291002:Dose 2 case
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Incorrect route of product administration, Nausea, Pain in extremity
Clinical narrative: Dizziness; Leg tremor; Arm pain; Huge rash that comes and goes; Nausea; Headache; Subcutaneous administration; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), RASH (Huge rash that comes and goes) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 10-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous administration). On an unknown date, the patient experienced DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), RASH (Huge rash that comes and goes), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown, RASH (Huge rash that comes and goes) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       The patient stated that she experienced a huge rash two to three days post-vaccination, which went away then came back. She also experienced nausea, dizziness, headache, tremors in her leg, pain on her arm. The patient stated that her entire arm was in pain the day before the call.  No concomitant product use was provided by the reporter.   No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tremor
Clinical narrative: Dizziness; Leg tremor; Arm pain; Huge rash that comes and goes; Nausea; Headache; Subcutaneous administration; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), RASH (Huge rash that comes and goes) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 10-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous administration). On an unknown date, the patient experienced DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), RASH (Huge rash that comes and goes), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown, RASH (Huge rash that comes and goes) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       The patient stated that she experienced a huge rash two to three days post-vaccination, which went away then came back. She also experienced nausea, dizziness, headache, tremors in her leg, pain on her arm. The patient stated that her entire arm was in pain the day before the call.  No concomitant product use was provided by the reporter.   No treatment medications were reported.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: Knot in the arm/Lump in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Knot in the arm/Lump in the arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sickle cell anemia.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced SKIN MASS (Knot in the arm/Lump in the arm). At the time of the report, SKIN MASS (Knot in the arm/Lump in the arm) had resolved.            Relevant concomitant medications were not provided.  Treatment information was not provided.  The patient stated that she should be taking medications but she does not.     This case was linked to MOD-2021-290615 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: New adverse effects 3 o 4 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (New adverse effects 3 o 4 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 (New adverse effects 3 o 4 days ago). At the time of the report, ADVERSE EVENT (New adverse effects 3 o 4 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: my heart is skipping/it stops beating for a second; Inappropriate schedule of vaccine administered; fever; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (my heart is skipping/it stops beating for a second), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and PYREXIA (fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced EXTRASYSTOLES (my heart is skipping/it stops beating for a second). an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, EXTRASYSTOLES (my heart is skipping/it stops beating for a second) and PYREXIA (fever) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.       Treatment information was not provided.   This case was linked to MOD-2021-291503 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Her body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts) 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 17-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Her body hurts) 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash) and HEADACHE (headachy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, AZELASTINE for Rhinitis, METOPROLOL for an unknown indication. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash). On an unknown date, the patient experienced VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), HEADACHE (headachy) and FATIGUE (extremely tired). At the time of the report, VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash), HEADACHE (headachy) and FATIGUE (extremely tired) outcome was unknown. No treatment medication were reported. This case was linked to MOD-2021-291193.
Sex: F
Vaccine: COVID19
Symptoms: Vascular injury
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash) and HEADACHE (headachy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, AZELASTINE for Rhinitis, METOPROLOL for an unknown indication. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash). On an unknown date, the patient experienced VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), HEADACHE (headachy) and FATIGUE (extremely tired). At the time of the report, VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash), HEADACHE (headachy) and FATIGUE (extremely tired) outcome was unknown. No treatment medication were reported. This case was linked to MOD-2021-291193.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Myalgia
Clinical narrative: first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021; pressure headache; swelling where the injection was given; Rash the size of an eye patch where the injection was given; sweats; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (pressure headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04C21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). On 17-Aug-2021, the patient experienced HEADACHE (pressure headache), VACCINATION SITE SWELLING (swelling where the injection was given) and VACCINATION SITE ERYTHEMA (Rash the size of an eye patch where the injection was given). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 17-Aug-2021, HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (pressure headache), VACCINATION SITE SWELLING (swelling where the injection was given) and VACCINATION SITE ERYTHEMA (Rash the size of an eye patch where the injection was given) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021) had resolved.            No concomitant medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021; pressure headache; swelling where the injection was given; Rash the size of an eye patch where the injection was given; sweats; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (pressure headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04C21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). On 17-Aug-2021, the patient experienced HEADACHE (pressure headache), VACCINATION SITE SWELLING (swelling where the injection was given) and VACCINATION SITE ERYTHEMA (Rash the size of an eye patch where the injection was given). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 17-Aug-2021, HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (pressure headache), VACCINATION SITE SWELLING (swelling where the injection was given) and VACCINATION SITE ERYTHEMA (Rash the size of an eye patch where the injection was given) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021) had resolved.            No concomitant medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) 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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: his fatigue after getting vaccine took much longer; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (his fatigue after getting vaccine took much longer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (Autoimmune disease). Concomitant products included CICLOSPORIN (CYCLOSPORINE) for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (his fatigue after getting vaccine took much longer). At the time of the report, FATIGUE (his fatigue after getting vaccine took much longer) outcome was unknown.            Treatment information was not provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid infection
Clinical narrative: An infection to right lower eyelid area; This spontaneous case was reported by a Health care professional and describes the occurrence of EYELID INFECTION (An infection to right lower eyelid area) in a forty-five-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced EYELID INFECTION (An infection to right lower eyelid area). The patient was treated with VORHYALURONIDASE ALFA (HYLENEX) on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency; CLARITHROMYCIN (BIAXIN) on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency; MINOCYCLINE on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency; CELECOXIB (CELEBREX) on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency and COLCHICINE on 13-Jul-2021 for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, EYELID INFECTION (An infection to right lower eyelid area) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the injector did the treatment of 1 mL of Restylane-L lot code 18885 off label to lower eyelids areas on 22 Apr 2021. The patient returned with an infection to right lower eyelid area. Patient had an unspecified vaccine in September 2020 and a routine dental cleaning on 08 Jul 2021.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyskinesia, Feeling hot, Flushing, Gait disturbance
Clinical narrative: Feels warm; Could not sleep straight because every 2-3 hours he will wake up with his leg pain; flushed; pain on his legs but mostly on his right leg; Legs jerks and it will cause pain again; Pain round the ankle going up to the legs; right arm is very itchy; Right arm is painful; veins on his both legs looks swollen; Veins on his both legs very painful to touch,; Limping/can hardly stand on his feet at the time of the call; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (right arm is very itchy), VACCINATION SITE PAIN (Right arm is painful), VASODILATATION (veins on his both legs looks swollen), VASCULAR PAIN (Veins on his both legs very painful to touch,) and GAIT DISTURBANCE (Limping/can hardly stand on his feet at the time of the call) in a 79-year-old male patient 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 Food allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced PRURITUS (right arm is very itchy), VACCINATION SITE PAIN (Right arm is painful), VASODILATATION (veins on his both legs looks swollen), VASCULAR PAIN (Veins on his both legs very painful to touch,), GAIT DISTURBANCE (Limping/can hardly stand on his feet at the time of the call), DYSKINESIA (Legs jerks and it will cause pain again) and ARTHRALGIA (Pain round the ankle going up to the legs). On 17-Aug-2021, the patient experienced FEELING HOT (Feels warm), INSOMNIA (Could not sleep straight because every 2-3 hours he will wake up with his leg pain), FLUSHING (flushed) and PAIN IN EXTREMITY (pain on his legs but mostly on his right leg). At the time of the report, PRURITUS (right arm is very itchy), VACCINATION SITE PAIN (Right arm is painful), VASODILATATION (veins on his both legs looks swollen), VASCULAR PAIN (Veins on his both legs very painful to touch,), GAIT DISTURBANCE (Limping/can hardly stand on his feet at the time of the call), FEELING HOT (Feels warm), INSOMNIA (Could not sleep straight because every 2-3 hours he will wake up with his leg pain), FLUSHING (flushed), PAIN IN EXTREMITY (pain on his legs but mostly on his right leg), DYSKINESIA (Legs jerks and it will cause pain again) and ARTHRALGIA (Pain round the ankle going up to the legs) outcome was unknown.            patient took vitamin C as concomitant medication and also  mentioned that took his first dose on 12-JUL-2021 and experienced some events. No treatment medications are provided by reporter.   This case was linked to MOD-2021-291444 (Patient Link).