chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise
Clinical narrative: feeling sick; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick) and DIARRHOEA (diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (feeling sick) and DIARRHOEA (diarrhea). At the time of the report, MALAISE (feeling sick) and DIARRHOEA (diarrhea) was resolving.            No relevant concomitant medications were reported. The patient said the lot number was unclear on the card. The patient did not receive any treatment. Action taken with mRNA-1273 in response to events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of Shingles in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced Shingles. At the time of the report, Shingles outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.  No treatment information was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pyrexia
Clinical narrative: strong heart pain that woke her up at 4 AM; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (strong heart pain that woke her up at 4 AM) and PYREXIA (Fever) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever). On 02-Apr-2021, the patient experienced CHEST PAIN (strong heart pain that woke her up at 4 AM). On 03-Apr-2021, CHEST PAIN (strong heart pain that woke her up at 4 AM) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: headache; dizziness; sore arm; felt like the bed was turning over and I falling out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt like the bed was turning over and I falling out) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (felt like the bed was turning over and I falling out). On 04-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, DIZZINESS (dizziness) was resolving and PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt like the bed was turning over and I falling out) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Headache, Pain in extremity
Clinical narrative: Bad stomach pain; Harder to breathe; headache; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN (Bad stomach pain), DYSPNOEA (Harder to breathe) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included OXYGEN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 19-Mar-2021, the patient experienced ABDOMINAL PAIN (Bad stomach pain), DYSPNOEA (Harder to breathe) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN (Bad stomach pain), DYSPNOEA (Harder to breathe) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: rash on his arm; red little raised size of baseball; red little raised size of baseball; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his arm), ERYTHEMA (red little raised size of baseball) and PERIPHERAL SWELLING (red little raised size of baseball) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash on his arm), ERYTHEMA (red little raised size of baseball) and PERIPHERAL SWELLING (red little raised size of baseball). At the time of the report, RASH (rash on his arm), ERYTHEMA (red little raised size of baseball) and PERIPHERAL SWELLING (red little raised size of baseball) had not resolved.            There were no concomitant medications provided in source document. The patient treated his symptoms with diphenhydramine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Gait disturbance, Headache, Myalgia, Vaccination site pain
Clinical narrative: Left leg uncomfortable to walk; Can feel pain in my bone; Injection  pain; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Left leg uncomfortable to walk), BONE PAIN (Can feel pain in my bone), VACCINATION SITE PAIN (Injection  pain), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016BZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced GAIT DISTURBANCE (Left leg uncomfortable to walk), BONE PAIN (Can feel pain in my bone), VACCINATION SITE PAIN (Injection  pain), HEADACHE (Headache) and MYALGIA (Muscle pain). On 03-Apr-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, GAIT DISTURBANCE (Left leg uncomfortable to walk), VACCINATION SITE PAIN (Injection  pain) and HEADACHE (Headache) outcome was unknown and BONE PAIN (Can feel pain in my bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received on 19 JUL 2021 does not contains any  new information
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pharyngeal hypoaesthesia, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Numbness continued to throat; Swelling in throat; Numbness in her left cheek and neck; Itching on the back of her neck continuing down her left arm (arm she received injection in).; Whelps; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).), PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Numbness in her left cheek and neck) and URTICARIA (Whelps) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Whelps) and RASH (Rash). On 07-Mar-2021 at 3:00 PM, the patient experienced PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).). On an unknown date, the patient experienced PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat) and HYPOAESTHESIA (Numbness in her left cheek and neck). At the time of the report, PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).), PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Numbness in her left cheek and neck) and URTICARIA (Whelps) had resolved and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Numbness continued to throat; Swelling in throat; Numbness in her left cheek and neck; Itching on the back of her neck continuing down her left arm (arm she received injection in).; Whelps; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).), PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Numbness in her left cheek and neck) and URTICARIA (Whelps) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Whelps) and RASH (Rash). On 07-Mar-2021 at 3:00 PM, the patient experienced PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).). On an unknown date, the patient experienced PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat) and HYPOAESTHESIA (Numbness in her left cheek and neck). At the time of the report, PRURITUS (Itching on the back of her neck continuing down her left arm (arm she received injection in).), PHARYNGEAL HYPOAESTHESIA (Numbness continued to throat), PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Numbness in her left cheek and neck) and URTICARIA (Whelps) had resolved and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pain, Eye pruritus, Herpes zoster, Paraesthesia
Clinical narrative: Itching; Redness; Hives; Tingling sensation; itching eye; eye pain; a cluster of bumps came up on my head; shingles; woke up with a whole swollen face and eye; severe sinusitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles), SWELLING FACE (woke up with a whole swollen face and eye), SINUSITIS (severe sinusitis), PRURITUS (Itching) and ERYTHEMA (Redness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 15-Feb-2014, Hashimoto's disease since 12-Apr-2006, Increased blood pressure and High cholesterol. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure increased, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, CARVEDILOL, LINAGLIPTIN, METFORMIN HYDROCHLORIDE (JENTADUETO) and ATORVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SWELLING FACE (woke up with a whole swollen face and eye) and SINUSITIS (severe sinusitis). On 25-Mar-2021, the patient experienced HERPES ZOSTER (shingles) and RASH (a cluster of bumps came up on my head). On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), URTICARIA (Hives), PARAESTHESIA (Tingling sensation), EYE PRURITUS (itching eye) and EYE PAIN (eye pain). The patient was treated with CEPHALEXIN [CEFALEXIN] at an unspecified dose and frequency; ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles), SWELLING FACE (woke up with a whole swollen face and eye), SINUSITIS (severe sinusitis) and RASH (a cluster of bumps came up on my head) outcome was unknown and PRURITUS (Itching), ERYTHEMA (Redness), URTICARIA (Hives), PARAESTHESIA (Tingling sensation), EYE PRURITUS (itching eye) and EYE PAIN (eye pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was with Rocephin (ceftriaxone sodium) shot and prednisone shot on 21-Mar-2021. On 23-Mar-2021 she was started on cephalexin and acyclovir and continued with oral prednisone.  No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: significant Follow-up appended
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Sinusitis, Swelling face, Urticaria
Clinical narrative: Itching; Redness; Hives; Tingling sensation; itching eye; eye pain; a cluster of bumps came up on my head; shingles; woke up with a whole swollen face and eye; severe sinusitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles), SWELLING FACE (woke up with a whole swollen face and eye), SINUSITIS (severe sinusitis), PRURITUS (Itching) and ERYTHEMA (Redness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 15-Feb-2014, Hashimoto's disease since 12-Apr-2006, Increased blood pressure and High cholesterol. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure increased, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, CARVEDILOL, LINAGLIPTIN, METFORMIN HYDROCHLORIDE (JENTADUETO) and ATORVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SWELLING FACE (woke up with a whole swollen face and eye) and SINUSITIS (severe sinusitis). On 25-Mar-2021, the patient experienced HERPES ZOSTER (shingles) and RASH (a cluster of bumps came up on my head). On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), URTICARIA (Hives), PARAESTHESIA (Tingling sensation), EYE PRURITUS (itching eye) and EYE PAIN (eye pain). The patient was treated with CEPHALEXIN [CEFALEXIN] at an unspecified dose and frequency; ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles), SWELLING FACE (woke up with a whole swollen face and eye), SINUSITIS (severe sinusitis) and RASH (a cluster of bumps came up on my head) outcome was unknown and PRURITUS (Itching), ERYTHEMA (Redness), URTICARIA (Hives), PARAESTHESIA (Tingling sensation), EYE PRURITUS (itching eye) and EYE PAIN (eye pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was with Rocephin (ceftriaxone sodium) shot and prednisone shot on 21-Mar-2021. On 23-Mar-2021 she was started on cephalexin and acyclovir and continued with oral prednisone.  No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: significant Follow-up appended
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: Missed 2nd dose of Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Missed 2nd dose of Vaccination) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Missed 2nd dose of Vaccination). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Missed 2nd dose of Vaccination) outcome was unknown. Not Provided      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.  It was reported that patient missed second dose of Vaccination on 05 Apr 2021 and now had her second dose. She was doing fine.      Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up information was received on 16 May 2021 as a telephone contact report in which patient details.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Irregular sleep wake rhythm disorder, Pruritus, Rash
Clinical narrative: Itchy all over; first started on back, stomach, arms, leg,; today on face; I still woke up from sleep because of itch; rash is hard to see, there are little bumps; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over), PRURITUS (first started on back, stomach, arms, leg,), PRURITUS (today on face), IRREGULAR SLEEP WAKE RHYTHM DISORDER (I still woke up from sleep because of itch) and RASH (rash is hard to see, there are little bumps) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PRURITUS (Itchy all over), PRURITUS (first started on back, stomach, arms, leg,), PRURITUS (today on face), IRREGULAR SLEEP WAKE RHYTHM DISORDER (I still woke up from sleep because of itch) and RASH (rash is hard to see, there are little bumps). The patient was treated with LIDOCAINE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy all over), PRURITUS (first started on back, stomach, arms, leg,), PRURITUS (today on face), IRREGULAR SLEEP WAKE RHYTHM DISORDER (I still woke up from sleep because of itch) and RASH (rash is hard to see, there are little bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blister, Cough, Diarrhoea, Herpes zoster
Clinical narrative: hives; prickling/tingling; cough; feeling hot/ flush; hypersensitivity reaction; nerve pain; shingles; severe diarrhea; upset stomach; swelling in armpit; fever; She experienced itchiness on her breast area; Blisters; She experienced itchiness on her left arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), URTICARIA (hives), PARAESTHESIA (prickling/tingling) and COUGH (cough) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Morphine, rash from head to toe), Allergy to antibiotic (amoxicillin rash, 5 to 10 days after.), Drug allergy (Opioids: Percocet, cause upset stomach, rash), Penicillin allergy (upset stomach after 5 days), Sulfonamide allergy (rash), Drug allergy (Vantin - severe diarrhea) and Drug allergy (Chlorycetin - rash and upset stomach). Concomitant products included RAMIPRIL, MULTIVITAMIN & MINERAL, UBIDECARENONE (COQ10 [UBIDECARENONE]), TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) and RASH (Rash). On 28-Mar-2021, the patient experienced URTICARIA (hives), PARAESTHESIA (prickling/tingling), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), NEURALGIA (nerve pain), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever). The patient was treated with CLOTRIMAZOLE (TERRASIL ANTI FUNGAL TREATMENT) at a dose of 1 dosage form. At the time of the report, PRURITUS (She experienced itchiness on her breast area), PARAESTHESIA (prickling/tingling), NEURALGIA (nerve pain) and VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) had not resolved and BLISTER (Blisters), URTICARIA (hives), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), RASH (Rash), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: ADR: safety info. anaphylaxis form
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypersensitivity, Lymphadenopathy, Neuralgia, Paraesthesia
Clinical narrative: hives; prickling/tingling; cough; feeling hot/ flush; hypersensitivity reaction; nerve pain; shingles; severe diarrhea; upset stomach; swelling in armpit; fever; She experienced itchiness on her breast area; Blisters; She experienced itchiness on her left arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), URTICARIA (hives), PARAESTHESIA (prickling/tingling) and COUGH (cough) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Morphine, rash from head to toe), Allergy to antibiotic (amoxicillin rash, 5 to 10 days after.), Drug allergy (Opioids: Percocet, cause upset stomach, rash), Penicillin allergy (upset stomach after 5 days), Sulfonamide allergy (rash), Drug allergy (Vantin - severe diarrhea) and Drug allergy (Chlorycetin - rash and upset stomach). Concomitant products included RAMIPRIL, MULTIVITAMIN & MINERAL, UBIDECARENONE (COQ10 [UBIDECARENONE]), TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) and RASH (Rash). On 28-Mar-2021, the patient experienced URTICARIA (hives), PARAESTHESIA (prickling/tingling), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), NEURALGIA (nerve pain), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever). The patient was treated with CLOTRIMAZOLE (TERRASIL ANTI FUNGAL TREATMENT) at a dose of 1 dosage form. At the time of the report, PRURITUS (She experienced itchiness on her breast area), PARAESTHESIA (prickling/tingling), NEURALGIA (nerve pain) and VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) had not resolved and BLISTER (Blisters), URTICARIA (hives), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), RASH (Rash), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: ADR: safety info. anaphylaxis form
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Urticaria, Vaccination site pruritus
Clinical narrative: hives; prickling/tingling; cough; feeling hot/ flush; hypersensitivity reaction; nerve pain; shingles; severe diarrhea; upset stomach; swelling in armpit; fever; She experienced itchiness on her breast area; Blisters; She experienced itchiness on her left arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), URTICARIA (hives), PARAESTHESIA (prickling/tingling) and COUGH (cough) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Morphine, rash from head to toe), Allergy to antibiotic (amoxicillin rash, 5 to 10 days after.), Drug allergy (Opioids: Percocet, cause upset stomach, rash), Penicillin allergy (upset stomach after 5 days), Sulfonamide allergy (rash), Drug allergy (Vantin - severe diarrhea) and Drug allergy (Chlorycetin - rash and upset stomach). Concomitant products included RAMIPRIL, MULTIVITAMIN & MINERAL, UBIDECARENONE (COQ10 [UBIDECARENONE]), TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) and RASH (Rash). On 28-Mar-2021, the patient experienced URTICARIA (hives), PARAESTHESIA (prickling/tingling), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), NEURALGIA (nerve pain), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever). The patient was treated with CLOTRIMAZOLE (TERRASIL ANTI FUNGAL TREATMENT) at a dose of 1 dosage form. At the time of the report, PRURITUS (She experienced itchiness on her breast area), PARAESTHESIA (prickling/tingling), NEURALGIA (nerve pain) and VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) had not resolved and BLISTER (Blisters), URTICARIA (hives), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), RASH (Rash), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: ADR: safety info. anaphylaxis form
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine is administered to 16yr old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine is administered to 16yr old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine is administered to 16yr old). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine is administered to 16yr old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills) and PYREXIA (fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (body aches), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills) and PYREXIA (fever) had not resolved. Not Provided          No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Fatigue, Pyrexia
Clinical narrative: Positive COVID-19 test 6 days after first vaccine shot; Fever; Fatigue; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), COVID-19 (Positive COVID-19 test 6 days after first vaccine shot), PYREXIA (Fever) and FATIGUE (Fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, BUPROPION HYDROCHLORIDE (WELLBUTRIN XL), ACETYLSALICYLIC ACID (ASPIRIN 1000) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion), PYREXIA (Fever) and FATIGUE (Fatigue). On 23-Mar-2021, the patient experienced COVID-19 (Positive COVID-19 test 6 days after first vaccine shot). At the time of the report, CONFUSIONAL STATE (Confusion), COVID-19 (Positive COVID-19 test 6 days after first vaccine shot), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       diagnosed with COVID-19 on 23Mar2021, 6 days after vaccination. He is scheduled for the second dose on 14Arp2021. Concomitant medication includes Sleeping aide pill. No treatment information were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Sore arm with limited mobility; Sore arm with limited mobility; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Sore arm with limited mobility), PAIN IN EXTREMITY (Sore arm with limited mobility), CHILLS (Chills) and MYALGIA (Body Aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced MOBILITY DECREASED (Sore arm with limited mobility), PAIN IN EXTREMITY (Sore arm with limited mobility), CHILLS (Chills) and MYALGIA (Body Aches). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Fever, at an unspecified dose and frequency and CAMPHOR, MENTHOL, METHYL SALICYLATE (BENGAY [CAMPHOR;MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Sore arm with limited mobility), PAIN IN EXTREMITY (Sore arm with limited mobility), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown.            Concomitant product details not provided.   This case was linked to MOD-2021-037106 (E2B Linked Report).; Sender's Comments:  MOD-2021-037106:1st Dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: 6 styes on her right eye; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (6 styes on her right eye) 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) (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 HORDEOLUM (6 styes on her right eye). At the time of the report, HORDEOLUM (6 styes on her right eye) outcome was unknown.            No relevant concomitant medications were reported. The reporter stated that patient had to get her eye drained and seek medical attention. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. The reporter did not provide an assessment for the event (s), HORDEOLUM (6 styes on her right eye).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-significant Follow-up Appended/ Patient's contact information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-156188:Case for dose 2
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces soft, Flatulence
Clinical narrative: Diarrhea; Gassiness; Soft stool; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA, FLATULENCE, and FAECES SOFT in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA, FLATULENCE, and FAECES SOFT. At the time of the report, DIARRHOEA, FLATULENCE, and FAECES SOFT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details not provided.  Treatment details not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: sore throat; flu-like syndrome; fever (99.8F); fatigue; Headache; body aches; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (body aches), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, Headache and Chills, at an unspecified dose and frequency. On 04-Apr-2021, OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (body aches), NAUSEA (nausea) and CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products details not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; flu-like syndrome; fever (99.8F); fatigue; Headache; body aches; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (body aches), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, Headache and Chills, at an unspecified dose and frequency. On 04-Apr-2021, OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (body aches), NAUSEA (nausea) and CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products details not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: soreness in arm; stiffness in joints, shoulders and knees; left leg swelling; feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), MUSCULOSKELETAL STIFFNESS (stiffness in joints, shoulders and knees), PERIPHERAL SWELLING (left leg swelling) and FEELING ABNORMAL (feeling horrible) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm), MUSCULOSKELETAL STIFFNESS (stiffness in joints, shoulders and knees), PERIPHERAL SWELLING (left leg swelling) and FEELING ABNORMAL (feeling horrible). The patient was treated with PREDNISONE at an unspecified dose and frequency and MONTELUKAST at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm), MUSCULOSKELETAL STIFFNESS (stiffness in joints, shoulders and knees), PERIPHERAL SWELLING (left leg swelling) and FEELING ABNORMAL (feeling horrible) outcome was unknown. Not Provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site induration, Injection site warmth
Clinical narrative: Injection site was warm; Injection site was pink; Injection site hardening; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site was warm), INJECTION SITE DISCOLOURATION (Injection site was pink) and INJECTION SITE INDURATION (Injection site hardening) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced INJECTION SITE WARMTH (Injection site was warm), INJECTION SITE DISCOLOURATION (Injection site was pink) and INJECTION SITE INDURATION (Injection site hardening). At the time of the report, INJECTION SITE WARMTH (Injection site was warm), INJECTION SITE DISCOLOURATION (Injection site was pink) and INJECTION SITE INDURATION (Injection site hardening) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient explained that she would experience injection site warmth, induration and discoloration immediately after receiving tetanus shot.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: soreness at the site of the injection in left arm; headache; chills; muscle pains,; joint pain; feverish; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,), ARTHRALGIA (joint pain) and PYREXIA (feverish). The patient was treated with ACETAMINOPHEN for Fever, Chills and Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, Muscle pain and Joint pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,), ARTHRALGIA (joint pain) and PYREXIA (feverish) outcome was unknown.            There were no concomitant medications provided in source document. The patient has taken acetaminophen and ibuprofen as needed for her symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the site of the injection in left arm; headache; chills; muscle pains,; joint pain; feverish; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,), ARTHRALGIA (joint pain) and PYREXIA (feverish). The patient was treated with ACETAMINOPHEN for Fever, Chills and Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, Muscle pain and Joint pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,), ARTHRALGIA (joint pain) and PYREXIA (feverish) outcome was unknown.            There were no concomitant medications provided in source document. The patient has taken acetaminophen and ibuprofen as needed for her symptoms.