chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     Previously administered products included for Shingles: Shingrix (Shingles Vaccine). Past adverse reactions to the above products included No adverse event with Shingrix. Concurrent medical conditions included Asthma since 1996, Hypersensitivity reaction, Allergy to antibiotic (Avelox allergy Facial swelling, lip swelling, eye lid swelling), Overgrowth bacterial since 13-Apr-2013, Hay fever and Hives. Concomitant products included MELATONIN from April 2020 to an unknown date for Sleep problem, VITAMIN D3 from April 2015 to an unknown date for an unknown indication.    On 10-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). The patient was treated with SALBUTAMOL (nasal) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 10-Mar-2021 to 13-Mar-2021 for Hypersensitivity reaction, at a dose of UNK, prn. On 13-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had headache and fatigue for 3 or 4 days.Event was recovered on 26-2021. Patient experienced similar events after second dose.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient's medical history of previous hypersensitivity reactions is a confounding factor that may play a possible contributory role.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: ADR form was received on 17-JUN-2021. Patient's demographics such as race, ethnicity, weight, height was added. Patient's relevant medical history, concomitant medications was updated. Patient was diagnosed with hypersensitivity reaction, so this event was included. Event outcome was updated. It contains significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient's medical history of previous hypersensitivity reactions is a confounding factor that may play a possible contributory role.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue
Clinical narrative: Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark; Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark). At the time of the report, PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: The completed Form includes an update to patient's race and additional event details, the patient had not received 2nd dose at the time of the FU report
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea, Somnolence
Clinical narrative: Dizziness; head feels like its numb; feels like he is in "drunk mode"; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient reached primary care professional (PCP) who advised him to wait for 48 hours for events to subside. No treatment was taken by the patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore) and FATIGUE (extremely fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included DILTIAZEM for Atrial fibrillation, APIXABAN (ELIQUIS) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (arm was sore). On 07-Feb-2021, the patient experienced FATIGUE (extremely fatigue). At the time of the report, MYALGIA (arm was sore) and FATIGUE (extremely fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Treatment information was not provided.   This case was linked to MOD-2021-045433 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.     On 14-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Weak; Flu like symptoms; Sore arm; chills really bad; Really tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (chills really bad) and FATIGUE (Really tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history 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 ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (chills really bad), FATIGUE (Really tired) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (chills really bad), FATIGUE (Really tired) and PYREXIA (Fever) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weak; Flu like symptoms; Sore arm; chills really bad; Really tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (chills really bad) and FATIGUE (Really tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history 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 ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (chills really bad), FATIGUE (Really tired) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (chills really bad), FATIGUE (Really tired) and PYREXIA (Fever) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Hard on Injection Site; Itchiness; Rash; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard on Injection Site), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard on Injection Site), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE INDURATION (Hard on Injection Site), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-Apr-2021, email id received. On 20-Apr-2021: Follow up received on 20-Apr-2021, no new information was recorded
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site haemorrhage
Clinical narrative: Vaccination site discolouration; Vaccination site hemorrhage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Vaccination site discolouration) and VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Vaccination site discolouration) and VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage). At the time of the report, VACCINATION SITE DISCOLOURATION (Vaccination site discolouration) and VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 1 dose Moderna / second dose Johnson and Johnson; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1 dose Moderna / second dose Johnson and Johnson) 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 INTERCHANGE OF VACCINE PRODUCTS (1 dose Moderna / second dose Johnson and Johnson). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1 dose Moderna / second dose Johnson and Johnson) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No specific patient information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling) and ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Knee swelling) and ARTHRALGIA (Knee pain). At the time of the report, JOINT SWELLING (Knee swelling) and ARTHRALGIA (Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.   The reporter noted that the patient did not have any chronic medical problems.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash under the armpits of both arms, groin area, and under her breasts.; Red itchy rash under the armpits of both arms, groin area, and under her breasts.; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) and RASH PRURITIC (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) and RASH PRURITIC (Red itchy rash under the armpits of both arms, groin area, and under her breasts.). At the time of the report, RASH ERYTHEMATOUS (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) and RASH PRURITIC (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Heart rate, Pain, Pain in extremity, Vaccination site mass
Clinical narrative: A friend's bad reaction, so weird; He had a pop/knot raised in the shot arm; the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great; Radiating up and down his spine/radiating up and down his head; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (A friend's bad reaction, so weird), VACCINATION SITE MASS (He had a pop/knot raised in the shot arm), PAIN IN EXTREMITY (the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great) and PAIN (Radiating up and down his spine/radiating up and down his head) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L020A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 15-Jan-2021 to 21-Jan-2021.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (A friend's bad reaction, so weird), VACCINATION SITE MASS (He had a pop/knot raised in the shot arm), PAIN IN EXTREMITY (the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great) and PAIN (Radiating up and down his spine/radiating up and down his head). The patient was treated with MELATONIN at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (A friend's bad reaction, so weird), VACCINATION SITE MASS (He had a pop/knot raised in the shot arm), PAIN IN EXTREMITY (the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great) and PAIN (Radiating up and down his spine/radiating up and down his head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 102 (High) heart rate was 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was reported.   No treatment information was reported.   This case was linked to MOD-2021-059391 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Secondary reporter information, Patient's medical history, Batch/Lot number of vaccine and treatment medicine were added.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick after second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 (Got sick after second shot). At the time of the report, ILLNESS (Got sick after second shot) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-053335, MOD21-053410 (E2B Linked Report).; Sender's Comments:  MOD21-053335:Cross link MOD21-053410:Cross link
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Site of injection started itching; site of injection started itching and developed red mark/Red mark is 2 inches by 3inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection started itching) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark/Red mark is 2 inches by 3inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     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 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection started itching) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark/Red mark is 2 inches by 3inches). At the time of the report, VACCINATION SITE PRURITUS (Site of injection started itching) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark/Red mark is 2 inches by 3inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up appended.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Headache; Joint Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs was provided No treatment information was provided.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Depressed mood, Dizziness, Fatigue
Clinical narrative: Itchiness on different parts of his Body; Dizziness; I am not my usual self / everything is turned upside down; Pain on his right knee; Usually walk a mild daily and now i can not get out of my house / I am very tired; morning when i went to have breakfast y laid down, did not loose my conscious; It is hard to sleep, last night i was up and down all night, did not get my sleep; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (morning when i went to have breakfast y laid down, did not loose my conscious), PRURITUS (Itchiness on different parts of his Body), DIZZINESS (Dizziness), DEPRESSED MOOD (I am not my usual self / everything is turned upside down) and INSOMNIA (It is hard to sleep, last night i was up and down all night, did not get my sleep) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 14-Mar-2021, the patient experienced INSOMNIA (It is hard to sleep, last night i was up and down all night, did not get my sleep). On 15-Mar-2021, the patient experienced ASTHENIA (morning when i went to have breakfast y laid down, did not loose my conscious). On an unknown date, the patient experienced PRURITUS (Itchiness on different parts of his Body), DIZZINESS (Dizziness), DEPRESSED MOOD (I am not my usual self / everything is turned upside down), ARTHRALGIA (Pain on his right knee) and FATIGUE (Usually walk a mild daily and now i can not get out of my house / I am very tired). The patient was treated with CORTISOL [HYDROCORTISONE] (topical) ongoing since an unknown date for Itching, at a dose of UNK dosage form. At the time of the report, ASTHENIA (morning when i went to have breakfast y laid down, did not loose my conscious), PRURITUS (Itchiness on different parts of his Body), DIZZINESS (Dizziness), DEPRESSED MOOD (I am not my usual self / everything is turned upside down), INSOMNIA (It is hard to sleep, last night i was up and down all night, did not get my sleep), ARTHRALGIA (Pain on his right knee) and FATIGUE (Usually walk a mild daily and now i can not get out of my house / I am very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take concomitant cholesterol medicine. The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR received on 22-Jun-21 Updated all the first dose events are resolved, Patient did not experience anything after his second Dose.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: Itchiness on different parts of his Body; Dizziness; I am not my usual self / everything is turned upside down; Pain on his right knee; Usually walk a mild daily and now i can not get out of my house / I am very tired; morning when i went to have breakfast y laid down, did not loose my conscious; It is hard to sleep, last night i was up and down all night, did not get my sleep; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (morning when i went to have breakfast y laid down, did not loose my conscious), PRURITUS (Itchiness on different parts of his Body), DIZZINESS (Dizziness), DEPRESSED MOOD (I am not my usual self / everything is turned upside down) and INSOMNIA (It is hard to sleep, last night i was up and down all night, did not get my sleep) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 14-Mar-2021, the patient experienced INSOMNIA (It is hard to sleep, last night i was up and down all night, did not get my sleep). On 15-Mar-2021, the patient experienced ASTHENIA (morning when i went to have breakfast y laid down, did not loose my conscious). On an unknown date, the patient experienced PRURITUS (Itchiness on different parts of his Body), DIZZINESS (Dizziness), DEPRESSED MOOD (I am not my usual self / everything is turned upside down), ARTHRALGIA (Pain on his right knee) and FATIGUE (Usually walk a mild daily and now i can not get out of my house / I am very tired). The patient was treated with CORTISOL [HYDROCORTISONE] (topical) ongoing since an unknown date for Itching, at a dose of UNK dosage form. At the time of the report, ASTHENIA (morning when i went to have breakfast y laid down, did not loose my conscious), PRURITUS (Itchiness on different parts of his Body), DIZZINESS (Dizziness), DEPRESSED MOOD (I am not my usual self / everything is turned upside down), INSOMNIA (It is hard to sleep, last night i was up and down all night, did not get my sleep), ARTHRALGIA (Pain on his right knee) and FATIGUE (Usually walk a mild daily and now i can not get out of my house / I am very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take concomitant cholesterol medicine. The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR received on 22-Jun-21 Updated all the first dose events are resolved, Patient did not experience anything after his second Dose.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizzy; Low Grade Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and PYREXIA (Low Grade Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy) and PYREXIA (Low Grade Fever). At the time of the report, DIZZINESS (Dizzy) had not resolved and PYREXIA (Low Grade Fever) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: feet swelling; yellow bumps; fever; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PERIPHERAL SWELLING (feet swelling), MASS (yellow bumps) and PYREXIA (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thalassemia.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and PYREXIA (fever). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (feet swelling) and MASS (yellow bumps). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DICLOFENAC DIETHYLAMINE (VOLTAREN EMULGEL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), PERIPHERAL SWELLING (feet swelling), MASS (yellow bumps) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm got sore; Red circle 1-1/2 inches in diameter around the injection site; Swollen at the injection site; Itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm got sore), VACCINATION SITE ERYTHEMA (Red circle 1-1/2 inches in diameter around the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LETROZOLE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm got sore), VACCINATION SITE ERYTHEMA (Red circle 1-1/2 inches in diameter around the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site). At the time of the report, PAIN IN EXTREMITY (Arm got sore), VACCINATION SITE ERYTHEMA (Red circle 1-1/2 inches in diameter around the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Musculoskeletal stiffness, Neck pain, Neuralgia
Clinical narrative: stiff neck; numbness; neuritis; pain on the shoulder; pain on the neck area; nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain on the neck area), NEURALGIA (nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm), MUSCULOSKELETAL STIFFNESS (stiff neck), HYPOAESTHESIA (numbness) and NEURITIS (neuritis) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (history of arthritis in the shoulder and neck), Allergy to antibiotic (Sulfa allergy) and Seasonal allergy (seasonal allergies). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced NECK PAIN (pain on the neck area), NEURALGIA (nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm) and ARTHRALGIA (pain on the shoulder). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), HYPOAESTHESIA (numbness) and NEURITIS (neuritis). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain on the neck area), NEURALGIA (nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm) and MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved and HYPOAESTHESIA (numbness), NEURITIS (neuritis) and ARTHRALGIA (pain on the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       MRI lab test was performed and it presented as neuritis.  Muscle relaxer and anit- inflammatory were used as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10 May 2021: lad details, medical history, concomitant medication, events and event outcome were updated. On 15-Jul-2021: followup was received on 15 Jul 2021: contains no new information
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neuritis
Clinical narrative: stiff neck; numbness; neuritis; pain on the shoulder; pain on the neck area; nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain on the neck area), NEURALGIA (nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm), MUSCULOSKELETAL STIFFNESS (stiff neck), HYPOAESTHESIA (numbness) and NEURITIS (neuritis) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (history of arthritis in the shoulder and neck), Allergy to antibiotic (Sulfa allergy) and Seasonal allergy (seasonal allergies). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced NECK PAIN (pain on the neck area), NEURALGIA (nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm) and ARTHRALGIA (pain on the shoulder). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), HYPOAESTHESIA (numbness) and NEURITIS (neuritis). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain on the neck area), NEURALGIA (nerve pain still through my left shoulder,nerve pain still through my neck,nerve pain still all the way down my arm - left arm) and MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved and HYPOAESTHESIA (numbness), NEURITIS (neuritis) and ARTHRALGIA (pain on the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       MRI lab test was performed and it presented as neuritis.  Muscle relaxer and anit- inflammatory were used as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10 May 2021: lad details, medical history, concomitant medication, events and event outcome were updated. On 15-Jul-2021: followup was received on 15 Jul 2021: contains no new information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter) and PAIN IN EXTREMITY (Arm was sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CONTUSION (Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter) and PAIN IN EXTREMITY (Arm was sore). At the time of the report, CONTUSION (Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter) and PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; A spontaneous report was received from Pharmacist concerning a 58-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial that went through a temperature excursion/product storage error.  The patient's medical history was not provided. Concomitant medications were not provided.  On an unknown date, the patient received their first of the two planned doses of mRNA-1273 (lot number: 027L20A) intramuscularly for the prophylaxis of COVID-19 infection.  It was reported that patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion.  Treatment medication included none.  No lab tests were mentioned.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion was considered resolved.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 027L20A with no associated Adverse Events.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 20 patients rceeived vaccine with possible temperature ecursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (20 patients rceeived vaccine with possible temperature ecursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (20 patients rceeived vaccine with possible temperature ecursion). On 15-Mar-2021, PRODUCT STORAGE ERROR (20 patients rceeived vaccine with possible temperature ecursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Ear haemorrhage, Fatigue, Headache
Clinical narrative: Body pain; Blood in ears; Shortness of breath; Congested; Flu-like symptoms; Sore and red at injection site; Sore and red at injection site; Headaches in temples and across head; Low grade fever; Really tired; Throwing up; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain), EAR HAEMORRHAGE (Blood in ears), DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congested) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039V20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body pain), EAR HAEMORRHAGE (Blood in ears), DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congested), INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE PAIN (Sore and red at injection site), VACCINATION SITE ERYTHEMA (Sore and red at injection site), HEADACHE (Headaches in temples and across head), PYREXIA (Low grade fever), FATIGUE (Really tired), VOMITING (Throwing up) and NAUSEA (Nauseous). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, PAIN (Body pain), EAR HAEMORRHAGE (Blood in ears), DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congested), INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE PAIN (Sore and red at injection site), VACCINATION SITE ERYTHEMA (Sore and red at injection site), HEADACHE (Headaches in temples and across head), PYREXIA (Low grade fever), FATIGUE (Really tired), VOMITING (Throwing up) and NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) Low.         No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.    Action taken with mRNA-1273 in response to the events was not applicable.