chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Recieved the 1st Dose of the Moderna Vaccine 48 Days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recieved the 1st Dose of the Moderna Vaccine 48 Days ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recieved the 1st Dose of the Moderna Vaccine 48 Days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recieved the 1st Dose of the Moderna Vaccine 48 Days ago) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient reported that no AEs experienced after 2nd dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: very tired; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (very tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Undergoing Chemotherapy.  Patient is also in the process of getting chemotherapy, got the first chemo on 21Dec2020, second chemo on 11Jan2021, third chemo on 1Feb2021, and fourth chemo on 22Feb2021. He is expected to get two more chemo treatments.).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (soreness). On 13-Feb-2021, the patient experienced FATIGUE (very tired). On 13-Feb-2021, PAIN (soreness) and FATIGUE (very tired) had resolved. Not Provided          Treatment information was not provided.   This case was linked to MOD-2021-039321 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ASTHMA (persisted asthma for a month), PYREXIA (Fever) and CHILLS (chills) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (persisted asthma for a month), PYREXIA (Fever) and CHILLS (chills). At the time of the report, ASTHMA (persisted asthma for a month), PYREXIA (Fever) and CHILLS (chills) outcome was unknown. Not Provided. 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 medication were provided by the reporter. Reporter did not allow further contact.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Nausea; Body aches; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), MYALGIA (Body aches) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Body aches) and FATIGUE (Tired). At the time of the report, NAUSEA (Nausea), MYALGIA (Body aches) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information  received on 07-May-2021 contains non-significant information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot injection site; A big huge hive is covering injection site is huge; Itchy injection site; Injection site is red; Swollen injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.     This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), INJECTION SITE URTICARIA (A big huge hive is covering injection site is huge), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Swollen injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history. ).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), INJECTION SITE URTICARIA (A big huge hive is covering injection site is huge), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE WARMTH (Hot injection site), INJECTION SITE URTICARIA (A big huge hive is covering injection site is huge), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Swollen injection site) 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. The treatment was included Benadryl as advise by her pharmacy  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Rash
Clinical narrative: chilie; lymph gland swollen; rash; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilie), LYMPHADENOPATHY (lymph gland swollen) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chilie), LYMPHADENOPATHY (lymph gland swollen) and RASH (rash). At the time of the report, CHILLS (chilie) was resolving, LYMPHADENOPATHY (lymph gland swollen) had not resolved and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling cold, Myalgia, Pain in extremity
Clinical narrative: back pain,can not straighten up; body pain; shaking chills; Felt cold; her right arm hurts as much as her left arm ( the one who was vaccinated); the right it is a little swollen but the left arm is more swollen; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold) and PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) in a 52-year-old female 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 information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold), PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) and PERIPHERAL SWELLING (the right it is a little swollen but the left arm is more swollen). At the time of the report, BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold), PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) and PERIPHERAL SWELLING (the right it is a little swollen but the left arm is more swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: back pain,can not straighten up; body pain; shaking chills; Felt cold; her right arm hurts as much as her left arm ( the one who was vaccinated); the right it is a little swollen but the left arm is more swollen; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold) and PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) in a 52-year-old female 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 information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold), PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) and PERIPHERAL SWELLING (the right it is a little swollen but the left arm is more swollen). At the time of the report, BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold), PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) and PERIPHERAL SWELLING (the right it is a little swollen but the left arm is more swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination site inflammation
Clinical narrative: hot at injection site; itchy at injection site; pink at injection site; hard inflamation on shoulder 2.5 inches and lasted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (hard inflamation on shoulder 2.5 inches and lasted), INJECTION SITE WARMTH (hot at injection site), INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (pink at injection site) in an 80-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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (hard inflamation on shoulder 2.5 inches and lasted). On 25-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot at injection site), INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (pink at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 20-Feb-2021, VACCINATION SITE INFLAMMATION (hard inflamation on shoulder 2.5 inches and lasted) had resolved. At the time of the report, INJECTION SITE WARMTH (hot at injection site), INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (pink at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: face started tingling; Swelling of lymph nodes in right arm pit; When she lifts her arm, she feels pain down to her wrist; All her skin became very sensitive / her blankets felt like burlap; Teeth chattering chills; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist), PARAESTHESIA (face started tingling), LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit) and CHILLS (Teeth chattering chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), CHILLS (Teeth chattering chills) and MYALGIA (Body pain). On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist) and LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit). On an unknown date, the patient experienced PARAESTHESIA (face started tingling). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 06-Mar-2021, SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), CHILLS (Teeth chattering chills) and MYALGIA (Body pain) had resolved. At the time of the report, PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist), PARAESTHESIA (face started tingling) and LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit) outcome was unknown.            No concomitant medication reported. Patient reported that she had the vaccine last Friday (2nd dose) 05-Mar-2021 at 10 AM in her right arm, lot 029A21A. That evening, patient had teeth chattering chills, body pain, all her skin became very sensitive, her blankets felt like burlap. Patient took acetaminophen. The symptoms subsided by Saturday. Sunday, patient started with swelling of lymph nodes in right arm pit. When she lifts her arm, she feels pain down to her wrist.. Patient still has a lot of swelling in her lymph nodes in that arm.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: follow up received on 19-Mar-2021. No significant information updated
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: face started tingling; Swelling of lymph nodes in right arm pit; When she lifts her arm, she feels pain down to her wrist; All her skin became very sensitive / her blankets felt like burlap; Teeth chattering chills; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist), PARAESTHESIA (face started tingling), LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit) and CHILLS (Teeth chattering chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), CHILLS (Teeth chattering chills) and MYALGIA (Body pain). On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist) and LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit). On an unknown date, the patient experienced PARAESTHESIA (face started tingling). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 06-Mar-2021, SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), CHILLS (Teeth chattering chills) and MYALGIA (Body pain) had resolved. At the time of the report, PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist), PARAESTHESIA (face started tingling) and LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit) outcome was unknown.            No concomitant medication reported. Patient reported that she had the vaccine last Friday (2nd dose) 05-Mar-2021 at 10 AM in her right arm, lot 029A21A. That evening, patient had teeth chattering chills, body pain, all her skin became very sensitive, her blankets felt like burlap. Patient took acetaminophen. The symptoms subsided by Saturday. Sunday, patient started with swelling of lymph nodes in right arm pit. When she lifts her arm, she feels pain down to her wrist.. Patient still has a lot of swelling in her lymph nodes in that arm.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: follow up received on 19-Mar-2021. No significant information updated
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site warmth, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Skin reaction was hot to touch; Hardness around the injection site; Itchiness around the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Skin reaction was hot to touch), INJECTION SITE INDURATION (Hardness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE WARMTH (Skin reaction was hot to touch), INJECTION SITE INDURATION (Hardness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Skin reaction was hot to touch), INJECTION SITE INDURATION (Hardness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Mar-2021, patient got a second reaction larger than first. The original injection site, skin all around the first injection site from the shoulder to wear the arm bend the redness, hardness and itchiness had returned.  No concomitant medication were provided by the reporter.   Patient used Hydrocortisone cream as directed by pharmacy for treatment which helped to dissolve the reaction.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Neck pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain) and HEADACHE (Headache). At the time of the report, NECK PAIN (Neck pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided by reporter.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Not received the second dose after 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 36 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 36 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up information was received and contain no new information
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: Dizziness; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and MYALGIA (Body Aches) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and MYALGIA (Body Aches). At the time of the report, DIZZINESS (Dizziness) and MYALGIA (Body Aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    This case was linked to MOD-2021-039244 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI; Sender's Comments:  MOD-2021-039244:mother case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersomnia, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Did not feel good; Slept all day; Fever 101.4F to 101.6F; Joints ache; Tenderness at site of injection; Pain at site of injection; Legs ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs ache), MALAISE (Did not feel good), HYPERSOMNIA (Slept all day), PYREXIA (Fever 101.4F to 101.6F) and ARTHRALGIA (Joints ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs ache), PYREXIA (Fever 101.4F to 101.6F), ARTHRALGIA (Joints ache), VACCINATION SITE PAIN (Tenderness at site of injection) and VACCINATION SITE PAIN (Pain at site of injection). On 07-Mar-2021, the patient experienced MALAISE (Did not feel good) and HYPERSOMNIA (Slept all day). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site tenderness, Pain in extremity, Joint pain and Pyrexia, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs ache), MALAISE (Did not feel good), HYPERSOMNIA (Slept all day), PYREXIA (Fever 101.4F to 101.6F), ARTHRALGIA (Joints ache), VACCINATION SITE PAIN (Tenderness at site of injection) and VACCINATION SITE PAIN (Pain at site of injection) was resolving.            Concomitant medications also included eye vitamin.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Did not feel good; Slept all day; Fever 101.4F to 101.6F; Joints ache; Tenderness at site of injection; Pain at site of injection; Legs ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs ache), MALAISE (Did not feel good), HYPERSOMNIA (Slept all day), PYREXIA (Fever 101.4F to 101.6F) and ARTHRALGIA (Joints ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs ache), PYREXIA (Fever 101.4F to 101.6F), ARTHRALGIA (Joints ache), VACCINATION SITE PAIN (Tenderness at site of injection) and VACCINATION SITE PAIN (Pain at site of injection). On 07-Mar-2021, the patient experienced MALAISE (Did not feel good) and HYPERSOMNIA (Slept all day). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site tenderness, Pain in extremity, Joint pain and Pyrexia, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs ache), MALAISE (Did not feel good), HYPERSOMNIA (Slept all day), PYREXIA (Fever 101.4F to 101.6F), ARTHRALGIA (Joints ache), VACCINATION SITE PAIN (Tenderness at site of injection) and VACCINATION SITE PAIN (Pain at site of injection) was resolving.            Concomitant medications also included eye vitamin.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Cough, Decreased appetite, Fatigue
Clinical narrative: Cough; Hotness; Lack of appetite; Bone and muscle ache; Fatigue; Fever; Bone and muscle ache; Tested positive to Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive to Covid-19), COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite) and BONE PAIN (Bone and muscle ache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L20A) 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) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Tested positive to Covid-19). On an unknown date, the patient experienced COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite), BONE PAIN (Bone and muscle ache), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Bone and muscle ache). At the time of the report, COVID-19 (Tested positive to Covid-19), COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite), BONE PAIN (Bone and muscle ache), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Bone and muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive to Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included cough and fever medicine to treat symptoms and was given an injection. Second dose was scheduled on 02Apr2021. No relevant concomitant medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough; Hotness; Lack of appetite; Bone and muscle ache; Fatigue; Fever; Bone and muscle ache; Tested positive to Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive to Covid-19), COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite) and BONE PAIN (Bone and muscle ache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L20A) 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) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Tested positive to Covid-19). On an unknown date, the patient experienced COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite), BONE PAIN (Bone and muscle ache), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Bone and muscle ache). At the time of the report, COVID-19 (Tested positive to Covid-19), COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite), BONE PAIN (Bone and muscle ache), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Bone and muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive to Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included cough and fever medicine to treat symptoms and was given an injection. Second dose was scheduled on 02Apr2021. No relevant concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Pruritus, Rash
Clinical narrative: discomfort in her arm; rash on her face; I had a severely itchy face that burned; I had a severely itchy face that burned; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in her arm), RASH (rash on her face), PRURITUS (I had a severely itchy face that burned) and BURNING SENSATION (I had a severely itchy face that burned) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gluten sensitivity (She notes that she has to watch her gluten or else she gets a rash.), Asthma, Hypersensitive skin (Skin Allergies, severe) and Drug allergy (Allergy, Desoximetasone (cortisone)).   On 24-Feb-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 an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in her arm), RASH (rash on her face), PRURITUS (I had a severely itchy face that burned) and BURNING SENSATION (I had a severely itchy face that burned). The patient was treated with TACROLIMUS MONOHYDRATE (PROTOPIC) for Rash, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (discomfort in her arm) outcome was unknown and RASH (rash on her face), PRURITUS (I had a severely itchy face that burned) and BURNING SENSATION (I had a severely itchy face that burned) had resolved.            The Patient found out around that time that she is allergic to Desoximetasone (cortisone), so it was difficult to find a medication to cure the issue.  Patient went to a rash specialist and Protopic was the medication that cured it.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: NNI case
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Malaise, Peripheral swelling, Vaccination site bruising
Clinical narrative: Did not feel very well for 2 or 3 days; Arm is hard; Discomfort; Arm is hard, like a bruise; Arm inflammed; A large red circle that does not go away; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Did not feel very well for 2 or 3 days), PERIPHERAL SWELLING (Arm is hard), DISCOMFORT (Discomfort), VACCINATION SITE BRUISING (Arm is hard, like a bruise) and VACCINATION SITE INFLAMMATION (Arm inflammed) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Allergy and Cholesterol. Concomitant products included MINERALS NOS, VITAMINS NOS (CENTRUM PLUS), ASCORBIC ACID (VITAMIN C ACID) and ZINC for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (Did not feel very well for 2 or 3 days), PERIPHERAL SWELLING (Arm is hard), DISCOMFORT (Discomfort), VACCINATION SITE BRUISING (Arm is hard, like a bruise), VACCINATION SITE INFLAMMATION (Arm inflammed) and VACCINATION SITE ERYTHEMA (A large red circle that does not go away). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel very well for 2 or 3 days) outcome was unknown, PERIPHERAL SWELLING (Arm is hard), VACCINATION SITE BRUISING (Arm is hard, like a bruise), VACCINATION SITE INFLAMMATION (Arm inflammed) and VACCINATION SITE ERYTHEMA (A large red circle that does not go away) had not resolved and DISCOMFORT (Discomfort) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 98.6 (Inconclusive) 98.6 ° F. Not a fever according to the doctor.. On 09-Mar-2021, Body temperature: 97 (Inconclusive) 97 ° F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medications for blood pressure, allergy, cholesterol and prostate. The medications were discontinued for 24 hours after receiving the vaccine. Treatment for the events included acetaminophen.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Did not feel very well for 2 or 3 days; Arm is hard; Discomfort; Arm is hard, like a bruise; Arm inflammed; A large red circle that does not go away; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Did not feel very well for 2 or 3 days), PERIPHERAL SWELLING (Arm is hard), DISCOMFORT (Discomfort), VACCINATION SITE BRUISING (Arm is hard, like a bruise) and VACCINATION SITE INFLAMMATION (Arm inflammed) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Allergy and Cholesterol. Concomitant products included MINERALS NOS, VITAMINS NOS (CENTRUM PLUS), ASCORBIC ACID (VITAMIN C ACID) and ZINC for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (Did not feel very well for 2 or 3 days), PERIPHERAL SWELLING (Arm is hard), DISCOMFORT (Discomfort), VACCINATION SITE BRUISING (Arm is hard, like a bruise), VACCINATION SITE INFLAMMATION (Arm inflammed) and VACCINATION SITE ERYTHEMA (A large red circle that does not go away). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel very well for 2 or 3 days) outcome was unknown, PERIPHERAL SWELLING (Arm is hard), VACCINATION SITE BRUISING (Arm is hard, like a bruise), VACCINATION SITE INFLAMMATION (Arm inflammed) and VACCINATION SITE ERYTHEMA (A large red circle that does not go away) had not resolved and DISCOMFORT (Discomfort) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 98.6 (Inconclusive) 98.6 ° F. Not a fever according to the doctor.. On 09-Mar-2021, Body temperature: 97 (Inconclusive) 97 ° F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medications for blood pressure, allergy, cholesterol and prostate. The medications were discontinued for 24 hours after receiving the vaccine. Treatment for the events included acetaminophen.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Achy arm; Really really tired; Queasy stomach; Headache; Achy muscles; Little bitty fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Queasy stomach), PAIN IN EXTREMITY (Achy arm), HEADACHE (Headache), MYALGIA (Achy muscles) and PYREXIA (Little bitty fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Queasy stomach), HEADACHE (Headache), MYALGIA (Achy muscles) and PYREXIA (Little bitty fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Achy arm) and FATIGUE (Really really tired). At the time of the report, ABDOMINAL DISCOMFORT (Queasy stomach), PAIN IN EXTREMITY (Achy arm), HEADACHE (Headache), MYALGIA (Achy muscles), PYREXIA (Little bitty fever) and FATIGUE (Really really tired) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Achy arm; Really really tired; Queasy stomach; Headache; Achy muscles; Little bitty fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Queasy stomach), PAIN IN EXTREMITY (Achy arm), HEADACHE (Headache), MYALGIA (Achy muscles) and PYREXIA (Little bitty fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Queasy stomach), HEADACHE (Headache), MYALGIA (Achy muscles) and PYREXIA (Little bitty fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Achy arm) and FATIGUE (Really really tired). At the time of the report, ABDOMINAL DISCOMFORT (Queasy stomach), PAIN IN EXTREMITY (Achy arm), HEADACHE (Headache), MYALGIA (Achy muscles), PYREXIA (Little bitty fever) and FATIGUE (Really really tired) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia, Mobility decreased, Muscle tightness, Pain
Clinical narrative: Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot; Both ears itched, felt warm to the touch and were pinker.; Welt on the spine; Itching; Both ears itched, felt warm to the touch and were pinker.; Soreness; Facial tightness on left side of face down to neck shoulder and arm; Couldn't lift her arm above hip that evening; Couldn't sleep.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening), INSOMNIA (Couldn't sleep.) and PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening) and INSOMNIA (Couldn't sleep.). On an unknown date, the patient experienced PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ), SKIN DISCOLOURATION (Both ears itched, felt warm to the touch and were pinker.), URTICARIA (Welt on the spine), PRURITUS (Itching) and FEELING HOT (Both ears itched, felt warm to the touch and were pinker.). At the time of the report, PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening), INSOMNIA (Couldn't sleep.), PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ), SKIN DISCOLOURATION (Both ears itched, felt warm to the touch and were pinker.), URTICARIA (Welt on the spine), PRURITUS (Itching) and FEELING HOT (Both ears itched, felt warm to the touch and were pinker.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Urticaria
Clinical narrative: Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot; Both ears itched, felt warm to the touch and were pinker.; Welt on the spine; Itching; Both ears itched, felt warm to the touch and were pinker.; Soreness; Facial tightness on left side of face down to neck shoulder and arm; Couldn't lift her arm above hip that evening; Couldn't sleep.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening), INSOMNIA (Couldn't sleep.) and PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening) and INSOMNIA (Couldn't sleep.). On an unknown date, the patient experienced PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ), SKIN DISCOLOURATION (Both ears itched, felt warm to the touch and were pinker.), URTICARIA (Welt on the spine), PRURITUS (Itching) and FEELING HOT (Both ears itched, felt warm to the touch and were pinker.). At the time of the report, PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening), INSOMNIA (Couldn't sleep.), PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ), SKIN DISCOLOURATION (Both ears itched, felt warm to the touch and were pinker.), URTICARIA (Welt on the spine), PRURITUS (Itching) and FEELING HOT (Both ears itched, felt warm to the touch and were pinker.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.