chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Fatigue, Insomnia, Lip swelling, Pain
Clinical narrative: I felt fatigue, I had go lie down.; I could not sleep well because of the pain; pain got worse;  I could not sleep well because of the pain; Joints started to hurt a little bit/Hips, back, legs and shoulders hurt; my temperature was 100.4 F; chills; My hips, back, legs and shoulders hurt; Face swollen; Cheeks and lips swollen; arm was a little bit sore; A spontaneous report was received from a 72-years-old female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events face swollen, cheeks and lips swollen, my joints started to hurt a little bit, my hips, back, legs and shoulders hurt, my arm was a little bit sore, pain got worse, my temperature was 100.4 f, chills, felt fatigue, had go lie down..  The patient's medical history was not provided. Concomitant medications reported were Nexium, Statin, Calcium, probiotics, iron supplements, fish oil for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route and unknown anatomical location for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced the event arm was a little bit sore .   On 23 Jan 2021, the patient developed face swollen, cheeks and lips swollen.   On 27 Jan 2021, the patient experienced the events joints started to hurt a little bit,hips, back ,legs and shoulders hurt and temperature was 100.4 F.   On 29 Jan 2021, the patient experienced the events pain got worse and chills. On 31 Jan 2021, the patient experienced the event felt fatigue .   Treatment details included Benadryl, Hydroxyzine HCL 25 mg, Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event fatigue was considered resolved on 2 Feb 2021. The outcome of events face swollen, cheeks and lips swollen, joints started to hurt a little bit , hips, back ,legs and shoulders hurt, arm was a little bit sore ,pain got worse, temperature was 100.4 F and chills was unknown..; Reporter's Comments: This case concerns a 72-year-old female with NS unexpected events of swelling face, lip swelling, back pain, and 'could not sleep because of pain' and NS expected events of arthralgia, vaccination site swelling, fatigue, body temperature increased and chills. Event onset the same day as the first dose of mRNA-1273. 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site swelling
Clinical narrative: I felt fatigue, I had go lie down.; I could not sleep well because of the pain; pain got worse;  I could not sleep well because of the pain; Joints started to hurt a little bit/Hips, back, legs and shoulders hurt; my temperature was 100.4 F; chills; My hips, back, legs and shoulders hurt; Face swollen; Cheeks and lips swollen; arm was a little bit sore; A spontaneous report was received from a 72-years-old female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events face swollen, cheeks and lips swollen, my joints started to hurt a little bit, my hips, back, legs and shoulders hurt, my arm was a little bit sore, pain got worse, my temperature was 100.4 f, chills, felt fatigue, had go lie down..  The patient's medical history was not provided. Concomitant medications reported were Nexium, Statin, Calcium, probiotics, iron supplements, fish oil for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route and unknown anatomical location for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced the event arm was a little bit sore .   On 23 Jan 2021, the patient developed face swollen, cheeks and lips swollen.   On 27 Jan 2021, the patient experienced the events joints started to hurt a little bit,hips, back ,legs and shoulders hurt and temperature was 100.4 F.   On 29 Jan 2021, the patient experienced the events pain got worse and chills. On 31 Jan 2021, the patient experienced the event felt fatigue .   Treatment details included Benadryl, Hydroxyzine HCL 25 mg, Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event fatigue was considered resolved on 2 Feb 2021. The outcome of events face swollen, cheeks and lips swollen, joints started to hurt a little bit , hips, back ,legs and shoulders hurt, arm was a little bit sore ,pain got worse, temperature was 100.4 F and chills was unknown..; Reporter's Comments: This case concerns a 72-year-old female with NS unexpected events of swelling face, lip swelling, back pain, and 'could not sleep because of pain' and NS expected events of arthralgia, vaccination site swelling, fatigue, body temperature increased and chills. Event onset the same day as the first dose of mRNA-1273. 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: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: I'm having problems please call me; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I'm having problems please call me) 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 ADVERSE EVENT (I'm having problems please call me). At the time of the report, ADVERSE EVENT (I'm having problems please call me) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Body aches; Muscle pain; Joint pain; Fatigue; Injection site swelling; Redness at the injection site; Tenderness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE PAIN (Tenderness to the touch at the injection site), PAIN (Body aches) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Allergy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PAIN (Tenderness to the touch at the injection site). On 22-Jan-2021, the patient experienced PAIN (Body aches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE PAIN (Tenderness to the touch at the injection site), PAIN (Body aches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Body aches; Muscle pain; Joint pain; Fatigue; Injection site swelling; Redness at the injection site; Tenderness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE PAIN (Tenderness to the touch at the injection site), PAIN (Body aches) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Allergy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PAIN (Tenderness to the touch at the injection site). On 22-Jan-2021, the patient experienced PAIN (Body aches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE PAIN (Tenderness to the touch at the injection site), PAIN (Body aches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm is still sore) 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 08-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 PAIN IN EXTREMITY (her arm is still sore). At the time of the report, PAIN IN EXTREMITY (her arm is still sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area) and FATIGUE (feel tired and crummy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (feel tired and crummy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area), PYREXIA (Feverish), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area), FATIGUE (feel tired and crummy), PYREXIA (Feverish), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Not Provided          The concomitant medications were not reported. The action taken with the mRNA 1273 with respective to the events was considered as not applicable.   This case was linked to MOD-2021-027246 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area) and FATIGUE (feel tired and crummy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (feel tired and crummy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area), PYREXIA (Feverish), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arms for 48hrs), ERYTHEMA (Red in bicep), SWELLING (Swollen  in her bicep area), PRURITUS (Itchy park in her bicep area), FATIGUE (feel tired and crummy), PYREXIA (Feverish), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Not Provided          The concomitant medications were not reported. The action taken with the mRNA 1273 with respective to the events was considered as not applicable.   This case was linked to MOD-2021-027246 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain in extremity
Clinical narrative: itchiness on the injection site; arm was sore for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchiness on the injection site) and PAIN IN EXTREMITY (arm was sore for 2 weeks) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not have the card) for COVID-19 vaccination.     Concomitant products included IBUPROFEN from 01-Feb-2021 to an unknown date for Toothache, METOPROLOL, AMLODIPINE, ATORVASTATIN and CLOPIDOGREL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness on the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for 2 weeks). At the time of the report, INJECTION SITE PRURITUS (itchiness on the injection site) and PAIN IN EXTREMITY (arm was sore for 2 weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR Form attachedphone number provided was added. Email provided was added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: arm began itching; splotchy-red warm to touch area on her arm 4in long 2.5 in wide; A spontaneous report was received from a Consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm began itching, splotchy-red warm to touch area on her arm 4in long 2.5 in wide.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events arm began itching. splotchy-red warm to touch area on her arm 4in long 2.5 in wide.  Treatment details included Took one Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, arm began itching, splotchy-red warm to touch area on her arm 4in long 2.5 in wide was not reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081611:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Blotch on her arm that was orange pinkish; A Spontaneous case was received from consumer, concerning a female patient and age 77, who received Moderna's COVID-19 vaccine experienced Vaccination site rash/ Blotch on her arm that was orange pinkish .  The patient had a medical history of cancer. The Patient's concomitant medications were cancer medications  On 25Jan2021 , prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number : 030L20A) via unspecified route for COVID-19 infection prophylaxis.  On 09Feb2021, she noticed a blotch on her arm that was orange pinkish looking on the injection site..  The action taken in response to the events, Vaccination site rash was unknown .  The outcome of the event Vaccination site rash was considered to be unknown.  No treatment medications were reported to be taken by the patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Induration, Pruritus, Rash
Clinical narrative: Rash; Felt hard; Felt warm; Itched like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Felt hard), FEELING HOT (Felt warm), PRURITUS (Itched like a mosquito bite) and RASH (Rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced INDURATION (Felt hard), FEELING HOT (Felt warm) and PRURITUS (Itched like a mosquito bite). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. On 24-Jan-2021, RASH (Rash) had resolved. At the time of the report, INDURATION (Felt hard), FEELING HOT (Felt warm) and PRURITUS (Itched like a mosquito bite) had resolved.            .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: No specific follow-up information recorded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Vaccination site pain
Clinical narrative: difficulty in breathing; fatigue; pain at the site of injection; Weakness; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced asthenia (weakness), dysponea (difficulty in breathing), fatigue and vaccination site pain ( pain at the site of injection).  The patient's medical history was not provided. No Concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 0NJ20A) via unknown route for prophylaxis of COVID-19 infection and On 9 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced weakness, difficulty in breathing, pain at the site of injection and fatigue.  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Insomnia, Mobility decreased, Muscle tightness, Neck pain
Clinical narrative: Tightness in their neck; Neck pain spread from the front to the back up to ear height; Could not move neck more than 20 degrees on either side; Pain in neck awoke patient in the middle of the night; Swollen, tight neck located mainly in the front of the neck; Bit of swelling in arm; No control of arm/could not lift arm/unable to move arm; Arm hurt/ a lot of pain in the arm during the night; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (No control of arm/could not lift arm/unable to move arm), PAIN IN EXTREMITY (Arm hurt/ a lot of pain in the arm during the night), PERIPHERAL SWELLING (Bit of swelling in arm), SWELLING (Swollen, tight neck located mainly in the front of the neck) and NECK PAIN (Neck pain spread from the front to the back up to ear height) in a 74-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 provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt/ a lot of pain in the arm during the night). On 04-Feb-2021, the patient experienced MOBILITY DECREASED (No control of arm/could not lift arm/unable to move arm). On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (Bit of swelling in arm). On 06-Feb-2021, the patient experienced SWELLING (Swollen, tight neck located mainly in the front of the neck). On 07-Feb-2021, the patient experienced NECK PAIN (Neck pain spread from the front to the back up to ear height), HYPOKINESIA (Could not move neck more than 20 degrees on either side) and INSOMNIA (Pain in neck awoke patient in the middle of the night). On 08-Feb-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in their neck). The patient was treated with PARACETAMOL (TYLENOL) on 04-Feb-2021 at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) from 05-Feb-2021 to 06-Feb-2021 at a dose of 2 dosage form. At the time of the report, MOBILITY DECREASED (No control of arm/could not lift arm/unable to move arm), PAIN IN EXTREMITY (Arm hurt/ a lot of pain in the arm during the night), PERIPHERAL SWELLING (Bit of swelling in arm), SWELLING (Swollen, tight neck located mainly in the front of the neck), NECK PAIN (Neck pain spread from the front to the back up to ear height), HYPOKINESIA (Could not move neck more than 20 degrees on either side), INSOMNIA (Pain in neck awoke patient in the middle of the night) and MUSCLE TIGHTNESS (Tightness in their neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 07 Feb2021, the patient applied ice on swollen neck. On 08 Feb 2021, the patient reported that, the degree of discomfort, however, has improved.  No relevant concomitant medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Tightness in their neck; Neck pain spread from the front to the back up to ear height; Could not move neck more than 20 degrees on either side; Pain in neck awoke patient in the middle of the night; Swollen, tight neck located mainly in the front of the neck; Bit of swelling in arm; No control of arm/could not lift arm/unable to move arm; Arm hurt/ a lot of pain in the arm during the night; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (No control of arm/could not lift arm/unable to move arm), PAIN IN EXTREMITY (Arm hurt/ a lot of pain in the arm during the night), PERIPHERAL SWELLING (Bit of swelling in arm), SWELLING (Swollen, tight neck located mainly in the front of the neck) and NECK PAIN (Neck pain spread from the front to the back up to ear height) in a 74-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 provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt/ a lot of pain in the arm during the night). On 04-Feb-2021, the patient experienced MOBILITY DECREASED (No control of arm/could not lift arm/unable to move arm). On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (Bit of swelling in arm). On 06-Feb-2021, the patient experienced SWELLING (Swollen, tight neck located mainly in the front of the neck). On 07-Feb-2021, the patient experienced NECK PAIN (Neck pain spread from the front to the back up to ear height), HYPOKINESIA (Could not move neck more than 20 degrees on either side) and INSOMNIA (Pain in neck awoke patient in the middle of the night). On 08-Feb-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in their neck). The patient was treated with PARACETAMOL (TYLENOL) on 04-Feb-2021 at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) from 05-Feb-2021 to 06-Feb-2021 at a dose of 2 dosage form. At the time of the report, MOBILITY DECREASED (No control of arm/could not lift arm/unable to move arm), PAIN IN EXTREMITY (Arm hurt/ a lot of pain in the arm during the night), PERIPHERAL SWELLING (Bit of swelling in arm), SWELLING (Swollen, tight neck located mainly in the front of the neck), NECK PAIN (Neck pain spread from the front to the back up to ear height), HYPOKINESIA (Could not move neck more than 20 degrees on either side), INSOMNIA (Pain in neck awoke patient in the middle of the night) and MUSCLE TIGHTNESS (Tightness in their neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 07 Feb2021, the patient applied ice on swollen neck. On 08 Feb 2021, the patient reported that, the degree of discomfort, however, has improved.  No relevant concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza, Nausea, Pain
Clinical narrative: I started feeling sever flu; aches; I am nauseated; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (I started feeling sever flu), PAIN (aches), NAUSEA (I am nauseated) and ARTHRALGIA (joint pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA (I started feeling sever flu), PAIN (aches), NAUSEA (I am nauseated) and ARTHRALGIA (joint pain). At the time of the report, INFLUENZA (I started feeling sever flu), PAIN (aches), NAUSEA (I am nauseated) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: A severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (A severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 HYPERSENSITIVITY (A severe allergic reaction). At the time of the report, HYPERSENSITIVITY (A severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: Extreme "brain fog"; Feels kind of dizzy but not really dizzy; Feels like my head has so much pressure like it is going to explode/ Feels like head is in a glass jar; Symptoms are getting weirder and weirder/ Getting intermittently worse; A spontaneous report was received from a healthcare professional concerning a 60-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced foggy feeling in head/feeling abnormal, dizzy/dizziness, head pressure/head discomfort and  condition aggravated  The patient's medical history was reported as Crohn's disease, left ventricular non-compaction, and had COVID-19. The Concomitant medications reported were metoprolol succinate, furosemide, potassium, acetyl salicylic acid, sertraline hydrochloride .  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced  extreme brain fog, feels like head is in a glass jar, kind of feel dizzy but not dizzy, head pressure like it is going to explode, symptoms got weirder and weirder, feeling very unusual. The patient reported that the brain fog initially started with covid-19 infection which she had in the past and she noticed it around 02 Feb 2021.The event got worse since 06 Feb 2021.The patient also enquired if this is an expected event after the vaccination.  The treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, extreme brain fog, feels like head is in a glass jar, kind of feel dizzy but not dizzy, feels like my head has so much pressure like it is going to explode, symptoms are getting weirder and weirder, feeling very unusual, getting intermittently worse were considered unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Mobility decreased
Clinical narrative: Nose congestion; No apetite; Can't move the arm; Fatigue and sleepiness; Arm pain; Headache; chills; Fatigue and sleepiness; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nose congestion), DECREASED APPETITE (No apetite), MOBILITY DECREASED (Can't move the arm), SOMNOLENCE (Fatigue and sleepiness) and PAIN IN EXTREMITY (Arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NASAL CONGESTION (Nose congestion), DECREASED APPETITE (No apetite), MOBILITY DECREASED (Can't move the arm), SOMNOLENCE (Fatigue and sleepiness), PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache), CHILLS (chills), FATIGUE (Fatigue and sleepiness) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Nose congestion), DECREASED APPETITE (No apetite), MOBILITY DECREASED (Can't move the arm), SOMNOLENCE (Fatigue and sleepiness), PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache), CHILLS (chills), FATIGUE (Fatigue and sleepiness) and MYALGIA (Body aches) 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.   Concomitant medication includes unspecified migraine medication. The patient was treated with Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: NNI (gender need clarification)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pain in extremity, Somnolence
Clinical narrative: Nose congestion; No apetite; Can't move the arm; Fatigue and sleepiness; Arm pain; Headache; chills; Fatigue and sleepiness; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nose congestion), DECREASED APPETITE (No apetite), MOBILITY DECREASED (Can't move the arm), SOMNOLENCE (Fatigue and sleepiness) and PAIN IN EXTREMITY (Arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NASAL CONGESTION (Nose congestion), DECREASED APPETITE (No apetite), MOBILITY DECREASED (Can't move the arm), SOMNOLENCE (Fatigue and sleepiness), PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache), CHILLS (chills), FATIGUE (Fatigue and sleepiness) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Nose congestion), DECREASED APPETITE (No apetite), MOBILITY DECREASED (Can't move the arm), SOMNOLENCE (Fatigue and sleepiness), PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache), CHILLS (chills), FATIGUE (Fatigue and sleepiness) and MYALGIA (Body aches) 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.   Concomitant medication includes unspecified migraine medication. The patient was treated with Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: NNI (gender need clarification)
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy; It is somewhat hard; eight days after the vaccine, I developed a red area around the point of the inoculation; rash-like texture; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (eight days after the vaccine, I developed a red area around the point of the inoculation), VACCINATION SITE INDURATION (It is somewhat hard), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (rash-like texture) 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.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (eight days after the vaccine, I developed a red area around the point of the inoculation), VACCINATION SITE INDURATION (It is somewhat hard), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (rash-like texture). At the time of the report, VACCINATION SITE ERYTHEMA (eight days after the vaccine, I developed a red area around the point of the inoculation), VACCINATION SITE INDURATION (It is somewhat hard), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (rash-like texture) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; could hardly walk; chills; had fever; extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), GAIT DISTURBANCE (could hardly walk), CHILLS (chills), PYREXIA (had fever) and FATIGUE (extreme tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for Diabetes, LORATADINE (CLARITINE) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.  On 29-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), GAIT DISTURBANCE (could hardly walk), CHILLS (chills), PYREXIA (had fever) and FATIGUE (extreme tiredness).   At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), GAIT DISTURBANCE (could hardly walk), CHILLS (chills), PYREXIA (had fever) and FATIGUE (extreme tiredness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood pressure measurement, Chills, Dizziness
Clinical narrative: Brain fog; Nonfunctional/debilitated/weakness; Dizziness; Headache; Overwhelming fatigue/ feeling tired; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Overwhelming fatigue/ feeling tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immune system disorder (lower immune system), Multimorbidity (Several comorbidities), Lung cancer, Lymphoma (non-Hodgkin's) (B -Cell follicular lymphoma stage 2 [NHL) and Visual impairment.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Overwhelming fatigue/ feeling tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Overwhelming fatigue/ feeling tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Blood pressure normal. On an unknown date, Oxygen saturation: normal (normal) Oxygen normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-253765 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up information contains Current Comorbidities and Preexisting Conditions
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Oxygen saturation
Clinical narrative: Brain fog; Nonfunctional/debilitated/weakness; Dizziness; Headache; Overwhelming fatigue/ feeling tired; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Overwhelming fatigue/ feeling tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immune system disorder (lower immune system), Multimorbidity (Several comorbidities), Lung cancer, Lymphoma (non-Hodgkin's) (B -Cell follicular lymphoma stage 2 [NHL) and Visual impairment.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Overwhelming fatigue/ feeling tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Overwhelming fatigue/ feeling tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Blood pressure normal. On an unknown date, Oxygen saturation: normal (normal) Oxygen normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-253765 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up information contains Current Comorbidities and Preexisting Conditions
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Very light site tingle; Very slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Very light site tingle) and HEADACHE (Very slight headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PARAESTHESIA (Very light site tingle) and HEADACHE (Very slight headache). On 24-Feb-2021, HEADACHE (Very slight headache) had resolved. At the time of the report, PARAESTHESIA (Very light site tingle) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID 19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LISINOPRIL, METOPROLOL and LEVOTHYROXINE SODIUM (TIROSINT) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) had not resolved. 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 treatment medication details was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation, Decreased appetite, Diarrhoea, SARS-CoV-2 test
Clinical narrative: diarrhea; Constipation; Decreased appetite; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CONSTIPATION (Constipation), DECREASED APPETITE (Decreased appetite) and ABDOMINAL DISCOMFORT (stomach pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient takes pressure medicines.). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 06-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 DIARRHOEA (diarrhea), CONSTIPATION (Constipation), DECREASED APPETITE (Decreased appetite) and ABDOMINAL DISCOMFORT (stomach pain). At the time of the report, DIARRHOEA (diarrhea), CONSTIPATION (Constipation), DECREASED APPETITE (Decreased appetite) and ABDOMINAL DISCOMFORT (stomach pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) The Patient confirmed that he did not have a positive COVID-19 test since he received COVID-19 vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other medications included pressure medicine and medicine for prostate.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site urticaria
Clinical narrative: Itchy Sensation near  injection site; Hives - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation near  injection site), VACCINATION SITE URTICARIA (Hives - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     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 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation near  injection site), VACCINATION SITE URTICARIA (Hives - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Feb-2021, VACCINATION SITE PRURITUS (Itchy Sensation near  injection site), VACCINATION SITE URTICARIA (Hives - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported; 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.