chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vestibular neuronitis
Clinical narrative: My doctor says he knows of 10-12 other patients that have vestibular neuritis after a COVID-19 shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR NEURONITIS (My doctor says he knows of 10-12 other patients that have vestibular neuritis after a COVID-19 shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR NEURONITIS (My doctor says he knows of 10-12 other patients that have vestibular neuritis after a COVID-19 shot). At the time of the report, VESTIBULAR NEURONITIS (My doctor says he knows of 10-12 other patients that have vestibular neuritis after a COVID-19 shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Myalgia, Pyrexia
Clinical narrative: body and muscle aches; a low fever; that nite the aches got worse; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (that nite the aches got worse), MYALGIA (body and muscle aches) and PYREXIA (a low fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS (tested positive for the SARS but had no symptoms) in November 2020.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced CONDITION AGGRAVATED (that nite the aches got worse). On 14-Jul-2021, the patient experienced MYALGIA (body and muscle aches) and PYREXIA (a low fever). At the time of the report, CONDITION AGGRAVATED (that nite the aches got worse), MYALGIA (body and muscle aches) and PYREXIA (a low fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash
Clinical narrative: Soft ball sized rash and lump at injection site in left arm; Soft ball sized rash and lump at injection site in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Soft ball sized rash and lump at injection site in left arm) and VACCINATION SITE RASH (Soft ball sized rash and lump at injection site in left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE MASS (Soft ball sized rash and lump at injection site in left arm) and VACCINATION SITE RASH (Soft ball sized rash and lump at injection site in left arm). At the time of the report, VACCINATION SITE MASS (Soft ball sized rash and lump at injection site in left arm) and VACCINATION SITE RASH (Soft ball sized rash and lump at injection site in left arm) outcome was unknown.            No concomitant medication was provided. Treatment included both a nerve medication and an anti-depressant.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-258036 (Patient Link).; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: I broke out with hives all over my body that started radiating from the arm; slight throat tightness the day of about 1 hour after the appointment; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I broke out with hives all over my body that started radiating from the arm) and THROAT TIGHTNESS (slight throat tightness the day of about 1 hour after the appointment) 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT TIGHTNESS (slight throat tightness the day of about 1 hour after the appointment). On 13-Feb-2021, the patient experienced URTICARIA (I broke out with hives all over my body that started radiating from the arm). At the time of the report, URTICARIA (I broke out with hives all over my body that started radiating from the arm) and THROAT TIGHTNESS (slight throat tightness the day of about 1 hour after the appointment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong technique in product usage process
Clinical narrative: Pain in arm; Wrong injection technique; 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 PAIN IN EXTREMITY (Pain in arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002623) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DICLOFENAC SODIUM (VALETAN [DICLOFENAC SODIUM]) for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site oedema
Clinical narrative: Edema circumferential 3/4 an inch size around the injection site; Tenderness on his axilla lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE OEDEMA (Edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (Tenderness on his axilla lymph nodes) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L21A) for COVID-19 vaccination.     Concurrent medical conditions included Marijuana use (smokes marijuana). Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and DIAZEPAM (VALIUM) 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 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE OEDEMA (Edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (Tenderness on his axilla lymph nodes). On 21-Feb-2021, VACCINATION SITE OEDEMA (Edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (Tenderness on his axilla lymph nodes) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-258035 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: The follow-up document received  contain No New Information
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Groin pain, Ligamentitis
Clinical narrative: Severe  pain in groin area; Ligament inflamed; Hurts when she walks; Severe pain in hips; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Severe  pain in groin area), LIGAMENTITIS (Ligament inflamed), GAIT DISTURBANCE (Hurts when she walks) and ARTHRALGIA (Severe pain in hips) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (Severe  pain in groin area), LIGAMENTITIS (Ligament inflamed), GAIT DISTURBANCE (Hurts when she walks) and ARTHRALGIA (Severe pain in hips). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, GROIN PAIN (Severe  pain in groin area), LIGAMENTITIS (Ligament inflamed), GAIT DISTURBANCE (Hurts when she walks) and ARTHRALGIA (Severe pain in hips) outcome was unknown.            No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Description to be coded was updated as per the description as reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site oedema
Clinical narrative: edema circumferential 3/4 an inch size around the injection site; tenderness on his axilla lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE OEDEMA (edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (tenderness on his axilla lymph nodes  ) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and unk) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and DIAZEPAM (VALIUM) 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 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE OEDEMA (edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (tenderness on his axilla lymph nodes  ). On 21-Feb-2021, VACCINATION SITE OEDEMA (edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (tenderness on his axilla lymph nodes  ) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient smokes marijuana.  No  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-258030 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-significant follow up
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: External shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (External shaking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (External shaking). At the time of the report, TREMOR (External shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: no appetite; blurry vision; nasty weakness; purple area around the injection site; vomit intensely; intense headache/like their head was going to explode/headache was really strong; felt like they were getting covid-19; could barely sleep; Chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep), DECREASED APPETITE (no appetite) and VISION BLURRED (blurry vision) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 11-Jul-2021, the patient experienced SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep) and CHILLS (Chills). On 14-Jul-2021, the patient experienced DECREASED APPETITE (no appetite), VISION BLURRED (blurry vision), ASTHENIA (nasty weakness), VACCINATION SITE DISCOLOURATION (purple area around the injection site), VOMITING (vomit intensely) and HEADACHE (intense headache/like their head was going to explode/headache was really strong). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 600 mg. On 13-Jul-2021, SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep) and CHILLS (Chills) had resolved. At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (no appetite), VISION BLURRED (blurry vision), ASTHENIA (nasty weakness), VACCINATION SITE DISCOLOURATION (purple area around the injection site), VOMITING (vomit intensely) and HEADACHE (intense headache/like their head was going to explode/headache was really strong) had not resolved.            Concomitants medication patient was on prenatal vitamins since last pregnancy. Patient states they have had very strong covid-19, that left the patient with asthma, that they did not have before. No lab data has been provided by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Suspected COVID-19, Vaccination site discolouration, Vision blurred, Vomiting
Clinical narrative: no appetite; blurry vision; nasty weakness; purple area around the injection site; vomit intensely; intense headache/like their head was going to explode/headache was really strong; felt like they were getting covid-19; could barely sleep; Chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep), DECREASED APPETITE (no appetite) and VISION BLURRED (blurry vision) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 11-Jul-2021, the patient experienced SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep) and CHILLS (Chills). On 14-Jul-2021, the patient experienced DECREASED APPETITE (no appetite), VISION BLURRED (blurry vision), ASTHENIA (nasty weakness), VACCINATION SITE DISCOLOURATION (purple area around the injection site), VOMITING (vomit intensely) and HEADACHE (intense headache/like their head was going to explode/headache was really strong). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 600 mg. On 13-Jul-2021, SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep) and CHILLS (Chills) had resolved. At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (no appetite), VISION BLURRED (blurry vision), ASTHENIA (nasty weakness), VACCINATION SITE DISCOLOURATION (purple area around the injection site), VOMITING (vomit intensely) and HEADACHE (intense headache/like their head was going to explode/headache was really strong) had not resolved.            Concomitants medication patient was on prenatal vitamins since last pregnancy. Patient states they have had very strong covid-19, that left the patient with asthma, that they did not have before. No lab data has been provided by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Tension headache
Clinical narrative: tension headache; brain fog; This spontaneous case was reported by a patient and describes the occurrence of TENSION HEADACHE (tension headache) and FEELING ABNORMAL (brain fog) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-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 TENSION HEADACHE (tension headache) and FEELING ABNORMAL (brain fog). At the time of the report, TENSION HEADACHE (tension headache) and FEELING ABNORMAL (brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment information provided.   This case was linked to MOD-2021-258051 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non significant follow up received on 15-JUL-2021. Contains updated secondary reporter's contact information.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Influenza like illness, Muscular weakness, Neuralgia
Clinical narrative: weakness in his legs; nerves on fire; anxiety reaction; flu like symptoms; tension headache; brain fog / "feels like I am fighting something off"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache), FEELING ABNORMAL (brain fog / "feels like I am fighting something off"), MUSCULAR WEAKNESS (weakness in his legs) and NEURALGIA (nerves on fire) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache) and FEELING ABNORMAL (brain fog / "feels like I am fighting something off"). On 06-Jun-2021, the patient experienced MUSCULAR WEAKNESS (weakness in his legs), NEURALGIA (nerves on fire) and ANXIETY (anxiety reaction). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache), FEELING ABNORMAL (brain fog / "feels like I am fighting something off"), MUSCULAR WEAKNESS (weakness in his legs), NEURALGIA (nerves on fire) and ANXIETY (anxiety reaction) outcome was unknown.            No concomitant medications were provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-258049 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up received and contains reporter contact details.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: weakness in his legs; nerves on fire; anxiety reaction; flu like symptoms; tension headache; brain fog / "feels like I am fighting something off"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache), FEELING ABNORMAL (brain fog / "feels like I am fighting something off"), MUSCULAR WEAKNESS (weakness in his legs) and NEURALGIA (nerves on fire) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache) and FEELING ABNORMAL (brain fog / "feels like I am fighting something off"). On 06-Jun-2021, the patient experienced MUSCULAR WEAKNESS (weakness in his legs), NEURALGIA (nerves on fire) and ANXIETY (anxiety reaction). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache), FEELING ABNORMAL (brain fog / "feels like I am fighting something off"), MUSCULAR WEAKNESS (weakness in his legs), NEURALGIA (nerves on fire) and ANXIETY (anxiety reaction) outcome was unknown.            No concomitant medications were provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-258049 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up received and contains reporter contact details.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: A lump in her lower left arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (A lump in her lower left arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy bilateral. Concurrent medical conditions included Blood pressure high. Concomitant products included ANASTROZOLE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Lupus erythematosus.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MASS (A lump in her lower left arm). At the time of the report, MASS (A lump in her lower left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: same day of vaccine she fell; This spontaneous case was reported by a consumer and describes the occurrence of FALL (same day of vaccine she fell) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient was allergic to novocaine.).    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 FALL (same day of vaccine she fell). At the time of the report, FALL (same day of vaccine she fell) 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.  As per the case narrative it was unable to obtain information about the type of vaccine administered by the patient.  There was no further information about the adverse event occurred and event was captured as per the statement "He reports the same day of vaccine she fell".  Follow up was requested
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Moderna vaccine side effect 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Moderna vaccine side effect 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna vaccine side effect 2nd dose). At the time of the report, VACCINATION COMPLICATION (Moderna vaccine side effect 2nd dose) had resolved. Not Provided          Treatment information was not provided by reporter.   This case was linked to MOD-2021-026594 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Decreased appetite, Illness, Loss of personal independence in daily activities, Nervousness
Clinical narrative: experiencing severe OCD / OCD symptoms; nervous; can't even go to the grocery store any more; asks weird questions a thousand times\ needs explaining like a 5-year-old; severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes; not eating; Lexapro it's been making her sick; This spontaneous case was reported by a consumer and describes the occurrence of OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old) and WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes) in a 69-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 information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old), WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes), DECREASED APPETITE (not eating) and ILLNESS (Lexapro it's been making her sick). The patient was treated with ESCITALOPRAM OXALATE (LEXAPRO) for Obsessive-compulsive disorder, at an unspecified dose and frequency. At the time of the report, OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old), WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes), DECREASED APPETITE (not eating) and ILLNESS (Lexapro it's been making her sick) outcome was unknown.            No concomitant medications were provided.  Patient got tested for dementia and other scan , everything came back 100% fine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Obsessive-compulsive symptom, Weight decreased
Clinical narrative: experiencing severe OCD / OCD symptoms; nervous; can't even go to the grocery store any more; asks weird questions a thousand times\ needs explaining like a 5-year-old; severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes; not eating; Lexapro it's been making her sick; This spontaneous case was reported by a consumer and describes the occurrence of OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old) and WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes) in a 69-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 information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old), WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes), DECREASED APPETITE (not eating) and ILLNESS (Lexapro it's been making her sick). The patient was treated with ESCITALOPRAM OXALATE (LEXAPRO) for Obsessive-compulsive disorder, at an unspecified dose and frequency. At the time of the report, OBSESSIVE-COMPULSIVE SYMPTOM (experiencing severe OCD / OCD symptoms), NERVOUSNESS (nervous), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't even go to the grocery store any more), ABNORMAL BEHAVIOUR (asks weird questions a thousand times\ needs explaining like a 5-year-old), WEIGHT DECREASED (severe weight loss - 35 pounds\ "Feels like she is disappearing before our eyes), DECREASED APPETITE (not eating) and ILLNESS (Lexapro it's been making her sick) outcome was unknown.            No concomitant medications were provided.  Patient got tested for dementia and other scan , everything came back 100% fine.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart gave a "great big pump" and is happening more frequently; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart gave a "great big pump" and is happening more frequently) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21E and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart gave a "great big pump" and is happening more frequently). At the time of the report, PALPITATIONS (Heart gave a "great big pump" and is happening more frequently) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication reported. No treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had something as bad as herself or worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had something as bad as herself or worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had something as bad as herself or worse). At the time of the report, VACCINATION COMPLICATION (had something as bad as herself or worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. Patient had a friend who had something as bad as herself or worse and that told her what to do.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: didn't feel great afterwards; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel great afterwards) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel great afterwards). At the time of the report, FEELING ABNORMAL (didn't feel great afterwards) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported .  Treatment medication were not reported .
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; 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 DIZZINESS (Dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient got dizzy with second Moderna injection.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Minor reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Minor reactions). At the time of the report, VACCINATION COMPLICATION (Minor reactions) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna vaccine received 25-Feb-2021 and Pfizer vaccine received 25-Mar-2021; 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 INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine received 25-Feb-2021 and Pfizer vaccine received 25-Mar-2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine received 25-Feb-2021 and Pfizer vaccine received 25-Mar-2021). On 25-Feb-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine received 25-Feb-2021 and Pfizer vaccine received 25-Mar-2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provide. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm swelled; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (Arm swelled) 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 PERIPHERAL SWELLING (Arm swelled). At the time of the report, PERIPHERAL SWELLING (Arm swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  Treatment medication were not reported.   This case was linked to MOD-2021-258739 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.            No relevant concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-258737.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Slowly losing hearing in one ear; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Slowly losing hearing in one ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Slowly losing hearing in one ear). At the time of the report, HYPOACUSIS (Slowly losing hearing in one ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not reported. Treatment was not reported.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Aldolase, Blood test, C-reactive protein, Fatigue, Insomnia
Clinical narrative: swollen calves/apparent inflammation is very painful; both calves are turgid, stiff and extremely warm; nights are sleepness; muscle pain in both calves; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen calves/apparent inflammation is very painful), MUSCULOSKELETAL STIFFNESS (both calves are turgid, stiff and extremely warm), INSOMNIA (nights are sleepness), MYALGIA (muscle pain in both calves) and FATIGUE (fatigue) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen calves/apparent inflammation is very painful), MUSCULOSKELETAL STIFFNESS (both calves are turgid, stiff and extremely warm), INSOMNIA (nights are sleepness), MYALGIA (muscle pain in both calves) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (swollen calves/apparent inflammation is very painful), MUSCULOSKELETAL STIFFNESS (both calves are turgid, stiff and extremely warm), INSOMNIA (nights are sleepness), MYALGIA (muscle pain in both calves) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Aldolase: 8.5 (High) High. On an unknown date, Blood test: normal (normal) No major blood problems found. On an unknown date, C-reactive protein: 22 (High) High. On an unknown date, Ultrasound Doppler: normal (normal) no presence of blood clots. On an unknown date, Urine analysis: normal (normal) no particular problems are found.         No relevant concomitant medications were reported. Patient was prescribed with some cream to alleviate the pain and facilitate sleeping.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Peripheral swelling, Ultrasound Doppler, Urine analysis
Clinical narrative: swollen calves/apparent inflammation is very painful; both calves are turgid, stiff and extremely warm; nights are sleepness; muscle pain in both calves; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen calves/apparent inflammation is very painful), MUSCULOSKELETAL STIFFNESS (both calves are turgid, stiff and extremely warm), INSOMNIA (nights are sleepness), MYALGIA (muscle pain in both calves) and FATIGUE (fatigue) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen calves/apparent inflammation is very painful), MUSCULOSKELETAL STIFFNESS (both calves are turgid, stiff and extremely warm), INSOMNIA (nights are sleepness), MYALGIA (muscle pain in both calves) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (swollen calves/apparent inflammation is very painful), MUSCULOSKELETAL STIFFNESS (both calves are turgid, stiff and extremely warm), INSOMNIA (nights are sleepness), MYALGIA (muscle pain in both calves) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Aldolase: 8.5 (High) High. On an unknown date, Blood test: normal (normal) No major blood problems found. On an unknown date, C-reactive protein: 22 (High) High. On an unknown date, Ultrasound Doppler: normal (normal) no presence of blood clots. On an unknown date, Urine analysis: normal (normal) no particular problems are found.         No relevant concomitant medications were reported. Patient was prescribed with some cream to alleviate the pain and facilitate sleeping.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Myalgia, Nausea, Pain
Clinical narrative: bedbound; dizziness; pain; fever; aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever) and MYALGIA (aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever), MYALGIA (aches) and NAUSEA (nausea). At the time of the report, BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever), MYALGIA (aches) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-055658 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bedbound; dizziness; pain; fever; aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever) and MYALGIA (aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever), MYALGIA (aches) and NAUSEA (nausea). At the time of the report, BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever), MYALGIA (aches) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-055658 (Patient Link).