chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness
Clinical narrative: Could not drive; Immobilized for 3 days in bed; Fever; Nausea; Arm was tender; Lethargy; Generalized burning pain; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive) and MOBILITY DECREASED (Immobilized for 3 days in bed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy in 1994. Concurrent medical conditions included Drug allergy (Allergy to Narcotics), Allergy to edible fungus (Allergy to Yeast), Allergy to nuts (Allergy to Peanuts), Allergy to vaccine (Tetanus), Fibromyalgia since 2009, Hypoglycemia since 1980, Hypothyroidism since 2015 and Irritable bowel syndrome since 1980. Concomitant products included LEVOTHYROXINE and ESTRADIOL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), MOBILITY DECREASED (Immobilized for 3 days in bed), PYREXIA (Fever) and NAUSEA (Nausea). On 19-Apr-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive). The patient was treated with PARACETAMOL (TYLENOL) for Pain, Fever, Nausea and Lethargy, at a dose of UNK dosage form; IBUPROFEN ongoing since an unknown date for Fever, Pain, Nausea and Lethargy, at a dose of UNK dosage form; GABAPENTIN ongoing since an unknown date for Pain, Fever, Nausea and Lethargy, at a dose of UNK dosage form and MELOXICAM ongoing since an unknown date for Fever, Nausea, Pain and Lethargy, at a dose of UNK dosage form. On 23-Apr-2021, TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive), MOBILITY DECREASED (Immobilized for 3 days in bed), PYREXIA (Fever) and NAUSEA (Nausea) had resolved.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to MOD-2021-073340 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) 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 CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspnoea, Faeces soft, Rhinorrhoea
Clinical narrative: shortness of breath; soft stool; diarrhea; runny nose; constant sneezing; gastro-intestinal issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose) and SNEEZING (constant sneezing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #045B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diverticulosis, Thyroid disorder and Diabetes.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), SNEEZING (constant sneezing) and ABDOMINAL DISCOMFORT (gastro-intestinal issues). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form once a day. At the time of the report, DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), SNEEZING (constant sneezing) and ABDOMINAL DISCOMFORT (gastro-intestinal issues) outcome was unknown.            The patient's concomitant medication included thyroid medication and diabetes medication. Treatment medication included medication for diarrhea Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-116349, MOD-2021-116401 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Medical history - Diverticulitis, New events added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: shortness of breath; soft stool; diarrhea; runny nose; constant sneezing; gastro-intestinal issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose) and SNEEZING (constant sneezing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #045B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diverticulosis, Thyroid disorder and Diabetes.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), SNEEZING (constant sneezing) and ABDOMINAL DISCOMFORT (gastro-intestinal issues). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form once a day. At the time of the report, DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), SNEEZING (constant sneezing) and ABDOMINAL DISCOMFORT (gastro-intestinal issues) outcome was unknown.            The patient's concomitant medication included thyroid medication and diabetes medication. Treatment medication included medication for diarrhea Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-116349, MOD-2021-116401 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Medical history - Diverticulitis, New events added.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026C21A) for COVID-19 vaccination.     Medical history was not provided.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  No Treatment medications were reported. No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non significant follow up appended
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Night sweats, Pyrexia
Clinical narrative: still feeling very sluggish; no energy during the day\ I've lost so much energy; night sweats/, gets up and is soaked; it is a little strange/has been bugging him; no appetite; at night feverish; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him) and DECREASED APPETITE (no appetite) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish). The patient was treated with VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]) at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-239185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received to safety on 29-Jun-2021 as Consent denied to follow up and no other information was added.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: still feeling very sluggish; no energy during the day\ I've lost so much energy; night sweats/, gets up and is soaked; it is a little strange/has been bugging him; no appetite; at night feverish; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him) and DECREASED APPETITE (no appetite) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish). The patient was treated with VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]) at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-239185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received to safety on 29-Jun-2021 as Consent denied to follow up and no other information was added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Insomnia, Micturition disorder, Nervousness
Clinical narrative: Nervous; Blood Pressure fluctuated ( Maximum 142/90 mmHg); Could not sleep; Decreased Urination; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous), BLOOD PRESSURE FLUCTUATION (Blood Pressure fluctuated ( Maximum 142/90 mmHg)), INSOMNIA (Could not sleep) and MICTURITION DISORDER (Decreased Urination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C21A) for COVID-19 vaccination.     The patient's past medical history included Kidney cancer and Cancer surgery. Concurrent medical conditions included Allergy to chemicals (Blood Pressure After Colonoscopy because sensitive to PEG).    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced NERVOUSNESS (Nervous), BLOOD PRESSURE FLUCTUATION (Blood Pressure fluctuated ( Maximum 142/90 mmHg)), INSOMNIA (Could not sleep) and MICTURITION DISORDER (Decreased Urination). At the time of the report, NERVOUSNESS (Nervous), BLOOD PRESSURE FLUCTUATION (Blood Pressure fluctuated ( Maximum 142/90 mmHg)), INSOMNIA (Could not sleep) and MICTURITION DISORDER (Decreased Urination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Blood pressure measurement: 142/90 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Myalgia
Clinical narrative: bad headache; body hurts; been in bed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed). At the time of the report, HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 40-year-old male patient 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 VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Pain in extremity, Pyrexia, Sluggishness
Clinical narrative: Sluggish; No energy; Sore arm; No appetite; In bed for 3 days; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite) and VACCINATION COMPLICATION (In bed for 3 days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for Sleep disorder NOS.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (In bed for 3 days) and PYREXIA (Fever). At the time of the report, SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (In bed for 3 days) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by reporter.   This case was linked to MOD-2021-239170 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Sluggish; No energy; Sore arm; No appetite; In bed for 3 days; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite) and VACCINATION COMPLICATION (In bed for 3 days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for Sleep disorder NOS.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (In bed for 3 days) and PYREXIA (Fever). At the time of the report, SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (In bed for 3 days) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by reporter.   This case was linked to MOD-2021-239170 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid). At the time of the report, COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment drug details was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Joint injury, Myalgia
Clinical narrative: injured knee; pain significant enough that it makes it difficult to sleep some nights; injured knee starts to hurt; muscle pain in his shoulder; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (injured knee), INSOMNIA (pain significant enough that it makes it difficult to sleep some nights), ARTHRALGIA (injured knee starts to hurt) and MYALGIA (muscle pain in his shoulder) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On 07-Feb-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced JOINT INJURY (injured knee), INSOMNIA (pain significant enough that it makes it difficult to sleep some nights), ARTHRALGIA (injured knee starts to hurt) and MYALGIA (muscle pain in his shoulder). At the time of the report, JOINT INJURY (injured knee) and ARTHRALGIA (injured knee starts to hurt) had not resolved and INSOMNIA (pain significant enough that it makes it difficult to sleep some nights) and MYALGIA (muscle pain in his shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter Reporter causality: related for joint injury and arthralgia; unassessable for rest of the events
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: vomiting; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and NAUSEA (nausea) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03621a and 047b21a) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy, Drug allergy (acetaminophen), Diabetic and Hypertension.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). On 20-May-2021, VOMITING (vomiting) had resolved. At the time of the report, NAUSEA (nausea) outcome was unknown.            No treatment information was provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-162788 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and MYALGIA (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN, PARACETAMOL (ACETAMINOPHEN) and IBUPROFEN (EXCEDRIN IB) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced HEADACHE (headache) and MYALGIA (body aches). On 27-Jun-2021, HEADACHE (headache) and MYALGIA (body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Blood test
Clinical narrative: Vivid dreams; This spontaneous case was reported by an other health care professional and describes the occurrence of ABNORMAL DREAMS (Vivid dreams) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. en6199) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Psoriatic arthritis since July 2007, Thyroid neoplasm malignant since an unknown date, Vivid dreams and Psoriasis since an unknown date. Concurrent medical conditions included Allergy (Sulfonamide allergy).   In July 2007, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. In June 2021, the patient experienced ABNORMAL DREAMS (Vivid dreams). At the time of the report, ABNORMAL DREAMS (Vivid dreams) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood test: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant Drugs Not Reported.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to MOD-2021-036773 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a 50-year-old female patient 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 24-Jun-2021, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information about concomitants was provided. No information about treatment medication was provided by the reporter.    This case was linked to MOD-2021-236539, MOD-2021-236555, MOD-2021-236569, MOD-2021-236580 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up information contains event onset date added.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Her neck  swollen 5 days/ neck was swollen; She had pain/ pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Her neck  swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced SWELLING (Her neck  swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain). At the time of the report, SWELLING (Her neck  swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-015272 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up included NNI
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Echocardiogram, Pain in extremity
Clinical narrative: enlarged heart; arm tenderness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (enlarged heart) and PAIN IN EXTREMITY (arm tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (triple bypass, performed two years ago.). Concurrent medical conditions included Osteoporosis (in left knee). Concomitant products included PARACETAMOL (TYLENOL) for Osteoporosis, CLOPIDOGREL, PAROXETINE, ATORVASTATIN, BUPROPION, LOSARTAN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE 10), VITAMIN D2 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm tenderness). On an unknown date, the patient experienced CARDIOMEGALY (enlarged heart). On 04-Feb-2021, PAIN IN EXTREMITY (arm tenderness) outcome was unknown. At the time of the report, CARDIOMEGALY (enlarged heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Echocardiogram: heart was slightly enlarged (abnormal) Heart was slightly enlarged.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient was told by their doctor that their heart was slightly enlarged, per echocardiogram. The date of discovery was not provided. No treatment information was provided.   This case was linked to MOD-2021-239309 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to a Moderna vaccine/unknown reaction; 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 VACCINATION COMPLICATION (reaction to a Moderna vaccine/unknown reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #029L24A) 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 28-Jun-2021, the patient experienced VACCINATION COMPLICATION (reaction to a Moderna vaccine/unknown reaction). At the time of the report, VACCINATION COMPLICATION (reaction to a Moderna vaccine/unknown reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: high fever of more than 104; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever of more than 104), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PYREXIA (high fever of more than 104), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, PYREXIA (high fever of more than 104), CHILLS (Chills) and MYALGIA (Body aches) had resolved.       Concomitant medications were not reported.  The patient reported receiving the second shot one month after the first, and experienced a high fever with chills and body aches that were worse than the first. It took about 3 days to resolve.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-008430 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Injection site erythema, Injection site pain, Vaccination site warmth
Clinical narrative: spine bones ached; chills; injection arm became reddened; injection arm became extremely sore; injection arm became warm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021. The most recent information was received on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (spine bones ached), VACCINATION SITE WARMTH (injection arm became warm), CHILLS (chills), INJECTION SITE ERYTHEMA (injection arm became reddened) and INJECTION SITE PAIN (injection arm became extremely 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 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 BACK PAIN (spine bones ached), VACCINATION SITE WARMTH (injection arm became warm), CHILLS (chills), INJECTION SITE ERYTHEMA (injection arm became reddened) and INJECTION SITE PAIN (injection arm became extremely sore). At the time of the report, BACK PAIN (spine bones ached), VACCINATION SITE WARMTH (injection arm became warm), CHILLS (chills), INJECTION SITE ERYTHEMA (injection arm became reddened) and INJECTION SITE PAIN (injection arm became extremely sore) had resolved.            No concomitant medications were reported. Treatment medications were not provided by the reporter   This case was linked to MOD-2021-030316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Reporters contact updated and patient gender.; 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Disturbance in attention, Dysphonia, Dyspnoea
Clinical narrative: Fever; Horrible chills; Bone pain; Difficulty breathing / Shortness of breath; Fogginess; Difficulty focusing; Absolute exhaustion; swelling; Sore throat; Difficulty eating; Voice keeps going hoarse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath) and FEELING ABNORMAL (Fogginess) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE for Insomnia, ATENOLOL, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion), SWELLING (swelling), OROPHARYNGEAL PAIN (Sore throat), EATING DISORDER (Difficulty eating) and DYSPHONIA (Voice keeps going hoarse). At the time of the report, PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion), SWELLING (swelling), OROPHARYNGEAL PAIN (Sore throat), EATING DISORDER (Difficulty eating) and DYSPHONIA (Voice keeps going hoarse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable. No treatment medication reported by reporter.   This case was linked to MOD-2021-239351 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Fatigue, Feeling abnormal, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; Horrible chills; Bone pain; Difficulty breathing / Shortness of breath; Fogginess; Difficulty focusing; Absolute exhaustion; swelling; Sore throat; Difficulty eating; Voice keeps going hoarse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath) and FEELING ABNORMAL (Fogginess) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE for Insomnia, ATENOLOL, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion), SWELLING (swelling), OROPHARYNGEAL PAIN (Sore throat), EATING DISORDER (Difficulty eating) and DYSPHONIA (Voice keeps going hoarse). At the time of the report, PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion), SWELLING (swelling), OROPHARYNGEAL PAIN (Sore throat), EATING DISORDER (Difficulty eating) and DYSPHONIA (Voice keeps going hoarse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable. No treatment medication reported by reporter.   This case was linked to MOD-2021-239351 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Fever; Horrible chills; Bone pain; Difficulty breathing / Shortness of breath; Fogginess; Difficulty focusing; Absolute exhaustion; swelling; Sore throat; Difficulty eating; Voice keeps going hoarse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath) and FEELING ABNORMAL (Fogginess) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE for Insomnia, ATENOLOL, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion), SWELLING (swelling), OROPHARYNGEAL PAIN (Sore throat), EATING DISORDER (Difficulty eating) and DYSPHONIA (Voice keeps going hoarse). At the time of the report, PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion), SWELLING (swelling), OROPHARYNGEAL PAIN (Sore throat), EATING DISORDER (Difficulty eating) and DYSPHONIA (Voice keeps going hoarse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable. No treatment medication reported by reporter.   This case was linked to MOD-2021-239351 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Echocardiogram, Pain in extremity, Tenderness
Clinical narrative: Enlarged heart; Arm soreness; arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Enlarged heart), PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (arm tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010 ( illegible digit/letter) 21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Triple bypass performed two years ago.). Concurrent medical conditions included Osteoporosis (Osteoporosis in left knee). Concomitant products included PARACETAMOL (TYLENOL) for Osteoporosis, CLOPIDOGREL, PAROXETINE, ATORVASTATIN, BUPROPION, LOSARTAN, AMLODIPINE BESYLATE, VITAMIN D2 and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (arm tenderness). On an unknown date, the patient experienced CARDIOMEGALY (Enlarged heart). On 04-Mar-2021, PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (arm tenderness) had resolved. At the time of the report, CARDIOMEGALY (Enlarged heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: heart was slightly enlarged (abnormal) Heart was slightly enlarged.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-239268 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Condition aggravated, Disturbance in attention, Dyspnoea
Clinical narrative: Symptoms got much worse after the 2nd shot; Bone pain; Difficulty breathing / Shortness of breath; Difficulty focusing; Fogginess; Absolute exhaustion; Horrible chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath) and FEELING ABNORMAL (Fogginess) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE, ATENOLOL, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion) and CONDITION AGGRAVATED (Symptoms got much worse after the 2nd shot). At the time of the report, PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion) and CONDITION AGGRAVATED (Symptoms got much worse after the 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-239302 (Patient Link).