chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyskinesia, Fatigue, Illness, Oropharyngeal pain
Clinical narrative: Sick as a dog; Runny nose; coughing; sneezing; scratchy throat; wants to sleep all the time; woken up by uncontrollable jerks of the upper body from waist up; was like restless legs but upper body only; sore arm in the injection arm with a knot about the size of the egg; sore arm in the injection arm with a knot about the size of the egg; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing) and OROPHARYNGEAL PAIN (scratchy throat) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired). At the time of the report, ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: hasn't gotten the results (Inconclusive) hasn't gotten the results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Theraflu, Theraflu Severe Cold & Cough Express Max Liquid.  No concomitant medication were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Rhinorrhoea, Sneezing, Somnolence, Vaccination site mass
Clinical narrative: Sick as a dog; Runny nose; coughing; sneezing; scratchy throat; wants to sleep all the time; woken up by uncontrollable jerks of the upper body from waist up; was like restless legs but upper body only; sore arm in the injection arm with a knot about the size of the egg; sore arm in the injection arm with a knot about the size of the egg; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing) and OROPHARYNGEAL PAIN (scratchy throat) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired). At the time of the report, ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: hasn't gotten the results (Inconclusive) hasn't gotten the results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Theraflu, Theraflu Severe Cold & Cough Express Max Liquid.  No concomitant medication were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sick as a dog; Runny nose; coughing; sneezing; scratchy throat; wants to sleep all the time; woken up by uncontrollable jerks of the upper body from waist up; was like restless legs but upper body only; sore arm in the injection arm with a knot about the size of the egg; sore arm in the injection arm with a knot about the size of the egg; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing) and OROPHARYNGEAL PAIN (scratchy throat) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired). At the time of the report, ILLNESS (sick as a dog), RHINORRHOEA (runny nose), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (scratchy throat), SOMNOLENCE (wants to sleep all the time), DYSKINESIA (woken up by uncontrollable jerks of the upper body from waist up), RESTLESSNESS (was like restless legs but upper body only), VACCINATION SITE MASS (sore arm in the injection arm with a knot about the size of the egg), VACCINATION SITE PAIN (sore arm in the injection arm with a knot about the size of the egg) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: hasn't gotten the results (Inconclusive) hasn't gotten the results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Theraflu, Theraflu Severe Cold & Cough Express Max Liquid.  No concomitant medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Swelling
Clinical narrative: had a great deal of swelling; had a great deal of heat; had a great deal of uncomfortableness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (had a great deal of swelling), FEELING HOT (had a great deal of heat) and MALAISE (had a great deal of uncomfortableness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (had a great deal of swelling), FEELING HOT (had a great deal of heat) and MALAISE (had a great deal of uncomfortableness). At the time of the report, SWELLING (had a great deal of swelling), FEELING HOT (had a great deal of heat) and MALAISE (had a great deal of uncomfortableness) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-344973 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination complication
Clinical narrative: felt a little roughness; about 7-8 hours of bad chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt a little roughness) and CHILLS (about 7-8 hours of bad chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION COMPLICATION (felt a little roughness) and CHILLS (about 7-8 hours of bad chills). At the time of the report, VACCINATION COMPLICATION (felt a little roughness) outcome was unknown and CHILLS (about 7-8 hours of bad chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included high blood pressure medication.  Treatment information was not provided.   This case was linked to MOD-2021-345280 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered past 30 days in refrigerator; Received dose from vial that was more than 30 days refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past 30 days in refrigerator) and PRODUCT STORAGE ERROR (Received dose from vial that was more than 30 days refrigerated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past 30 days in refrigerator) and PRODUCT STORAGE ERROR (Received dose from vial that was more than 30 days refrigerated). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past 30 days in refrigerator) and PRODUCT STORAGE ERROR (Received dose from vial that was more than 30 days refrigerated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the Moderna COVID-19 vaccine on 03-Oct-2021 from a vial that was past the 30-day beyond use date in the refrigerator. It was reported that vial was moved to refrigerator on 31-Aug-2021 and the 30-day use by date was 30-Sep-2021.  No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received contains no new information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site pain
Clinical narrative: Tenderness in left arm; Armpit of left arm is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness in left arm) and AXILLARY PAIN (Armpit of left arm is very painful) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third 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 SITE PAIN (Tenderness in left arm) and AXILLARY PAIN (Armpit of left arm is very painful). At the time of the report, VACCINATION SITE PAIN (Tenderness in left arm) and AXILLARY PAIN (Armpit of left arm is very painful) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (occurred 2 years ago on Thanksgiving 2019). Concomitant products included SIMVASTATIN for Cholesterol blood excessive, IBANDRONATE SODIUM (IBANDRONATE) for Disorder bone (NOS), CENTRUM FOR WOMEN for Nutritional supplementation, LEVOTHYROXINE for Thyroid therapy, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 02-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-345046 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, COVID-19, Chills, Cough, Discomfort
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating) and COUGH (Light cough) in a 60-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.   In July 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced FEELING ABNORMAL (not feeling quite right). On 03-Oct-2021, the patient experienced COUGH (Light cough) and OROPHARYNGEAL PAIN (Sore throat). On 06-Oct-2021, the patient experienced COVID-19 (diagnosed with covid-19, confirmed with PCR). On an unknown date, the patient experienced DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse). At the time of the report, FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), COUGH (Light cough), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), COVID-19 (diagnosed with covid-19, confirmed with PCR), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, Oxygen saturation: 98% (normal) 98%. On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Diagnosed with COVID-19, confirmed by PCR nasopharyngeal swab.. On 07-Oct-2021, Oxygen saturation: 96% (normal) 96%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received include NNI. On 11-Oct-2021: Follow up received include NNI.; Sender's Comments: This case concerns a 60-year-old female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of COVID-19. Time to onset from vaccination was not reported, as vaccination dates are not available. The rechallenge was not applicable, as no additional dosing will be given. The benefit-risk relationship of Covid19 Moderna is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating) and COUGH (Light cough) in a 60-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.   In July 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced FEELING ABNORMAL (not feeling quite right). On 03-Oct-2021, the patient experienced COUGH (Light cough) and OROPHARYNGEAL PAIN (Sore throat). On 06-Oct-2021, the patient experienced COVID-19 (diagnosed with covid-19, confirmed with PCR). On an unknown date, the patient experienced DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse). At the time of the report, FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), COUGH (Light cough), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), COVID-19 (diagnosed with covid-19, confirmed with PCR), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, Oxygen saturation: 98% (normal) 98%. On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Diagnosed with COVID-19, confirmed by PCR nasopharyngeal swab.. On 07-Oct-2021, Oxygen saturation: 96% (normal) 96%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received include NNI. On 11-Oct-2021: Follow up received include NNI.; Sender's Comments: This case concerns a 60-year-old female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of COVID-19. Time to onset from vaccination was not reported, as vaccination dates are not available. The rechallenge was not applicable, as no additional dosing will be given. The benefit-risk relationship of Covid19 Moderna is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating) and COUGH (Light cough) in a 60-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.   In July 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced FEELING ABNORMAL (not feeling quite right). On 03-Oct-2021, the patient experienced COUGH (Light cough) and OROPHARYNGEAL PAIN (Sore throat). On 06-Oct-2021, the patient experienced COVID-19 (diagnosed with covid-19, confirmed with PCR). On an unknown date, the patient experienced DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse). At the time of the report, FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), COUGH (Light cough), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), COVID-19 (diagnosed with covid-19, confirmed with PCR), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, Oxygen saturation: 98% (normal) 98%. On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Diagnosed with COVID-19, confirmed by PCR nasopharyngeal swab.. On 07-Oct-2021, Oxygen saturation: 96% (normal) 96%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received include NNI. On 11-Oct-2021: Follow up received include NNI.; Sender's Comments: This case concerns a 60-year-old female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of COVID-19. Time to onset from vaccination was not reported, as vaccination dates are not available. The rechallenge was not applicable, as no additional dosing will be given. The benefit-risk relationship of Covid19 Moderna is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Low grade headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Low grade headaches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Low grade headaches). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Low grade headaches) outcome was unknown.        No Concomitant medication was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Feeling hot, Flushing
Clinical narrative: it is getting worse; kidneys are not working like they should be; urine is pretty dark when  was never like that before; he waited a little (about 6 weeks) before he received his second dose; rash on chest\Rash: Generalised; On and off chills\chills; fever; nausea; exhaustion; Pain at injection site; Skin feeling warm; No energy; Itching; Flushing; feeling hot\Prickly heat; numbness; Prickling/Tingling sensation; Abdominal cramping; mild brain fog; DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (it is getting worse), RENAL DISORDER (kidneys are not working like they should be), CHROMATURIA (urine is pretty dark when  was never like that before), SKIN WARM (Skin feeling warm) and ASTHENIA (No energy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced SKIN WARM (Skin feeling warm), ASTHENIA (No energy), PRURITUS (Itching), FLUSHING (Flushing), FEELING HOT (feeling hot\Prickly heat), HYPOAESTHESIA (numbness), PARAESTHESIA (Prickling/Tingling sensation), ABDOMINAL PAIN (Abdominal cramping), FEELING ABNORMAL (mild brain fog), DIARRHOEA (DIARRHEA), VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea) and FATIGUE (exhaustion). On 23-Jul-2021, the patient experienced PYREXIA (fever). On 24-Jul-2021, the patient experienced RASH (rash on chest\Rash: Generalised) and CHILLS (On and off chills\chills). On an unknown date, the patient experienced CONDITION AGGRAVATED (it is getting worse), RENAL DISORDER (kidneys are not working like they should be), CHROMATURIA (urine is pretty dark when  was never like that before) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he waited a little (about 6 weeks) before he received his second dose). At the time of the report, CONDITION AGGRAVATED (it is getting worse), RENAL DISORDER (kidneys are not working like they should be), CHROMATURIA (urine is pretty dark when  was never like that before), SKIN WARM (Skin feeling warm), ASTHENIA (No energy), PRURITUS (Itching), FLUSHING (Flushing), FEELING HOT (feeling hot\Prickly heat), HYPOAESTHESIA (numbness), PARAESTHESIA (Prickling/Tingling sensation), ABDOMINAL PAIN (Abdominal cramping), FEELING ABNORMAL (mild brain fog), DIARRHOEA (DIARRHEA), RASH (rash on chest\Rash: Generalised), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever), CHILLS (On and off chills\chills), NAUSEA (nausea) and FATIGUE (exhaustion) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he waited a little (about 6 weeks) before he received his second dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-273339 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoglycaemia, Vaccination complication
Clinical narrative: appears that he has hypoglycemia; thought he was going to die after getting second vaccine; when he exerts himself or stands up sensation of headaches; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (appears that he has hypoglycemia), VACCINATION COMPLICATION (thought he was going to die after getting second vaccine), HEADACHE (when he exerts himself or stands up sensation of headaches) and FATIGUE (feels tired) 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.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOGLYCAEMIA (appears that he has hypoglycemia), VACCINATION COMPLICATION (thought he was going to die after getting second vaccine), HEADACHE (when he exerts himself or stands up sensation of headaches) and FATIGUE (feels tired). At the time of the report, HYPOGLYCAEMIA (appears that he has hypoglycemia), HEADACHE (when he exerts himself or stands up sensation of headaches) and FATIGUE (feels tired) had not resolved and VACCINATION COMPLICATION (thought he was going to die after getting second vaccine) outcome was unknown.            Concomitant medications include Prostate medication.  Treatment medication was not provided by the reporter.  Patient has an appointment with an Endocrinologist in November.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     The patient's past medical history included Hot flashes.   On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced HOT FLUSH (She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine). At the time of the report, HOT FLUSH (She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Arm hurts when she lays on it; cannot get my hand up past face; left arm was sore right away and lasted a couple of months; pain started to move down left arm all the way down to her wrist; left arm was sore right away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts when she lays on it), MOBILITY DECREASED (cannot get my hand up past face), MYALGIA (left arm was sore right away and lasted a couple of months), ARTHRALGIA (pain started to move down left arm all the way down to her wrist) and VACCINATION SITE PAIN (left arm was sore right away) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Restless leg syndrome.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts when she lays on it), MOBILITY DECREASED (cannot get my hand up past face), MYALGIA (left arm was sore right away and lasted a couple of months), ARTHRALGIA (pain started to move down left arm all the way down to her wrist) and VACCINATION SITE PAIN (left arm was sore right away). At the time of the report, PAIN IN EXTREMITY (Arm hurts when she lays on it), MOBILITY DECREASED (cannot get my hand up past face), MYALGIA (left arm was sore right away and lasted a couple of months) and ARTHRALGIA (pain started to move down left arm all the way down to her wrist) outcome was unknown and VACCINATION SITE PAIN (left arm was sore right away) had resolved.            Concomitant drug included medication for restless leg syndrome. Treatment medications were not provided.  It was reported that patient receive vaccine on left shoulder.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. Reporter stated that 14 patients were given vaccine which was expired. Number of doses/vials: 10-dose vial Date the vial was initially stored in the refrigerator: 02-SEP-2021   This case was linked to MOD-2021-345833, MOD-2021-345448, MOD-2021-345457, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021:  follow up appended  : Reporter added , Lot no added , Expiration Date updated .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.  The first and second vaccine information was not provided. Nurse reported that number of doses/vials were 14-dose vial. On 02-Sep-2021, the vial was initially stored in the refrigerator. The expiration date of vaccine was 2 Oct 2021.   This case was linked to MOD-2021-345445, MOD-2021-345456, MOD-2021-345457, MOD-2021-345460, MOD-2021-345565, MOD-2021-345619, MOD-2021-345620, MOD-2021-345642, MOD-2021-345666, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: significant follow up appended : Reporter / Lot no / Expiration Date Updated .
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given 2nd dose past expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given 2nd dose past expiration) 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 EXPIRED PRODUCT ADMINISTERED (Patient was given 2nd dose past expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given 2nd dose past expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Illness, Nausea, Pain
Clinical narrative: feeling nauseous and achy, had a sore back; feeling nauseous and achy, had a sore back; had fever and fatigue after the first two doses, a sick feeling; had fever and fatigue after the first two doses, a sick feeling; had fever and fatigue after the first two doses, a sick feeling; feeling nauseous and achy, had a sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling) and FATIGUE (had fever and fatigue after the first two doses, a sick feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 CARBAMAZEPINE for an unknown indication.    On 12-Jan-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 (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling), FATIGUE (had fever and fatigue after the first two doses, a sick feeling) and NAUSEA (feeling nauseous and achy, had a sore back). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling), FATIGUE (had fever and fatigue after the first two doses, a sick feeling) and NAUSEA (feeling nauseous and achy, had a sore back) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included carbamazepine XR.   This case was linked to MOD-2021-345463, MOD-2021-345470 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling nauseous and achy, had a sore back; feeling nauseous and achy, had a sore back; had fever and fatigue after the first two doses, a sick feeling; had fever and fatigue after the first two doses, a sick feeling; had fever and fatigue after the first two doses, a sick feeling; feeling nauseous and achy, had a sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling) and FATIGUE (had fever and fatigue after the first two doses, a sick feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 CARBAMAZEPINE for an unknown indication.    On 12-Jan-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 (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling), FATIGUE (had fever and fatigue after the first two doses, a sick feeling) and NAUSEA (feeling nauseous and achy, had a sore back). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling), FATIGUE (had fever and fatigue after the first two doses, a sick feeling) and NAUSEA (feeling nauseous and achy, had a sore back) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included carbamazepine XR.   This case was linked to MOD-2021-345463, MOD-2021-345470 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.  It was reported that the dose administered after 30-day Use By Date or after manufacturer date of expiry. Original expiration was 2Mar2021 but the expiration was changed to 2Oct2021 Nurse reported that she wrote expired on the box but the doses were accidentally administered . Date the vial was initially stored in the refrigerator was 30Sep2021.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345460, MOD-2021-345565, MOD-2021-345619, MOD-2021-345620, MOD-2021-345666, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received includes Reporter details, lot no and Expiration Date Updated .
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Oct-2021 and was forwarded to Moderna on 07-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345445, MOD-2021-345460, MOD-2021-345565, MOD-2021-345619, MOD-2021-345620, MOD-2021-345666, MOD-2021-345456, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received contains significant Information as batch and expiration date of the suspect product.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow-up appended: Reporter details/ lot no / expiration date updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Illness, Nausea, Pain
Clinical narrative: sick feeling; sore back; Achy; Fatigue; Nausea; I had fever and fatigue for the first two doses, a sick feeling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.  Concomitant products included CARBAMAZEPINE for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (I had fever and fatigue for the first two doses, a sick feeling). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (I had fever and fatigue for the first two doses, a sick feeling) outcome was unknown.            Concomitant medications include Carbamazepine XR 100mg. Treatment medications include Aspirin   This case was linked to MOD-2021-345452, MOD-2021-345470 (Patient Link).