chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Pain in extremity, Thinking abnormal
Clinical narrative: sore right arm; felt strange/unusual; hard to sleep; "felt like an alien entered my body"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), FEELING ABNORMAL (felt strange/unusual), INSOMNIA (hard to sleep) and THINKING ABNORMAL ("felt like an alien entered my body") in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     No medical history was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore right arm), FEELING ABNORMAL (felt strange/unusual), INSOMNIA (hard to sleep) and THINKING ABNORMAL ("felt like an alien entered my body"). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. On 24-Jan-2021, PAIN IN EXTREMITY (sore right arm), FEELING ABNORMAL (felt strange/unusual), INSOMNIA (hard to sleep) and THINKING ABNORMAL ("felt like an alien entered my body") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.   This case was linked to MOD-2021-036273 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Feeling abnormal, Headache
Clinical narrative: Bone Aches; weakness\ want's to stand and don't have the strength to do it; feels like drugged/laying in bed; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills) and MYALGIA (Body aches) in a 52-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.     The patient's past medical history included No adverse event (no medical history was reported.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Significant: Outcome of event provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Bone Aches; weakness\ want's to stand and don't have the strength to do it; feels like drugged/laying in bed; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills) and MYALGIA (Body aches) in a 52-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.     The patient's past medical history included No adverse event (no medical history was reported.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Significant: Outcome of event provided
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Feeling abnormal, Pancreatic disorder, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), PANCREATIC DISORDER (having pancreas issues) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Diabetes and Hypertension. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma, METFORMIN for an unknown indication.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (started feeling bad), PANCREATIC DISORDER (having pancreas issues) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started feeling bad), PANCREATIC DISORDER (having pancreas issues) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 400 (High) checked blood sugar and it was over 400. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include blood pressure meds.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Hypoaesthesia, Nervousness, Paraesthesia
Clinical narrative: She is talking a lot, she is out of breath; Anxiety; Nervousness; She felt in her arm/Went into fingertips/ Tingling and numbness feeling; She felt in her arm/Went into fingertips/ Tingling and numbness feeling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (She felt in her arm/Went into fingertips/ Tingling and numbness feeling), HYPOAESTHESIA (She felt in her arm/Went into fingertips/ Tingling and numbness feeling), DYSPNOEA (She is talking a lot, she is out of breath), ANXIETY (Anxiety) and NERVOUSNESS (Nervousness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (She felt in her arm/Went into fingertips/ Tingling and numbness feeling) and HYPOAESTHESIA (She felt in her arm/Went into fingertips/ Tingling and numbness feeling). On an unknown date, the patient experienced DYSPNOEA (She is talking a lot, she is out of breath), ANXIETY (Anxiety) and NERVOUSNESS (Nervousness). At the time of the report, PARAESTHESIA (She felt in her arm/Went into fingertips/ Tingling and numbness feeling), HYPOAESTHESIA (She felt in her arm/Went into fingertips/ Tingling and numbness feeling), DYSPNOEA (She is talking a lot, she is out of breath), ANXIETY (Anxiety) and NERVOUSNESS (Nervousness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication includes asthma and has inhaler. No Treatment information was  provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Muscle spasms, Pyrexia
Clinical narrative: Stomach upset after the 2nd dose; Leg cramps after the 2nd dose; Feels like has to go to bathroom after eats after 2nd dose; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset after the 2nd dose), MUSCLE SPASMS (Leg cramps after the 2nd dose), DIARRHOEA (Feels like has to go to bathroom after eats after 2nd dose) and PYREXIA (Fever after 2nd dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 032m20a) for COVID-19 vaccination.     No medical history was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-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 ABDOMINAL DISCOMFORT (Stomach upset after the 2nd dose), MUSCLE SPASMS (Leg cramps after the 2nd dose), DIARRHOEA (Feels like has to go to bathroom after eats after 2nd dose) and PYREXIA (Fever after 2nd dose). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset after the 2nd dose), MUSCLE SPASMS (Leg cramps after the 2nd dose), DIARRHOEA (Feels like has to go to bathroom after eats after 2nd dose) and PYREXIA (Fever after 2nd dose) outcome was unknown.            No treatment information was provided. Concomitant product use was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was reported.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Paraesthesia, Throat tightness
Clinical narrative: Could not breath; Throat shut down; Tingling in legs; Could not swallow; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Could not breath), THROAT TIGHTNESS (Throat shut down), PARAESTHESIA (Tingling in legs) and DYSPHAGIA (Could not swallow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was reported.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DYSPNOEA (Could not breath), THROAT TIGHTNESS (Throat shut down), PARAESTHESIA (Tingling in legs) and DYSPHAGIA (Could not swallow). On 20-Mar-2021, DYSPNOEA (Could not breath), THROAT TIGHTNESS (Throat shut down), PARAESTHESIA (Tingling in legs) and DYSPHAGIA (Could not swallow) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment product information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Vaccine at age 17; Invalid dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine at age 17) and INCORRECT DOSE ADMINISTERED (Invalid dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine at age 17) and INCORRECT DOSE ADMINISTERED (Invalid dose). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine at age 17) and INCORRECT DOSE ADMINISTERED (Invalid dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  This report refers to a case of product administered to patient of inappropriate age 17-year-old  and incorrect dose administered for mRNA-1273 (lot number unknown) with no associated AEs reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up information received on 31-MAR-2021. Updated event - Vaccine at 17 years.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age 17-year-old  and incorrect dose administered for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and MYALGIA (Body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No patient history was reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information were not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pain
Clinical narrative: Red spot on back (size of baseball); Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot on back (size of baseball)) and VACCINATION SITE PAIN (Pain at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (received shingles shot and had an allergic reaction) in January 2021. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MONTELUKAST SODIUM (SINGULAIR) and HCTZ for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced RASH MACULAR (Red spot on back (size of baseball)) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, RASH MACULAR (Red spot on back (size of baseball)) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include Deramil. The patient received shingles shot in January 2021 and had an allergic reaction. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling abnormal, Headache, Injection site discolouration
Clinical narrative: Brain fog; Blue color of arm at injection site; Black color of arm at injection site; Swelling of arm at injection site; Nauseated; Fever; Chills; Headache; Diarrhea; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PROPRANOLOL, ENALAPRIL and AMLODIPINE for an unknown indication.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm pain), NAUSEA (Nauseated), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 24-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site) and VACCINATION SITE SWELLING (Swelling of arm at injection site). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog). The patient was treated with PARACETAMOL (TYLENOL) for Symptom recurrence, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain fog), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site), VACCINATION SITE SWELLING (Swelling of arm at injection site), NAUSEA (Nauseated) and HEADACHE (Headache) had not resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: Brain fog; Blue color of arm at injection site; Black color of arm at injection site; Swelling of arm at injection site; Nauseated; Fever; Chills; Headache; Diarrhea; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PROPRANOLOL, ENALAPRIL and AMLODIPINE for an unknown indication.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm pain), NAUSEA (Nauseated), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 24-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site) and VACCINATION SITE SWELLING (Swelling of arm at injection site). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog). The patient was treated with PARACETAMOL (TYLENOL) for Symptom recurrence, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain fog), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site), VACCINATION SITE SWELLING (Swelling of arm at injection site), NAUSEA (Nauseated) and HEADACHE (Headache) had not resolved.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-059995 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments:  MOD-2021-059995:Crosslinked case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Burning sensation, Fatigue
Clinical narrative: burning pain; bone pain; old shoulder injury and that hurt worse; Tired; This spontaneous case was reported by a nurse and describes the occurrence of BURNING SENSATION (burning pain), BONE PAIN (bone pain), ARTHRALGIA (old shoulder injury and that hurt worse) and FATIGUE (Tired) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 BURNING SENSATION (burning pain), BONE PAIN (bone pain), ARTHRALGIA (old shoulder injury and that hurt worse) and FATIGUE (Tired). At the time of the report, BURNING SENSATION (burning pain), BONE PAIN (bone pain), ARTHRALGIA (old shoulder injury and that hurt worse) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was  not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-063219 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headache) 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 mellitus. Concomitant products included INSULIN for Diabetes mellitus.   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 MYALGIA (body aches) and HEADACHE (headache). At the time of the report, MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            No treatment medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-059899, MODERNATX, INC.-MOD-2021-059899 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-059899: MODERNATX, INC.-MOD-2021-059899:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            This case was linked to MOD-2021-036522 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands in her throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands in her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen glands in her throat). At the time of the report, LYMPHADENOPATHY (Swollen glands in her throat) outcome was unknown.            No Concomitant drugs were provided Upon Internal review on 04-Aug-2021, discrepant information was noticed in age and DOB of the patient hence, not updated in patient section.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: nauseous; chills; low-grade fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), CHILLS (chills) and PYREXIA (low-grade fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced NAUSEA (nauseous), CHILLS (chills) and PYREXIA (low-grade fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 25-Mar-2021 for Chills, at an unspecified dose and frequency. On 25-Mar-2021, NAUSEA (nauseous) outcome was unknown. At the time of the report, CHILLS (chills) and PYREXIA (low-grade fever) outcome was unknown.            Reporter stated that she does not require further follow up, her husband(patient) is fine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Reporter stated that she does not require further follow up, her husband(patient) is fine. Outcome of events that is chills and low grade fever changed to unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Light headed; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) and PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headed) and PAIN IN EXTREMITY (Sore arm). At the time of the report, DIZZINESS (Light headed) and PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR  received and Updated the event outcome to Recovered/Resolved
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: After the second dose it was noticeable on both cheeks. Mild, intermittent. Mostly in the morning/ Occasional numbness on cheeks; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (After the second dose it was noticeable on both cheeks. Mild, intermittent. Mostly in the morning/ Occasional numbness on cheeks) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0321.20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-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 HYPOAESTHESIA (After the second dose it was noticeable on both cheeks. Mild, intermittent. Mostly in the morning/ Occasional numbness on cheeks). At the time of the report, HYPOAESTHESIA (After the second dose it was noticeable on both cheeks. Mild, intermittent. Mostly in the morning/ Occasional numbness on cheeks) was resolving.            Concomitant and treatment medications were not provided.  The patient had checked teeth and eyes and the physician suspects that numbness could be result of the vaccine.   This case was linked to MOD-2021-035921 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Updated event outcome from unknown to resolving.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and DIARRHOEA (Diarrhea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, FATIGUE (Fatigue) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment medication was taken. No concomitant medication was taken.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: nauseas; left arm red around injection site; left arm slightly swollen around injection site; injection site very very hot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseas), INJECTION SITE ERYTHEMA (left arm red around injection site), INJECTION SITE SWELLING (left arm slightly swollen around injection site) and INJECTION SITE WARMTH (injection site very very hot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced NAUSEA (nauseas), INJECTION SITE ERYTHEMA (left arm red around injection site), INJECTION SITE SWELLING (left arm slightly swollen around injection site) and INJECTION SITE WARMTH (injection site very very hot). At the time of the report, NAUSEA (nauseas), INJECTION SITE ERYTHEMA (left arm red around injection site), INJECTION SITE SWELLING (left arm slightly swollen around injection site) and INJECTION SITE WARMTH (injection site very very hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site pruritus
Clinical narrative: Itchiness at injection site; Fever; Headache/strange headache; Painful arm / sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm / sore arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchiness at injection site), PYREXIA (Fever) and HEADACHE (Headache/strange headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful arm / sore arm) and PERIPHERAL SWELLING (Swollen arm). On 14-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache/strange headache). On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Pruritus, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (Painful arm / sore arm) and PERIPHERAL SWELLING (Swollen arm) had resolved. On 15-Feb-2021, PYREXIA (Fever) and HEADACHE (Headache/strange headache) had resolved. On 22-Feb-2021, VACCINATION SITE PRURITUS (Itchiness at injection site) had resolved.            No concomitant medications were reported.  Patient reported delayed injection site itchiness started 9 days post first vaccine dose. Patient administered one application of topical Benadryl gel and itchiness resolved immediately.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-063941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporters email address and  patients age was added.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna vaccine for her first dose and the Pfizer vaccine for her second dose.; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine for her first dose and the Pfizer vaccine for her second dose.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine for her first dose and the Pfizer vaccine for her second dose.). On 25-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine for her first dose and the Pfizer vaccine for her second dose.) outcome was unknown. Not Provided          Patient received the Moderna vaccine for her first dose and the Pfizer vaccine for her second dose. Patient received the Pfizer vaccine (lot: ER8732) in her right arm on 25 Mar 2021. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-063217 (E2B Linked Report).; Sender's Comments:  MOD21-063217:Case of Husband
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Pain
Clinical narrative: Headache; Pain; Could not raise arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Could not raise arm), HEADACHE (Headache) and PAIN (Pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025620A and 072A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Could not raise arm). On an unknown date, the patient experienced HEADACHE (Headache) and PAIN (Pain). At the time of the report, MUSCULAR WEAKNESS (Could not raise arm), HEADACHE (Headache) and PAIN (Pain) outcome was unknown.            No Concomitant medicine were reported. No treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-19 Vaccine was opened for more than 6 hours and it was administered to 7 patients; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Vaccine was opened for more than 6 hours and it was administered to 7 patients) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Vaccine was opened for more than 6 hours and it was administered to 7 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Vaccine was opened for more than 6 hours and it was administered to 7 patients) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment related informations were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received no newfurther information; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 030A21A)  with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Product dose omission issue
Clinical narrative: diarrhea; cancelled his 2nd dose due to diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PRODUCT DOSE OMISSION ISSUE (cancelled his 2nd dose due to diarrhea) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and PRODUCT DOSE OMISSION ISSUE (cancelled his 2nd dose due to diarrhea). On 25-Mar-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (cancelled his 2nd dose due to diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nervousness, Paraesthesia, Paraesthesia oral
Clinical narrative: Eyes tingling; Tired; Headache; Lip tingling; Tip of nose tingling; made her nervous.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Lip tingling), PARAESTHESIA (Tip of nose tingling), NERVOUSNESS (made her nervous.), PARAESTHESIA (Eyes tingling) and FATIGUE (Tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA ORAL (Lip tingling), PARAESTHESIA (Tip of nose tingling), NERVOUSNESS (made her nervous.), FATIGUE (Tired) and HEADACHE (Headache). On an unknown date, the patient experienced PARAESTHESIA (Eyes tingling). At the time of the report, PARAESTHESIA ORAL (Lip tingling), PARAESTHESIA (Tip of nose tingling), NERVOUSNESS (made her nervous.), PARAESTHESIA (Eyes tingling), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Patient had a UTI; This spontaneous case was reported by a patient family member or friend and describes the occurrence of URINARY TRACT INFECTION (Patient had a UTI) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced URINARY TRACT INFECTION (Patient had a UTI). At the time of the report, URINARY TRACT INFECTION (Patient had a UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs included no treatment drugs included; Sender's Comments: Event is of an infective origin , therefore, based on biological implausibility, causal association between the reported event and the administration of the reported is assessed as unlikely.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild pain in the arm of the injection) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included MELOXICAM, ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild pain in the arm of the injection). At the time of the report, VACCINATION SITE PAIN (Mild pain in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included Blood pressure medication, Medicine for his cold.  No Treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received and contains No NewInformation.