chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: pretty affected by the first two doses/it was very hard; felt weak; arm was weak; chills; headache for almost a month; fatigue; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard), ASTHENIA (felt weak), MUSCULAR WEAKNESS (arm was weak), CHILLS (chills) and HEADACHE (headache for almost a month) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) 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 TRAZODONE and HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for an unknown indication.    On 30-Mar-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 VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard), ASTHENIA (felt weak), MUSCULAR WEAKNESS (arm was weak), CHILLS (chills), HEADACHE (headache for almost a month), FATIGUE (fatigue) and MYALGIA (soreness). At the time of the report, VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard), ASTHENIA (felt weak) and MUSCULAR WEAKNESS (arm was weak) outcome was unknown and CHILLS (chills), HEADACHE (headache for almost a month), FATIGUE (fatigue) and MYALGIA (soreness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-342395 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pigmentation disorder, Product dose omission issue, Tremor, Vaccination site erythema
Clinical narrative: left skin pigmentation very dark, dark brown, almost like a sunburn; reaction in the arm where vaccine was injected; very hot; very red; Patient will not get 2nd dose as HCP recommended; tremors in the legs; tremors in the legs have been gradually getting worse; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors in the legs), PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn), VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ) and CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced TREMOR (tremors in the legs), CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) and PRODUCT DOSE OMISSION ISSUE (Patient will not get 2nd dose as HCP recommended). On an unknown date, the patient experienced PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn), VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ) and VACCINATION SITE ERYTHEMA (very red). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (tremors in the legs), PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn) and CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) had not resolved and VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ), VACCINATION SITE ERYTHEMA (very red) and PRODUCT DOSE OMISSION ISSUE (Patient will not get 2nd dose as HCP recommended) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: left skin pigmentation very dark, dark brown, almost like a sunburn; reaction in the arm where vaccine was injected; very hot; very red; Patient will not get 2nd dose as HCP recommended; tremors in the legs; tremors in the legs have been gradually getting worse; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors in the legs), PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn), VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ) and CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced TREMOR (tremors in the legs), CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) and PRODUCT DOSE OMISSION ISSUE (Patient will not get 2nd dose as HCP recommended). On an unknown date, the patient experienced PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn), VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ) and VACCINATION SITE ERYTHEMA (very red). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (tremors in the legs), PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn) and CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) had not resolved and VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ), VACCINATION SITE ERYTHEMA (very red) and PRODUCT DOSE OMISSION ISSUE (Patient will not get 2nd dose as HCP recommended) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Feeling of body temperature change, Impaired work ability, Insomnia
Clinical narrative: hardly sleep/I sleep about 3 hours a night; can't get comfortable; if I'm not freezing to death, then I'm roasting alive; extremely sensitive to bright light/if I go out in the sun, I'm blinded; it hurts bad; He hasn't gone to work since then. He can't drive his truck, which is what he does for a living; joints are killing me/shoulders, lower back, hips; feeling like crap; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive) and PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced MALAISE (feeling like crap). On an unknown date, the patient experienced INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips). The patient was treated with PARACETAMOL (TYLENOL) on 28-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips) had not resolved.            No concomitant medications were reported. The patient had driven trucks for 40 years, that all took away from him. The patient could no longer do what he was doing. The thing had got him terrified.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Photophobia
Clinical narrative: hardly sleep/I sleep about 3 hours a night; can't get comfortable; if I'm not freezing to death, then I'm roasting alive; extremely sensitive to bright light/if I go out in the sun, I'm blinded; it hurts bad; He hasn't gone to work since then. He can't drive his truck, which is what he does for a living; joints are killing me/shoulders, lower back, hips; feeling like crap; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive) and PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced MALAISE (feeling like crap). On an unknown date, the patient experienced INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips). The patient was treated with PARACETAMOL (TYLENOL) on 28-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips) had not resolved.            No concomitant medications were reported. The patient had driven trucks for 40 years, that all took away from him. The patient could no longer do what he was doing. The thing had got him terrified.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with Covid) and DRUG INEFFECTIVE (Lack of efficacy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 03M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced COVID-19 (diagnosed with Covid) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with REMDESIVIR on 05-Oct-2021 for COVID-19, at a dose of Infusion. At the time of the report, COVID-19 (diagnosed with Covid) outcome was unknown and DRUG INEFFECTIVE (Lack of efficacy) had resolved.            Concomitant medications were not provided.  This case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred 6 months and 4 days after second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred 6 months and 4 days after second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving dose from an expired Moderna COVID19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) 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.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist gave patients expired doses of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient was monitored for 15 min after and had no symptoms.  No concomitant medications was reported. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: flu like symptoms; nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain; she got nocturnal limb pain in her legs, arms, and buttocks; developed low grade fever; aches and pains/ nocturnal myalgia; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia). The patient was treated with PARACETAMOL (TYLENOL) on 19-Sep-2021 for Pain, at a dose of 1300 milligram and OXYCODONE on 19-Sep-2021 for Pain, at a dose of 5 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks) and PYREXIA (developed low grade fever) outcome was unknown and MYALGIA (aches and pains/ nocturnal myalgia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (abnormal) 100.3 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  The nocturnal pain stopped in the day time but at night she was disturbed with pain Tylenol together with Oxycodone,gave her sleep relief, event low grade fever lasted for one week noted.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Event (nocturnal myalgia) outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain; she got nocturnal limb pain in her legs, arms, and buttocks; developed low grade fever; aches and pains/ nocturnal myalgia; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia). The patient was treated with PARACETAMOL (TYLENOL) on 19-Sep-2021 for Pain, at a dose of 1300 milligram and OXYCODONE on 19-Sep-2021 for Pain, at a dose of 5 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks) and PYREXIA (developed low grade fever) outcome was unknown and MYALGIA (aches and pains/ nocturnal myalgia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (abnormal) 100.3 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  The nocturnal pain stopped in the day time but at night she was disturbed with pain Tylenol together with Oxycodone,gave her sleep relief, event low grade fever lasted for one week noted.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Event (nocturnal myalgia) outcome updated.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product dose omission issue
Clinical narrative: The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.; A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.) and PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.). On 31-Aug-2021, OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The second dose was not yet administered. Patient did not report any symptoms or side effects after receiving the vaccine.    Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Follow up information received on 11-OCT-2021 included ethnicity and race of the patient.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) 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 July 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 03-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) outcome was unknown.            Concomitant medications were not reported. The patient was also prescribed with some eye ointment, an eye patch at night to keep the eye shut and some eye drops for daytime.; Sender's Comments: This case refers to a male patient of unknown age with no relevant medical history who experienced the expected event of Bell's Palsy approximately 3 months after the second dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable since limited information on the first dose was provided. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: light flu symptoms after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (light flu symptoms after first dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included CORTICOSTEROIDS for Autoimmune disorder NOS.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (light flu symptoms after first dose). At the time of the report, INFLUENZA LIKE ILLNESS (light flu symptoms after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported for first dose events.   This case was linked to MOD-2021-342720 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Paraesthesia
Clinical narrative: Since yesterday (04Oct2021), her face has started tingling; Fatigue went away a week after.; On same day, she had stuffy nose; She had slight headache,All of those symptoms went away; She was fatigued,She was very tired,Fatigue went away a week after; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (On same day, she had stuffy nose), PARAESTHESIA (Since yesterday (04Oct2021), her face has started tingling), HEADACHE (She had slight headache,All of those symptoms went away), FATIGUE (She was fatigued,She was very tired,Fatigue went away a week after) and FATIGUE (Fatigue went away a week after.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Sep-2021, the patient experienced NASAL CONGESTION (On same day, she had stuffy nose), HEADACHE (She had slight headache,All of those symptoms went away) and FATIGUE (She was fatigued,She was very tired,Fatigue went away a week after). On 30-Sep-2021, the patient experienced FATIGUE (Fatigue went away a week after.). On 04-Oct-2021, the patient experienced PARAESTHESIA (Since yesterday (04Oct2021), her face has started tingling). The patient was treated with EUCALYPTUS GLOBULUS OIL, MENTHOL (HALLS) for Adverse event, at an unspecified dose and frequency and IRON for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (On same day, she had stuffy nose), PARAESTHESIA (Since yesterday (04Oct2021), her face has started tingling), HEADACHE (She had slight headache,All of those symptoms went away), FATIGUE (She was fatigued,She was very tired,Fatigue went away a week after) and FATIGUE (Fatigue went away a week after.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Blood pressure medicine and Diabetes medicine  Patient took Treatment with Halls, Vicks Vapor rub, Iron tablets
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-342886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received, contains no new information.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2021 at 1:30 PM, 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 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported. The vial was initially stored in the refrigerator on 02-Oct-2021.It was first punctured on 04-Oct-2021 at 8:30 am. The vial was stored at room temperature post puncture. It didn't undergo any temperature excursions. It was left at room temperature for 28 cumulative hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving dose from an expired Moderna COVID19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitants and treatment drugs were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hive size of 50 cent piece; Hive itched; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA and PRURITUS in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE for an unknown indication.    On 17-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 URTICARIA and PRURITUS. At the time of the report, URTICARIA and PRURITUS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took Diphenhydramine and the hive went away.   This case was linked to MOD-2021-342798 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Feeling hot, Mobility decreased, Vaccination site pain
Clinical narrative: feeling hot; feeling cold; woke up but could not move anything on his body but his eyelids (It lasted 20 minutes); feeling really tired; arm soreness at end of day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot), FEELING COLD (feeling cold), MOBILITY DECREASED (woke up but could not move anything on his body but his eyelids (It lasted 20 minutes), FATIGUE (feeling really tired) and VACCINATION SITE PAIN (arm soreness at end of day) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Patient prone to blood clots and had a concussion last week). Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy.   On 04-Oct-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 04-Oct-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at end of day). On 05-Oct-2021, the patient experienced FEELING HOT (feeling hot), FEELING COLD (feeling cold), MOBILITY DECREASED (woke up but could not move anything on his body but his eyelids (It lasted 20 minutes)) and FATIGUE (feeling really tired). At the time of the report, FEELING HOT (feeling hot), FEELING COLD (feeling cold), FATIGUE (feeling really tired) and VACCINATION SITE PAIN (arm soreness at end of day) outcome was unknown and MOBILITY DECREASED (woke up but could not move anything on his body but his eyelids (It lasted 20 minutes)) had resolved.            No treatment was reported by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: minor pains; I had a Fever of 101.3 degrees which lasted 1 day; minor aches; fatigue; minor headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor pains), PYREXIA (I had a Fever of 101.3 degrees which lasted 1 day), MYALGIA (minor aches), FATIGUE (fatigue) and HEADACHE (minor headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (minor pains), PYREXIA (I had a Fever of 101.3 degrees which lasted 1 day), MYALGIA (minor aches), FATIGUE (fatigue) and HEADACHE (minor headache). At the time of the report, PAIN (minor pains), PYREXIA (I had a Fever of 101.3 degrees which lasted 1 day), MYALGIA (minor aches), FATIGUE (fatigue) and HEADACHE (minor headache) outcome was unknown.            Treatment details was not reported by the reporter.   This case was linked to MOD-2021-342759 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: 2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 1730L20A) 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) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.). At the time of the report, DYSPNOEA (2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. Blood pressure medicine reported as concomitant medication.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Patient is Breast feeding received vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE VIA BREAST MILK (Patient is Breast feeding received vaccine) in a  patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Postpartum state. Concurrent medical conditions included Maternal exposure during breast feeding since 24-Sep-2021.    No Medical History information was reported.    On 24-Sep-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Sep-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Patient is Breast feeding received vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 24-Sep-2021, EXPOSURE VIA BREAST MILK (Patient is Breast feeding received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  This case of Maternal exposure during breast feeding concerns a  child of an unknown age and gender with no relevant medical history, who experienced no adverse events. The patient received the first dose of vaccine via transmammary route at an unknown age. The benefit-risk relationship of Spikevax is not affected by this report. ?   This case was linked to MOD-2021-342766, MOD-2021-342811 (Parent-Child Link).   See case MOD-2021-342811,MOD-2021-342766 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received contains no new information; Sender's Comments: This case of Maternal exposure during breast feeding concerns a  child of an unknown age and gender with no relevant medical history, who experienced no adverse events. The patient received the first dose of vaccine via transmammary route at an unknown age. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Myalgia
Clinical narrative: walked to the bathroom had a loss of balance; 8-9 hours body aches, recovered fine; lost balance of walking, lost balance again, loss control of his body while sitting on toilet.; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost balance of walking, lost balance again, loss control of his body while sitting on toilet.), GAIT DISTURBANCE (walked to the bathroom had a loss of balance) and MYALGIA (8-9 hours body aches, recovered fine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 052C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced BALANCE DISORDER (lost balance of walking, lost balance again, loss control of his body while sitting on toilet.). On an unknown date, the patient experienced GAIT DISTURBANCE (walked to the bathroom had a loss of balance) and MYALGIA (8-9 hours body aches, recovered fine). At the time of the report, BALANCE DISORDER (lost balance of walking, lost balance again, loss control of his body while sitting on toilet.) and GAIT DISTURBANCE (walked to the bathroom had a loss of balance) outcome was unknown and MYALGIA (8-9 hours body aches, recovered fine) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Muscular weakness, Myalgia
Clinical narrative: left arm pain; pain on the back; muscle weakness; pain under the arm; joint pain/shoulder pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm pain), BACK PAIN (pain on the back), MUSCULAR WEAKNESS (muscle weakness), AXILLARY PAIN (pain under the arm) and ARTHRALGIA (joint pain/shoulder pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-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 (left arm pain), BACK PAIN (pain on the back), MUSCULAR WEAKNESS (muscle weakness), AXILLARY PAIN (pain under the arm), ARTHRALGIA (joint pain/shoulder pain) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (left arm pain), BACK PAIN (pain on the back), MUSCULAR WEAKNESS (muscle weakness), AXILLARY PAIN (pain under the arm), ARTHRALGIA (joint pain/shoulder pain) and MYALGIA (muscle pain) had not resolved.            Concomitant medication was not provided. Treatment information was not provided.  After the second dose of vaccination patient has had left arm pain, then pain under the arm and on the back, joint pain, muscle pain, muscle weakness and shoulder pain. Still having all of these symptoms after 8 months.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm pain; pain on the back; muscle weakness; pain under the arm; joint pain/shoulder pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm pain), BACK PAIN (pain on the back), MUSCULAR WEAKNESS (muscle weakness), AXILLARY PAIN (pain under the arm) and ARTHRALGIA (joint pain/shoulder pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-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 (left arm pain), BACK PAIN (pain on the back), MUSCULAR WEAKNESS (muscle weakness), AXILLARY PAIN (pain under the arm), ARTHRALGIA (joint pain/shoulder pain) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (left arm pain), BACK PAIN (pain on the back), MUSCULAR WEAKNESS (muscle weakness), AXILLARY PAIN (pain under the arm), ARTHRALGIA (joint pain/shoulder pain) and MYALGIA (muscle pain) had not resolved.            Concomitant medication was not provided. Treatment information was not provided.  After the second dose of vaccination patient has had left arm pain, then pain under the arm and on the back, joint pain, muscle pain, muscle weakness and shoulder pain. Still having all of these symptoms after 8 months.