chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.; Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     Patient had not ever been diagnosed or tested positive for COVID-19.  Concurrent medical conditions included Fish allergy.    On 30-Mar-2022 at 11:09 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 11:09 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date the vial was initially stored in the refrigerator was on 01-Mar-2022. The nurse (healthcare provider) at a local county health department had inadvertently administered the expired Moderna COVID-19 vaccine on 30-Mar-2022 with expiration date on 19-Mar-2022. No patients had reported any adverse events for now. The adverse event had not caused the patient to seek the medical care. The vial had not undergone any temperature excursions.  No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Electroencephalogram, Headache
Clinical narrative: myoclonus; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCLONUS (myoclonus), DIZZINESS (dizziness) and HEADACHE (headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 001B21A) for COVID-19 vaccination.     Patient did not had Covid-19 diagnosis prior to and after getting the Covid-19 vaccine.  Concurrent medical conditions included Allergy (allergies to Pizigam). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Contraception.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). On 08-May-2021, the patient experienced MYOCLONUS (myoclonus). The patient was treated with PREDNISOLONE at an unspecified dose and frequency; TOPIRAMATE (TOPAMAX) at an unspecified dose and frequency; FREMANEZUMAB (AJOVY [FREMANEZUMAB]) at an unspecified dose and frequency; IMMUNOGLOBULIN HUMAN NORMAL (GAMMAGARD) at an unspecified dose and frequency; RIMEGEPANT SULFATE (NURTEC ODT) at an unspecified dose and frequency and UBROGEPANT (UBRELVY) at an unspecified dose and frequency. At the time of the report, MYOCLONUS (myoclonus) was resolving and DIZZINESS (dizziness) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported lot of blood tests. On an unknown date, Electrocardiogram: results not reported Results not reported. On an unknown date, Electroencephalogram: results not reported Results not reported. On an unknown date, Lumbar puncture: results not reported Results not reported. On an unknown date, Magnetic resonance imaging: results not reported Results not reported.         Vaccines were given in pharmacy in separate states.  Patient has consulted many neurologists.  Patient was treated with Pizigam and Qulipta. Prescribed treatment medications did not give her any relief so they stopped all these medications.  Laboratory information also included MRA and MRV.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Myoclonus
Clinical narrative: myoclonus; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCLONUS (myoclonus), DIZZINESS (dizziness) and HEADACHE (headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 001B21A) for COVID-19 vaccination.     Patient did not had Covid-19 diagnosis prior to and after getting the Covid-19 vaccine.  Concurrent medical conditions included Allergy (allergies to Pizigam). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Contraception.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). On 08-May-2021, the patient experienced MYOCLONUS (myoclonus). The patient was treated with PREDNISOLONE at an unspecified dose and frequency; TOPIRAMATE (TOPAMAX) at an unspecified dose and frequency; FREMANEZUMAB (AJOVY [FREMANEZUMAB]) at an unspecified dose and frequency; IMMUNOGLOBULIN HUMAN NORMAL (GAMMAGARD) at an unspecified dose and frequency; RIMEGEPANT SULFATE (NURTEC ODT) at an unspecified dose and frequency and UBROGEPANT (UBRELVY) at an unspecified dose and frequency. At the time of the report, MYOCLONUS (myoclonus) was resolving and DIZZINESS (dizziness) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported lot of blood tests. On an unknown date, Electrocardiogram: results not reported Results not reported. On an unknown date, Electroencephalogram: results not reported Results not reported. On an unknown date, Lumbar puncture: results not reported Results not reported. On an unknown date, Magnetic resonance imaging: results not reported Results not reported.         Vaccines were given in pharmacy in separate states.  Patient has consulted many neurologists.  Patient was treated with Pizigam and Qulipta. Prescribed treatment medications did not give her any relief so they stopped all these medications.  Laboratory information also included MRA and MRV.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: her arm was also red almost like a rash; very sore arm; her arm was also red almost like a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease (She has a history of Hashimoto's disease.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  It was reported that patient took acetaminophen and events dissipated within 24 hours.   This case was linked to MOD-2022-537593, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: her arm was also red almost like a rash; very sore arm; her arm was also red almost like a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease (She has a history of Hashimoto's disease.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  It was reported that patient took acetaminophen and events dissipated within 24 hours.   This case was linked to MOD-2022-537593, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Ocular discomfort, Oral herpes, Pain in extremity, Psoriasis
Clinical narrative: her arm was also red almost like a rash; very sore arm; her arm was also red almost like a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease (She has a history of Hashimoto's disease.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  It was reported that patient took acetaminophen and events dissipated within 24 hours.   This case was linked to MOD-2022-537593, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: her arm was also red almost like a rash; very sore arm; her arm was also red almost like a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease (She has a history of Hashimoto's disease.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (her arm was also red almost like a rash), PAIN IN EXTREMITY (very sore arm) and RASH (her arm was also red almost like a rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  It was reported that patient took acetaminophen and events dissipated within 24 hours.   This case was linked to MOD-2022-537593, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm). At the time of the report, ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) outcome was unknown. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2022-537566, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm). At the time of the report, ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) outcome was unknown. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2022-537566, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Ocular discomfort, Oral herpes, Pain in extremity, Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm). At the time of the report, ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) outcome was unknown. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2022-537566, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm). At the time of the report, ERYTHEMA (Her arm was also red almost like a rash) and PAIN IN EXTREMITY (Very sore arm) outcome was unknown. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2022-537566, MOD-2022-537594 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Cold sores in my mouth; Psoriasis; Not feeling so hot; Sore arm; A bout of vertigo; Nerve thing going on around my eye; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo) and FEELING ABNORMAL (Not feeling so hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 011J20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease (History of Hashimoto's disease.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced OCULAR DISCOMFORT (Nerve thing going on around my eye). On 10-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (A bout of vertigo). On an unknown date, the patient experienced ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ORAL HERPES (Cold sores in my mouth) had not resolved and PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.  Patient was concerned about when to get a second booster dose as she received a "full dose" booster dose of the vaccine which was before change in authorization from a full dose to a half dose.  No treatment  medications were reported.   This case was linked to MOD-2022-537593, MOD-2022-537566 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Cold sores in my mouth; Psoriasis; Not feeling so hot; Sore arm; A bout of vertigo; Nerve thing going on around my eye; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo) and FEELING ABNORMAL (Not feeling so hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 011J20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease (History of Hashimoto's disease.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced OCULAR DISCOMFORT (Nerve thing going on around my eye). On 10-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (A bout of vertigo). On an unknown date, the patient experienced ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ORAL HERPES (Cold sores in my mouth) had not resolved and PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.  Patient was concerned about when to get a second booster dose as she received a "full dose" booster dose of the vaccine which was before change in authorization from a full dose to a half dose.  No treatment  medications were reported.   This case was linked to MOD-2022-537593, MOD-2022-537566 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Ocular discomfort, Oral herpes, Pain in extremity, Psoriasis
Clinical narrative: Cold sores in my mouth; Psoriasis; Not feeling so hot; Sore arm; A bout of vertigo; Nerve thing going on around my eye; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo) and FEELING ABNORMAL (Not feeling so hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 011J20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease (History of Hashimoto's disease.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced OCULAR DISCOMFORT (Nerve thing going on around my eye). On 10-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (A bout of vertigo). On an unknown date, the patient experienced ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ORAL HERPES (Cold sores in my mouth) had not resolved and PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.  Patient was concerned about when to get a second booster dose as she received a "full dose" booster dose of the vaccine which was before change in authorization from a full dose to a half dose.  No treatment  medications were reported.   This case was linked to MOD-2022-537593, MOD-2022-537566 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Cold sores in my mouth; Psoriasis; Not feeling so hot; Sore arm; A bout of vertigo; Nerve thing going on around my eye; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo) and FEELING ABNORMAL (Not feeling so hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 011J20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis (Used to have psoriasis on her elbows that had gone away) and Vertigo (She has had in the past, but not anytime in the past year). Concurrent medical conditions included Hashimoto's disease (History of Hashimoto's disease.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced OCULAR DISCOMFORT (Nerve thing going on around my eye). On 10-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (A bout of vertigo). On an unknown date, the patient experienced ORAL HERPES (Cold sores in my mouth), PSORIASIS (Psoriasis), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ORAL HERPES (Cold sores in my mouth) had not resolved and PSORIASIS (Psoriasis), OCULAR DISCOMFORT (Nerve thing going on around my eye), VERTIGO (A bout of vertigo), FEELING ABNORMAL (Not feeling so hot) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.  Patient was concerned about when to get a second booster dose as she received a "full dose" booster dose of the vaccine which was before change in authorization from a full dose to a half dose.  No treatment  medications were reported.   This case was linked to MOD-2022-537593, MOD-2022-537566 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: After the first dose, he had mild Flu like symptoms; After the first dose, he had pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After the first dose, he had mild Flu like symptoms) and PAIN IN EXTREMITY (After the first dose, he had pain in the left arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Medical History: Clear and healthy.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (After the first dose, he had mild Flu like symptoms) and PAIN IN EXTREMITY (After the first dose, he had pain in the left arm). At the time of the report, INFLUENZA LIKE ILLNESS (After the first dose, he had mild Flu like symptoms) and PAIN IN EXTREMITY (After the first dose, he had pain in the left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Reported that after the first dose, he had minor side effects, pain in the left arm, and mild Flu like symptoms.  No treatment medications were reported.   This case was linked to MOD-2022-537571, MOD-2022-537572, MOD-2022-537573 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the left arm after 2nd primary dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the left arm after 2nd primary dose). At the time of the report, VACCINATION SITE PAIN (Pain in the left arm after 2nd primary dose) outcome was unknown. Patient medical history reported as clear and healthy. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2022-537568, MOD-2022-537572, MOD-2022-537573 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the left arm after first booster (3rd shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the left arm after first booster (3rd shot)) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 047B21A and 001B21A) for COVID-19 vaccination.     Previously administered products included for Shingles: Shingles vaccine on 06-Apr-2022. Past adverse reactions to the above products included No adverse event with Shingles vaccine.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Dec-2021, the patient experienced VACCINATION SITE PAIN (Pain in the left arm after first booster (3rd shot)). On 01-Jan-2022, VACCINATION SITE PAIN (Pain in the left arm after first booster (3rd shot)) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-537571, MOD-2022-537568, MOD-2022-537573 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.; Aching; Chills; High fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), CHILLS (Chills), PYREXIA (High fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol and Penicillin allergy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.). On an unknown date, the patient experienced PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever). At the time of the report, PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included High blood pressure medication and Cholesterol medication It was reported that Patient did not had COVID positive nor Diagnosis No treatments were reported.   This case was linked to MOD-2022-537569 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Immunisation reaction, Malaise
Clinical narrative: severe adverse reaction to the second booster; laid up in bed for the past couple of days; he has been battling for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe adverse reaction to the second booster), BEDRIDDEN (laid up in bed for the past couple of days) and MALAISE (he has been battling for a couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe adverse reaction to the second booster), BEDRIDDEN (laid up in bed for the past couple of days) and MALAISE (he has been battling for a couple of days). At the time of the report, VACCINATION COMPLICATION (severe adverse reaction to the second booster), BEDRIDDEN (laid up in bed for the past couple of days) and MALAISE (he has been battling for a couple of days) had not resolved.            No concomitant medication was provided. The patient was administered the second booster. It was reported that the patient had experienced severe adverse reaction to the second booster that had been distributed. Reported wanted to know what was the best course of action and may have to take him in to the Emergeny Room if don't hear soon.  Reporter had already talked to the pharmacy that gave him the booster shot and they really didn't have much to say other than that well it's gonna last for a couple of days.  Treatment medication was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction
Clinical narrative: "got sick" after each dose; experienced side effects after each dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("got sick" after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Previously administered products included for Flu: Seasonal Flu vaccine (Intramuscular) in October 2021. Past adverse reactions to the above products included No adverse event with Seasonal Flu vaccine. Concurrent medical conditions included Sulfonamide allergy, Allergic reaction to bee sting and High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced ILLNESS ("got sick" after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose). At the time of the report, ILLNESS ("got sick" after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   Patient received the second dose after the first dose , followed by two booster doses. Symptoms resolved in 2 days.   This case was linked to MOD-2022-537585, MOD-2022-537584, MOD-2022-537582 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Caller reported patient has had migraine for over 30 years and this was not unusual for her.).    On 10-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had not resolved.            Concomitant medications were not reported.. Treatment medications were not reported.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; Product was placed in refrigerator on 5Apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 5Apr2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 5Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 5Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Reporter reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patients had not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021 Vial was initially placed in refrigerator on 5-Apr-2022. The product did not undergo any temperature excursion issue.  Reporter wants to know if the patients need to be re-vaccinated. No treatment drug information was reported.   This case was linked to MOD-2022-538688, MOD-2022-538614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Patient details were added. Updated reporter information. Added dose of Suspect drug and updated suspect product coding.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction
Clinical narrative: "got sick" after each dose; experienced side effects after each dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("got sick" after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy), Allergic reaction to bee sting (Bee stings allergy) and High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced ILLNESS ("got sick" after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose). At the time of the report, ILLNESS ("got sick" after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose) had resolved.            No treatment drug details was reported. Patient received the second dose after the first dose , followed by two booster doses. Symptoms resolved after two days.   This case was linked to MOD-2022-537585, MOD-2022-537584, MOD-2022-537576 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction
Clinical narrative: Got sick after each dose; experienced side effects after each dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Seasonal Flu Vaccine (IM) in October 2021. Past adverse reactions to the above products included No adverse event with Seasonal Flu Vaccine. Concurrent medical conditions included Sulfonamide allergy, Allergy to sting and High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ILLNESS (Got sick after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose). At the time of the report, ILLNESS (Got sick after each dose) and VACCINATION COMPLICATION (experienced side effects after each dose) had resolved.            It was reported that patient has never been diagnosed/tested positive for COVID-19. Treatment medications were not reported.   This case was linked to MOD-2022-537585, MOD-2022-537576, MOD-2022-537582 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Illness
Clinical narrative: Least amount of being sick; Received expired 2nd booster dose,"a few days expired"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Least amount of being sick) and EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose,"a few days expired") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2a, 028A21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: FLU (Intramuscular) in October 2021. Past adverse reactions to the above products included No adverse event with FLU. Concurrent medical conditions included Sulfonamide allergy, Allergic reaction to bee sting and High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Apr-2022, the patient experienced ILLNESS (Least amount of being sick) and EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose,"a few days expired"). At the time of the report, ILLNESS (Least amount of being sick) and EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose,"a few days expired") outcome was unknown.            After receiving the second booster dose on 01-Apr-2022, patient reported the "least amount of being sick" compared to the other three Moderna injections.  The adverse event did not cause the patient to seek medical care. The patient did not experienced a similar event in the past.  No treatment information was provided.   This case was linked to MOD-2022-537576, MOD-2022-537582, MOD-2022-537584 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.; administered an expired vaccine to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to a patient) and PRODUCT STORAGE ERROR (Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to a patient) and PRODUCT STORAGE ERROR (Vial expired on 07-Apr-2022/ The vial was put in Freezer and then taken out to thaw on 8-Apr-2022, which is the same day (8-Apr-2022) of administration to the patient.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  vial was did not undergo any temperature excursions.  No treatment medications were reported.