chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysuria, Fear, Feeling abnormal, Hyperhidrosis
Clinical narrative: urinated on herself; everything went black; broke out in sweats; felt her heart "go down to her feet"/petrified; petrified/felt like she was dying; getting nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified) and FEAR (petrified/felt like she was dying) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K10-2A and 012C20A or 012C70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD, Blood pressure, High cholesterol and Hypothyroidism. Concomitant products included DENOSUMAB (XGEVA) for Osteoporosis, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OLMESARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), AMLODIPINE and FAMOTIDINE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified), FEAR (petrified/felt like she was dying) and NAUSEA (getting nauseated). At the time of the report, DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified), FEAR (petrified/felt like she was dying) and NAUSEA (getting nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller reported no known drug or food allergies.   She did report she switched from Prolia to Xgeva to treat osteoporosis because her doctor suspected she may have an allergy to latex, but it is unknown.   This case was linked to MOD-2021-346435 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: urinated on herself; everything went black; broke out in sweats; felt her heart "go down to her feet"/petrified; petrified/felt like she was dying; getting nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified) and FEAR (petrified/felt like she was dying) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K10-2A and 012C20A or 012C70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD, Blood pressure, High cholesterol and Hypothyroidism. Concomitant products included DENOSUMAB (XGEVA) for Osteoporosis, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OLMESARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), AMLODIPINE and FAMOTIDINE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified), FEAR (petrified/felt like she was dying) and NAUSEA (getting nauseated). At the time of the report, DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified), FEAR (petrified/felt like she was dying) and NAUSEA (getting nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller reported no known drug or food allergies.   She did report she switched from Prolia to Xgeva to treat osteoporosis because her doctor suspected she may have an allergy to latex, but it is unknown.   This case was linked to MOD-2021-346435 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: Headache like flu; Headache like flu; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache). At the time of the report, INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported.  No treatments were reported.   This case was linked to MOD-2021-286293, MOD-2021-024366, MOD-2021-024366, MOD-2021-329115, MOD-2021-329194, MOD-2021-329313 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired). On 25-Sep-2021, COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired) had resolved.            Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  The patient suffered from covid19 after vaccination, the symptoms were exhaustion for a month as well as feeling tired, fever for a day when she first discovered she had COVID-19, could hardly move her body and had an awful taste in her mouth.  Company Comment: This case concerns a 73-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred after receiving the second dose of Spikevax, which administration date is unknown. The rechallenge is not applicable since no additional dose will be administered. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 73-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred after receiving the second dose of Spikevax, which administration date is unknown. The rechallenge is not applicable since no additional dose will be administered. The benefit-risk relation of Spikevax is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Neuropathy peripheral, Pain
Clinical narrative: neuropathy in her feet; could hardly walk for 2 & 1/2 months because they were so painful; Arthritis in her knees; could hardly walk for 2 & 1/2 months because they were so painful; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in her feet), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful), ARTHRITIS (Arthritis in her knees) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in her feet) (seriousness criterion medically significant), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful) (seriousness criterion medically significant), ARTHRITIS (Arthritis in her knees) (seriousness criterion medically significant) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in her feet), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful), ARTHRITIS (Arthritis in her knees) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) outcome was unknown.            No concomitant and treatment information were reported by the reporter  Company Comment: This case concerns a 74-year-old, female patient with no reported relevant medical history, who experienced the serious (medically significant) unexpected events of neuropathy peripheral, gait disturbance, arthritis and pain. The events occurred within 4 to 5 days after the second dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the first another dose was disclosed.  The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, female patient with no reported relevant medical history, who experienced the serious (medically significant) unexpected events of neuropathy peripheral, gait disturbance, arthritis and pain. The events occurred within 4 to 5 days after the second dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the first another dose was disclosed.  The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Mild headache and then went away; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Mild headache and then went away) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 24-Nov-2020. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015, Restless legs syndrome since 20-Jun-2021 and Insomnia since 23-Oct-2015. Concomitant products included LAMOTRIGINE (LAMICTAL) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Insomnia and Restless legs syndrome, ESTRADIOL (ESTROGEN), ESCITALOPRAM OXALATE (LEXAPRO), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Mild headache and then went away). At the time of the report, HEADACHE (Mild headache and then went away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive (Positive) Rapid Test Positive.     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.   Treatment medications were not provided.   This case was linked to MOD-2021-348417, MOD-2021-348434 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received contains added patient demographic and details, medical history, concomitants medications.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Erythema, Feeling hot
Clinical narrative: Feel weak; burning sensation in my chest; dizziness; neck felt really hot/neck got hotter; had red rash all over the front of me/ back of me; throat was numb; neck got redder; Vomiting; felt like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like I had the flu), RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder) and ASTHENIA (Feel weak) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (patient states that makes me sick to my stomach'). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ASPIRIN [ACETYLSALICYLIC ACID] (Aspirin 325mg once a day) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like I had the flu) and VOMITING (Vomiting). On 06-Oct-2021, the patient experienced RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder) and FEELING HOT (neck felt really hot/neck got hotter). On 11-Oct-2021, the patient experienced ASTHENIA (Feel weak), CHEST PAIN (burning sensation in my chest) and DIZZINESS (dizziness). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) for Adverse event, at an unspecified dose and frequency; EPINEPHRINE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) for Adverse event, at an unspecified dose and frequency and IVs for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like I had the flu), RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder), ASTHENIA (Feel weak), CHEST PAIN (burning sensation in my chest), FEELING HOT (neck felt really hot/neck got hotter), DIZZINESS (dizziness) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pharyngeal hypoaesthesia, Rash erythematous, Vomiting
Clinical narrative: Feel weak; burning sensation in my chest; dizziness; neck felt really hot/neck got hotter; had red rash all over the front of me/ back of me; throat was numb; neck got redder; Vomiting; felt like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like I had the flu), RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder) and ASTHENIA (Feel weak) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (patient states that makes me sick to my stomach'). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ASPIRIN [ACETYLSALICYLIC ACID] (Aspirin 325mg once a day) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like I had the flu) and VOMITING (Vomiting). On 06-Oct-2021, the patient experienced RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder) and FEELING HOT (neck felt really hot/neck got hotter). On 11-Oct-2021, the patient experienced ASTHENIA (Feel weak), CHEST PAIN (burning sensation in my chest) and DIZZINESS (dizziness). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) for Adverse event, at an unspecified dose and frequency; EPINEPHRINE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) for Adverse event, at an unspecified dose and frequency and IVs for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like I had the flu), RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder), ASTHENIA (Feel weak), CHEST PAIN (burning sensation in my chest), FEELING HOT (neck felt really hot/neck got hotter), DIZZINESS (dizziness) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Rhinorrhoea, Sneezing
Clinical narrative: running nose; sneezing; allergy reaction; terrible diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (terrible diarrhea), RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced DIARRHOEA (terrible diarrhea). On an unknown date, the patient experienced RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction). At the time of the report, DIARRHOEA (terrible diarrhea) had not resolved and RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chronic obstructive pulmonary disease, Feeling abnormal, Headache, Multiple sclerosis
Clinical narrative: MS; COPD; He couldn't feel his stomach. If he ate something, he could not tell if he ate it.; the shot almost killed me; Did not receive his second dose yet; Head felt it was as big as a Volkswagen/ had headaches/ really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS) in a male patient of an unknown age 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 23-Jul-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 MULTIPLE SCLEROSIS (MS) (seriousness criterion medically significant), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me), PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache). At the time of the report, MULTIPLE SCLEROSIS (MS), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company comment This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: MS; COPD; He couldn't feel his stomach. If he ate something, he could not tell if he ate it.; the shot almost killed me; Did not receive his second dose yet; Head felt it was as big as a Volkswagen/ had headaches/ really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS) in a male patient of an unknown age 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 23-Jul-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 MULTIPLE SCLEROSIS (MS) (seriousness criterion medically significant), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me), PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache). At the time of the report, MULTIPLE SCLEROSIS (MS), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company comment This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: Minor kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Minor kidney problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (Minor kidney problems). At the time of the report, RENAL DISORDER (Minor kidney problems) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered >12 hours post puncture; stored at room temperature beyond 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patients received the second dose of Moderna COVID-19 vaccine from a vial that was punctured and stored at room temperature beyond 12 hours. no of vials is given as 1 , vial was initially stored in the refrigerator 2-oct-2021,first punctured on 10-oct-2021,administered on 11-oct-2021 at noon. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 30 hours. no concomitant and treatment medications are provided by the reporter.   This case was linked to MOD-2021-348346 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: mild headache and then went away; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (mild headache and then went away) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Insomnia on 20-Oct-2015. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015 and Restless leg syndrome since 20-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 23-Oct-2015 to an unknown date and LAMOTRIGINE (LAMICTAL) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Restless leg syndrome, ESTRADIOL (ESTROGEN), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 25-Feb-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (mild headache and then went away). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. In 2021, HEADACHE (mild headache and then went away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive (Positive) POSITIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-348352, MOD-2021-348434 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-oct-2021 Patient demographic details added, Medical history with start date added, Suspect anatomical location added,Concomitant medication with indication, Dose,Route added, Event start/stop date for third dose added, newverbatim added for event headache (PT) and intensity of event updated from mild to severe for 3rd dose event
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose of the Moderna vaccine was administered that was expired by two days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported.  No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Significant follow up : Event start date added., anatomical location of vaccine updated, patient demographics added
Sex: U
Vaccine: COVID19
Symptoms: Death, Vaccination complication
Clinical narrative: Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week; All had the same problems; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DEATH (Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week) (seriousness criteria death and medically significant) and VACCINATION COMPLICATION (All had the same problems). The patient died in October 2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION COMPLICATION (All had the same problems) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Death (unknown cause). The event occurred an unknown number of days after tan unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Death (unknown cause). The event occurred an unknown number of days after tan unspecified dose of mRNA-1273 vaccine.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Warm to the touch Injection Site after 3rd shot; Itching from Head to toe after 3rd shot; Itchy Injection Site after 3rd shot; Swollen Injection Site after 3rd shot; Histamine reaction after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot). At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot) outcome was unknown.            No relevant concomitant medication was reported. Treatment information were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Neoplasm malignant
Clinical narrative: After getting the COVID 19 vaccine the lady was diagnosed with cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: normal (normal) Mammogram done three months prior and was fine.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.  Patient had no history of breast cancer in her family as per the reporter.  Assessment is limited due to very scarce information regarding the patient age, medical history, habits, familiar history, exact vaccination date, concomitant medications, type of malignant neoplasm and other risk factors.  Company Comment - This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of neoplasm malignant of unknown type and location. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of neoplasm malignant of unknown type and location. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: 24 hours of not feeling good after the first shot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (24 hours of not feeling good after the first shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BREZTRI AEROSPHERE) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (24 hours of not feeling good after the first shot). At the time of the report, VACCINATION COMPLICATION (24 hours of not feeling good after the first shot) 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 treatment information was provided.   This case was linked to MOD-2021-348894 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Walking aid user
Clinical narrative: his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days; after his first shot he could not use his legs he had to use a cane; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in October 2020. Concomitant products included WARFARIN, SINCALIDE, ATORVASTATIN, OMEPRAZOLE, HYDROCODONE and TESTOSTERONE for an unknown indication.    On 07-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 MONOPLEGIA (his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days) (seriousness criterion medically significant) and WALKING AID USER (after his first shot he could not use his legs he had to use a cane). At the time of the report, MONOPLEGIA (his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days) and WALKING AID USER (after his first shot he could not use his legs he had to use a cane) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.  Company comment: This case concerns a male patient of unknown age with medical history of back surgery, who experienced the unexpected serious event of Monoplegia. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. the history of back surgery for unspecified indication remains a confounder considering that the underlying pathology may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-349164 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age with medical history of back surgery, who experienced the unexpected serious event of Monoplegia. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. the history of back surgery for unspecified indication remains a confounder considering that the underlying pathology may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Dermatitis contact, Herpes zoster, Inappropriate schedule of product administration, Psoriasis
Clinical narrative: had long term super hypersensitive skin; flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal; Her psoriasis had bigger breakouts than ever before; had poison ivy that was worse than ever; got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed; 1st dose 9Mar2021; 2nd dose 21Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before), DERMATITIS CONTACT (had poison ivy that was worse than ever) and HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 9Mar2021; 2nd dose 21Apr2021). On 27-Aug-2021, the patient experienced HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed). On an unknown date, the patient experienced SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before) and DERMATITIS CONTACT (had poison ivy that was worse than ever). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 9Mar2021; 2nd dose 21Apr2021) had resolved. At the time of the report, SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before), DERMATITIS CONTACT (had poison ivy that was worse than ever) and HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed) outcome was unknown.            No Concomitant medication was reported.  No treatment medication was reported.