chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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 relevant concomitant medication was reported. Treatment information were not provided.    Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired product has been administered to consumer with storage error. No concomitant and treatment information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Influenza like illness, Pain in extremity, Paraesthesia
Clinical narrative: after first vaccine sick for 4-5 days; flu like symptoms; left hand tingling in finger tips/feels like pins and needles; sometimes numb; fingers swell; hand is sensitive to the touch; pain in left hand; This case was received via an unknown source, no reference has been entered for a health authority, on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, and PERIPHERAL SWELLING in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALSARTAN HCL, OMEPRAZOLE, ASPIRIN, DILTIAZEM, TERAZOSIN, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE TIMOLOL, HUMALAND, and VITAMIN C for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (after first vaccine sick for 4-5 days), INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY. At the time of the report, ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-326687 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sensitive skin
Clinical narrative: after first vaccine sick for 4-5 days; flu like symptoms; left hand tingling in finger tips/feels like pins and needles; sometimes numb; fingers swell; hand is sensitive to the touch; pain in left hand; This case was received via an unknown source, no reference has been entered for a health authority, on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, and PERIPHERAL SWELLING in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALSARTAN HCL, OMEPRAZOLE, ASPIRIN, DILTIAZEM, TERAZOSIN, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE TIMOLOL, HUMALAND, and VITAMIN C for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (after first vaccine sick for 4-5 days), INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY. At the time of the report, ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-326687 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Vaccination complication
Clinical narrative: become pregnant since receiving both doses; the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine) and MATERNAL EXPOSURE BEFORE PREGNANCY (become pregnant since receiving both doses) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-May-2022. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (become pregnant since receiving both doses). On an unknown date, the patient experienced VACCINATION COMPLICATION (the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine). On 16-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (become pregnant since receiving both doses) had resolved. At the time of the report, VACCINATION COMPLICATION (the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine) had resolved.            No relevant concomitant medication were provided.  No treatment information was provided. This case concerns a female patient, unknown age with no relevant medical history, who experienced the unexpected events of maternal exposure before pregnancy and vaccine complication. The event vaccine complication was said to occur one day after the vaccine. The rechallenge is unknown since details of vaccine complication was not disclosed. The benefit-risk relationship of is not affected by this report.   This case was linked to MOD-2021-326826 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient, unknown age with no relevant medical history, who experienced the unexpected events of maternal exposure before pregnancy and vaccine complication. The event vaccine complication was said to occur one day after the vaccine. The rechallenge is unknown since details of vaccine complication was not disclosed. The benefit-risk relationship of is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait inability, Gingivitis, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Gum infection; a really bad one; Vertigo; Was not able to walk for about four hours after the shot; Feeling so weak; The second dose hit her hard; Dizzy; Swollen lymph nodes on the right side by the upper neck under her chin; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak) and VACCINATION COMPLICATION (The second dose hit her hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over). April 2021, the patient experienced GAIT INABILITY (Was not able to walk for about four hours after the shot). On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PENICILLIN NOS for Gum infection, at a dose of 500 milligram. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over) outcome was unknown.            After receiving second dose vaccine, patient also experienced high temperature for 2 days and light temperature for 3 to 4 days at least.   This case was linked to MOD-2021-325583, MOD-2021-326895 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Vaccination complication, Vertigo
Clinical narrative: Inappropriate schedule of vaccine administered; Gum infection; a really bad one; Vertigo; Was not able to walk for about four hours after the shot; Feeling so weak; The second dose hit her hard; Dizzy; Swollen lymph nodes on the right side by the upper neck under her chin; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak) and VACCINATION COMPLICATION (The second dose hit her hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over). April 2021, the patient experienced GAIT INABILITY (Was not able to walk for about four hours after the shot). On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PENICILLIN NOS for Gum infection, at a dose of 500 milligram. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over) outcome was unknown.            After receiving second dose vaccine, patient also experienced high temperature for 2 days and light temperature for 3 to 4 days at least.   This case was linked to MOD-2021-325583, MOD-2021-326895 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Myalgia, Pain
Clinical narrative: not in the mood, I'm in pain right now; wouldn't have called if it wasn't so bad; pain is sore; it was horrible last night; fever; injection site pain; little bit of chills; feeling specific pectoral muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Sep-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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 FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night), PYREXIA (fever), VACCINATION SITE PAIN (injection site pain), CHILLS (little bit of chills) and MYALGIA (feeling specific pectoral muscle pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night), PYREXIA (fever), VACCINATION SITE PAIN (injection site pain), CHILLS (little bit of chills) and MYALGIA (feeling specific pectoral muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) a degree and a half of temperature.         Concomitant medications was not provided by the reporter Treatment  Ice  The patient was rude and said it was not in the mood, I'm in pain right now, pain is sore, in the past a little bit of chills, fever but now I'm feeling specific pectoral muscle pain. The patient received the doses in the left arm. On Sunday it felt injection site pain and on Monday started to feel the pectoral. The patient said it was horrible last night it was terrible and that wouldn't have called if it wasn't so bad.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: not in the mood, I'm in pain right now; wouldn't have called if it wasn't so bad; pain is sore; it was horrible last night; fever; injection site pain; little bit of chills; feeling specific pectoral muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Sep-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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 FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night), PYREXIA (fever), VACCINATION SITE PAIN (injection site pain), CHILLS (little bit of chills) and MYALGIA (feeling specific pectoral muscle pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night), PYREXIA (fever), VACCINATION SITE PAIN (injection site pain), CHILLS (little bit of chills) and MYALGIA (feeling specific pectoral muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) a degree and a half of temperature.         Concomitant medications was not provided by the reporter Treatment  Ice  The patient was rude and said it was not in the mood, I'm in pain right now, pain is sore, in the past a little bit of chills, fever but now I'm feeling specific pectoral muscle pain. The patient received the doses in the left arm. On Sunday it felt injection site pain and on Monday started to feel the pectoral. The patient said it was horrible last night it was terrible and that wouldn't have called if it wasn't so bad.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Brain natriuretic peptide, Cardiac failure congestive, Dyspnoea, Fibrin D dimer
Clinical narrative: congestive heart failure; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) and DYSPNOEA (short of breath) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (short of breath) (seriousness criteria death, hospitalization and medically significant). The patient died on 28-Aug-2021. The reported cause of death was Congestive heart failure and Short of breath. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: elevated (High) elevated. On an unknown date, Brain natriuretic peptide: elevated (High) elevated. On an unknown date, Fibrin D dimer: elevated (High) elevated. On an unknown date, Hepatic enzyme: elevated (High) elevated.         No concomitant medication details was provided. No treatment medication details was provided.  Company comment: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Reported Cause(s) of Death: congestive heart failure; short of breath
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme
Clinical narrative: congestive heart failure; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) and DYSPNOEA (short of breath) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (short of breath) (seriousness criteria death, hospitalization and medically significant). The patient died on 28-Aug-2021. The reported cause of death was Congestive heart failure and Short of breath. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: elevated (High) elevated. On an unknown date, Brain natriuretic peptide: elevated (High) elevated. On an unknown date, Fibrin D dimer: elevated (High) elevated. On an unknown date, Hepatic enzyme: elevated (High) elevated.         No concomitant medication details was provided. No treatment medication details was provided.  Company comment: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Reported Cause(s) of Death: congestive heart failure; short of breath
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Somnolence
Clinical narrative: Funny chemical taste in the mouth; Felt groggy like someone had given the patient a sedative; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Funny chemical taste in the mouth) and SOMNOLENCE (Felt groggy like someone had given the patient a sedative) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B2119) for COVID-19 vaccination.     The patient's past medical history included Total knee replacement on 21-Jun-2021.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (Funny chemical taste in the mouth). 15-Mar-2021, the patient experienced SOMNOLENCE (Felt groggy like someone had given the patient a sedative). On 15-Mar-2021, DYSGEUSIA (Funny chemical taste in the mouth) and SOMNOLENCE (Felt groggy like someone had given the patient a sedative) had resolved.            Concomitant product use was not provided.  It was reported that the knee surgery was scheduled on December last year in 2020, but due to COVID surge it was cancelled and re-scheduled. The reporter was unsure about the lot number of the second dose.  Treatment information was not provided.  The patient was glad that the patient did not have a reaction like those women who got the J and J vaccination and died from a bad, weird sinus reaction. The patient knows a social worker who received the Pfizer vaccine and has had no problems with the first dose, but reacted to the second dose.  The knee replacement was a major surgery and the patient was at the three month mark now.  This case concerns a 69-year-old female patient with no relevant medical history, who experienced the unexpected events of Dysgeusia and Somnolence. These events occurred one day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 69-year-old female patient with no relevant medical history, who experienced the unexpected events of Dysgeusia and Somnolence. These events occurred one day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Pain, Paraesthesia
Clinical narrative: I feel horrible; feeling so hot/my body is so hot inside; tingling in my body; hurting a lot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel horrible), FEELING HOT (feeling so hot/my body is so hot inside), PARAESTHESIA (tingling in my body) and PAIN (hurting a lot) 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 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in my body) and PAIN (hurting a lot). On 22-Sep-2021, the patient experienced FEELING ABNORMAL (I feel horrible) and FEELING HOT (feeling so hot/my body is so hot inside). At the time of the report, FEELING ABNORMAL (I feel horrible), FEELING HOT (feeling so hot/my body is so hot inside), PARAESTHESIA (tingling in my body) and PAIN (hurting a lot) outcome was unknown.            No concomitant medication provided. no treatment medication was reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Taste disorder, Tinnitus
Clinical narrative: "lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"; laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus; taste seems different; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS ("lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"), TINNITUS (laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus) and TASTE DISORDER (taste seems different) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019E21A and 019E21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Anxiety. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced DIZZINESS ("lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"), TINNITUS (laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus) and TASTE DISORDER (taste seems different). At the time of the report, DIZZINESS ("lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"), TINNITUS (laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus) and TASTE DISORDER (taste seems different) had not resolved.            Concomitant medications include medications for Thyroid and Anxiety.  Treatment medications were not provided.  Patient stated that she never had symptoms after the vaccine doses until about 1-2 weeks ago. Patient stated when laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus. Per reporter, lightheadedness but she was not sure due to dehydration because she was in the mountains and her tasted seems different.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (left arm). At the time of the report, PAIN IN EXTREMITY (left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. Patient reported that after receiving first dose his left arm was sore.   This case was linked to MOD-2021-327934, MOD-2021-327671 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Red; Lump; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), VACCINATION SITE MASS (Lump) and VACCINATION SITE PAIN (arm pain) 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, the patient experienced ERYTHEMA (Red), VACCINATION SITE MASS (Lump) and VACCINATION SITE PAIN (arm pain). At the time of the report, ERYTHEMA (Red), VACCINATION SITE MASS (Lump) and VACCINATION SITE PAIN (arm pain) outcome was unknown.            No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2021-328266, MOD-2021-328332 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: last one had her experiencing really bad arm pain, red, and lump; last one had her experiencing really bad arm pain, red, and lump; last one had her experiencing really bad arm pain, red, and lump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump). At the time of the report, ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump) outcome was unknown.            No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2021-328266, MOD-2021-328331 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: Her arm was sore; had no energy; felt extremely tired for several days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included PANTOPRAZOLE for an unknown indication.    On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-328467, MOD-2021-328498 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: magnet sticking/He can stick a magnet to arm and it sticks; 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 UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks). At the time of the report, UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks) outcome was unknown.      No concomitant medication information was provided.  Reporter stated that, he had 2 family members who got the vaccine. Reporter stated that 100 plus days later, which he had been tracking. He could stick a magnet to arm and it sticks. He had seen many videos online showing similar situation.   No treatment medication information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: chills for 4 hours (12 hours after flu shot); sore arm for 24 hours after the second dose; chills for 24 hours after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 24 hours after the second dose), CHILLS (chills for 24 hours after the second dose) and CHILLS (chills for 4 hours (12 hours after flu shot)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included Thyroidectomy on 15-Aug-2011. Concomitant products included LEVOTHYROXINE from 16-Aug-2011 to an unknown date for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm for 24 hours after the second dose) and CHILLS (chills for 24 hours after the second dose). On 21-Sep-2021, the patient experienced CHILLS (chills for 4 hours (12 hours after flu shot)). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm for 24 hours after the second dose) and CHILLS (chills for 24 hours after the second dose) had resolved. On 22-Sep-2021, CHILLS (chills for 4 hours (12 hours after flu shot)) had resolved.            No treatment medication was reported by the reporter.  The patient received the high dose flu shot of the Fluzone HD QUAD 2021-22 PFS shot and they experienced chills for 4 hours (9 pm  21-Sep-2021-1 am  22-Sep-2021), the onset was 12 hours after shot. They have never in the past had chills after the flu shot (right arm), and they think this might have to do with the COVID vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up information received: Added patient demographics, race and ethnicity. Added medical history. Added concomitant product information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: four patients received expired Moderna COVID-19 doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Dyspnoea, Tachycardia
Clinical narrative: she still feels having shortness of breath; tachycardia; Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose; The same thing happened next night exactly same way; The same thing happened next night exactly same way; and chest pain.; 4 days later (04Sep2021), she woke up with gasping the breath; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (she still feels having shortness of breath), TACHYCARDIA (tachycardia), CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose), DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included West Nile virus meningoencephalitis in May 2021. Concurrent medical conditions included Herpetic whitlow (she has for over 20 years seems to have triggered after 1st dose).    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Sep-2021, the patient experienced CHEST PAIN (and chest pain.) and DYSPNOEA (4 days later (04Sep2021), she woke up with gasping the breath). On 05-Sep-2021, the patient experienced DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way). On an unknown date, the patient experienced DYSPNOEA (she still feels having shortness of breath), TACHYCARDIA (tachycardia) and CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose). At the time of the report, DYSPNOEA (she still feels having shortness of breath) and TACHYCARDIA (tachycardia) had not resolved, CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose), DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way) outcome was unknown and CHEST PAIN (and chest pain.) and DYSPNOEA (4 days later (04Sep2021), she woke up with gasping the breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported. It was reported that first episode of chest and gasping was resolved within 10 minutes after patient sat up on her bed.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: just a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just a little bit of a sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (just a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (just a little bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-329129 (Patient Link).